Catalogue: Quality

Download as pdf or txt
Download as pdf or txt
You are on page 1of 56

QUALITY

EFFICIENCY

SERVICE

C ATA L O G U E

T H I R D PA R T Y Q U A L I T Y C O N T R O L S | Q C S O F T WA R E | SERVICE
Clinical Chemistry ........................................................12 Immunosuppressant ....................................................36

Multichem S Plus..........................................................13 Multichem WBT ...........................................................36


Multichem WBT Distributed by
2 x 6 x 5mL 05P80-10
Multichem S ...................................................................14
Abbott Diagnostics....................................................37
Multichem AE ................................................................15

Navigating this Catalogue


Multichem CSF .............................................................15
Multichem NB................................................................16
Coagulation ..................................................................38
Multichem D-Dimer ....................................................38
Multichem S Plus Distributed by
Abbott Diagnostics ...................................................17
This interactive document is designed to provide quick and easy access to all product information, both in
Multichem S Plus Barcoded QC Distributed Infectious Disease .......................................................39
this catalogue andDiagnostics
by Abbott website, www.technopathcd.com.
on our ..............................................18 Multichem ID-B ........................................................... 40

2 x 6 x 5mL 08P89-10 23
Multichem ID-G.............................................................41
Immunology ................................................................. 19 Multichem ID-SeroNeg ..............................................41
Hyper-links are provided throughout and are highlighted in bold text.
Multichem P ................................................................. 20

Multichem ® URINE CHEMISTRY QC


Multichem P Distributed by Informatics Solutions ..................................................42

®Other navigation tools include:


Abbott Diagnostics.....................................................21

chem Urine Chemistry Quality Controls


IAMQC QC Software Solutions .............................42
Multichem P Barcoded QC Distributed IAMQC Peer ................................................................ 43
by Abbott Diagnostics .............................................22
What is an Interlaboratory program? ................ 43
urine chemistry control is Multichem U. This product provides a single
Whyproduct to an
should you use cover the 23

ations Urine Chemistry ...........................................................23


standard urine chemistry assays, including Microalbumin, which someInterlaboratory competitors provide
program? a
....................................... 43

Multichem ® URINE CHEMISTRY QC


Multichem U..................................................................23 How does IAMQC Peer help with
C product for. The full list of products available are shown below.
closed vial stability at 2°CMultichem
to 8°C. U Distributed by Multichem
participation in an interlaboratory Urineprogram? Chemistry . 43 Quality Controls ®

en vial stability at 2°C to Abbott


8°C. Diagnostics ..................................................24 IAMQC Infinity
Our leading urine............................................................
chemistry control is Multichem U.45 This product provides a single product to cover the
KIT majority of standard urine chemistry assays, including Microalbumin, which some competitors provide a
UCT Items Multichem
on the UContents
DESCRIPTION Barcoded QC page Distributed link to their IAMQC
CONFIGURATION
PART
Daily The CODE Technopath logo
................................................................
separate QC product for. The full list of products available are shown below.
46at the top of each page
by Abbott Diagnostics .............................................24 IAMQC Expert ............................................................. 46
ents corresponding page. provides a quick link to www.technopathcd.com.
KIT
Assayed Single Level (Level 1) 15 x 10mL IAMQC UC201A.10
PRODUCT
Transfer DESCRIPTION PART CODE
...........................................................47 CONFIGURATION
Immunoassay QC .........................................................25 Assayed Single Level (Level 1) 15 x 10mL UC201A.10
Assayed Single Level
Multichem IA(Level 2) 15 x 10mL
Plus .......................................................26 UC202A.10
is suitable for use on all major platforms. IVD Raw Materials .......................................................48
Assayed Single Level (Level 2) 15 x 10mL UC202A.10

Multichem IA ................................................................27 Off-Clot Serum ...........................................................


Unassayed Single Level (Level 49 1) 15 x 10mL UC201X
Unassayed Single Level (Level 1) 15 x 10mL UC201X
Multichem U
hem U Multichem IA Speciality ...........................................28 Triglyceride Extract...................................................
Unassayed Single Level (Level 49 2) 15 x 10mL UC202X

Unassayed Multichem IA Plus


Single Level Distributed
(Level 2) by 15 x 10mL UC202X Extract
Human Lipoprotein ...................................
Unassayed Mini Kit 50
List
2 x 10mL UC200MX
Abbott Diagnostics....................................................29 (contains one vial of each level)
Human High Density Lipoprotein Extract ........ 50
Unassayed Multichem
Mini Kit IA Plus Barcoded QC Distributed Multichem U
HumanDistributed
Low Density Lipoprotein Extract ...........51
............................................230
x 10mL UC200MX
By Abbott
Microalbumin
(contains by Abbott
one vial ofDiagnostics
each level)
Delipidised Assayed Bi-Level Kit 2 x 6 x 5mL 05P80-10
ContactHuman
your localSerum........................................51
Abbott distributor to
Osmolality
The QC visit website icon links to the Normal Human
place Serum ..............................................52
an order.
The menu icon on the side of each page
hem U Cardiac ....................................................................31
buted By Abbott Phosphorous PooledMultichem
Recovered Human Plasma .......................52
U Alinity
corresponding product web page.
Multichem hsTn ............................................................31 Barcoded QC links back to the contents page.
Distributed By Abbott
Potassium
Assayed Bi-Level
MultichemKithsTn Distributed by 2 x 6 x 5mL 05P80-10 Assayed Bi-Level Kit 2 x 6 x 5mL 08P89-10
ct your local Contact
9 ........................................................................53
Contact your local
Abbott Diagnostics....................................................32
tt distributor to Sodium Abbott distributor to
place an order.
an order.
Specific Gravity*
P R O D U C T / A N A LY T E G U I D E

Product / Analyte Guide


nic U Alinity
hem Urea Nitrogen Multichem® U Specifications
ded QC Uric Acid
Multichem D-Dimer

• 24 month closed vial stability at 2°C to 8°C.


Multichem IA Plus
Multichem S Plus

Analytes
Multichem WBT
Multichem AMH

Multichem hsTn

Multichem ID-G
Multichem ID-B

• 30 day open vial stability at 2°C to 8°C.


Multichem CSF

buted● By
ClaimedAbbott
Multichem A1c
Multichem NB

Multichem AE
Multichem IA

IA Speciality
Multichem U
Multichem P
Multichem S

Hemoglobin

Analytes
ID-SeroNeg

UrinaryBi-Level
ProteinKit
Multichem

Multichem

⃝ Listed Analytes
(No Claims on performance)
Assayed 2 x 6 x 5mL 08P89-10 Instruments
ct your local
tt distributor to
17 Hydroxyprogesterone
Multichem U is suitable for use on all major platforms.
⃝ ⃝

A
oanlotorder.
specific package inserts for stability and
Acetaminophen
Acid Phosphatase




● ●

laims. ACTH
ADNase ⃝ ⃝
● ● ●
Features Analyte List
ADNase B ⃝

Alanine Aminotransferase (ALT) ● ● • Human based matrix proprietary formulation. Amylase Microalbumin
Albumin ● ● ⃝
• Mimics performance of patient samples.
Calcium Osmolality
Link to product pages directly from the
Aldosterone ⃝ ⃝
• Targeted at key clinical decision points.

Multichem UProduct / Analyte ®


Alkaline Phosphatase ● ●
• Liquid for ease of use. Chloride Phosphorous
Alpha Fetoprotein (AFP) ● ●

Specifications
α-Hydroxybutyrate Dehydrogenase (α-HBDH) ⃝ ⃝ Cortisol Potassium
Guide
Alpha-1-acid glycoprotein
Alpha-1-Antitrypsin (A1AT)





● Order Information Creatinine Sodium
Alpha 2-macroglobulin ⃝ ⃝ ⃝
Glucose Specific Gravity*
Amikacin ● ● ● ● Multichem U Config. Part Code
Ammonia • 24 month closed vial stability at 2°C to 8°C.

Assayed Single Level (Level 1) 15 x 10mL UC201A.10
Human Chorionic
Gonadotropin
Urea Nitrogen
Amylase, Pancreatic ● ● Uric Acid
Amylase, Total ● ● ● • 30 day open vial stability at 2°C to 8°C. Magnesium Urinary Protein
Androstenedione ⃝ ⃝ Assayed Single Level (Level 2) 15 x 10mL UC202A.10
Angiotensin Converting Enzyme ⃝ ⃝ ⃝ ⃝ ⃝

Anti-HBc IgG ● ● ● Unassayed Single Level (Level 1) 15 x 10mL UC201X *Please refer to lot specific package inserts for stability and
Anti-HCV IgG ● ● ●
performance claims.
Anti-HIV 1
Anti-HTLV IgG Instruments ●





Unassayed Single Level (Level 2) 15 x 10mL UC202X

Ordering Products
Antistreptolysin O ⃝ ⃝ ⃝
Unassayed Mini Kit 2 x 10mL UC200MX
Anti-Treponema Pallidum IgG ● ● ●
(Contains one vial of each level)
Anti-Thyroglobulin ● ● ⃝

Multichem U is suitable for use on all major platforms.


Anti-Mullerian Hormone ●
Antithrombin III ⃝ ⃝ ⃝

Anti-TPO ● ● www.te ch n o p at h cd .co m


Apolipoprotein A1 (APO A1) ● ● ●
Apolipoprotein B (APO B) ● ● ●
AST
B
To order Technopath's Multichem® QC products, IAMQC® software solutions or other services please
● ●

Beta Hydroxybutyrate Dehydrogenase ⃝ ⃝

Beta-2-Microglobulin
Beta-HCG contact:
● ●
● ●

● Analyte List
Bile Acids ● ●
Bilirubin, Direct ● ● ●
sed matrix proprietary formulation.
Bilirubin, Total ● ● ●
Amylase Microalbumin
BNP ● ● ●
formance of patient samples.
C
Calcium Osmolality
info@technopathcd.com
C1 Inhibitor

t key clinical decision


C3 points.

● ●
⃝ ⃝

● or from USA, info@technopathusa.com.


C4

ease of use.
● ●


Chloride Phosphorous
Abbott customers, please order
CA 125
CA 15-3
CA 19-9
through your local Abbott
Cortisol

Potassium

distributor.
Caffeine ⃝ ⃝ ⃝ ⃝ ⃝

Calcitonin ● ● ●
Creatinine Sodium
formation Calcium
Calcium, Ionized




Carbamazepine, Free
Carbamazepine, Total ● ●



Glucose Specific Gravity*
Carbon Dioxide (CO2) Config.
● ● Part Code
CEA
Ceruloplasmin ● ●
● ●

Human Chorionic Urea Nitrogen
LevelCH50
(Level 1)
(Total hemolytic Complement)
Chloramphenicol
15 x 10mL
⃝ ⃝

⃝ ⃝
UC201A.10

Gonadotropin Uric Acid
Chloride ● ● ●
Cholesterol, HDL ● ● Magnesium Urinary Protein
LevelCholesterol,
(Level LDL 2) 15 x 10mL
● ● UC202A.10
Cholesterol, Total ● ●
Cholinesterase (CHE) ● ●

gle Level (Level 1)


Creatine Kinase (CK)
CK-MB
15 x 10mL
● ●
● ●
UC201X *Please refer to lot specific package inserts for stability and
performance claims.
Copper ⃝ ⃝

Cortisol ● ● ● ● ●
gle Level (Level 2)
C-Peptide 15 x 10mL ● ● UC202X
C-Reactive Protein ● ●

Kit 2 x 10mL UC200MX


vial of each level) www.technopathcd.com
Contents
Introduction................................................................. 04 Diabetes.........................................................................33
Customer value........................................................... 05 Multichem A1c...............................................................33
Quality matters............................................................ 06 Multichem A1c Distributed by
Service and Support.................................................. 07 Abbott Diagnostics.................................................... 34

Support Through Strategic Partnerships.......... 08


Fertility..........................................................................35

Product Analyte Guide............................................... 09 Multichem AMH............................................................35

Clinical Chemistry.........................................................12 Immunosuppressant.....................................................36

Multichem S Plus...........................................................13 Multichem WBT............................................................36

Multichem S....................................................................14 Multichem WBT Distributed by


Abbott Diagnostics.....................................................37
Multichem AE.................................................................15
Multichem CSF..............................................................15
Coagulation...................................................................38
Multichem NB.................................................................16
Multichem D-Dimer.....................................................38
Multichem S Plus Distributed by
Abbott Diagnostics ....................................................17
Multichem S Plus Barcoded QC Distributed Infectious Disease........................................................39
by Abbott Diagnostics...............................................18 Multichem ID-B............................................................ 40
Multichem ID-G.............................................................41
Immunology.................................................................. 19 Multichem ID-SeroNeg...............................................41
Multichem P.................................................................. 20
Multichem P Distributed by Informatics Solutions...................................................42
Abbott Diagnostics......................................................21 IAMQC QC Software Solutions..............................42
Multichem P Barcoded QC Distributed IAMQC Peer ................................................................. 43
by Abbott Diagnostics..............................................22
What is an Interlaboratory program?.............. 43
Why should you use an
Urine Chemistry............................................................23 Interlaboratory program?..................................... 43
Multichem U...................................................................23 How does IAMQC Peer help with participation
Multichem U Distributed by in an interlaboratory program?.......................... 43
Abbott Diagnostics ...................................................24 IAMQC Infinity............................................................. 45
Multichem U Barcoded QC Distributed IAMQC Daily................................................................. 46
by Abbott Diagnostics..............................................24 IAMQC Expert.............................................................. 46
IAMQC Transfer............................................................47
Immunoassay QC..........................................................25
Multichem IA Plus........................................................26 IVD Raw Materials........................................................48
Multichem IA.................................................................27 Off-Clot Serum............................................................ 49
Multichem IA Speciality............................................28 Triglyceride Extract................................................... 49
Multichem IA Plus Distributed by Human Lipoprotein Extract.................................... 50
Abbott Diagnostics.....................................................29
Human High Density Lipoprotein Extract......... 50
Multichem IA Plus Barcoded QC Distributed
Human Low Density Lipoprotein Extract............51
by Abbott Diagnostics............................................. 30
Delipidised Human Serum.........................................51
Normal Human Serum...............................................52
Cardiac QC.....................................................................31
Pooled Recovered Human Plasma........................52
Multichem hsTn.............................................................31
Multichem hsTn Distributed by
Contact .........................................................................53
Abbott Diagnostics.....................................................32
4
I NTR ODUC TI ON

Introduction

"Technopath Clinical Diagnostics mission is to provide clinical diagnostics solutions


which positively impact the quality of people's lives by improving healthcare."

