COVID-19 IgM / I gG is a rapid blood test for antibodies.

Format: Cartridge.

Sample: Serum / Plasma / Whole Blood.


Artron COVID-19 IgM / IgG is a fast, high-quality, convenient immunochromatographic in vitro test for the differential detection of IgM & IgG antibodies against SARS-COV-2 in human serum, plasma or whole blood. The device is designed to help determine the recent or previous exposure of the SARS-COV-2 virus to monitor the condition of the disease after SARS-COV-2 infection.

This analysis provides preliminary data only. A positive result does not necessarily mean an ongoing infection, but it does condition a different stage of the disease after being infected. IgM positive or IgM + IgG positive suggest recent exposure, whereas IgG positive suggests previous or latent infection. The present infection must be confirmed by real-time reverse transcriptase (RT-PCR) or viral gene sequencing. Clinical expertise and professional judgment should be sought to further evaluate the test result. COVID-19 IgM / I gG is intended for professional use as an aid in diagnosing only SARS-COV-2 infection.

Summary and principle of the test

SARS-COV-2 is an acute illness that can lead to death. The deceased patients after infection are about 2%. Since late December 2019, SARS-COV-2 has triggered an outbreak of new coronavirus disease (COVID-19; formerly known as 2019-nCoV), which has subsequently affected more than 114 countries and regions worldwide. The disease can lead to death due to massive damage to the alveoli and progressive respiratory failure. The pathogen has since been identified as a zoonotic coronavirus, similar to SARS coronavirus and MERS coronavirus, and has been declared a severe acute coronavirus 2 syndrome (SARS-CoV-2). The new 2019 epidemic (SARS-CoV-2) has been declared by the World Health Organization as a public health emergency of international concern and may develop into a pandemic associated with significant morbidity and mortality. SARS-CoV-2 is genetically linked to SARS-CoV, causing a global epidemic with 8096 confirmed cases in more than 25 countries in 2002-2003.

The principle of the Artron COVID-19 IgM / IgG test is immunochromatographic analysis for the capture, detection and differentiation of IgM & IgG antibodies to SARS-COV-2 virus in human serum, plasma or whole blood. The specific antigens of SARS-COV-2 are conjugated with colloidal gold and deposited on the conjugated support. Monoclonal anti-human IgM and monoclonal anti-human IgG are immobilized on two separate test lines (T-line 2 and T-line 1) on the nitrocellulose membrane. The IgM line (T2) is closer to the sample well and is followed by the IgG line (T1). When the sample is added, the gold-antigen conjugate is rehydrated and the SARS-COV-2 IgM and / or IgG antibodies, if present in the sample, are reacted with the gold conjugated antigen. The immunocomplex migrates to the test window to the test area (T1 & T2), where it is captured by the respective anti-human IgM (T2) and / or anti-human IgG (T1), forming a visible pink line indicating positive results. If the SARS-COV-2 antibodies are absent in the sample, no pink line (T1 & T2) will appear in the test lines, showing a negative result.




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