Progesterone Rapid Test Kits Prog diagnostic kit

For in vitro diagnostic use only

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Progesterone (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Progesterone (PROG) in human serum or plasma, it is used for auxiliary diagnosis of progesterone abnormally associated diseases.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

Progesterone is an important hormone that plays an important role in the regulation of the menstrual cycle and is essential in maintaining pregnancy. The progesterone concentration in the serum increased rapidly after ovulation. It is a reliable indicator of natural ovulation or induction of ovulation.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with the conjugate of BSA and PROG on the test region and goat anti rabbit IgG antibody on the control region.Marker pad are coated by fluorescence mark anti PROG antibody and rabbit IgG in advance. When testing sample, PROG in sample combine with fluorescence marked anti PROG antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, The free fluorescent marker will be combined with PROG on the membrane.The concentration of PROG is negative correlation for fluorescence signal, and the concentration of PROG in sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components:

Test card individually foil pouched with a desiccant25T

Sample diluents25T

Package insert1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container,timer

SAMPLE COLLECTION AND STORAGE

1.The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma.

2.According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months.

3.All sample avoid freeze-thaw cycles.

ASSAY PROCEDURE

Please read the instrument operation manual and package insert before testing.

1.Lay aside all reagents and samples to room temperature.

2.Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.

3.Scan the dentification code to confirm the test item.

4.Take out the test card from the foil bag.

5.Insert the test card into the card slot, scan the QR code, and determine the test item.

6.Add 20μL serum or plasma sample to sample diluent, and mix well..

7.Add 80μL sample solution to sample well of the card.

8.Click the"standard test"button, after 10 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.

9.Refer to the instruction of Portable Immune Analyzer(WIZ-A101).