Technopath Clinical Diagnostics is a global leader Trusted Provider


in the development, manufacturing and delivery of
high quality third party quality controls and QC data Technopath is now valued as a single, trusted source
management software for the In-Vitro Diagnostics that helps laboratories achieve their QC goals with a
industry. broad portfolio of QC products and comprehensive
range of informatics solutions and support services.
Our customers include hospitals, clinical laboratories,
research facilities, CROs and blood banks in over Third-party QC material facilitates meeting
130 countries globally. Our partners equally are accreditation and regulatory guidelines,
the leading innovators of clinical diagnostics such as CLIA, CLSI, CAP and ISO.
instruments and systems and we collaborate
with the most experienced academic institutions Control materials targeted at clinical
and reference laboratories in our research and decision points helps improve clinicians’
development activities. confidence in the validity of test results.

Human-based matrices provide patient-


like performance to increase confidence in
QC material results.

Large lot sizes and fewer lot changes,


LOT
support continuity, efficiency and
confidence in the QC process.

Automated Results Upload To IAMQC®


Peer supported to efficiently fulfill
accreditation requirements.

www.te c h n o p ath cd .co m


5

I NTR ODUC TI ON
Customer Value

Corresponding Competitor The Technopath QC solution allows you to unlock


Product QC process inefficiencies by:

• Reducing errors and improving Turn


Around Time through reduced QC handling
requirements.

Multichem® • Eliminating wasted QC material by up to 75%*.


IA Plus

Our independent quality control materials • Reducing QC storage by up to 80%* to help


incorporate a greater number of analytes, which reclaim your inventory space.
enables extensive test menu consolidation. This in
turn allows laboratories to simplify their inventory, • Reducing carbon footprint, consolidated

reduce costs and improve efficiencies. products use fewer vials, which require less
packaging.
Our two flagship products, Multichem IA Plus and
Multichem S Plus, contain more than 190 tests • Powering automation of reporting and analysis

combined. These two products can replace up to 8 of QC results and Peer comparison through our

competitor products, driving significant efficiencies data management IAMQC software system.

for laboratories.

Combine Multichem Consolidated QC with IAMQC® Data Management


Solutions for optimal laboratory efficiencies

REDUCE REDUCE REDUCE REDUCE REDUCE


REDUCE RECLAIM NO. OF
QC ANALYSIS QC INSTRUMENT DEAD
CARBON STORAGE QC LOT
TIME HANDLING TESTING VOLUME
FOOTPRINT SPACE EVALUATIONS
TIME TIME WASTE

* Study on file with manufacturer

www.te c h n o p ath cd .co m


6
I NTR ODUC TI ON

Quality Matters

Every day we are committed to delivering high


quality, safe and effective clinical diagnostic
products to achieve maximum customer
satisfaction; by complying with the appropriate
regulatory requirements supported by our Quality
Management System.

Technopath Clinical Diagnostics is certified and


has successfully achieved international regulatory
market approvals for example:

• IVD 98/79/EC

• Europe CE Mark

• US FDA (previously 510k approved)


banks. Having direct access to high quality fresh
• Health Canada
frozen plasma ensures that our products mimic
• China NMPA the performance of patient samples as closely
as possible, giving increased commutability. We
• Brazil ANVISA maintain particular expertise in the stabilisation

• Australia TGA of labile analytes (i.e Troponin, Bilirubin, etc.) and


we also use Human matrix based lipid additions to
Multichem is manufactured to the highest quality ensure commutability across testing systems.
standards in our ISO 13485 accredited facility.
Our proprietary manufacturing processes allow The combination of these high quality raw materials
incorporation of greater numbers of analytes in to and our proprietary process gives Technopath a
a single matrix, which enables extensive test menu significant competitive advantage over key global
consolidation. competitors.

Our products are manufactured using fresh frozen


plasma sourced directly from national blood

www.te c h n o p ath cd .co m


7

I NTR ODUC TI ON
Service and Support

With pressures increasing on the laboratory to turn


around fast, accurate patient results, at Technopath
we know that a high quality service offering is critical
to success with any product entering the laboratory.

Our focus is to deliver high quality service, as well


as advanced technology solutions to facilitate the
entire quality control process from end to end.

QC Data Management Support

Our data management


systems, IAMQC®, are
designed to complement
and support the Multichem
product range. Having instant access to automated • Technopath Guide to Running QC
data analysis ensures that results can be reviewed
• The importance of Independent QC
efficiently, while reducing the potential for manual
• Six Sigma Explained
entry errors. We offer a range of software solutions
from inter-laboratory analysis to next generation • Uncertainty of Measurement Explained

real-time software. • The Essentials of Quality Control

Our expertise and informatics solutions enable And many others including support and guidelines
Technopath to offer a unique and comprehensive around current and future RiliBAK, IVDR and
total QC solution. international standards requirements.

Education Services

Technopath Clinical Diagnostics provides a full suite


of Quality Control training services supported by
our training materials.

Our support team will guide you through the


process of establishing your independent Quality
Control programme as a critical part of your Internal
Quality Control Process.

Whether you are just getting started or seeking


to advance to six sigma verification within your
laboratory, we have the solution to support your
needs.
The Knowledge Centre is also home to 'My
Supporting content, useful resources and reference Technopath'. Use My Technopath to quickly link to
materials are available through the Knowledge IAMQC® Peer, access IFUs (Technical Library). For
Centre on our website. It provides quick and easy Abbott customers, XML files are also available.
access to useful documents including:

www.te c h n o p ath cd .co m


8
I NTR ODUC TI ON

Technical Support Services


qcsoftware@technopathcd.com for IAMQC data
Our technical support team comprises of management solutions.
experienced Laboratory Technologists, who
are available to offer support for Multichem QC For support in the USA, please contact:
products and IAMQC informatics. qcsupport@technopathusa.com for Multichem
quality control products.
For support in all countries (outside the USA),
please contact: qcsoftware@technopathusa.com for IAMQC data
qcsupport@technopathcd.com for Multichem management solutions.
quality control products.

Support Through Strategic Partnerships

Technopath products are used by over 13,000


leading clinical laboratories in over 130 countries
globally. Our significant growth over the last
number of years has been directly linked to the
success of our valued partnerships. These long
term global distribution agreements are with some
of the world's largest IVD platform manufacturers,
including Abbott Laboratories, Radiometer and
Beckman Coulter.

In addition, we continue to grow our educational


In 2018, Technopath Clinical partnerships with two leading organisations in the
Diagnostics USA opened its world of Quality Control.
doors in Long Island, New York.
This enterprise is a joint venture Our partnership with Westgard QC ensures we
between Technopath and Northwell Health, New can facilitate all customer education and training
York’s largest healthcare group. Technopath USA requirements for Clinical Chemistry QC, including
markets and sells our Multichem and IAMQC the Sigma Verification Program.
products throughout the USA.
Together with NRL Science of Quality (NRL), we
deliver education and training in Serology QC
backed by decades of experience and data.

www.te c h n o p ath cd .co m


9

P R ODU C T / ANALY TE G UI DE
Product / Analyte Guide

Multichem D-Dimer
Multichem IA Plus
Multichem S Plus
Analytes

Multichem WBT
Multichem AMH

Multichem hsTn

Multichem ID-G
Multichem ID-B
Multichem CSF

Multichem A1c
Multichem NB

Multichem AE
Multichem IA

IA Speciality
● Claimed Analytes

Multichem U
Multichem P
Multichem S

Hemoglobin

ID-SeroNeg
Multichem

Multichem
⃝ Listed Analytes
(No Claims on performance)

17 Hydroxyprogesterone ⃝ ⃝

A
Acetaminophen ● ● ● ●
Acid Phosphatase ● ●
ACTH ● ● ●
ADNase ⃝ ⃝

ADNase B ⃝

Alanine Aminotransferase (ALT) ● ●


Albumin ● ● ⃝

Aldosterone ⃝ ⃝

Alkaline Phosphatase ● ●
Alpha Fetoprotein (AFP) ● ●
Alpha-hydroxybutyrate Dehydrogenase (α-HBDH) ⃝ ⃝

Alpha-1-acid Glycoprotein ● ● ●
Alpha-1-Antitrypsin (A1AT) ● ● ●
Alpha 2-macroglobulin ⃝ ⃝ ⃝

Amikacin ● ● ● ●
Ammonia ●
Amylase, Pancreatic ● ●
Amylase, Total ● ● ●
Androstenedione ⃝ ⃝

Angiotensin Converting Enzyme ⃝ ⃝ ⃝ ⃝ ⃝

Anti-HBc IgG ● ● ●
Anti-HCV IgG ● ● ●
Anti-HIV 1 ● ● ●
Anti-HTLV I IgG ● ● ●
Antistreptolysin O ⃝ ⃝ ⃝

Anti-Treponema Pallidum IgG ● ● ●


Anti-Thyroglobulin ● ● ⃝

Anti-Mullerian Hormone ●
Antithrombin III ⃝ ⃝ ⃝

Anti-TPO ● ●
Apolipoprotein A1 (APO A1) ● ● ●
Apolipoprotein B (APO B) ● ● ●
AST ● ●
B
Beta-hydroxybutyrate Dehydrogenase ⃝ ⃝

Beta-2-Microglobulin ● ● ●
Beta-HCG ● ● ●
Bile Acids ● ●
Bilirubin, Direct ● ● ●
Bilirubin, Total ● ● ●
BNP ● ● ●
C
C1 Inhibitor ⃝ ⃝ ⃝

C3 ● ● ●
C4 ● ● ●
CA 125 ●
CA 15-3 ●
CA 19-9 ●
Caffeine ⃝ ⃝ ⃝ ⃝ ⃝

Calcitonin ● ● ●
Calcium ● ● ●
Calcium, Ionized ⃝ ⃝

Carbamazepine, Free ⃝ ⃝

Carbamazepine, Total ● ● ● ●
Carbon Dioxide (CO2) ● ●
CEA ● ●
Ceruloplasmin ● ● ●
CH50 (Total hemolytic Complement) ⃝ ⃝ ⃝

Chloramphenicol ⃝ ⃝

Chloride ● ● ●
Cholesterol, HDL ● ●
Cholesterol, LDL ● ●
Cholesterol, Total ● ●
Cholinesterase (CHE) ● ●
Creatine Kinase (CK) ● ●
CK-MB ● ●
Copper ⃝ ⃝

Cortisol ● ● ● ● ●
C-Peptide ● ●
C-Reactive Protein ● ●

www.te c h n o p ath cd .co m


10
P R ODU C T / ANALY TE G UI DE

Multichem D-Dimer
Multichem IA Plus
Multichem S Plus
Analytes

Multichem WBT
Multichem AMH

Multichem hsTn

Multichem ID-G
Multichem ID-B
Multichem CSF

Multichem A1c
Multichem NB

Multichem AE
Multichem IA

IA Speciality
● Claimed Analytes

Multichem U
Multichem P
Multichem S

Hemoglobin

ID-SeroNeg
Multichem

Multichem
⃝ Listed Analytes
(No Claims on performance)

CO2 ● ●
Creatinine ● ● ●
CRP, Ultra-sensitive ⃝ ⃝

Cyclosporine ⃝ ⃝ ●
Cystatin C ⃝ ⃝ ⃝

D
D-Dimer ●
DHEA Sulfate ● ●
Digoxin ● ● ● ●
Disopyramide ⃝ ⃝

E
EPO ● ●
Estradiol ● ●
Estriol, Total ⃝ ⃝

Estriol. Free ● ●
Estrogen, Total ⃝ ⃝

Ethanol ● ● ●
Ethosuximide ⃝ ⃝

F
Ferritin ⃝ ⃝ ● ● ⃝

Folate ● ● ⃝

Fructosamine ⃝ ⃝

FSH ● ●
G
Gentamicin ● ● ● ●
GGT ● ●
Glucose ● ● ● ● ⃝

H
Haptoglobin ● ● ●
HBsAg ● ● ●
Hemopexin ⃝ ⃝ ⃝

HbA1c ●
Homocysteine ● ●
Human Growth Hormone ● ●
I
Ibuprofen ⃝ ⃝

IgA ● ● ●
IgE ⃝ ⃝ ● ● ⃝

IGF-1 ⃝ ⃝

IgG ● ● ● ●
IgG1 Subclass ⃝ ⃝ ⃝

IgG2 Subclass ⃝ ⃝ ⃝

IgG3 Subclass ⃝ ⃝ ⃝

IgG4 Subclass ⃝ ⃝ ⃝

IgM ● ● ●
Insulin ● ●
Iron ● ●
K
Kappa Light Chain ⃝ ⃝ ⃝

L
Lactate (Lactic Acid) ● ● ●
Lambda Light Chain ⃝ ⃝ ⃝

LDH ● ●
LH ● ●
Lidocaine ⃝ ⃝

Lipase ● ●
Lipoprotein (a) ⃝ ⃝ ⃝

Lithium ● ● ● ●
M
Magnesium ● ● ●
Microalbumin ●
Myoglobin ● ●
N
N-Acetyl-Procainamide (NAPA) ⃝ ⃝

NT-proBNP ⃝ ⃝ ● ●
O
Osmolality ⃝ ⃝ ●
Ostase ⃝ ⃝

P
Phenobarbital ● ● ● ●
Phenytoin, Free ⃝ ⃝

Phenytoin, Total ● ● ● ●
Phosphorous ● ● ●
Potassium ● ● ●
Prealbumin ● ● ●
Primidone ⃝ ⃝

Procollagen type 1 (P1NP) ⃝ ⃝

www.te c h n o p ath cd .co m


11

P R ODU C T / ANALY TE G UI DE
Multichem D-Dimer
Multichem IA Plus
Multichem S Plus
Analytes

Multichem WBT
Multichem AMH

Multichem hsTn

Multichem ID-G
Multichem ID-B
Multichem CSF

Multichem A1c
Multichem NB

Multichem AE
Multichem IA

IA Speciality
● Claimed Analytes

Multichem U
Multichem P
Multichem S

Hemoglobin

ID-SeroNeg
Multichem

Multichem
⃝ Listed Analytes
(No Claims on performance)

