Theradiag COVID19-LISA IgG + IgM

The novel coronavirus (SARS-CoV-2) belongs to β-coronavirus gender. It is responsible for an acute respiratory infectious disease named COVID-19. Currently, patients, including asymptomatic carriers, infected by this new virus are the primary source of infection. Based on the current epidemiologic information, the time between first contact and symptoms is usually from five to six days, but it can range from 1 to 14 days. Most common symptoms of COVID-19 are fever, dry cough, and fatigue. Other less common symptoms can arise on some people such as body aches, nasal congestion, headaches or sore throat, diarrhoea or loss of taste or smell.
The novel SARS-CoV-2 virus is a single-stranded RNA coronavirus with a methylated cap on 5’ and a polyA tail on 3' side. The virus is composed of 4 major structural proteins: the spike protein (S protein), the nucleocapsid protein (N protein), the membrane protein (M protein) and the envelope protein (E protein).
The S protein is a trimeric glycoprotein that will bind to the viral receptor of the host cell, this is a key protein that determines the contamination of the virus sensitive cells. This S protein can be split by the host cell protease in two subunits: S1 and S2. S1 links to the ACE2 receptor of the host cell, that plays an important role in the viral infection. The S protein is displayed predominantly on the virus surface. As it is responsible for the virus entry, it is a major binding site for neutralizing antibodies, so a key target for the immune detection.
IgG and IgM antibodies against SARS-CoV-2 can be detected from the second week after symptoms onset. However, it has also been reported cases with later antibodies production, beyond 15 days after post symptoms onset, and up to 30 days after the infection, especially for asymptomatic or paucisymptomatic patients.
The HM080 kit allows quantitative detection of IgG antibodies directed against the N and S proteins of the SARS-CoV-2 virus and HM081 kit allows quantitative detection of IgM antibodies directed against S protein of the SARS-CoV-2 virus in human serum or plasma using immunoenzymatic method (ELISA). It is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

Correlation

HM080 (IgG) - The study had been performed using 169 serum samples. 91 positive samples were confirmed SARS-CoV-2 by RT-PCR and 78 negative samples. Sensitivity, specificity and correlation are 99% on the studied cohort.

HM081 (IgM) - The study had been performed using 166 serum samples. 80 positive samples were confirmed SARS-CoV-2 by RT-PCR and 86 negative samples. Sensitivity, specificity and correlation are 99% on the studied cohort.

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