Thyroid Stimulating Hormone (TSH) CLIA 2 X 50 Test

52025005

Intended Use
TSH (CLIA) is intended for in-vitro quantitative measurement of Thyroid
Stimulating Hormone in human serum or plasma by chemiluminescent
immunoassay.
Clinical Significance
TSH is a key regulator in thyroid hormones generation. TSH testing is the first line
test for thyroid function. TSH, with a molecular weight of 28KD weight. TSH is
produced and secreted by the pituitary gland, and it stimulates the production and
secretion of the thyroid hormones, including thyroxine (T4) and triiodothyronine
(T3), by interacting with a specific receptor on the thyroid cell surface. TSH secretion
in turn is control led by negative feed back from circulating T4 and T3 by the
hypothalamic hormone TRH (thyrotropin releasing hormone). Hyperthyroidism
(including thyroiditis, nodular goiter and etc.) is associated with depressed or even
undetectable levels of TSH. Primary hypothyroidism is increased levels of TSH.
However, some secondary hypothyroidism has a normal or slightly arose TSH, which
is the result of hypothalamic or pituitary disorders, TSH low activity, pituitary low
stress to TRH, and etc. At present, methods commonly used for TSH detection are
chemiluminescent immunoassay and enzyme-linked immunoassay.
This product contains chemical ingredients. Contacting with skin or mucosa should
be avoided. If the product is spilled into eyes, mouth or skin accidentally, rinse
with running water and seek for doctor advice if necessary.
This product does not involve human source substances and has no biosafety hazard,
but it should still be considered as a potential infectious substance. The treatment,
use, storage of each component and the disposal of solid and liquid wastes
generated in the analysis process should be hand led in accordance with the
corresponding measures of local biosafety guidelines or regulations.
All test equipment and related glass and plastic wares should be clean and free of
contaminants.
Packaging materials that are non-degradation should be collected and delivered
to the local process center.
Do not use reagent kits beyond the expiration date.
Waste Management
Reagents must be disposed o in accordance with local regulations

Principle Sample
Serum/Plasma
This TSH assay is a “sandwich” chemiluminescent microparticle immunoassay.
Immunomagnetic microparticle, sample, and conjugate labelled with acridinium Specimen Col lection&Storage
ester (AE) are mixed and incubated to form “immunomagnetic microparticle-TSH- Follow this package insert as well as the specimen collection tube manufacturer’s
conjugate” immune complexes. The wash step removes excess AE labelled conjugate instructions for specimen collection and preparation. Raw materials and addictive
and other substances. After the chemiluminescence analyzer substrate buffer is may vary among different manufactures’ collection tubes, which may result in
added, the resulting chemiluminescent reaction is quantified in relative light unit different results. This kit has not been tested with all collection tube manufactures.
(RLU). The value of RLU is direct proportional to the concentration of TSH in the Each laboratory needs to determine the feasibility of the collection tubes or serum
specimen. separation products. The specimens should be free of microbial contamination,
fibrin, cells or other particulate matter, severe lipemia, severe hemolysis. If the
sample is cloudy or has visible flocculent, the sample shall be centrifuged, and the
Kit Components supernatant can be used for detection.
Reagent Product Code Description If testing cannot be done before 24 hours after blood collection, the specimens
52025005 shall be separated to serum or plasma and then be stored. Specimens may be stored
TSH R1 3.5 mL Magnetic microparticles coated with for up to 7 days at 2-8°C or 3 months at -20°C. Multiple freeze-thaw cycles of
specimens should be avoided
anti- TSH monoclonal antibody
Ensure the patients’ samples, calibrators and controls are at ambient temperature
TSH R2 6.0 mL Acridinium ester labelled (15-25°C) before measurement.
TSH monoclonal antibody Do not use mixed specimens.
Calibrator-1 1 mL TSH recombinant antigen Volume required: 200 µL for the first TSH test plus 50 µL for each additional TSH
Calibrator-2 1 mL TSH recombinant antigen test from the same sample tube.

Plastic Opener 2 nos Materials provided

* Note: Do not mix or interchange d ifferent batches of kit.
Risk & Safety
Material Safety data sheets (MSDS) will be provided on request
Reagent Storage and Stability
The unopened reagents and calibrators are stable until the expiration dates stated
on the labels, when stored upright at 2-8OC and protected from direct sunlight.
Avoid freezing. After opening, the reagents are stable for 35 days when used on
board, and the calibrators are stable for 35 days at 2-8OC.
Open Vial Stability
TSH Casette,Calibrator & Plastic Opener
Procedure
Follow the procedures described in Maccura i1000 Automatic Chemiluminescence
Analyzer User Manual.
Verify that test parameters are loaded before reagents are loaded, for specific
operations, please refer to the analyzer user manual.
Prior to running the kit, ensure that the magnetic microparticles are mixed to
keep them suspended and avoid formation of foam.
Place the reagents in the reagent compartment. When the reagent compartment is
closed, the analyzer will automatically scan and read the reagent RFID information.

Once opened, the reagent casette is stable up to 35 days when kept at 2-8OC.
Calibration
On-board Calibration Stability Ensure the calibrator to ambient temperature, mix and place it on the calibrator
rack.
Calibration is stable for 7 days.
Make sure that the reagent and calibrator lot are same before loading.
Precaution
Place the reagent kit in upright position always. Ensure the related calibrator information is obtained by the analyzer, for specific
operations, please refer to the analyzer user manual.
For in vitro diagnostic use only.
Recommended calibration frequency:
Package insert must be followed accordingly. Reliability of assay results cannot For every new reagent lot.
be guaranteed if there are any deviations from the instructions in this package
insert. The controls are out of range.
After 35 days when using the same reagent lot.
This product requires the handling of human specimens. It is recommended that
all human sourced After 7 days when using the same reagent kit.
After major repair or replacing spare parts.
materials be considered potentially infectious and hand led in accordance with
applicable laws. All materials contaminated with patient specimens should be
inactivated by validated procedures (autoclaving or chemical treatment) in
accordance with applicable regulations.

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ISO 9001:2015
www.agappe.com EN ISO 13485:2016
Rev.0.220622
Thyroid Stimulating Hormone (TSH) CLIA 2 X 50 Test
52025005

Quality control Performance

Ensure the control to ambient temperature, mix and place it on the required rack.
Ensure the related control information is obtained by the analyser for specific
operations, please refer to the analyser user manual.
Ensure that control values are within the concentration ranges.
Recommended quality control frequency:
For every new reagent.
After every calibration.
1.Accuracy:
The titer ratio of the measured value and the labeled value of the calibrator is
within 0.900 - 1.100.
The relative deviation is within the range of ±10.0%.
2.Sensitivity:
Limit of blank is  0.005µIU/mL; The limit of blank is the 95th percentile value
of the zero-concentration calibrator for repeated determination.

Once every 24 hours when the test is in use. Limit of detection is  0.01µIU/mL

If the quality control procedures in user’s laboratory require more frequent use of The limit of detection is the lowest analytical concentration which is distinguished
controls to verify test results, follow the laboratory specific procedures. from the limit of blank (Miscalculation probability = 0.05).

Limitation Limit of quantification is 0.02µIU/mL.

This assay has only been validated for the specimen type of human serum and
3.Linearity:
plasma (heparin and EDTA). Other types of specimens have not been validated.
In the range of 0.02µIU/mL-120.00µIU/mL, the coefficient of correlation r is not
Specimens of severe icterus, hemolysis, lipemia and contamination may result in
less than 0.9900.
error results.
4.Precision:
Interference due to extremely high titers of antibodies to streptavidin and intake
of high dose of biotin can occur. The intra-lot coefficient of variation (CV) is not higher than 8.0%.
Heterophilic antibodies in specimen can react with reagent immunoglobulins, The inter-lot coefficient of variation (CV) is not higher than 15.0%.
interfering with in vitro immunoassays.
5. Interference
Patients routinely exposed to animals or animal serum products can be prone to
this interference and anomalous values may be observed. Interfering Substance Concentration (Max)

The results of different detection systems cannot be used interactively. Hemoglobin  9 g/L

Reference Range Triglyceride  10.84 mmol/L

0.3µIU/mL-4.3µIU/mL Bilirubin  426.7 µmol/L

The above reference interval is the midd le 95% interval of the results of 233 Biotin  30ng/mL
apparently healthy individual samples. It is recommended that each laboratory EDTA-Na  5mg/mL
establish its own normal range which may be unique to the population it serves Heparin sodium  30IU/mL
depending upon ethnics, geographical, patient, dietary, or environmental factors

Interpretation of Result
For diagnostic purposes, the results should always be assessed in combination
with the patients’ medical history, clinical examination and other findings.
If the results are inconsistent with clinical evidence, additional testing is suggested
to confirm the result.
6. Specificity
When the concentration of FSH isn’t lower than 200IU/L, the concentration of LH
isn’t lower than 200IU/L or the concentration of hCG isn’t lower than 1000IU/L,
the result is not higher than 0.01µIU/mL.
Bibliography
1. Lin Z, Wang X,Li ZJ, et al. Development of a sensitive, rapid, biotin-streptavidin
based chemiluminescent enzyme immunoassay for human thyroid stimulating
hormone. Talanta, 2008, 75(4): 965-972.
2. Stochigt J. Assessment of thyroid function: towards an integrated laboratory-
clinical approach. Clin Biochem Rev, 2003; 24(4): 109-122.

 N

ISO 9001:2015
www.agappe.com EN ISO 13485:2016
Rev.0.220622