Procainamide ⃝ ⃝

Procalcitonin ●
Progesterone ● ●
Prolactin ● ●
Properdin Factor B ⃝ ⃝ ⃝

Prostatic Acid Phosphatase ⃝ ⃝

Protein Electrophoresis ⃝ ⃝

Protein, Total ● ● ⃝ ●
PSA, Free ● ●
PSA, Total ● ●
Pseudocholinesterase ⃝ ⃝

PTH, Total ● ●
PTH, Intact ●
Q
Quinidine ⃝ ⃝

R
Renin ⃝ ⃝

Retinol Binding Protein ⃝ ⃝ ⃝

Rheumatoid Factor (RF) ● ●


S
Salicylate ● ● ● ●
SHBG ● ●
Sirolimus ●
Sodium ● ● ●
Soluble Transferrin Receptor (sTfR) ⃝ ⃝ ⃝

Specific Gravity ⃝

T
T3, Free ● ●
T3, Total ⃝ ⃝ ● ●
T4, Free ● ●
T4, Total ⃝ ⃝ ● ●
Tacrolimus ●
TBG ⃝ ⃝

Testosterone, Total ● ●
Testosterone, Free ⃝ ⃝

Theophylline ● ● ● ● ●
Thyroglobulin ● ●
Tobramycin ● ● ● ●
Total Iron Binding Capacity (TIBC) ● ●
Transferrin ● ● ●
Triglycerides ● ●
Troponin I ● ● ●
Troponin T ⃝ ⃝ ● ● ●
TSH ● ●
T-Uptake ● ●
U
UIBC ● ●
Urea Nitrogen ● ● ●
Uric Acid ● ● ●
Urinary Protein (Urine Total Protein) ●
V
Valproic Acid, Total ● ● ● ●
Valproic Acid, Free ⃝ ⃝

Vancomycin ● ● ● ●
Vitamin B12 ● ●
Vitamin D ● ●
Z
Zinc ⃝ ⃝

Sign up to our newsletter for the latest updates


Be one of the first to get the latest news and updates from
Technopath Clinical Diagnostics straight to your inbox. Sign up

www.te c h n o p ath cd .co m


12
Mul ti chem ® C H EMISTRY QC

Multichem® Chemistry Quality Controls


The Multichem Chemistry product range incorporates serum chemistry, immunology, lipid, TDM , enzymes
and esoterics. It includes liquid-only unassayed and assayed products based on human matrix formulations.

Our human based matrix facilitates unrivaled test consolidation and offers increased stability. Together,
these control characteristics offer greater quality control efficiencies without compromising compliance or
confidence in patient results.

PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE


Assayed Single Level (Level 1) 15 x 10mL CH101PLA

Assayed Single Level (Level 2) 15 x 10mL CH102PLA

Assayed Single Level (Level 3) 15 x 10mL CH103PLA


Multichem S Plus
Unassayed Single Level (Level 1) 15 x 10mL CH101CRP

Unassayed Single Level (Level 2) 15 x 10mL CH102CRP

Unassayed Single Level (Level 3) 15 x 10mL CH103CRP

Assayed Single Level (Level 1) 15 x 10mL CH101A

Assayed Single Level (Level 2) 15 x 10mL CH102A

Multichem S Assayed Single Level (Level 3) 15 x 10mL CH103A

Unassayed Single Level (Level 1) 15 x 10mL CH101X

Unassayed Single Level (Level 2) 15 x 10mL CH102X

Unassayed Single Level (Level 3) 15 x 10mL CH103X

Assayed Single Level (Level 1) 12 x 2mL AE611A

Assayed Single Level (Level 2) 12 x 2mL AE612A

Assayed Single Level (Level 3) 12 x 2mL AE613A

Unassayed Single Level (Level 1) 12 x 2mL AE611X

Unassayed Single Level (Level 2) 12 x 2mL AE612X


Multichem AE
Unassayed Single Level (Level 3) 12 x 2mL AE613X

Assayed Bi-Level 2 x 6 x 2mL AE600A

Unassayed Bi-Level 2 x 6 x 2mL AE600X

Assayed Tri-Level 3 x 4 x 2mL AE610A

Unassayed Tri-Level 3 x 4 x 2mL AE610X

Mini Kit (one vial of each level) 3 x 1 x 2mL AE610MX

Assayed Bi-Level 2 x 6 x 2mL CF100A


Multichem CSF
Unassayed Bi-Level 2 x 6 x 2mL CF100X

Assayed Single Level 12 x 2mL NB800A

Multichem NB Unassayed Single Level 12 x 2mL NB800X

Mini Kit (unassayed single level) 3 x 2mL NB800MX

Assayed Single Level (Level 1) 12 x 5mL 05P78-10


Multichem S Plus for
Assayed Single Level (Level 2) 12 x 5mL 05P78-11
Architect c
Distributed by Abbott Assayed Single Level (Level 3) 12 x 5mL 05P78-12

Contact your local Unassayed Single Level (Level 1) 12 x 5mL 05P79-10


Abbott distributor to
Unassayed Single Level (Level 2) 12 x 5mL 05P79-11
place an order.
Unassayed Single Level (Level 3) 12 x 5mL 05P79-12

Assayed Single Level (Level 1) 12 x 5mL 08P88-10


Multichem S Plus for
Alinity c Assayed Single Level (Level 2) 12 x 5mL 08P88-11
Barcoded QC
Distributed by Abbott Assayed Single Level (Level 3) 12 x 5mL 08P88-12

Unassayed Single Level (Level 1) 12 x 5mL 08P87-10


Contact your local
Abbott distributor to Unassayed Single Level (Level 2) 12 x 5mL 08P87-11
place an order.
Unassayed Single Level (Level 3) 12 x 5mL 08P87-12

www.te c h n o p ath cd .co m


13

Mul ti chem ® C H EMISTRY QC


Features
Multichem® S Plus
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information
Multichem S Plus Config. Part Code

Assayed Single Level (Level 1) 15 x 10mL CH101PLA


Assayed Single Level (Level 2) 15 x 10mL CH102PLA
Assayed Single Level (Level 3) 15 x 10mL CH103PLA

Unassayed Single Level (Level 1) 15 x 10mL CH101CRP


Unassayed Single Level (Level 2) 15 x 10mL CH102CRP
Unassayed Single Level (Level 3) 15 x 10mL CH103CRP
Replace up to four competitor chemistry QC
products with Multichem S Plus Mini kit 3 x 1 x 10mL CH100MCRP
(contains one vial of each level)

Specifications
Corresponding Competitor Products Multichem
S Plus • 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C.
2 3 2 3 2 3 2 3
1 1 1 1

Instruments

Multichem S Plus is suitable for use on all major


platforms.

Analyte List
Chemistry Immunoproteins Enzymes

Albumin Alpha-1-acid glycoprotein Acid Phosphatase


Bilirubin, Direct Alpha-1 Antitrypsin Alanine Aminotransferase (ALT)
Bilirubin, Total Alpha 2-macroglobulin* Alkaline Phosphatase (ALP)
Calcium Antistreptolysin O (ASO)* Amylase (Pancreatic)
Carbon Dioxide (Bicarbonate) ADNase B (Anti-Streptococcal DNase B)* Amylase (Total)
Chloride Antithrombin III* Aspartate Aminotransferase (AST)
Creatinine Apolipoprotein A1 (APO A1) Alpha-hydroxybutyrate Dehydrogenase (α-HBDH)*
Glucose Apolipoprotein B (APO B) Beta-hydroxybutyrate Dehydrogenase*
Iron Beta-2 Microglobulin Cholinesterase
Lactate (Lactic acid) C1 Inhibitor* Creatine Kinase (CK)
Magnesium CH5O (Total hemolytic Complement)* CK-MB*
Phosphorous Cystatin C* Gamma Glutamyltransferase
Potassium Complement C3 Lactate Dehydrogenase (LDH)
Protein, Total Complement C4 Lipase
Sodium Ceruloplasmin Prostactic Acid Phosphatase*
Total Iron Binding Capacity (TIBC) C-Reactive Protein
Unsaturated Iron Binding Capacity (UIBC) Ferritin* Lipids
Urea Haptoglobin
Uric Acid Hemopexin* Cholesterol, HDL
Immunoglobulin A Cholesterol, LDL
Esoterics Immunoglobulin G Cholesterol, Total
Immunoglobulin M Phospholipids*
ACE* IgE* Triglycerides
Bile Acids IgG1, Subclass*
Bilirubin, Indirect* IgG2, Subclass* Therapeutic Drugs
Caffeine* IgG3, Subclass*
Calcium, Ionized* Acetaminophen
IgG4, Subclass* Amikacin
Copper* Kappa Light Chain*
Cortisol Carbamazepine
Lambda Light Chain* Digoxin
Ethanol Lipoprotein (a)*
Fructosamine* Gentamicin
Prealbumin Lithium
NT-proBNP* Properdin Factor B*
Osmolality* Phenobarbital
Retinol Binding Protein* Phenytoin
Protein Electrophoresis* Rheumatoid Factor
Triiodothyronine, (Total T3)* Salicylate
Transferrin Theophylline
Thyroxine, (Total T4) sTfR (Soluble Transferrin Receptor)*
Troponin T* Tobramycin
Zinc* Valproic Acid
Vancomycin

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


14
Mul ti chem ® C H EMISTRY QC

Multichem® S Order Information


Multichem S Plus Config. Part Code

Assayed Single Level (Level 1) 15 x 10mL CH101A


Assayed Single Level (Level 2) 15 x 10mL CH102A
Assayed Single Level (Level 3) 15 x 10mL CH103A

Unassayed Single Level (Level 1) 15 x 10mL CH101X


Unassayed Single Level (Level 2) 15 x 10mL CH102X
Unassayed Single Level (Level 3) 15 x 10mL CH103X

Mini Kit (contains one vial of each level) 3 x 1 x 10mL CH100MX

Specifications
Features
• 36 month closed vial stability at -20°C to -80°C.
• Human based matrix proprietary formulation. • 10 day open vial stability at 2°C to 8°C.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use. Instruments

Multichem S is suitable for use on all major platforms.


Multichem S contains 101 analytes, but excludes
CRP and RF, which are available in Multichem S Plus

Analyte List
Chemistry Immunoproteins Alanine Aminotransferase (ALT)
Alkaline Phosphatase (ALP)
Albumin Alpha-1-acid glycoprotein
Amylase (Pancreatic)
Bilirubin, Direct Alpha-1 Antitrypsin
Amylase (Total)
Bilirubin, Total Alpha 2-macroglobulin*
Aspartate Aminotransferase (AST)
Calcium Antistreptolysin O (ASO)*
Alpha-hydroxybutyrate Dehydrogenase (α-HBDH)*
Carbon Dioxide (Bicarbonate) ADNase B (Anti-Streptococcal DNase B)*
Beta-hydroxybutyrate Dehydrogenase*
Chloride Antithrombin III*
Cholinesterase
Creatinine Apolipoprotein A1 (APO A1)
Creatine Kinase (CK)
Glucose Apolipoprotein B (APO B)
CK-MB*
Iron Beta -2 Microglobulin
Gamma Glutamyltransferase
Lactate (Lactic acid) C1 Inhibitor*
Lactate Dehydrogenase (LDH)
Magnesium CH5O (Total hemolytic Complement)*
Lipase
Phosphorous Cystatin C*
Prostactic Acid Phosphatase*
Potassium Complement C3
Protein, Total Complement C4
Lipids
Sodium Ceruloplasmin
Total Iron Binding Capacity (TIBC) Ferritin* Cholesterol, HDL
Unsaturated Iron Binding Capacity (UIBC) Haptoglobin Cholesterol, LDL
Urea Hemopexin* Cholesterol, Total
Uric Acid Immunoglobulin A Phospholipids*
Immunoglobulin G Triglycerides
Esoterics Immunoglobulin M
IgE* Therapeutic Drugs
ACE*
IgG1, Subclass*
Bile Acids Acetaminophen
IgG2, Subclass*
Bilirubin, Indirect* Amikacin
IgG3, Subclass*
Caffeine* Carbamazepine
IgG4, Subclass*
Calcium, Ionized* Digoxin
Kappa Light Chain*
Copper* Gentamicin
Lambda Light Chain*
Cortisol Lithium
Lipoprotein (a)*
Ethanol Phenobarbital
Prealbumin
Fructosamine* Phenytoin
Properdin Factor B*
NT-proBNP* Salicylate
Retinol Binding Protein*
Osmolality* Theophylline
Transferrin
Protein Electrophoresis* Tobramycin
sTfR (Soluble Transferrin Receptor)*
Triiodothyronine, (Total T3)* Valproic Acid
Thyroxine, (Total T4) Vancomycin
Enzymes
Troponin T*
Zinc* Acid Phosphatase

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


15

Mul ti chem ® C H EMISTRY QC


Multichem® AE Multichem® CSF

Features Features
• Human based matrix proprietary formulation. • Human based matrix proprietary formulation.
• Mimics performance of patient samples. • Mimics performance of patient samples.
• Targeted at key clinical decision points. • Targeted at key clinical decision points.
• Liquid for ease of use. • Liquid for ease of use.

Order Information Order Information


Multichem AE Config. Part Code Multichem CSF Config. Part Code

Assayed Single Level (Level 1) 12 x 2mL AE611A Assayed Bi-Level 2 x 6 x 2mL CF100A
Assayed Single Level (Level 2) 12 x 2mL AE612A Unassayed Bi-Level 2 x 6 x 2mL CF100X
Assayed Single Level (Level 3) 12 x 2mL AE613A

Unassayed Single Level (Level 1) 12 x 2mL AE611X


Unassayed Single Level (Level 2) 12 x 2mL AE612X
Unassayed Single Level (Level 3) 12 x 2mL AE613X Specifications
Assayed Bi-Level 2 x 6 x 2mL AE600A • 36 month closed vial stability at -20°C to -80°C.
Unassayed Bi-Level 2 x 6 x 2mL AE600X • 30 day open vial stability at 2°C to 8°C.

Assayed Tri-Level 3 x 4 x 2mL AE610A


Unassayed Tri-Level 3 x 4 x 2mL AE610X
Instruments
Mini Kit (one vial of each level) 3 x 1 x 2mL AE610MX
Multichem CSF is suitable for use on all major platforms.

Specifications
Analyte List
• 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C. Glucose
Lactate
IgG
Instruments Protein

Multichem AE is suitable for use on all major platforms.

