Tg iFlash

Immunoassay Analyzer

Anti-Tg acridinium-ester-labeled conjugate;

REF C86027 2×50 Tests R2 4.0mL/pack; 0.05% ProClin 300.

Calibrator 1, 1 bottle, phosphate buffer with

INTENDED USE CAL1 protein stabilizers, 0.05% ProClin 300,
The iFlash-Tg assay is a paramagnetic particle lyophilized product.
chemiluminescent immunoassay (CLIA) for the
quantitative determination of thyroglobulin (Tg) in human Calibrator 2, 1 bottle, Tg in phosphate
serum and plasma using the iFlash Immunoassay CAL2 buffer with protein stabilizers, 0.05%
ProClin 300, lyophilized product.
Analyzer.

SUMMARY AND EXPLANATION Calibrator 3, 1 bottle, 1.0 mL, Tg in

CAL3 phosphate buffer with protein stabilizers,
Thyroglobulin (Tg) is synthesized in the thyrocytes of the
0.05% ProClin 300, lyophilized product.
thyroid gland and is secreted into the internal parts of the
thyroid follicle, which molecular weight is approx. 660,000
dalton. Elevated Tg levels are present in a variety of MATERIALS REQUIRED (BUT NOT PROVIDED)
thyroid disorders such as Graves’ disease, Hashimoto’s REF C89999/C89959/C89949, iFlash Pre-Trigger
thyroiditis, and differentiated thyroid carcinoma (papillary Solution: hydrogen peroxide solution.
and follicular).
REF C89998/ C89958/ C89948, iFlash Trigger Solution:
Low levels of circulating Tg indicate the presence of sodium hydroxide solution.
thyroid tissue. Following successful total thyroidectomy,
REF C89997, iFlash Wash Buffer: phosphate buffered
Tg is no longer detectable. Due to its high diagnostic
saline solution with 0.05% ProClin 300.
specificity and sensitivity, Tg can be used also as marker
in the postoperative follow-up of patients who underwent REF C80001, iFlash Wash Buffer (10×): phosphate
thyroidectomy. Furthermore, the determination of Tg can buffered saline solution with 0.05% ProClin 300.
be useful in distinguishing between subacute thyroiditis REF C89996, reaction vessels.
and factitious thyrotoxicosis. Thyroglobulin determinations Controls: Commercial controls could be used.
can be affected by the presence of anti-thyroglobulin
antibodies (Anti-Tg) in patient samples for its high WARNINGS AND PRECAUTIONS
antigenic potential. IVD For in vitro diagnostic use
 No known test method can offer the complete
ASSAY PRINCIPLE
assurance that products derived from human sources
The iFlash-Tg assay is a sandwich immunoassay. will not transmit infection. Therefore, all humanized
 Incubation: Tg in the sample, Anti-Tg coated materials should be considered potentially infectious.
paramagnetic microparticles and Anti-Tg Exercise the normal precautions required for handling
acridinium-ester-labeled conjugate react to form a all laboratory reagents.
sandwich complex.  Disposal of all waste material should be in accordance
 Wash: The unbound materials are washed away from with local guidelines.
the solid phase in a magnetic field.  Wear gloves when handling specimens or reagents.
 Trigger of signal: The Pre-Trigger and Trigger  Clean and disinfect all spills of specimens or reagents
Solutions are added to the reaction mixture. The using a suitable disinfectant.
resulting chemiluminescent reaction is measured as
 iFlash Trigger solution contains sodium hydroxide
relative light units (RLUs).
(NaOH) and should be avoided contact with eyes.
 A direct relationship exists between the amount of total
Tg in the sample and the RLUs detected by the iFlash REAGENT HANDLING
optical system.  The reagents may not be used after the stated
 Results are determined via a calibration curve, which expiration date.
is instrument-specifically generated by 3-point  Avoid the formation of foam with all reagents.
calibration and a master curve provided via the
 The reagents in the pack are ready for use.
reagent QR code.
 Each tube of lyophilized powder, as a calibrator, needs
REAGENTS adding 1.0 mL deionized water, dissolving within 15
Reagent kit, 100 tests, 2 packs, 50 tests/pack minutes and gently blending for the first time.
Anti-Tg coated microparticles, 3.5 mL/pack,  After dissolving calibrators, they should be measured
R1 0.05% ProClin 300. within 4 hours. Then, they should be frozen to
preserve.

