Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test


Background

The 2019 novel coronavirus, abbreviated as 2019-nCov, is a new strain of coronavirus discovered in the human body from the outbreak in Wuhan at the end of 2019. The symptoms of the virus are fever, fatigue, dry cough, and progressive dyspnea. In severe cases, the symptoms are acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulation dysfunction that can’t be reversed. The virus has the capacity of human-to-human transmission; the shortest incubation period of the virus is only 1 day, while the longest is 14 days. The patients in incubation period is contagious and there is no specific treatment for the disease. Once infected with a new virus, the body's immune system will start to defend and produce specific antibodies. Generally, IgM antibody will appear in 1-2 weeks and IgG antibody will appear in 4 weeks.

IgM/IgG antibody

IgM antibody is the first antibody in the first humoral immune response, and it is the "first force" to fight against infection. IgM antibody detected in serum indicates a new infection, which can be used for early diagnosis of infection. The detection of IgG antibody can be used for the overall diagnosis of infection.

Intended use

This kit uses immunocolloidal gold chromatography to detect novel coronavirus IgM/IgG antibodies in human serum, plasma or whole blood in vitro.

Suitable for suspected novel coronavirus patients.

Package Specifications

1 test/bag

1 test/box

20 tests/box

50 tests/box

Detection Time

Rapid detection of novel coronavirus within 15 minutes( 2019-nCoV )

Specimen Requirements

(1) This kit can be used for the detection of serum, plasma or whole blood.

(2) Serum and plasma samples can be stored at 2 ~ 8℃ for a short period of time (1 week), and below -20℃ for more than one week and avoid repeated freezing and thawing; whole blood samples must be fresh.

(3) It can be used for samples of heparin, EDTA, sodium citrate and other anticoagulants.

Testing Principle

This product adopts the method of immunochromatography, the detection card contains colloidal gold labeled novel coronavirus recombinant antigen and gold labeled rabbit IgG antibody, and is coated with the mixture of anti-human IgM and anti-human IgG in the nitrocellulose-membrane detection line, and the quality control line is coated with sheep anti-rabbit IgG. When testing, if there is a novel coronavirus antibody in the sample, then the "novel coronavirus antigen colloidal gold - coronavirus antibody - anti-human IgM/IgG" complex is formed in the nitro cellulose membrane detection line to coagulate and display color, indicating a positive result. In the absence of antibodies to the novel coronavirus in the sample, the complex formed is insufficient to coagulate to produce color, indicating a negative result.

Storage Conditions

4 ~ 30℃ storage in dark and dry, the validity is tentatively 12 months.

Freezing or use after expiration is prohibited.

Production date and expiry date are shown on the packaging label.

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All certification can be provided upon request. Please reach out to our account executives at info@apeironmed.com or give us a call at +855 (0)85 555 792.