Analyte List
Ammonia
Ethanol

www.te c h n o p ath cd .co m


16
Mul ti chem ® C H EMISTRY QC

Multichem® NB

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information
Multichem NB Config. Part Code

Assayed Single Level 12 x 2mL NB800A

Unassayed Single Level 12 x 2mL NB800X

Mini Kit (unassayed single level) 3 x 2mL NB800MX

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.

Instruments

Multichem NB is suitable for use on all major platforms.

Analyte List
Chemistry

Bilirubin, Direct
Bilirubin, Total

Therapeutic Drugs

Caffeine*
Theophylline

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


17

Mul ti chem ® C H EMISTRY QC


Multichem® S Plus Order Information

Distributed by Abbott Diagnostics Please order through your local Abbott distributor.

Multichem S Plus for ARCHITECT Config. Part Code

Assayed Single Level (Level 1) 12 x 5mL 05P78-10


Assayed Single Level (Level 2) 12 x 5mL 05P78-11
Assayed Single Level (Level 3) 12 x 5mL 05P78-12

Unassayed Single Level (Level 1) 12 x 5mL 05P79-10


Unassayed Single Level (Level 2) 12 x 5mL 05P79-11
Unassayed Single Level (Level 3) 12 x 5mL 05P79-12

Specifications
• 30 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C.
Features
• Human based matrix proprietary formulation. Instruments
• Mimics performance of patient samples.

DIST RIB UT E D BY AB B OT T DIAG NOSTIC S


• Targeted at key clinical decision points.
Multichem S Plus, distributed by Abbott Diagnostics, is
• Liquid for ease of use. assayed for Abbott Architect c series Instruments.

Analyte List

Acetominophen Cholesterol, LDL Lipoprotein (a)*


Acid Phosphatase Cholesterol, Total Lithium
ADNase B (Anti-Streptococcal Dnase)* Cholinesterase Magnesium
Alanine Aminotransferase (ALT) CK-MB* NT-Pro BNP*
Albumin Complement C3 Osmolality*
Alkaline Phosphatase (ALkP) Complement C4 Phenobarbital
Alpha Hydroxybutyrate Dehydrogen* Copper* Phenytoin
Alpha-1-acid Glycoprotein (α1AGp, AGP or AAG) Cortisol Phospholipids*
Alpha-1 Antitrypsin C-Reactive Protein Phosphorous
Alpha-2-Macroglobulin* Creatine Kinase (CK) Potassium
Amikacin Creatinine Enzymatic Prealbumin
Amylase (Pancreatic) Cystatin C* Properdin Factor B*
Amylase (Total) Digoxin Prostatic Acid Phosphatase*
Angiotensin Converting Enzyme* Ethanol Protein Electrophoresis*
Anti-streptolysin O (ASO)* Ferritin* Protein, Total
Antithrombin III* Fructosamine* Retinol Binding Protein*
Apolipoprotein A1 (APO A1) Gamma Glutamyltransferase Rheumatoid Factor (RF)
Apolipoprotein B (APO B) Gentamicin Salicylate
Aspartate Aminotransferase (AST) Glucose Sodium
Beta Hydroxybutyrate Dehydrogenase* Haptoglobin sTfR (Soluble Transferrin Receptor)*
Beta-2 Microglobulin Hemopexin* Theophylline
Bile Acids IgE* Thyroxine, Total
Bilirubin Indirect* IgG1, Subclass* Tobramycin
Bilirubin, Direct IgG2, Subclass* Total Iron Binding Capacity*
Bilirubin, Total IgG3, Subclass* Transferrin
C1 Inhibitor* IgG4, Subclass* Triglycerides
Caffeine* Immunoglobulin A Triiodothyronine, Total (TT3)*
Calcium Immunoglobulin G Troponin T*
Calcium Ionized* Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC)
Carbamazepine Iron Urea
Carbon Dioxide (Bicarbonate) Kappa Light Chain* Uric Acid
Ceruloplasmin Lactate (Lactic acid) Valproic Acid
CH50 (Total hemolytic Complement)* Lactate Dehydrogenase (LDH) Vancomycin
Chloride Lamda Light Chain* Zinc*
Cholesterol, HDL Lipase

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


18
Mul ti chem ® C H EMISTRY QC

Multichem® S Plus Order Information

Barcoded QC Please order through your local Abbott distributor.

Distributed by Abbott Diagnostics Multichem S Plus for ALINITY Config. Part Code

Assayed Single Level (Level 1) 12 x 5mL 08P88-10


Assayed Single Level (Level 2) 12 x 5mL 08P88-11
Assayed Single Level (Level 3) 12 x 5mL 08P88-12

Unassayed Single Level (Level 1) 12 x 5mL 08P87-10


Unassayed Single Level (Level 2) 12 x 5mL 08P87-11
Unassayed Single Level (Level 3) 12 x 5mL 08P87-12

Specifications
• 30 month closed vial stability at -20°C to -80°C.
Benefits • 10 day open vial stability at 2°C to 8°C.
• 5 day on-board storage stability*.

• On-board storage on the Alinity c system in a


temperature controlled reagent carousel. Instruments
• Automatically runs directly from the vial at user-
Barcoded Multichem S Plus, distributed by Abbott
defined intervals.
Diagnostics, is assayed for Abbott Alinity c and
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

• Barcoded vials make loading faster and easier - Architect c series instruments.
minimizing errors.
• On-board stability is monitored by the Alinity system
software.

Features
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List
Acetominophen Cholesterol, LDL Lipoprotein (a)*
Acid Phosphatase Cholesterol, Total Lithium
ADNase B (Anti-Streptococcal Dnase)* Cholinesterase Magnesium
Alanine Aminotransferase (ALT) CK-MB* NT-proBNP*
Albumin Complement C3 Osmolality*
Alkaline Phosphatase (ALkP) Complement C4 Phenobarbital
Alpha-hydroxybutyrate Dehydrogenase (α-HBDH)* Copper* Phenytoin
Alpha-1-acid glycoprotein Cortisol Phospholipids*
Alpha-1 Antitrypsin C-Reactive Protein Phosphorous
Alpha 2-macroglobulin* Creatine Kinase (CK) Potassium
Amikacin Creatinine Enzymatic Prealbumin
Amylase (Pancreatic) Cystatin C* Properdin Factor B*
Amylase (Total) Digoxin Prostatic Acid Phosphatase*
Angiotensin Converting Enzyme* Ethanol Protein Electrophoresis*
Antistreptolysin O (ASO)* Ferritin* Protein, Total
Antithrombin III* Fructosamine* Retinol Binding Protein*
Apolipoprotein A1 (APO A1) Gamma Glutamyltransferase Rheumatoid Factor (RF)
Apolipoprotein B (APO B) Gentamicin Salicylate
Aspartate Aminotransferase (AST) Glucose Sodium
Beta-hydroxybutyrate Dehydrogenase* Haptoglobin sTfR (Soluble Transferrin Receptor)*
Beta-2 Microglobulin Hemopexin* Theophylline
Bile Acids IgE* Thyroxine, Total
Bilirubin Indirect* IgG1, Subclass* Tobramycin
Bilirubin, Direct IgG2, Subclass* Total Iron Binding Capacity*
Bilirubin, Total IgG3, Subclass* Transferrin
C1 Inhibitor* IgG4, Subclass* Triglycerides
Caffeine* Immunoglobulin A Triiodothyronine, Total (TT3)*
Calcium Immunoglobulin G Troponin T*
Calcium Ionized* Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC)
Carbamazepine Iron Urea
Carbon Dioxide (Bicarbonate) Kappa Light Chain* Uric Acid
Ceruloplasmin Lactate (Lactic acid) Valproic Acid
CH50 (Total hemolytic Complement)* Lactate Dehydrogenase (LDH) Vancomycin
Chloride Lambda Light Chain* Zinc*
Cholesterol, HDL Lipase

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


19

Mul ti chem ® IMMUNOLOGY QC


Multichem® Immunology Quality Controls
Multichem P (Protein) is specifically designed as a supplementary QC product for immunoproteins to be used
in conjunction with our clinical chemistry QC. This product offers elevated concentrations for immunoproteins.
Users can use this in conjunction with 1, 2 or 3 levels of Multichem S Plus or Multichem S, each of which already
include multiple concentrations for immunoproteins. The full list of products available are shown below.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Single Level Kit 12 x 3mL SP41PA

Multichem P Unassayed Single Level Kit 12 x 3mL SP40PX

Mini Kit - Unassayed Single Level 2 x 3mL SP40PMX

Multichem P for Architect c


Distributed By Abbott
Assayed Single Level Kit 12 x 3mL 05P81-10
Contact your local Abbott
distributor to place an
order.

Multichem P for
Alinity c
Barcoded QC
Distributed By Abbott
Assayed Single Level Kit 12 x 3mL 08P90-10
Contact your local Abbott
distributor to place an
order.

www.te c h n o p ath cd .co m


20
Mul ti chem ® IMMUNOLOGY QC

Multichem® P Order Information

Multichem P Config. Part Code

Assayed Single Level 12 x 3mL SP41PA

Unassayed Single Level 12 x 3mL SP40PX

Mini kit - Unassayed Single Level 2x 3mL SP40PMX

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.

Features
Instruments
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
Multichem P is suitable for use on all major platforms.
• Targeted at key clinical decision points
• Key elevated protein concentration for key medical
relevance.
• Liquid for ease of use.

Analyte List
Immunoproteins Chemistry IgG4, Subclass*
Immunoglobulin A
Alpha-1-acid glycoprotein Albumin* Immunoglobulin G
Alpha-1 Antitrypsin Angiotensin Converting Enzyme* Immunoglobulin M
Alpha 2-macroglobulin* Ceruloplasmin Kappa Light Chain*
Antistreptolysin O (ASO)* Complement C3 Lambda Light Chain*
ADNase B (Anti-Streptococcal Dnase)* Complement C4 Lipoprotein (a)*
Antithrombin III* C-Reactive Protein Prealbumin
Apolipoprotein A1 (APO A1) Ferritin* Properdin Factor B*
Apolipoprotein B (APO B) Haptoglobin Retinol Binding Protein*
Beta -2 Microglobulin Hemopexin* Rheumatoid Factor
C1 Inhibitor* IgE* sTfR (Soluble Transferrin Receptor)*
CH50 (Total hemolytic Complement)* IgG1, Subclass* Total Protein*
Cystatin C* IgG2, Subclass* Transferrin
IgG3, Subclass*
*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


21

Mul ti chem ® IMMUNOLOGY QC


Multichem® P
Order Information
Distributed by Abbott Diagnostics
Please order through your local Abbott distributor.

Multichem P for ARCHITECT Config. Part Code

Assayed Single Level 12 x 3mL 05P81-10

Specifications
• 30 month closed vial stability at -20°C to -80°C.
Features • 14 day open vial stability at 2°C to 8°C.

• Human based matrix proprietary formulation.


• Mimics performance of patient samples. Instruments
• Targeted at key clinical decision points.
• Key elevated protein concentration for key medical
Multichem P, distributed by Abbott Diagnostics, is
relevance.

DIST RIB UT E D BY AB B OT T DIAG NOSTIC S


assayed for Abbott Architect c instruments.
• Liquid for ease of use.

Analyte List
Immunoproteins Chemistry IgG4, Subclass*
Immunoglobulin A
Alpha-1-acid glycoprotein Albumin* Immunoglobulin G
Alpha-1 Antitrypsin Angiotensin Converting Enzyme* Immunoglobulin M
Alpha 2-macroglobulin* Ceruloplasmin Kappa Light Chain*
Antistreptolysin O (ASO)* Complement C3 Lambda Light Chain*
ADNase B (Anti-Streptococcal Dnase)* Complement C4 Lipoprotein (a)*
Antithrombin III* C-Reactive Protein Prealbumin
Apolipoprotein A1 (APO A1) Ferritin* Properdin Factor B*
Apolipoprotein B (APO B) Haptoglobin Retinol Binding Protein*
Beta -2 Microglobulin Hemopexin* Rheumatoid Factor
C1 Inhibitor* IgE* sTfR (Soluble Transferrin Receptor)*
CH50 (Total hemolytic Complement)* IgG1, Subclass* Total Protein*
Cystatin C* IgG2, Subclass* Transferrin
IgG3, Subclass*

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


22
Mul ti chem ® IMMUNOLOGY QC

Multichem® P
Barcoded QC Order Information
Distributed by Abbott Diagnostics
Please order through your local Abbott distributor.

Multichem P for ALINITY Config. Part Code

Assayed Single Level 12 x 3mL 08P90-10

Specifications
• 30 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.
Benefits • 7 day on-board storage stability*.
• On-board storage on the Alinity c system in
temperature controlled reagent carousel.
• Automatically run directly from the vial at user- Instruments
defined intervals .
• Barcoded vials make loading faster and easier - Barcoded Multichem P, distributed by Abbott
minimizing errors. Diagnostics, is assayed for Abbott Alinity and Architect c
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

systems.
• On-board stability is monitored by the Alinity system
software.

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Key elevated protein concentration for key medical
relevance.
• Liquid for ease of use.

Analyte List
Immunoproteins Chemistry Analytes IgG4, Subclass*
Immunoglobulin A
Alpha-1-acid glycoprotein Albumin* Immunoglobulin G
Alpha-1 Antitrypsin Angiotensin Converting Enzyme* Immunoglobulin M
Alpha 2-macroglobulin* Ceruloplasmin Kappa Light Chain*
Antistreptolysin O (ASO)* Complement C3 Lambda Light Chain*
ADNase B (Anti-Streptococcal Dnase)* Complement C4 Lipoprotein (a)*
Antithrombin III* C-Reactive Protein Prealbumin
Apolipoprotein A1 (APO A1) Ferritin* Properdin Factor B*
Apolipoprotein B (APO B) Haptoglobin Retinol Binding Protein*
Beta -2 Microglobulin Hemopexin* Rheumatoid Factor
C1 Inhibitor* IgE* sTfR (Soluble Transferrin Receptor)*
CH50 (Total hemolytic Complement)* IgG1, Subclass* Total Protein*
Cystatin C* IgG2, Subclass* Transferrin
IgG3, Subclass*
*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


23

Multichem ® URINE CHEMISTRY QC


Multichem® Urine Chemistry Quality Controls
Our leading urine chemistry control is Multichem U. This product provides a single product to cover the
majority of standard urine chemistry assays, including Microalbumin, which some competitors provide a
separate QC product for. The full list of products available are shown below.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Single Level (Level 1) 15 x 10mL UC201A.10

Assayed Single Level (Level 2) 15 x 10mL UC202A.10

Unassayed Single Level (Level 1) 15 x 10mL UC201X


Multichem U
Unassayed Single Level (Level 2) 15 x 10mL UC202X

Unassayed Mini Kit


2 x 10mL UC200MX
(contains one vial of each level)

Multichem U
Distributed By Abbott
Assayed Bi-Level Kit 2 x 6 x 5mL 05P80-10
Contact your local
Abbott distributor to
place an order.

