BNIBT

Primary DI

06975456580281

Basic UDI-DI Code

B-06975456580281

Reference

RFPDGS

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing North Institute of Biotechnology Co.,Ltd.

The Progesterone Rapid Test is a lateral flow immunochromatographic assay in which a chemically labeled PdG-BSA competes with the PdG which may be present in urine for limited antibody binding sites. The test strip contains a membrane strip which has been pre-coated with PdG-BSA conjugate on the test band region. A colored anti-PdG antibody-colloidal gold conjugate pad is placed at the end of the membrane. The colored antibody-colloidal gold conjugate moves along with urine, chromatographically by capillary action, across the membrane. In the absence of PdG in the urine, the colored antibody colloidal gold conjugate attaches to the PdG-BSA conjugate on the Test Line region to form a visible line as the antibody/ PdG-BSA conjugate complexes. Therefore, the formation of a visible precipitant in the Test Line region occurs when the test urine is negative for the PdG. When the PdG is present in the urine, the PdG/metabolite antigen competes with the PdG-BSA conjugate on the Test Line region for the limited antibody sites. When a sufficient amount of PdG is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the PdG-BSA conjugate zone on the Test Line region. Therefore, absence for the color line on the test region indicates a positive result. A control or reference line with a different antigen/antibody reaction is also added to the immunochromatographic membrane strip to indicate that the test is performed properly. This Control Line should always appear regardless of the presence of drug of metabolite. This means that negative urine will produce two colored lines, and positive urine will produce only one line. The presence of this colored line in the Control Line region also serves as verification that 1) sufficient volume has been added, and 2) that proper flow was obtained.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).