BNIBT

Primary DI

06975456580236

Basic UDI-DI Code

B-06975456580236

Reference

RICOV2

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing North Institute of Biotechnology Co.,Ltd.

The reagent utilizes the principle of capture reaction and combines with colloidal gold immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant COVID-19 antigen and gold markers for quality control antibodies; 2) nitrocellulose membrane with two test lines (G and M lines) and one quality control line (C line). The M line is fixed with a monoclonal anti-human IgM antibody for detecting the COVID-19 IgM antibody; the G line is fixed with a reagent for detecting the COVID-19 IgG antibody; the C line is fixed with a quality control antibody. When an appropriate amount of the test sample is added into the sample hole of the test card, the sample will be move forward along the test card under the action of capillary. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled COVID-19 antigen. The immune complex will be captured by anti-human IgM antibodies immobilized on the membrane, forming a purple-red M line, showing that the COVID-19 IgM antibody is positive. If the sample contains IgG antibody, the antibody will bind to the colloidal gold-labeled COVID-19 antigen. The immune complex will be captured by IgG antibodies immobilized on the membrane, forming a purple-red G line, showing that the COVID-19 IgG antibody is positive. If the test line G and M are not colored, a negative result is displayed. The test card also contains a quality control line C, which should appear regardless of whether there is a test line. The quality control line C is the color belt of the quality control antibody immune complex. If quality control line C does not appear, it indicates that the test result is invalid, and the sample shall be retested with another test.

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