Multichem U Alinity
Barcoded QC
Distributed By Abbott
Assayed Bi-Level Kit 2 x 6 x 5mL 08P89-10
Contact your local
Abbott distributor to
place an order.

Multichem® U Specifications
• 24 month closed vial stability at 2°C to 8°C.
• 30 day open vial stability at 2°C to 8°C.

Instruments

Multichem U is suitable for use on all major platforms.

Features Analyte List


• Human based matrix proprietary formulation. Amylase Microalbumin
• Mimics performance of patient samples.
Calcium Osmolality
• Targeted at key clinical decision points.
• Liquid for ease of use. Chloride Phosphorous
Cortisol Potassium
Creatinine Sodium
Order Information
Glucose Specific Gravity*
Multichem U Config. Part Code
Human Chorionic Urea Nitrogen
Assayed Single Level (Level 1) 15 x 10mL UC201A.10 Gonadotropin Uric Acid
Magnesium Urinary Protein
Assayed Single Level (Level 2) 15 x 10mL UC202A.10

Unassayed Single Level (Level 1) 15 x 10mL UC201X *Please refer to lot specific package inserts for stability and
performance claims.
Unassayed Single Level (Level 2) 15 x 10mL UC202X

Unassayed Mini Kit 2 x 10mL UC200MX


(Contains one vial of each level)

www.te c h n o p ath cd .co m


24
Mul ti chem ® UR INE C H EMISTRY QC

Multichem® U Multichem® U
Barcoded QC
Distributed by Abbott Diagnostics
Distributed by Abbott Diagnostics

Features Benefits
• Human based matrix proprietary formulation. • On-board storage on the Alinity c system in
• Mimics performance of patient samples. temperature controlled reagent carousel
• Targeted at key clinical decision points. • Automatically run directly from the vial at user-
• Liquid for ease of use. defined intervals.
• Barcoded vials make loading faster and easier -
Order Information minimizing errors.
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

• On-board stability is monitored by the Alinity system


Please order through your local Abbott distributor. software.

Features
Multichem U Config. Part Code
• Human matrix based proprietary formulation.
Assayed Bi-Level 2 x 6 x 5mL 05P80-10 • Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.
Specifications
• 24 month closed vial stability at 2°C to 8°C. Order Information
• 30 day open vial stability at 2°C to 8°C.
Please order through your local Abbott distributor.

Instruments
Multichem U Config. Part Code

Multichem U, distributed by Abbott Diagnostics, is Assayed Bi-Level 2 x 6 x 5mL 08P89-10


assayed for Abbott Architect c series instruments.

Specifications
Analyte List
• 24 month closed vial stability at 2°C to 8°C.
Amylase Microalbumin • 30 day open vial stability.
Calcium Osmolality* • 7 day on-board storage stability*.
Chloride Phosphorous
Cortisol* Potassium Instruments
Creatinine Sodium
Glucose Specific Gravity* Barcoded Multichem U, distributed by Abbott Diagnos-
Human Chorionic Urea Nitrogen tics, is assayed for Abbott Alinity c and Architect c series
Gonadotropin* instruments.
Uric Acid
Magnesium Urinary Protein
Analyte List
*Please refer to lot specific package inserts for stability and Amylase Microalbumin
performance claims.
Calcium Osmolality*
Chloride Phosphorous
Cortisol* Potassium
Creatinine Sodium
Glucose Specific Gravity*
Human Chorionic Urea Nitrogen
Gonadotropin* Uric Acid
Magnesium Urinary Protein
*Please refer to lot specific package inserts for stability and
performance claims.

www.te c h n o p ath cd .co m


25

Mul ti chem ® IMMUNOASSAY QC


Multichem® Immunoassay Quality Controls
Our flagship immunoassay product is Multichem IA Plus. Multichem IA Plus consolidated over 90 analytes
into a single product and can replace up to four competitor products in your lab. We also offer Multichem
IA, which omits CA 19-9, CA 15-3 and CA 125 from the consolidated list of analytes. In addition to the two
consolidated controls, we offer Multichem IA Speciality, providing extended open vial stability for peptide
hormones, in addition to tri-level utility for BNP, PTH, ACTH, PCT and CT.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION
Assayed Tri-Level 3 x 4 x 5mL IA310A

Assayed Single Level (Level 1) 12 x 5mL IA311A

Assayed Single Level (Level 2) 12 x 5mL IA312A

Assayed Single Level (Level 3) 12 x 5mL IA313A

Multichem IA Plus Unassayed Tri-Level 3 x 4 x 5mL IA310X

Unassayed Single Level (Level 1) 12 x 5mL IA311X

Unassayed Single Level (Level 2) 12 x 5mL IA312X

Unassayed Single Level (Level 3) 12 x 5mL IA313X

Mini Kit (contains one vial of each level) 3 x 1 x 5mL IA310M

Assayed Tri-Level 3 x 4 x 5mL IA300A

Assayed Single Level (Level 1) 12 x 5mL IA301A

Assayed Single Level (Level 2) 12 x 5mL IA302A

Assayed Single Level (Level 3) 12 x 5mL IA303A

Multichem IA Unassayed Tri-Level 3 x 4 x 5mL IA300X

Unassayed Single Level (Level 1) 12 x 5mL IA301X

Unassayed Single Level (Level 2) 12 x 5mL IA302X

Unassayed Single Level (Level 3) 12 x 5mL IA303X

Mini kit (contains one vial of each level) 3 x 1 x 5mL IA300MX

Assayed Tri-Level 3 x 4 x 2mL BP300A

Assayed Single Level (Level 1) 12 x 2mL BP301A

Assayed Single Level (Level 2) 12 x 2mL BP302A

Assayed Single Level (Level 3) 12 x 2mL BP303A


Multichem
IA Speciality Unassayed (Tri-Level) 3 x 4 x 2mL BP300X

Unassayed Single Level (Level 1) 12 x 2mL BP301X

Unassayed Single Level (Level 2) 12 x2mL BP302X


Unassayed Single Level (Level 3) 12 x 2mL BP303X
Mini kit (contains one vial of each level) 3 x 1 x 2mL BP300MX

Multichem IA Plus for Architect i


Distributed by Abbott
Assayed Tri-Level 3 x 4 x 5mL 05P76-10
Contact your local Abbott
distributor to place an order.

Multichem IA Plus for Architect


and Alinity i
Barcoded QC
Assayed Tri-Level 3 x 4 x 5mL 08P86-10
Distributed by Abbott

Contact your local Abbott


distributor to place an order.

www.te c h n o p ath cd .co m


26
Mul ti chem ® IMMUNOASSAY QC

Multichem® IA Plus Features


• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information
Multichem IA Plus Config. Part Code

Assayed Tri-Level 3 x 4 x 5mL IA310A


Assayed Single Level (Level 1) 12 x 5mL IA311A
Assayed Single Level (Level 2) 12 x 5mL IA312A
Assayed Single Level (Level 3) 12 x 5mL IA313A

Unassayed Tri-Level 3 x 4 x 5mL IA310X


Unassayed Single Level (Level 1) 12 x 5mL IA311X
Unassayed Single Level (Level 2) 12 x 5mL IA312X
Unassayed Single Level (Level 3) 12 x 5mL IA313X
Replace up to four competitor immunoassay QC
Mini kit 3 x 1 x 5mL IA310MX
products with Multichem IA Plus (contains one vial of each level)

Corresponding Competitor Products Multichem


Specifications
IA Plus
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.
2 3 2 3 2 3 2 3
1 1 1 1

Instruments
Multichem IA Plus is suitable for use on all major
platforms.

Analyte List
Cancer Markers Folate Renal
Vitamin B12
Alpha Fetoprotein Angiotensin*
CA 125 Pituitary/Adrenal Renin*
CA 15-3
CA 19-9 Adrenocorticotropic hormone (ACTH) Bone Metabolism
Carcinogenic Embryonic Antigen Aldosterone*
Androstenedione* Ostase*
Prostate Specific Antigen, Free
Cortisol Parathyroid hormone (PTH)
Prostate Specific Antigen, Total
Human Growth Hormone Procollagen type 1 amino-terminal propeptide
Cardiac (P1NP)*
Therapeutic Drugs
BNP Reproductive/Fertility
CK-MB Acetaminophen
Amikacin DHEA Sulfate
Myoglobin
Caffeine* Estriol, Free
NT-proBNP
Carbamazepine Estriol, Total*
Troponin I
Carbamazepine, Free* Estrogen, Total*
Troponin T
Chloramphenicol* Estradiol
Ultrasensitive CRP*
Cyclosporine* Follicle Stimulating Hormone
Allergy Digoxin Human Chorionic Gonadotropin
Disopyramide* 17-Hydroxyprogesterone*
IgE Ethosuximide* Leutinizing Hormone
Gentamicin Progesterone
Thyroid Prolactin
Ibuprofen*
Lidocaine* Sex Hormone Binding Globulin (SHBG)
Anti-Thyroperoxidase
Lithium Testosterone
Anti-Thyroglobulin
N-Acelyl procainamide* Testosterone, Free*
Calcitonin
Thyroglobulin Phenobarbital
Diabetes
Thyroid Stimulating Hormone Phenytoin
Thyroxine Binding Globulin* Phenytoin, Free* C-Peptide
Thyroxine, Free (FT4) Primidone* Insulin
Thyroxine, Total (TT4) Procainamide* Insulin-like Growth Factor (IGF-1)*
Triiodothyronine, Free (FT3) Quinidine*
Triiodothyronine, Total (TT3) Salicylate Esoterics
T Uptake Theophylline
Tobramycin 25 (OH) Vitamin D
Anaemia Valproic Acid Homocysteine
Valproic Acid, Free*
Erythropoietin (EPO) Vancomycin
Ferritin
*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


27

Mul ti chem ® IMMUNOASSAY QC


Multichem® IA Order Information
Multichem IA Config. Part Code

Assayed Tri-Level 3 x 4 x 5mL IA300A


Assayed Single Level (Level 1) 12 x 5mL IA301A
Assayed Single Level (Level 2) 12 x 5mL IA302A
Assayed Single Level (Level 3) 12 x 5mL IA303A

Unassayed Tri-Level 3 x 4 x 5mL IA300X


Unassayed Single Level (Level 1) 12 x 5mL IA301X
Unassayed Single Level (Level 2) 12 x 5mL IA302X
Unassayed Single Level (Level 3) 12 x 5mL IA303X

Mini kit 3 x 1 x 5mL IA300MX


(contains one vial of each level)

Features Specifications
• Human based matrix proprietary formulation. • 36 month closed vial stability at -20°C to -80°C.
• Mimics performance of patient samples. • 10 day open vial stability at 2°C to 8°C*.
• Targeted at key clinical decision points.
• Liquid for ease of use.
Instruments
Multichem IA contains 83 analytes, but excludes tumour Multichem IA is suitable for use on all major platforms.
markers, which are available in Multichem IA Plus

Analyte List
Cancer Markers Pituitary/Adrenal Renal
Alpha Fetoprotein Adrenocorticotropic hormone (ACTH) Angiotensin*
Carcinogenic Embryonic Antigen Aldosterone* Renin*
Prostate Specific Antigen, Free Androstenedione*
Prostate Specific Antigen, Total Cortisol Bone Metabolism
Human Growth Hormone
Ostase*
Cardiac
Parathyroid hormone (PTH)
Drugs
BNP Procollagen type 1 amino-terminal
CK-MB Acetaminophen propeptide (P1NP)*
Myoglobin Amikacin
NT-proBNP Caffeine* Reproductive/Fertility
Troponin I Carbamazepine
DHEA Sulfate
Troponin T Carbamazepine, Free*
Estriol, Free
Ultrasensitive CRP* Chloramphenicol*
Estriol, Total*
Cyclosporine*
Estrogen, Total*
Allergy Digoxin
Estradiol
Disopyramide*
IgE Follicle Stimulating Hormone
Ethosuximide*
Human Chorionic Gonadotropin
Thyroid Gentamicin
17-Hydroxyprogesterone*
Ibuprofen*
Leutinizing Hormone
Anti-Thyroperoxidase Lidocaine*
Progesterone
Anti-Thyroglobulin Lithium
Prolactin
Calcitonin N-Acetyl procainamide*
Sex Hormone Binding Globulin (SHBG)
Thyroglobulin Phenobarbital
Testosterone
Thyroid Stimulating Hormone Phenytoin
Testosterone, Free*
Thyroxine Binding Globulin* Phenytoin, Free*
Thyroxine, Free (FreeT4) Primidone* Diabetes
Thyroxine, (Total T4) Procainamide*
Triiodothyronine, Free (FreeT3) Quinidine* C-Peptide
Triiodothyronine, (Total T3) Salicylate Insulin
T Uptake Theophylline Insulin-like Growth Factor (IGF-1)*
Tobramycin
Anaemia Valproic Acid Esoterics
Erythropoietin (EPO) Valproic Acid, Free* 25 (OH) Vitamin D
Ferritin Vancomycin Homocysteine
Folate
Vitamin B12

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


28
Mul ti chem ® IMMUNOASSAY QC

Multichem®
IA Speciality

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information
Multichem IA Speciality Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL BP300A


Assayed Single Level (Level 1) 12 x 2mL BP301A
Assayed Single Level (Level 2) 12 x 2mL BP302A
Assayed Single Level (Level 3) 12 x 2mL BP303A

Unassayed Tri-Level 3 x 4 x 2mL BP300X


Unassayed Single Level (Level 1) 12 x 2mL BP301X
Unassayed Single Level (Level 2) 12 x 2mL BP302X
Unassayed Single Level (Level 3) 12 x 2mL BP303X

Mini kit 3 x 1 x 2mL BP300MX


(contains one vial of each level)

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 7 day open vial stability at 2°C to 8°C*.