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Tg iFlash
Immunoassay Analyzer

 Close the bottles of calibrator right after calibration and ASSAY PROCEDURE
store at 2 ~ 8°C.  Refer to the system operating instruction or the online
 Do not pool reagents within a reagent kit or between help system for detailed information on preparing the
reagent kits. system.
 Prior to loading the iFlash-Tg reagent pack on the  The test-specific parameters stored in barcode on the
system for the first time, resuspend the microparticles reagent pack are read in. In case the barcode cannot
by inverting the reagent pack slightly. be read, enter the sequence numbers.
 For further information on reagent handling  Carry out calibration, if necessary.
precautions during system operation, refer to the  Place the calibrators CAL1, CAL2 and CAL3 in the
iFlash system operating instruction. calibrator rack in the sample zone. Only keep
calibrators open during calibration.
STORAGE AND STABILITY
 Test application.
Storage:  Load samples (Use 80 μL of sample for each
 Store at 2 ~ 8°C in an upright position. determination in addition to the sample container and
 The kit may be used immediately after removal from 2 system dead volumes).
~ 8°C storage.  Click RUN, the iFlash System performs all the
functions automatically and calculates the results.
Stability:
 Unopened at 2 ~ 8°C: up to the stated expiration date. CALIBRATION
 Opened at 2 ~ 8°C: 28 days.  Traceability: This assay is traceable to a commercial
 Store on-board: 28 days. available kit.
 Every iFlash-Tg reagent kit has a QR code label
SPECIMEN COLLECTION AND PREPARATION containing the specific information for calibration of the
 Serum or plasma (lithium heparin, sodium heparin particular reagent lot.
potassium EDTA, and sodium citrate) are the  To perform an iFlash-Tg calibration, test CAL1, CAL2
recommended samples. Other anticoagulants have and CAL3 in duplicate, and the predefined master
not been validated for use with the iFlash-Tg assay. curve is adapted to the analyzer.
 Ensure that serum specimens to form complete clot  Once an iFlash-Tg calibration is accepted and stored,
prior to centrifugation. all subsequent samples may be tested without further
 Centrifuge the specimens. calibration unless:
 Store specimens at room temperature (20 to 25°C) for  After 28 days when using the same reagent lot.
no longer than 8 hours.  A reagent kit with a new lot number is used.
 If the testing will not be completed within 8 hours,  Controls are out of range.
refrigerate the samples at 2 to 8°C.
 Required by pertinent regulations.
 If the testing will not be completed within 14 days, or
for shipment of samples, freeze at -20°C or colder. MEASURING RANGE
 Frozen specimens must be mixed thoroughly after  0.1 ~ 1,000 ng/mL
thawing.
QUALITY CONTROL
 The samples may be frozen for maximum 1 time.
Quality control materials should be run as single
 Centrifuge specimens with a lipid layer on the top, and determinations at least once every 24 hours when the test
transfer only the clarified specimen without the lipemic is in use, once per reagent kit and after every calibration.
material. Include commercially available quality control materials
 Ensure that residual fibrin and cellular matter has been that cover at least two levels of analyte. Follow
removed prior to analysis. manufacturer’s instructions for reconstitution and storage.
 Use with caution in handling patient specimens to Each laboratory should establish mean values and
prevent cross-contamination. acceptable ranges to assure proper performance. Quality
 Do not use heat-inactivated samples. control results that do not fall within acceptable ranges
may indicate invalid test results.
 Ensure that the patient samples, calibrators and
controls are at ambient temperature (20 ~ 25°C) RESULT
before measurement.
Calculation:
 Due to the possible evaporation, specimens and
calibrators on the analyzers should be measured The iFlash system automatically calculates the analyte
within 2 hours. concentration of each sample. The results are given in
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Tg iFlash
Immunoassay Analyzer

ng/mL. consisting low, median, and high concentration of Tg were

assayed.
Interpretation of Results
The within run precision was determined by testing each
A study of with iFlash-Tg assay on samples from 162 sample in replicates of 10 (n = 10), and calculating percent
apparently healthy males and 105 females of relevant coefficient of variation (%CV). The results of the study are
diseases yielded the following result: shown below:
Reference interval: 2.59 ~ 49.03 ng/mL Sample Mean (ng/mL) SD %CV
It is recommended that each laboratory establish its own 1 4.91 0.24 4.84%
expected reference range for the specific population.
2 71.78 2.97 4.13%
LIMITATIONS 3 187.47 9.20 4.91%
 The iFlash-Tg assay is limited to the determination of
The between run precision was determined by testing
Tg in human serum or plasma (lithium heparin, sodium each sample in duplicate, two separate runs daily for 20
heparin, potassium EDTA, and sodium citrate). It has days (n = 80), and calculating percent coefficient of
not been validated for use with other types of plasma. variation (%CV). The results of the study are shown
 The use of serum separator (gel) blood collection below:
tubes has been validated for use with this assay.
Sample Mean (ng/mL) SD %CV
However, it is not possible to survey all manufacturers
1 4.95 0.16 3.25%
or tube types.
2 191.16 7.27 3.80%
 The upper limit of the measuring range of this assay is
1,000 ng/mL. Over-range samples may be diluted with Analytical Sensitivity
wash buffer (1:20 recommended) and re-tested to
The detection limit representing the lowest measurable
obtain an estimate of the actual concentration. analyte level is 0.1 ng/mL, which can be distinguished
 If the results are inconsistent with clinical evidence, from zero. It is calculated as the value lying two standard
additional testing is suggested to confirm the result. deviations above that of the lowest standard of the master
curve (standard 1 + 2 SD, n = 20).
 For diagnostic purposes, the results should be
interpreted in light of the total clinical presentation of Analytical Specificity
the patient, including symptoms, clinical history results. The analytical specificity of iFlash-Tg assay was evaluated
 Specimens from heparinized patients may be partially with viral antibody specimens. The nonreactive Tg status
coagulated and erroneous results could occur due to of each specimen was verified using a commercially
available Tg assay.
the presence of fibrin.
 The results from an alternative assays (i.e. EIA or RIA) iFlash-Tg
Concentration
may not be equivalent and cannot be used Clinical Category Nonreactive
(ng/mL)
interchangeably. (ng/mL)
 Samples containing an apparent Tg level as high as tryiodothyronine 500 0.06
1,800,000 ng/mL did not exhibit a hook effect in the
iFlash-Tg assay. thyroxine 500 0.06
 The assay is unaffected by icterus (bilirubin < 10
mg/dL), hemolysis (Hb < 500 mg/dL), lipemia
Method comparison
(Intralipid < 1,800 mg/dL) and total serum protein (< 10
g/dL). A comparison of the iFlash-Tg assay (y) with a
commercially available Tg assay (x) using clinical samples
 No interference was observed from rheumatoid factors was performed, and the curve is fitted with Linear
up to a concentration of 2,000 IU/mL. regression)
 No interference was observed from anti-nuclear
y = 1.002x + 48.83
antibodies up to a concentration of 500 AU/mL.
 No interference was observed from HAMA up to a r = 0.9935
concentration of 600 ng/mL. Sample concentration: 0.5 ng/mL ~ 1,000 ng/mL
PERFORMANCE CHARACTERISTICS Number of samples measured: 89
Below are the representative performance data, and the
results obtained in individual laboratories may differ REFERENCES
1. Malthiery Y, Lissitzky S. Primary structure of human
Precision
thyroglobulin deduced from sequence of its
The precision of iFlash-Tg was determined using Tg 8448-base complementary DNA. Eur J Biochem
reagents, samples and controls. Three serum samples,
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Tg iFlash
Immunoassay Analyzer

1987;165:491-498. ANNEX A:
Explanation of abbreviation
2. Torréns J, Burch H. Serum thyroglobulin
measurement: utility in clinical practice. The Abbreviation Explanation
Endocrinologist 1996; 6:125-144.

3. Saboori AM, Rose NR, Butscher WG, Burek CL. Product No.
Modification f a Nonincinerative Method for
etermination of Iodine in odoproteins. Anal Biochem Calibrator
1993; 214: 335-338.

4. Rüter A, Smeds S, Lennquist S. Value of Serum Reagent

Thyroglobulin Measurement in Patients Operated on
for Well Differentiated Thyroid Carcinoma. Eur J Surg
Number of tests
1998;164: 665-671.

5. Erali M, Bigelow RB, Meikle AW. ELISA for Manufactured by

thyroglobulin in serum: ecovery studies to evaluate
autoantibody interference and reliability f
EU Representative
thyroglobulin values. Clin Chem 996; 42(5): 766-770.

EC Declaration of Conformity
SHENZHEN YHLO BIOTECH CO., LTD.

1st-4th Floor, No.5 Building, Lishan Industrial Caution

Area, Xinghai Road, Nanshan District,
Shenzhen 518054, P.R. China
Instructions for use

In vitro diagnostic medical

Wellkang Ltd (www.CE-marking.eu) device
Suite B, 29 Harley St., London W1G 9QR, UK
Lot No.

Date of manufacture

Expiry date

Biohazard Symbol

Pictograms for Caution

Pictograms for Hazardous to the

aquatic environment

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