Erba Lachema

- 40 years of experience with urinalysis products

- Located in Czech Republic (Central Europe)
- Part of Erba/Transasia corporation
 Urine
analysis

Urine test Urine

strips controls
Urine
analysers
 Urine analysers
Urine
analysers

Semi- Fully
automated automated
 LAURA® Smart
Built-in thermal
printer

Touch screen

Strip placement
point

• Effective and powerful solution for laboratories, ambulances of general

practitioners, family doctors and specialists
• Eliminate any subjective interpretation of the colour reaction of the
diagnostic pads
 LAURA®
Built-in thermal
printer

Status indicator
biLED Touch screen

Strip placement
Waste container
point

• Semi-automated machine for semi-quantitative urine analysis

• Designed for clinical laboratories
 LAURA® M

Built-in thermal
printer

Touch screen

Status indicator
biLED

Strip placement
point Waste container
 LAURA® XL

Fully Automated Urine Strip Reader

& Sediment Analyser
 Sediment Analysis
Urine sediment:
• Gold standard – visual microscopy
• Trained laboratory stuff is required
• Manipulation with urine sample - laborious
(homogenization, centrifuging, dosing on microscopic glass slide or
using of „Fast read“ plates – defined thickness of urine layer)
• Coloration of urine sediment – Sternheimer dye
(Alcian blue + Pyronin B)
 Sediment Analysis
Urine sediment – visual microscopy:
  1. Sternheimer dye (2 µl)
2. Urine sediment (10 µl)
3. Covering by microscopic glass plate
4. Evaluation (enlargement 100x, 400x)
5. Using of „Fast read“ plates

Source: MUDr. Petr Kubáč, Atlas of Urinary Sediment

 Automated Sediment Analysis
 Alternative to visual microscopy
 Simplifies laboratory workflow
 Storage of reports
 FC -confirmation for ambigious samples required

Digital Microscopy Imaging Flow Cytometry

 LAURA® XL

Automatization

Walk away Automated

system sample
Automated
evaluation
handling with
samples

LAURA® XL
 LAURA® XL
Key features:
• Hybrid concept: urine strip reading and microscopic
sediment analysis in one “box”
• Sediment concentration achieved without centrifuging
• Automated recognition of sediment particles by means
of sophisticated artificial intelligence
• Automated measurement of physical parameters of
urine (colour and clarity)
• Unique active humidity control to protect the strips on
board
• Consumables: urine test strips + optical cleaning solution
 LAURA® XL
Main
switch

LCD touch Waste container

Sample entry Strip feeder
screen (used strips)
Strip Analysis:
- ready-to-use trully walk-away system
- 10/11-parameter strips, RFID control
- automated evaluation of diagnostic strips using colour matrix definition
(CMD) technology
- speed: 240 measurements/hour
- convenient strip loading
- input capacity: 200 strips
- sample load capacity: 120 samples
- measurement of colour and clarity (automatically)
- unique active humidity protection
- capacity of memory: 500,000+ measurements
- sample identification – BCR/manual if required
Sediment Analysis:
- fully automated sediment analyser
- measurement principle: digital microscopy – automated brightfield microscopy
with advanced element recognition (ABM/AER) (15 images/sample, full field)
- sophisticated automatic recognition of elements based on the principle of
arteficial inteligence
- format comparable with manual microscopy – clear and sharp images
- automatic evaluation of samples + manual re-evaluation possible
- 21 automated/16 manual categories
- element concentration without centrifugation
(centrifugation could lead to degradation of elements)
- measurement capacity: 180 measurements/hour
- measurement without dyes, no special buffer required
- flagging, filtering, RFID…………
Analysis:
• Measuring modes:
 Combined
 Chemistry only
 Sediment only
• Identification of tubes
• Detection of bar codes
• Automated homogenization of urine samples
• Evaluation of sample colour and clarity (turbidimetric method)
• Strip analysis – 1 drop for each diagnostic pad
• Minimal volume for analysis – 2,0 ml
• Aspirated volume - ˂ 1,5 ml
• Consumables – strip analysis: distilled water, urine test strips
• Consumables – sediment: distilled water, optical stabilisation
solution
 LAURA®
Evaluation – urine test strips:
XL
• Urine chemistry measurement provides the following parameters:
 Specific gravity (SG)
 Leukocytes (LEU)
 Nitrites (NIT)
 pH
 Proteins (PRO)
 Glucose (GLU)
 Ketones (KET)
 Urobilinogen (UBG)
 Bilirubin (BIL)
 Blood (BLD)
• Additional parameters automatically measured for each sample:
 Colour
 Clarity
 LAURA®
Evaluation – urine sediment:
XL
• Auto-recognition of following categories:
 White blood cells (WBC)
 White blood cell clumps (WBCc)
 Red blood cells (RBC)
 Dysmorphic red blood cells (dRBC)
 Squamous epithelium (SQEP)
 Non-squamous epithelium (NSQE)
 Hyaline casts (HYA)
 Pathological casts (PATC)
 Calcium oxalate (CaOX)
 Triple phosphate (TRIP)
 Uric acid (UA)
 Rod-shaped bacteria (ROD)
 Bacteria (BACT)
 Yeast (YST)
 Mucus (MUC)
 Sperm (SPRM)
 Unclassified cells (UNCC)
Guide user interface – Measurement
Guide user interface – Measurement
Guide user interface – Measurement
Guide user interface – Measurement
Guide user interface – Measurement
 LAURA® XL
Guide user interface - Results
Guide user interface – Results (individual images)
Guide user interface – Results (individual images – ZOOM)
Guide user interface – Results
Guide user interface – Setup (System)
Guide user interface – criterions for chemistry
Guide user interface – criterions for sediment
Reporting
RBC
LAURA® XL
RBC
 LAURA® XL
WBC
 LAURA® XL
WBCc
 LAURA® XL
NSE
 LAURA® XL
CaOX
 LAURA® XL
TRIP
 LAURA® XL
Calcium
Phosphate
 LAURA® XL
MUC
 LAURA® XL
CaOX /SPRM
 LAURA® XL
Gran CAST
 LAURA® XL
Bacterial Rods
 LAURA® XL
YEAST
 ADVANTAGES OF FULLY
AUTOMATED URINE ANALYSIS:

- Fully walk-away system

- Small foorprint
- High speed
- Convenient strip loading
- Active humidity protection of strips
- Format similar to visual microscopy – high quality images
- Sophisticated and reliable element recognition
- Manual re-checking of sediment results possible
- Premium range of elements - 21+16
- Centrifugation free procedure
- Intuitive software and data processing
 EL Product Portfolio - SWOT
Strength Weakness

Widest range of automatically detected elements on Missing STAT

the market (including dRBC)
High quality of sediment images Missing phase-contrast images
Unique Element Concentration - centrifugation free Compromised speed for hybrid mode
(gentle workflow to avoid element degradation)
Highest throughput for sediment analysis on the market
(180 samples/hours)
Active humidity control for long on-board strip stability
Output format comparable with visual microscopy
RFID controlled procedure for both chemistry and
sediment analysis
Small footprint
Attractive price
High price/performance ratio
User-friendly
European origin

Opportunity Threat

Large pool of medium to large labs - min 100-150 Relatively late to the market
samples/day
Addressing shift on the market - semiautomated → fully Less recognition on some markets
automated
Strong customer reach and reputation on some markets
 Target customers
• hospital laboratories – low throughput – visual/semi-automated
• hospital laboratories – medium throughput – semi-automated/fully
automated
• hospital laboratories – high throughput – full automation
• general practitioners – visual/semi-automated (Laura Smart)
• endocrinologists – visual/semi-automated (Laura Smart)
• gynaecologists – visual/semi-automated (Laura Smart)
 Laboratory workflows

Low Throughput / Workload High

 Laboratory workflows

Low Throughput / Workload High

 Main competitors
• Sysmex
• Beckman Coulter (Iris)
• Roche
• 77 Elektronika
• Arkray
• Siemens
• Dirui
• Analyticon, YD, Urit, Mindray, Ave, THME…..
 Main competitors
Combur 10M Multistix 10SG
 Main competitors

Roche Lachema Siemens Dirui Arkray

DekaPHAN Aution Sticks
  Combur 10M LAURA Multistix 10SG H-10 10AE
1 Specific gravity Specific gravity Glucose CP CP
2 pH CP Bilirubin pH Leukocytes
3 Leucocytes Leucocytes Ketones Specific gravity Nitrites
4 Nitrites Nitrites Specific gravity Glucose Ketones
5 Proteins pH Blood Leucocytes Blood
6 Glucose Proteins pH Nitrites Specific Gravity
7 Ketones Glucose Proteins Proteins pH
8 UBG Ketones UBG Blood Urobilinogen
9 Bilirubin UBG Nitrites Ketones Bilirubin
10 Blood Bilirubin Leucocytes Bilirubin Proteins
11 CP Blood   UBG Glucose
 Main competitors
Siemens – Bayer Diagnostics (Germany)
web: diagnostics.siemens.com

Main advantages of PHAN®:

- unified reading time (60 sec., LEU 120 sec.)
good conformity with colour scale
- marked difference between neg. and 1st pos. Field
- 2.8 x 5.5 mmol/L min. positive glucose concentration (traces at
Roche)
- ketones (5mmol/L) don’t inhibit glucose (5.5 ml/L (interference)
– risk for diabetes patiens
-Ascorbate protection (empirical)
Main competitors
Roche Diagnostics (Switzerland)
web: www.roche.com

Basic information:
- technology with polymer mesh
(better for stability, ineterferences)
- folded pads (LEU, GLU,…)
- good conformity with colour scale
- comparative strips for clinical
testing
(comparison with higher reference
method
and with competitors)
- Contamination/overflow by first pad
(SG contaminates pH zone)
Main competitors
Roche Diagnostics (Switzerland)
web: www.roche.com
 Main competitors
Dirui Industrial Co., Ltd. (China)
web: english.dirui.com.cn

Main advantages of PHAN®:

- good protection against ascorbic acid
limit 200 mg/l
presence of ascorbic acid hasn´t influence on results
- good conformity with colour scale

- marked difference between neg. and 1st pos. field

- homogeneous coloration

Products are copies of Roche.

(polymer mesh, folded pads)
Main competitors
YD diagnostics (Korea)
web: www.yd-diagnostics.com

Main advantages of PHAN®:

- good protection against ascorbic acid
limit 200 mg/l
presence of ascorbic acid hasn´t influence on results
- good conformity with colour scale

- marked difference between neg. and 1st pos. field

- homogeneous coloration
 Main competitors
Analyticon (Germany)
web: www.analyticon-diagnostics.com

Products
- only two types of diagnostics strips
Combi Screen 10 SLplus
test strips for visual evaluation

Combi Screen 11 SYSplus

test strips for objective evaluation

Analyticon is a supplier of strips to 77 Elektronika (producer of urine readers).

 Selling strategy
• Product features:
– Strips – glucose sensitivity, AA protection, limited interference
– Instruments – premium specs – throughput/speed, range of detected
elements, high quality images, additional manual evaluation of sediment,
centrifugation-free procedure, active humidity control, small size
• Brand recognition
– European origin
– Long-term reputation
– Strict QC procedure
• Suitable pricing
– Between high end players and chinese vendors
• Close cooperation with customers
– Frequent visits, KOL network development
• Product intelligence
– Training programs
Thank you!