Instruments

Multichem IA Speciality is suitable for use on all major


platforms.

Analyte List
BNP
PTH Intact
ACTH
Calcitonin
Procalcitonin

*Please refer to lot specific package inserts for stability and


performance claims.

www.te c h n o p ath cd .co m


29

Mul ti chem ® IMMUNOASSAY QC


Multichem® IA Plus Order Information

Please order through your local Abbott distributor.


Distributed by Abbott Diagnostics
Multichem IA Plus for ARCHITECT Config. Part Code

Assayed Tri-Level 3 x 4 x 5mL 05P76-10

Specifications
• 28 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Instruments
Features Multichem IA Plus, distributed by Abbott Diagnostics, is
assayed for Abbott Architect i series instruments.
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

DIST RIB UT E D BY AB B OT T DIAG NOSTIC S


Analyte List
Cancer Markers Pituitary/Adrenal Bone Metabolism
Alpha Fetoprotein Adrenocorticotropic hormone (ACTH)* Ostase*
CA 125 Aldosterone* Parathyroid Hormone (PTH) (1-84)
CA 15-3 Androstenedione* Parathyroid Hormone (PTH) (1-84) (STAT)
CA 19-9 Cortisol Procollagen type 1 amino-terminal
Carcinogenic Embryonic Antigen Human Growth Hormone* propeptide (P1NP)*
Prostate Specific Antigen, Free
Prostate Specific Antigen, Total Therapeutic Drugs Reproductive/Fertility
Acetaminophen* DHEA Sulfate
Cardiac
Amikacin* Estriol, Free*
BNP (1-32) Caffeine* Estriol, Total*
CK-MB Carbamazepine Estrogen, Total*
High Sensitive Troponin I Carbamazepine, Free* Estradiol
Myoglobin Chloramphenicol* Follicle Stimulating Hormone
NT-proBNP Cyclosporine* Human Chorionic Gonadotropin (BhCG)
Troponin I Digoxin 17-Hydroxyprogesterone*
Troponin T* Disopyramide* Leutinizing Hormone
Ultrasensitive CRP* Ethosuximide* Progesterone
Gentamicin Prolactin
Allergy Ibuprofen* Sex Hormone Binding Globulin (SHBG)
Lidocaine* Testosterone
IgE
Lithium* Testosterone, Free*
Thyroid N-Acelyl procainamide*
Phenobarbital Diabetes
Anti-Thyroperoxidase Phenytoin
C-Peptide
Anti-Thyroglobulin Phenytoin, Free*
Insulin
Calcitonin* Primidone*
Insulin-like Growth Factor (IGF-1)*
Thyroglobulin* Procainamide*
Thyroid Stimulating Hormone (TSH) Quinidine* Esoterics
Thyroxine Binding Globulin* Salicylate*
Thyroxine, Free (FT4) Theophylline 25 (OH) Vitamin D
Thyroxine, Total (TT4) Tobramycin* Homocysteine
Triiodothyronine, Free (FT3) Valproic Acid
Triiodothyronine, Total (TT3) Valproic Acid, Free*
T Uptake Vancomycin

Anaemia Renal
Erythropoietin (EPO)* Angiotensin*
Ferritin Renin*
Folate
Vitamin B12
*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


30
Mul ti chem ® IMMUNOASSAY QC

Multichem® IA Plus Order Information

Barcoded QC Please order through your local Abbott distributor.


Distributed by Abbott Diagnostics

Multichem IA Plus for Alinity Config. Part Code

Assayed Tri-Level 3 x 4 x 5mL 08P86-10

Specifications
• 28 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.
• 5 day on-board storage stability*.
Features
• On-board storage on the Alinity i system in
temperature controlled reagent carousel.
Instruments
• Automatically run directly from the vial at user-
defined intervals. Barcoded Multichem IA Plus, distributed by Abbott
• Barcoded vials make loading faster and easier - Diagnostics, is assayed for Abbott Alinity i and Architect
minimizing errors. i instruments.
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

• On-board stability is monitored by the Alinity system


software.
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List
Cancer Markers Ferritin Vancomycin
Folate
Alpha Fetoprotein Renal
Vitamin B12
CA 125
CA 15-3 Angiotensin*
Pituitary/Adrenal
CA 19-9 Renin*
Carcinogenic Embryonic Antigen Adrenocorticotropic hormone (ACTH)*
Prostate Specific Antigen, Free Aldosterone* Bone Metabolism
Prostate Specific Antigen, Total Androstenedione*
Ostase*
Cortisol
Parathyroid Hormone (PTH) (1-84)
Cardiac Human Growth Hormone*
Parathyroid Hormone (PTH) (1-84) (STAT)
BNP (1-32) Procollagen type 1 amino-terminal
Therapeutic Drugs
CK-MB propeptide (P1NP)*
High Sensitive Troponin I Acetaminophen*
Myoglobin Amikacin* Reproductive/Fertility
NT-proBNP Caffeine*
DHEA Sulfate
Troponin I Carbamazepine
Estriol, Free*
Troponin T* Carbamazepine, Free*
Estriol, Total*
Ultrasensitive CRP* Chloramphenicol*
Estrogen, Total*
Cyclosporine*
Estradiol
Allergy Digoxin
Follicle Stimulating Hormone
Disopyramide*
IgE Human Chorionic Gonadotropin (BhCG)
Ethosuximide*
17-Hydroxyprogesterone*
Gentamicin
Thyroid Leutinizing Hormone
Ibuprofen*
Progesterone
Anti-Thyroperoxidase Lidocaine*
Prolactin
Anti-Thyroglobulin Lithium*
Sex Hormone Binding Globulin (SHBG)
Calcitonin* N-Acelyl procainamide*
Testosterone
Thyroglobulin* Phenobarbital
Testosterone, Free*
Thyroid Stimulating Hormone (TSH) Phenytoin
Thyroxine Binding Globulin* Phenytoin, Free* Diabetes
Thyroxine, Free (FT4) Primidone*
Thyroxine, Total (TT4) Procainamide* C-Peptide
Triiodothyronine, Free (FT3) Quinidine* Insulin
Triiodothyronine, Total (TT3) Salicylate* Insulin-like Growth Factor (IGF-1)*
T Uptake Theophylline
Tobramycin* Esoterics
Anaemia Valproic Acid 25 (OH) Vitamin D
Valproic Acid, Free* Homocysteine
Erythropoietin (EPO)*
*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


31

Mul ti chem ® C AR DIAC QC


Multichem® Cardiac Quality Controls
Our core cardiac assessment product is the Multichem hsTn QC for high sensitive troponin assays. This
product provides a high level of stability and confidence in your testing at the low concentrations that are
relevant for today's cardiac assessment strategies. This product can be used as a stand-alone product or in
conjunction with our consolidated immunoassay products; Multichem IA Plus or Multichem IA, that include
a wide range of cardiac markers.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION
Assayed Single Level Kit 12 x 3mL HS301A

Multichem hsTn Unassayed Single Level Kit 12 x 3mL HS301X

Mini Kit - Unassayed Single Level 3 x 3mL HS301MX

Multichem hsTn for


Architect Assayed Single Level Kit 12 x 3mL 04W26-10
Distributed By Abbott

Multichem® hsTn Order Information


Multichem hsTn Config. Part Code

Assayed Single Level 12 x 3mL HS301A

Unassayed Single Level 12 x 3mL HS301X

Mini kit 3 x 3mL HS301MX


Unassayed Single Level

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.
Features
• Human based matrix proprietary formulation.
Instruments
• Mimics performance of patient samples.
• Targeted at key clinical decision points. Multichem hsTn is suitable for use on all major platforms.
• Liquid for ease of use.

Analyte List
Troponin I
Troponin T

Example of Multichem hsTn Targeted Concentration on a Sample Platform


Multichem® Multichem® Multichem® Multichem®
hsTn IA Plus IA Plus IA Plus
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 22.0 150.0 1000.0

Troponin I ng/L

2.3 11.6 19.8


LoD Female Male
5.6 99th
99th Percentile
10%CV Percentile
URL
URL

17.5
IFCC Conc. 1 Consensus IFCC Conc. IFCC Conc.
99 Percentile
th 2 3
URL

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


32
Mul ti chem ® C AR DIAC QC

Multichem® hsTn Order Information

Please order through your local Abbott distributor.


Distributed by Abbott Diagnostics
Multichem hsTn for ARCHITECT Config. Part Code

Assayed Single Level 12 x 3mL 04W26-10

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Instruments
Features
Multichem hsTn, distributed by Abbott Diagnostics, is
• Human based matrix proprietary formulation.
assayed for Abbott Architect i instruments.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.
Analyte List
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

Troponin I

Abbott Architect STAT High Sensitive Troponin-I


Multichem® Multichem® Multichem® Multichem®
hsTn IA Plus IA Plus IA Plus
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 20.0 60.0 3500.0

Troponin I ng/L

1.9 4.7 15.6 34.2


LoD 10%CV Female 99th Male 99th
Percentile Percentile
URL URL
3.2 26.2
20% CV Consensus
LoQ IFCC 99th Percentile IFCC IFCC
Conc. 1 URL Conc. 2 Conc. 3

Abbott Alinity i STAT High Sensitive Troponin-I


Multichem® Multichem® Multichem® Multichem®
hsTn IA Plus IA Plus IA Plus
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 20.0 60.0 3500.0

Troponin I ng/L

1.6 5.1 15.6 34.2


LoD LOQ Female 99th Male 99th
10%CV Percentile Percentile
URL URL
26.2
Consensus
IFCC 99 Percentile
th IFCC IFCC
Conc. 1 URL Conc. 2 Conc. 3

*Please refer to lot specific package inserts for stability and performance claims.

www.te c h n o p ath cd .co m


33

Mul ti chem ® DIAB ETES QC


Multichem® Diabetes Quality Controls
Our leading diabetes product is Multichem A1c, third party QC for haemoglobin A1c. The haemoglobin A1c
test, also called HbA1c, glycated haemoglobin test, or glyco-haemoglobin, is an important blood test that
shows how well a patient’s diabetes is being controlled. The full list of products available are shown below.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Bi-Level 2 x 6 x 1mL HB000A

Assayed Single Level (Level 1) 12 x 1mL HB001A

Multichem A1c

Assayed Single Level (Level 2) 12 x 1mL HB002A

Assayed Mini Kit


2 x 1 x 1mL HB000M
(contains one vial of each level)

Multichem A1c for Architect


Distributed By Abbott
Assayed Bi-Level Kit 2 x 6 x 1mL 04V0610
Contact your local Abbott
distributor to place an order.

Multichem® A1c Order Information

Multichem A1c Config. Part Code

Assayed Bi-Level 2 x 6 x 1mL HB000A

Assayed Single Level (Level 1) 12 x 1mL HB001A

Assayed Single Level (Level 2) 12 x 1mL HB002A

Assayed Mini Kit 2 x 1 x 1mL HB000M


(Contains one vial of each level)

Features Specifications
• 24 month closed vial stability at -20°C to -80°C.
• Human based matrix proprietary formulation. • 30 day open vial stability at 2°C to 8°C.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use. Instruments

Multichem A1c is suitable for use on all major platforms.

Analyte List
HbA1c

www.te c h n o p ath cd .co m


34
Mul ti chem ® DIAB ETES QC

Multichem® A1C
Distributed by Abbott Diagnostics

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.
DIST RIB UT E D BY AB B OT T DIAG NOSTIC S

Order Information

Please order through your local Abbott distributor.

Multichem A1c Config. Part Code


for ARCHITECT & ALINITY

Assayed Bi-Level 2 x 6 x 1mL 04V06-10

Specifications
• 24 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C.

Instruments

Multichem A1c, distributed by Abbott Diagnostics, is


assayed for Abbott Architect c4000, c8000 and Alinity c
systems.

Analyte List
HbA1c

www.te c h n o p ath cd .co m


35

Mul ti chem ® FER TIL ITY QC


Multichem® Fertility Quality Controls
Multichem AMH Control is intended for use as a third party, tri-level, liquid stable quality control material to
monitor the precision of laboratory testing procedures for Anti-Müllerian Hormone Assays.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Tri-Level 3 x 4 x 2mL AM500A

Multichem AMH Unassayed Tri-Level 3 x 4 x 2mL AM500X

Unassayed Mini Kit


3 x 1 x 2mL AM500MX
(contains one vial of each level)

Multichem® AMH

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information
Multichem AMH Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL AM500A

Unassayed Tri-Level 3 x 4 x 2mL AM500X

Unassayed Mini Kit 3 x 1 x 2mL AM500MX


(Contains one vial of each level)

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C.

Instruments

Multichem AMH is suitable for use on all major platforms..

Analyte List
Anti-Müllerian Hormone

www.te c h n o p ath cd .co m


36
Multichem® IMMUNOSUPPRESSANT QC

Multichem® Immunosuppressant Quality Controls


Multichem WBT (WBT for Whole Blood Transplant), provides tri-level QC to monitor the precision of
laboratory testing procedures for Cyclosporine, Tacrolimus and Sirolimus assays. The full list of products
available are shown below.

KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Tri-Level 3 x 4 x 2mL WB000A

Multichem WBT Unassayed Tri-Level 3 x 4 x 2mL WB000X

Unassayed Mini Kit


3 x 1 x 2mL WB000MX
(contains one vial of each level)

Multichem WBT
Assayed Tri-Level for Architect 3 x 4 x 2mL 05P77-10
Distributed By Abbott

Contact your local


Abbott distributor to
Assayed Tri-Level for Alinity 3 x 4 x 2mL 04S16-10
place an order.

Multichem® WBT Order Information


Multichem WBT Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL WB000A

Unassayed Tri-Level 3 x 4 x 2mL WB000X

Unassayed Mini Kit 3 x 1 x 2mL WB000MX


(Contains one vial of each level)

Specifications
• 30 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.
Features
Instruments
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points. Multichem WBT is suitable for use on all major platforms.
• Liquid for ease of use.

Analyte List
Cyclosporine
Folate*
Glucose*
Sirolimus
Tacrolimus

*Please refer to lot specific package inserts for stability and


performance claims.

www.te c h n o p ath cd .co m


37

Multichem® IMMUNOSUPPRESSANT QC
Multichem® WBT
Distributed by Abbott Diagnostics

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.

