Progesterone(Prog)Rapid Quantitative Test (Fluorescence Immunoassay)

Ⅰ.Intended use

This kit is used for quantitative determination of progesterone in human whole blood, plasma and serum.

Progesterone is secreted by the ovarian corpus luteum in the early stage of pregnancy. It has a significant morphological effect on the endometrium .The main function is to maintain pregnancy, which is secreted by the placenta in the middle and third trimester of pregnancy. Low progesterone also indicates the deficiency of luteal function. Progesterone can maintain the growth of endometrium, which is conducive to the implantation and growth of fertilized eggs. Otherwise, it will delay the development of endometrium, fail to produce normal secretory response, and it is difficult to support the planting of fertilized eggs, resulting in infertility, or although it can be temporarily implanted, it cannot maintain its development and growth, and eventually lead to abortion. Repeated occurrence will lead to habitual abortion. Therefore, the detection of progesterone can be used to determine ovulation and luteal phase defects. In addition, the detection of progesterone can also monitor progesterone treatment and evaluate early pregnancy.

Ⅱ.Principle of product Testing

The kit adopts the principle of competitive method. Take the sample to be tested, add it into the sample diluent and mix it evenly. Add the mixed sample into the sample adding hole. Prog in the sample combines with the fluorescent labeled antibody on the binding pad to form a complex. Under the action of chromatography, the complex moves forward along the nitrocellulose membrane, and the fluorescent labeled antibody that does not bind to the test line is captured by Prog-BSA coated on the nitrocellulose membrane detection line. The more Prog in the sample, the fewer complexes gathered on the detection line, and the signal of fluorescent antibody is inversely proportional to the number of objects to be tested in the sample. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyzer.

Ⅲ.Components of a product

Ⅳ.Test procedure

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.

2. Start NIR-1000 dry fluoroimmunoassay analyzer and correctly select the corresponding sample type on the instrument.

3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.

4. Take out the test card from the aluminum foil bag and use it within 15 minutes.

5. Place the test card on a clean horizontal table and mark it horizontally.

6. Mix 100 µL of sample with 200µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.

7. At 15 minutes after addition of samples, insert the test card into NIR-1000 dry fluoroimmunoassay analyzer and click the “Instant test” button to read the results.

Ⅴ.Reference interval

It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.

Ⅵ. Performance

1. Limits of detection No higher than 1.40 ng/mL.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (1.40~ 60.00 ng/mL), the linear correlation coefficient R≥0.990.

Ⅵ.Prog.pdf