COVID-19 Antibody rapid test

Short Description:

SUMMARY This product is used for in vitro qualitative detection of COVID-19 antigen in human throat swabs, nasal swab and saliva. Coronavirus (CoV) is belongs to the Nestovirus, Coronaviridae, and is divided into three genera: α, β, and γ. Genera α, β are only pathogenic to mammals, genera γ mainly cause bird infection. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral ro...

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Product Parameters

CAT #	PRODUCT	DESCRIPTION	SPECIMEN	CUT-OFF	SENSITIVITY	SPECIFICITY	ACCURACY	FORMAT	KIT SIZE
RICOV0	COVID-19 IgG/IgM individual	SARS-CoV2 IgG/IgM 3-line Test,with blood needle	WB/S/P	N/A	96.40%	98.70%	98.10%	Cassette	25T
RICOV1	COVID-19 IgM	IgM antibody to SARS-Cov2	WB/S/P	N/A	95.50%	100%	98.60%	Cassette	25T
RICOV2	COVID-19 IgG/IgM	SARS-CoV2 IgG/IgM 3-line Test	WB/S/P	N/A	96.40%	98.70%	98.10%	Cassette	25T

Summary

This product is used for in vitro qualitative detection of SARS-CoV2 IgG/IgM antibodies in human serum/plasma/whole blood.

Coronavirus (CoV) is belongs to the Nestovirus, Coronaviridae, and is divided into three genera: α, β, and γ. Genera α, β are only pathogenic to mammals, genera γ mainly cause bird infection. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route.

There are 7 types of human coronavirus (HCoV) that cause human respiratory disease: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV2, which are the important pathogens of human respiratory infections.

SARS-CoV2 may cause COVID-19 which first appeared in Wuhan China in November 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, and acute breathing Distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. and even life-threatening.

SARS-CoV2 also named as 2019-nCoV.

Principle

The reagent utilizes the principle of capture reaction and combines with colloidal gold immunochromatography.

The test card contains: 1) colloidal gold-labeled recombinant SARS-CoV2 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 SARS-CoV2 IgM antibody; the G line is fixed with a reagent for detecting the SARS-CoV2 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 SARS-CoV2 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 SARS-CoV2 IgM antibody is positive. If the sample contains IgG antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV2 antigen. The immune complex will be captured by IgG antibodies immobilized on the membrane, forming a purple-red G line, showing that the SARS-CoV2 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.