DIST RIB UT E D BY AB B OT T DIAG NOSTIC S


• Targeted at key clinical decision points.
• Liquid for ease of use.

Order Information

Multichem WBT Config. Part Code

Assayed Tri-Level for Architect 3 x 4 x 2mL 05P77-10

Assayed Tri-Level for Alinity 3 x 4 x 2mL 04S16-10

Specifications
• 30 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Instruments

Multichem WBT, distributed by Abbott Diagnostics, is


assayed for Abbott Architect and Alinity systems.

Please order through your local Abbott distributor.

Analyte List
Cyclosporine
Folate*
Glucose*
Sirolimus
Tacrolimus

*Please refer to lot specific package inserts for stability and


performance claims.

www.te c h n o p ath cd .co m


38
Mul ti chem ® COAG UL ATION QC

Multichem® Coagulation Quality Controls


Multichem D-Dimer Control is intended for use as a third party, bi-level, liquid stable quality control material
to monitor the precision of laboratory testing procedures for D-Dimer Assays

Multichem® D-Dimer Order Information

Multichem D-Dimer Config. Part Code

Assayed Bi-Level 2 x 6 x 1mL DM900A

Assayed Single Level (Level 1) 12 x 1mL DM901A

Assayed Single Level (Level 2) 12 x 1mL DM902A

Unassayed Bi-Level 2 x 6 x 1mL DM900X

Unassayed Single Level (Level 1) 12 x 1mL DM901X

Unassayed Single Level (Level 12 12 x 1mL DM902X

Features Unassayed Mini Kit 2 x 1 x 1mL DM900MX


(Contains one vial of each level)
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
Specifications
• Liquid for ease of use.
• 36 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C.

Instruments

Multichem D-Dimer is suitable for use on all major


platforms.

Analyte List
D-Dimer

www.te c h n o p ath cd .co m


39

Multichem® INFECTIOUS DISEASE QC


Multichem® ID Infectious Disease QC
Technopath’s Multichem ID (Infectious Disease) range has been specifically tested to match assays commonly
used for infectious diseases testing. The first two products brought to market include Multichem ID-B a
positive multi-marker QC, and Multichem ID-SeroNeg, a negative QC

SUITABLE ON KIT PART


PRODUCT DESCRIPTION
PLATFORMS FROM CONFIGURATION CODE

Multichem ID-B Multi-Analyte Positive Control Abbott, Diasorin 4 x 5mL SR101B

Multichem ID-B
Multi-Analyte Positive Control Abbott, Diasorin 1 x 5mL SR101MB
Mini Kit

Multichem ID-G Multi-Analyte Positive Control Roche 4 x 5mL SR102G

Multichem ID-G
Multi-Analyte Positive Control Roche 1 x 5mL SR102MG
Mini Kit

Multichem ID-SeroNeg Negative Control All 4 x 5mL SR100N

Multichem ID-SeroNeg
Negative Control All 1 x 5mL SR100MN
Mini Kit

Powerful Infectious Disease QC Support with


NRL Science of Quality

Technopath's partnership with NRL Science of QConnect is your completely integrated and
Quality (NRL) combines our new range of third simplified QC solution. QConnect includes the
party quality control materials for infectious disease, Multichem ID product range, results management
Multichem ®
ID, with NRL’s QConnect program. and reporting through IAMQC and EDCNet, control
Technopath has further collaborated with NRL to limits, Uncertainty of Measurement (MoU) reports,
provide an integrated cloud-based QC software troubleshooting and the
program, utilizing the most advanced functionality ability to liaise with other
available from Technopath’s IAMQC® software and users.
NRL’s EDCNet software specifically designed for
monitoring serology results. For a consolidated laboratory that is performing
serology testing with chemistry and immunoassay
Traditional QC approaches used to determine QC testing, this means there is one user interface,
limits have been derived or modified from clinical IAMQC Peer, to access all peer data
chemistry and may not be applicable to serology.
QConnect Limits, developed by NRL, utilises EDCNet is an internet-based software program
historical data by determining expected upper and specifically designed for monitoring both serology
lower values of results for each QC sample/assay and NAT QC results. EDCNet allows for the simple
combination. collection, management and analysis of QC data
in real-time. Technopath provides instant access
Multichem ID controls to EDCNet via IAMQC Peer software. For more
can be used as part of information visit our informatics section.
the QConnect solution,
developed by NRL.

www.te c h n o p ath cd .co m


40 ATION QC

Multichem® ID-B
COAG ULDISEASE
INFECTIOUS

Analyser Systems
®
Mul ti chem

Manufacturer System Assay Name


®

Anti-HBc II
Multichem

Anti-HCV

HBsAg Qualitative II
Abbott Alinity i
Features HIV Ag/Ab Combo

• Ready to use liquid stable controls rHTLV I/II


• Manufactured using native human plasma
• Direct sampling from control tubes Syphilis TP
• Instrument specific barcodes Anti-HBc
• Technical and Scientific support
Anti-HCV
Order Information HBsAg
Abbott Alinity s
Multichem ID-B Config. Part Code
HIV Ag/Ab Combo
Positive Control 4 x 5mL SR101B
HTLV I/II
Positive Control Mini Kit 1 x 5mL SR101MB
Syphilis

Anti-HBc II CMIA
Specifications
Anti-HCV CMIA
• 24 month* closed tube stability at 2°C to 8°C.
• 30 day open tube stability at 2°C to 8°C. HBsAg Qualitative II CMIA
Abbott Architect
HIV Ag/Ab Combo CMIA
Instruments rHTLV-I/II CMIA

Multichem ID-B is specifically optimised for Abbott and Syphilis TP CMIA


Diasorin instrument platforms.
Anti-HBc CLIA
DiaSorin Liaison
Treponema Screen CLIA
Analyte List
HBsAg Quant CLIA
Anti-HIV-1 IgG
Anti-HCV IgG Liaison Xl HCV Ab CLIA
DiaSorin
Anti-HBc IgG Murex HIV Ab/Ag CLIA
HBsAg
recHTLV-I/II CLIA
Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG

* Lot specific at launch - Targeted 24 month closed tube stability.

Alinity, Alinity ci-series, Alinity c, Alinity i and ARCHITECT are trademarks of Abbott Laboratories in various jurisdictions.

www.te c h n o p ath cd .co m


41

Multichem® INFECTIOUS DISEASE QC


Multichem® ID-G Specifications
• 24 month* closed tube stability at 2°C to 8°C.
• 30 day open tube stability at 2°C to 8°C.

Instruments

Multichem ID-G is specifically optimised for Roche


instrument platforms.

Analyte List
Coming
Anti-HIV-1 IgG
Soon
Anti-HCV IgG
Anti-HBc IgG
HBsAg
Features Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG
• Ready to use liquid stable controls
• Manufactured using native human plasma
• Direct sampling from control tubes
• Instrument specific barcodes Analyser Systems
• Technical and Scientific support
Manufacturer System Assay Name

Anti-HBc ECLIA
Order Information
Anti-HCV II ECLIA
Multichem ID-G Config. Part Code
HBsAg II ECLIA
Positive Control 4 x 5mL SR102G ROCHE Elecsys
HIV Combi ECLIA
Positive Control Mini Kit 1 x 5mL SR102MG
HIV Combi PT ECLIA

* Lot specific at launch - Targeted 24 month closed tube stability.


Syphilis ECLIA

Multichem® ID-SeroNeg Order Information

Multichem ID-SeroNeg Config. Part Code

Negative Control 4 x 5 mL SR100N

Negative Control Mini Kit 1 x 5mL SR100MN

Specifications
• 36 month closed tube stability at 2°C to 8°C.
• 30 day open tube stability at 2°C to 8°C.

Instruments

Multichem ID-SeroNeg is made from human base


materials and can be run on all major platforms.

Features Negative For:


Anti-HIV-1 IgG
• Ready to use liquid stable controls
• Manufactured using native human plasma Anti-HCV IgG
• Direct sampling from control tubes Anti-HBc IgG
• Instrument specific barcodes HBsAg
• Technical and Scientific support Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG

www.te c h n o p ath cd .co m


42
I NFOR MATI C S SOLUTIONS

IAMQC® QC Software Solutions


PRODUCT DESCRIPTION ORDERING

IAMQC Peer Real-time peer cloud-based comparison software


Contact our QC Software experts
Next generation cloud based software, designed to exactly to find the 'best fit' QC software
meet your QC solution needs. solution for your laboratory.
IAMQC Infinity
Incorporates IAMQC Daily, the comprehensive internal QC
software Worldwide:
qcsoftware@technopathcd.com
IAMQC Expert Interactive system that selects and suggests QC rules
USA:
qcsoftware@technopathusa.com
IAMQC Transfer Advanced connectivity solution for laboratories

Analyse QC results in real-time IAMQC Software Products Help:

Designed to complement and support Technopath’s BENCH TECHNOLOGISTS:


Multichem ®
Quality Control (QC) product range, • Spend less time on false positive QC flags.
• Concentrate on tests that require their
IAMQC Software provides Laboratory Managers
attention.
and Technologists with a range of QC software tools • Spend less time trouble-shooting QC.
to analyse their QC results in real-time. • Know how to react when the mean shifts.
• Assess the acceptability of new reagent lots
and calibration events.
IAMQC Software products allow users to automate,
• Solve QC problems.
centralise, standardise and improve QC processes in
a laboratory setting. Our combination of modules LAB MANAGERS:
satisfy the varying levels of QC requirements in • Choose QC rules to maximise true rejects and
minimise false rejects.
individual laboratories and are easily tailored to
• Quickly see the tests that require their
meet different QC management expectations. attention.
• Skim graphics to quickly review current or
Technopath's full suite of software products provide historical data by lab, department, instrument
clinical laboratories with significant cost and time or test.
• Monitor performance in groups of
savings, whilst delivering higher confidence in
laboratories.
analytical testing methods. Choose from Intranet • Review problem tests and QA activities in
and/or Internet based statistical quality control local and remote labs.
and quality assurance software products. IAMQC
LAB OR HOSPITAL ADMINISTRATORS:
software products are practical, graphical, user-
• Save money.
definable and easy to use. • Improve quality.
• Improve service.
• Review Administrative Summary Reports to
ensure quality performance.

www.te c h n o p ath cd .co m


43

I NFOR MATI C S SOLUTIONS


IAMQC® Peer What is an interlaboratory
program?

In its simplest form, an interlaboratory program


is a means for individual labs to compare their
performance against other labs. The comparison
will be against other labs using the same lot of
quality control (QC) material on the same test
and on the same instrument type. Interlaboratory
programs offer various reports to show how your
instruments in your lab compare against all others
Order Information
with these reports being generated at the end of
Contact our QC Software experts to find the 'best fit' QC the month once all data has been submitted. Some
software solution for your laboratory.
interlaboratory programs offer real-time peer
Worldwide: qcsoftware@technopathcd.com comparison where the values displayed are based
USA: qcsoftware@technopathusa.com
on all of the data that has been submitted up to the
time of report generation or statistic viewing.
IAMQC Peer - At a Glance
Bias Report  Why should you use an
interlaboratory program?
Exception Notes Report 
Any laboratory that strives to achieve ISO
Group Coordinator Report 
accreditation should be part of an interlaboratory
Levey Jennings Report  program:

Measurement of Uncertainty  “The laboratory shall participate in interlaboratory


Monthly Standard Report  comparison programme(s) ...”- ISO 15189:2012(E),
Subclause 5.6.3.1.
Peer Report 
Sigma Metrics Report  This ISO standard specifies the quality management
system requirements particular to medical
Youden Plot Report  laboratories and helps to set a level of performance
and competency that labs should attain. The medical
laboratory is an important part of patient care as
Benefits - IAMQC Peer
all tests results come from the lab so ensuring your
Real-time Peer data comparison  systems are in control is a vital part of this process.
An interlaboratory program can provide comfort to
Facilitates Standards approvals  the lab by demonstrating that your performance is in
Centralised data management  line with other labs. When your lab’s performance is
not in line with others, the interlaboratory program
Automatic data submission  highlights this to you quickly.
Cloud based system 
How does IAMQC Peer help with
User-Friendly  participation in an interlaboratory
program?

IAMQC Peer is a web based truly real time peer


comparison system. Truly real-time means that all

www.te c h n o p ath cd .co m


44
I NFOR MATI C S SOLUTIONS

data submitted is included in the peer statistics at


the time of report generation or when viewing the
interactive peer statistics. IAMQC Peer shows labs
each of their individual instruments performance
and compares the accuracy and precision of the
analytical processes to their peer group. The peer
group will contain instruments of the same type
from other laboratories using the same lot of QC
material and using the same method for the test.
The information from the reports and interactive
peer statistics in IAMQC Peer can be extremely
valuable, indicating the user’s performance relative
to their peer group as well as providing powerful
troubleshooting tools when attempting to resolve
potential problems. IAMQC Peer has multiple • Youden Plot
interfacing solutions to allow for the automation The Youden plot visualizes both bias and
of data submission helping busy lab personnel to imprecision graphically and can be used to
concentrate on the important activities of testing evaluate systematic and/or random error.
and result interpretation. • Six Sigma
The six sigma report automatically calculates
IAMQC Peer contains multiple reports, all of which the labs’ sigma score based on the Total
provide key information to the lab in interpreting Allowable Error values entered.
their instrument performance. • Measurement of Uncertainty
The system calculates the MoU value
• Group Coordinator report automatically based on the time range selected
A test by test listing of statistics of the laboratory for the lot in question along with the SEM value
and it’s peer groups for up to 3 levels of control or the running SD of each test for the time
• Levey-Jennings Report period selected.
The LJ report displays individual QC means per • Bias Report
analyte for the selected month. The bias report contains all the information in
• Exceptions Report the Group Co-ordinator report plus a bias score
This report summarises the labs tests and against the cumulative peer mean for each test
analytical methods which differ in performance and is generated in Microsoft excel format.
from its peer group using SDi and CVi.
• Monthly Summary Report
A rolling twelve-month window of summary
statistics, including monthly mean for each test
and level is displayed along with peer group
values

www.te c h n o p ath cd .co m


45

I NFOR MATI C S SOLUTIONS


IAMQC® Infinity

Next Generation Solutions Order Information


Contact our QC Software experts to find the 'best fit' QC
software solution for your laboratory.
IAMQC Infinity is a powerful cloud based software,
designed to exactly meet your QC solution needs. Worldwide: qcsoftware@technopathcd.com
USA: qcsoftware@technopathusa.com

Incorporating the popular IAMQC Daily software,


this feature based interface allows the laboratory to IAMQC Infinity - At a Glance
build their custom solution and then to seamlessly
add in further sophisticated features as and when Instant Comparison 
needed. Centralised Data Management 
IAMQC Infinity allows users to automate, centralise, Cloud Based SAAS Model 
standardise and improve QC processes in a
laboratory setting. Our combination of features
Compliance with Standards 
Westgard and/or user defined QC rules
in one system satisfies the varying levels of QC
fully supported 
requirements in individual laboratories and are
easily tailored to meet different QC management Focused Troubleshooting 
expectations – IAMQC Infinity provides the customer QC Monitor 
with the ability to build their own QC solution.
Configurable per Instrument and per
IAMQC Infinity provides clinical laboratories with Test 
significant cost and time savings, whilst delivering
higher confidence in analytical testing methods.
Benefits - IAMQC Infinity
IAMQC Infinity is a powerful cloud based software,
Design and select your exact QC
which is feature rich, responding to your custom QC system requirements 
solution needs.
Automate your QC process 
Consolidate all your QC Processes 
User-Friendly 
Centralised data management 
Automatic data submission 
Cloud based system 

www.te c h n o p ath cd .co m


46
I NFOR MATI C S SOLUTIONS

IAMQC® Daily IAMQC® Expert

Order Information Order Information

Contact our QC Software experts to find the 'best fit' QC Contact our QC Software experts to find the 'best fit' QC
software solution for your laboratory. software solution for your laboratory.

