REF:

C2101 (Cassette)

INTENDED USE：

SARS-CoV-2 IgM/IgG Antibody Joint Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of SARS-CoV-2 in human serum, plasma or whole blood.

SARS-CoV-2 IgM/IgG Antibody Joint Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

Results from SARS-CoV-2 IgM/IgG Antibody Joint Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the qSARS-CoV-2 IgG/IgM Antibody Joint Test early after infection is unknown.

False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

For prescription use only. For emergency use authorization use only.

For in vitro diagnostic use only.

SUMMARY:

Coronavirus (CoV) belongs to order Nidovirales, family Coronavirus, and is divided into α、β、γ three genera.  The α、β genera is only pathogenic to mammals, while the γ genus mainly causes infection in birds. CoV is mainly transmitted by direct contact with secretions, by aerosol or droplet, and there is also evidence that it can be transmitted by fecal-oral route.

So far, there have been seven types of human coronavirus (HCoV) that cause respiratory diseases in humans: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV-2 is an important pathogen of human respiratory tract infection.

The novel coronaviruses belong to the β genus. SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

SARS-CoV-2 IgM/IgG Antibody Joint Test is intended for qualitative detection of antibodies indicative of SARS-CoV-2 infection and is to be used as an aid for diagnosis of SARS-CoV-2 infection.