Free Triiodothyronine (FT3) Test Kit (Homogeneous Chemiluminescence Immunoassay)

【Product Name】

Free Triiodothyronine (FT3) Test Kit (Homogeneous Chemiluminescence Immunoassay)?

【Packing Specification】

25 servings/?box

【Intended Use】

The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are secreted into the bloodstream by the thyroid gland and play a vital role in regulating the body's metabolic rate, influencing the cardiovascular system, growth and bone metabolism, and are important for normal development of gonadal functions and nervous system.

T3 circulates in the bloodstream as an equilibrium mixture of free and serum bound hormone. Free T3 (fT3) is the unbound and biologically active form, which represents only 0.2-0.4 % of the total T3. The remaining T3 is inactive and bound to serum proteins, while the distribution of T3 between these binding proteins (thyroxine binding globulin, pre-albumin, albumin) is controversially discussed.

The determination of free T3 has the advantage of being independent of changes in the concentrations and binding properties of the binding proteins; additional determination of a binding parameter (T-uptake, TBG) is therefore unnecessary. Therefore free T3 is a useful tool in clinical routine diagnostics for the assessment of the thyroid status. Free T3 measurements support the differential diagnosis of thyroid disorders, are needed to distinguish different forms of hyperthyroidism, and to identify patients with T3 thyrotoxicosis.

【Principle】

Competition principle.

The Free Triiodothyronine (FT3)?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 decreased with the increasing FT3?concentration.

【Main Components】

Lyophilized sphere reagents: DNA1-labeled T3 antibody (mouse) (≤1.0ug/mL), DNA2-labeled T3-coupled antigen (≤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.

2?Reaction cups

2?Buffer?solution

2?Substrate solution

2?Pipette

2?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°C 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°C 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. The sample must be returned to room temperature (15-30℃) before testing. The frozen sample must 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 chemiluminescent 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 FT3 in the unknown sample, which can be read at the level of pmol/L.

4. Calibration

Each batch of the kit contains its own specific calibration information, which is stored on a calibration card.

【Reference Interval】

The following reference range was determined by statistical analysis of the 95% confidence interval distribution range of FT3 levels in 200 healthy human samples according to the normal distribution method.

Normal reference value: 3.1-6.8 pmol/L

The FT3 levels measured will vary depending on the region, individual differences and the testing method used. 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 should not be used as the sole 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.