Worldwide: qcsoftware@technopathcd.com Worldwide: qcsoftware@technopathcd.com


USA: qcsoftware@technopathusa.com USA: qcsoftware@technopathusa.com

IAMQC Daily - At a Glance IAMQC Expert - At a Glance


Westgard and/or any user defined QC
rules  Data Review - Traffic Light System 
Interactive Levy Jennings Report  Problem Solver Report 
Superimpose instruments  Expert Reports in MS Excel 
Tools such as Reagent Verification and
Custom Rules Sets  Mean Shift Analysis 
Customisable Reports in MS Excel  Customisable Reports in MS Excel 
Audit trail support  Audit trail support 
Powerful reporting and charting  Powerful reporting and charting 

Benefits - IAMQC Daily Benefits - IAMQC Expert


Multiple Sites  Manage Multiple Sites 
Facilitates Standards approvals  Facilitates Standards approvals 
Centralised data management  Centralised data management 
Automatic data submission  Automatic data submission 
User-Friendly  Advanced QC data analysis 
User-Friendly 

www.te c h n o p ath cd .co m


47

I NFOR MATI C S SOLUTIONS


The most advanced connectivity solution
available for laboratory instrumentation.

IAMQC Transfer is a connectivity device that can


communicate with Laboratory Information Systems
IAMQC® Transfer
(LIS), Middleware, automated instrumentation and
Point Of Care platforms. Through the use of our
proprietary drivers and a single board computer
device, IAMQC Transfer processes and communicates
data from your system to any one of our powerful
IAMQC software packages; IAMQC Peer, IAMQC
Daily, IAMQC Expert or IAMQC Proficiency Testing
module. By combining software and hardware
elements, we can eliminate the requirement for
additional PCs or servers. A plug-and-play set up,
combined with over 200 available connectivity Order Information
options ensure an un-matched level of flexibility – all
Contact our QC Software experts to find the 'best fit' QC
within an incredibly small, seamless enclosure. software solution for your laboratory.

qcsoftware@technopathcd.com

IAMQC Transfer - At a Glance


S E RVE R PE E R Simple Set Up 
Secure System 
Internet
Secure Connection
Future Proof System 
Firewall

LAB
Automatic QC Data Upload 

POCT
Benefits - IAMQC Transfer
INTERNAL
QC

Instant QC data comparison 


IN ST RUM E NTS M I D D L EWA R E
/ L IS
DA I LY E X P E RT
Facilitates Standards approvals 
Centralised data management 
Automatic data submission 
User-Friendly 

www.te c h n o p ath cd .co m


48
IVD RAW MATERIALS

IVD Raw Materials


High Quality “Off-the-Shelf” and Custom IVD Raw Materials

At Technopath we understand and appreciate


the complexity of single and multi-analyte
quality control, PT sample, calibrator and reagent
manufacturing.

By applying our expertise in multi-analyte quality


control manufacturing to the development of our
IVD Raw Materials it allows us to take an end-to-end
view of the entire production process. This means
we do not just consider the elements that our team
is responsible for during the production of the
material, but also the aspects that our customers
intend to perform.

The benefit of this approach is that by working


closely with our customers, we can eliminate
duplication of effort and provide tailored solutions
that are not available elsewhere.

PRODUCT DESCRIPTION SOURCE FORM PART CODE

Off the clot human serum extracted


Off-Clot Serum Human Plasma Frozen Liquid SOC-0001
from whole blood samples

Triglyceride Extract Triglyceride concentrate Avian Frozen Liquid TGL-0001

Human Total Cholesterol concentrate


Human Lipoprotein Extract Human Plasma Frozen Liquid HLPX
containing HDL and LDL

Human High Density


Elevated Human HDL Human Plasma Frozen Liquid HHDL
Lipoprotein Extract

Human Low Density


Elevated Human LDL Human Plasma Frozen Liquid HLDL
Lipoprotein Extract

Lipid depleted and optically clear


Delipidised Human Serum Human Plasma Frozen Liquid DLHS
human serum

Derived from high quality human


Normal Human Serum Human Plasma Frozen Liquid SF-0001
plasma

Pooled Recovered Human Manufactured using fresh frozen


Human Plasma Frozen Liquid PF-0001
Plasma human plasma

www.te c h n o p ath cd .co m


49

IVD RAW MATERIALS


Off Clot Human Serum Triglyceride Extract

Features Features
• Can be manufactured to custom specifications and • Product can be manufactured to custom
aliquoted into bulk containers for ease of use and specifications providing you with the solution you
ease of storage. need.
• Single units and pooled options available. • Triglyceride extract manufactured using proprietary
processing techniques developed by Technopath
• Human Plasma derived and allowed to clot naturally
Clinical Diagnostics.
without being treated with anti-coagulant.
• Preservative additions optional.
• Product is collected from plasma that is recovered
from whole blood samples. • Off-the-shelf product specification available.
• Product can provided unfiltered or filtered to 0.22 • Material can be provided filtered to 0.22 micron
micron absolute pore size, if required. absolute pore size.
• Preservative addition optional. • Certificate of Analysis (COA) - available on request.
• Closest performance to patient sample. • Safety Data Sheet (SDS) – available on request.
• Certificate of Analysis (COA) - available on request.
• Safety Data Sheet (SDS) – available on request. Order Information

Order Information Product Source Form Part Code

Triglyceride Extract Avian Frozen TGL-0001


Liquid
Product Source Form Part Code

Off Clot Human Frozen SOC-0001


Human Serum Plasma Liquid To order Triglyceride Extract, please contact:
ivdsupport@technopathcd.com

To order Off Clot Human Serum, please contact:


ivdsupport@technopathcd.com

www.te c h n o p ath cd .co m


50
IVD RAW MATERIALS

Human Lipoprotein Human High Density


Extract Lipoprotein Extract

Features Features
• Combined extract of human low density lipoproteins • Product can be manufactured to custom
(LDL) and high density lipoproteins (HDL) in specifications providing you with the solution you
physiological ratios. need.
• Product can be manufactured to custom • Manufactured from plasma recovered from units of
specifications providing you with the solution you whole blood with a final HDL concentration typically
need. 20.7 mmol/L or ~800 mg/dL.
• Manufactured from plasma recovered from units • High density lipoproteins are extracted from
of whole blood with a minimum Total Cholesterol normal human serum using proprietary processing
concentration of 20.7 mmol/L or ~800 mg/dL techniques developed by Technopath.
• Lipoproteins are extracted from normal human • Preservative additions are optional.
serum using proprietary processing techniques
• Filtered to 0.22 micron absolute pore size to reduce
developed by Technopath.
bio-burden levels and improve yield for customers
• Preservative additions optional. intending to perfrom downstream filtrations.
• Filtered to 0.22 micron absolute pore size to ensure • “Tailored” specifications can be developed
low levels of bioburden and improved yield for in conjunction with the customer to provide a
our customers intending to perform downstream customised solution to match specific requirements.
filtrations.
• Certificate of Analysis (COA) - available on request.
• “Tailored” specifications can be developed
• Safety Data Sheet (SDS) – available on request.
in conjunction with the customer to provide a
customised solution to match specific requirements.
• Certificate of Analysis (COA) - available on request.
Order Information
• Safety Data Sheet (SDS) – available on request.
Product Source Form Part Code

Order Information Human High Density


Lipoprotein Extract
Human
Plasma
Frozen
Liquid
HHDL

Product Source Form Part Code To order Human High Density Lipoprotein Extract,
please contact:
Human Lipoprotein Human Frozen HLPX
Extract Plasma Liquid
ivdsupport@technopathcd.com

To order Human Lipoprotein Extract, please contact:


ivdsupport@technopathcd.com

www.te c h n o p ath cd .co m


51

IVD RAW MATERIALS


Human Low Density Delipidised Human
Lipoprotein Extract Serum

Features Features
• Product can be manufactured to custom • Product can be manufactured to custom
specifications providing you with the solution you specifications providing you with the solution you
need. need.
• Manufactured from plasma recovered from units of • Manufactured from plasma recovered from units of
whole blood with a final minimum LDL concentration whole blood with a total cholesterol concentration
typically 20.7 mmol/L (or ~800 mg/dL). typically <0.4mmol/L.
• Low density lipoproteins are extracted from • Serum is defibrinated and lipoproteins are extracted
normal human serum using proprietary processing using proprietary processing techniques developed
techniques developed by Technopath. by Technopath Clinical Diagnostics.
• Preservative additions are optional. • Preservative additions optional.
• Filtered to 0.22um pore size prior to final dispensing • Off-the-shelf product contains normal salt levels.
to reduce bio-burden and improve yields for
• Filtered to 0.22um pore size.
customers intending to perform downstream
filtrations. • “Tailored” specifications can be developed
in conjunction with the customer to provide a
• Low levels of HDL present in the finished product.
customised solution to match specific requirements.
• Certificate of Analysis (COA) - available on request.
• Certificate of Analysis (COA) - available on request.
• Safety Data Sheet (SDS) – available on request. • Safety Data Sheet (SDS) – available on request.

Order Information Order Information


Product Source Form Part Code Product Source Form Part Code

Human Low Density Human Frozen HLDL Delipidised Human Human Frozen DLHS
Lipoprotein Extract Plasma Liquid Serum Plasma Liquid

To order Human Low Density Lipoprotein Extract, To order Delipidised Human Serum, please contact:
please contact: ivdsupport@technopathcd.com
ivdsupport@technopathcd.com

www.te c h n o p ath cd .co m


52
IVD RAW MATERIALS

Normal Human Pooled Recovered


Serum Human Plasma

Features Features
• Product can be manufactured to custom • Product can be manufactured to custom
specifications providing you with the solution you specifications providing you with the solution you
need. need and dispensed into bulk containers for ease of
handling, use and storage.
• Manufactured from high quality, consistent source of
plasma that is recovered from units of whole blood. • Manufactured from high quality, fresh frozen plasma
recovered from units of whole blood. Plasma frozen
• Serum is defibrinated using proprietary processing
within 72 hours of collection.
techniques developed by Technopath with or
without the use of bovine thrombin. • Tested and certified negative for the standard panel
of viral markers. Full traceability back to the donor
• Preservatives addition is optional and based on
units.
customers' individual preferences.
• Preservative additions optional and filtrations
• Off-the-shelf product contains normal salt levels.
performed if required.
• Filtered to 0.22 micron absolute pore size to reduce
• Material also manufactured to off-the-shelf
levels of potential bio-burden.
specification.
• “Tailored” specifications can be developed
• Certificate of Analysis - available on request.
in conjunction with the customer to provide a
customised solution to match specific requirements. • Safety Data Sheet (SDS) – available on request.
• Certificate of Analysis (COA) - available on request.
• Safety Data Sheet (SDS) – available on request.
Order Information
Product Source Form Part Code
Order Information
Pooled Recovered Human Frozen PF-0001
Human Plasma Plasma Liquid
Product Source Form Part Code

Normal Human Human Frozen SF-0001 To order Pooled Recovered Human Plasma,
Serum Plasma Liquid
please contact:
ivdsupport@technopathcd.com
To order Normal Human Serum, please contact:
ivdsupport@technopathcd.com

Contact us for information on our IVD Raw Materials including:


Pricing | Bulk Quotation | Custom Specifications Contact
Availability | Lead Time | Shipping Information

www.te c h n o p ath cd .co m


53

TI ON
CONTAC T
Contact Information

I NTR ODUC
Multichem Quality Control Products IVD Raw Materials:

ivdsupport@technopathcd.com
Outside of USA:
qcsupport@technopathcd.com
General Enquiries
Within the USA:
qcsupport@technopathusa.com. Outside of USA:
info@technopathcd.com

IAMQC Software Solutions Within the USA:


info@technopathusa.com.
Outside of USA:
qcsoftware@technopathcd.com

Within the USA:


qcsoftware@technopathusa.com

Have a Question?

It may have been answered already -


FAQs
Visit the FAQ page of our website.

Alinity c, Alinity i and ARCHITECT are trademarks of Abbott Laboratories in various jurisdictions.
QConnect and EDC Net are trademarks of NRL in various jurisdictions.

www.te c h n o p ath cd .co m


54
NOTES

www.te c h n o p ath cd .co m


This page is intentionally blank.
www.technopathcd.com

info@technopathcd.com | Tel: +353 61 525700


Technopath Life Sciences Park, Fort Henry, Ballina, Co. Tipperary, V94 FF1P, Ireland.

USA:
info@technopathusa.com | Tel: 1.888.235.3597
99 Lafayette Drive, Suite 179, Syosset, NY 11791

© Technopath Clinical Diagnostics 2020. All content correct at time of publishing. E. & O.E.
Multichem and IAMQC are trademarks of Technopath Clinical Diagnostics.

MM_CAT_Digi_R14

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy