Thyroid ? Stimulating Hormone (TSH) Test Kit (Homogeneous Chemiluminescence Immunoassay)

【Packing Specification】

25 servings/ box

【Intended Use】

Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Thyroid-stimulating hormone (TSH, thyrotropin) is a glycoprotein having a molecular weight of approximately 30000 daltons and consisting of two subunits. The β-subunit carries the TSH-specific immunological and biological information, whereas the α-chain carries species-specific information and has an identical amino acid sequence to the α-chains of LH, FSH and hCG. TSH is formed in specific basophil cells of the anterior pituitary and is subject to a circadian secretion sequence. The hypophyseal release of TSH (thyrotropic hormone) is the central regulating mechanism for the biological action of thyroid hormones. TSH has a stimulating action in all stages of thyroid hormone formation and secretion; it also has a proliferative effect.

The determination of TSH serves as the initial test in thyroid diagnostics. Even very slight changes in the concentrations of the free thyroid hormones bring about much greater opposite changes in the TSH level. Accordingly, TSH is a very sensitive and specific parameter for assessing thyroid function and is particularly suitable for early detection or exclusion of disorders in the central regulating circuit between the hypothalamus, pituitary and thyroid.

【Principle】

Sandwich principle.

The Thyroid ? Stimulating Hormone (TSH) test kit employs a wash-free and homogeneous strategy based on proximity hybridization-regulated CRET(Chemiluminescence resonance energy transfer). The AE demonstrated strong chemiluminescence (CL) in the presence of H2O2. Graphene oxide (GO) as an excellent quencher was used to produce the “Signal off” mode that little CL emission was observed through CRET between GO and the AE-labelled DNA3. Once the antigen was introduced, the target-induced proximity hybridization occurred to form a proximate complex, which inhibited the CRET by preventing GO from absorbing AE-labelled DNA3. The CL intensity increased with the increasing TSH concentration.

【Main Components】

Lyophilized sphere reagents: DNA1-labeled TSH1 antibody (mouse) (≤1.0ug/mL), DNA2-labeled TSH2 antibody (mouse) (≤1.0ug/mL), DNA3-labeled acridine ester (AE), graphene oxide (GO) conjugated antioxidant (AOD), preservative (P300) (0.1%). Calibration card: containing standard curve for product calibration.

※ The components in the kits of different batches are not

interchangeable.

? Reaction cups

? Buffer solution

? Substrate solution

? Pipette

? Disposable tip

【Storage Conditions and Expiration Date】

Stable for 18 months when stored at 2-8℃ away from light. Reagents are used immediately upon opening.

【Applicable Instruments】

Chemiluminescence immunoassay analyzer (HSCL-5000) produced by Nanjing Poclight Biotechnology Co. Ltd.

【Sample Requirements】

1. The serum is recommended to be collected by ordinary serum

collection tubes or tubes with procoagulant. If it cannot be used

immediately, it is recommended to be stored at 2-8℃ and the test

should be completed within 24 hours. If the test cannot be performed

within 24 hours, the sample needs to be frozen at -20℃ for 1 month.

2. Plasma is recommended to be anticoagulated with heparin or EDTA.

If it cannot be used immediately, it is recommended to be stored at

2-8 ℃ to complete the test within 24 hours. If the test cannot be

performed within 24 hours, the sample should be frozen at -20℃, valid

for 1 month.

3. Samples containing sediment or flocculent material should be

centrifuged (4000rpm, 10min) and then tested.

4. Samples must be returned to room temperature (15-30℃) before

testing. Frozen samples should be completely thawed, rewarmed and

mixed well before use. Do not repeatedly freeze and thaw.

5. Heat inactivated samples, hemolysis and other abnormal samples

should be discarded.

【Test Method】

The test method is homogeneous chemiluminescence immuoassay.

1. Preparation before testing.

1.1 Please read this manual and the instrument manual carefully before

use.

1.2 Check whether the instrument can work normally, whether the

reaction cup or sample tube, substrate solution and buffer are prepared

adequately, and prepare other related consumables.

2. Test procedure

2.1 Turn on the chemiluminescence immunoassay analyzer.

2.2 Check whether the calibration code is consistent with the lot

number of the kit and scan the calibration code.

2.3 Mix 50μL of the sample to be tested into the reaction cup, put it

into the instrument and start incubation, measurement, data processing

and test results.

2.4 The total detection time is 10 minutes.

3.Result analysis.

The measured chemiluminescence intensity is converted from the

standard curve to obtain the concentration of PCT in the unknown

sample, which can be read to the level of μIU/mL.

4. Calibration

Each batch of the kit contains its specific calibration information,

which is stored in the calibration card.

【Reference Interval】

The following reference range was determined by statistical analysis

of the 95% confidence interval distribution range of TSH levels in 200

healthy human samples according to the normal distribution method.

Normal reference value: 0.270-4.20 μIU/mL

Due to regional differences, individual differences and different testing

methods used, the TSH levels measured may vary. Therefore, it is

recommended that each laboratory should establish its own reference

value range for its own characteristic population.

【Interpretation of Test Results】

1. The test results are for clinical reference only and should be

considered in conjunction with clinical symptoms, medical history,

other laboratory tests and other circumstances, and are not to be used

as a basis for clinical diagnosis.

2. If the test result is abnormal or differs from the clinical diagnosis,

verification is recommended.

3. The operation must be done in strict accordance with the operation

procedures and carefully in order to get the correct results. Any

modification to the operating procedures may affect the accuracy of

the test results.

4. Bacterial contamination of the sample or repeated freeze-thawing

may also affect the results.