Whole Blood/Serum/Plasma Test Cassette
INTENDED USE
Hecin COVID-19 IgM Antibody Rapid Test Kit is an immunochromatographic assay for rapid, qualitative detection of COVID-19 IgM Antibody in whole blood, serum, plasma and fingertip blood. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results don’t preclude COVID-19 infection and they cannot be used as the sole basis for treatment or other management decision.
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SUMMARY
On December 31, 2019, several cases of pneumonia in Wuhan City, Hubei Province of China were reported to the World Health Organization (WHO). The novel virus, now known as 2019-nCoV (also referred to as SARS-CoV-2), is a member of the beta coronavirus family and has spread across China and to other countries or regions. The WHO has named the disease caused by 2019-nCoV as coronavirus disease 2019 (abbreviated“COVID-19”). The major clinical symptoms of COVID-19 include fever, fatigue and dry cough, while some patients also showed nasal congestion, runny nose, and diarrhea, etc. Most severe cases have dyspnea a week later. Condition of critical patients could deteriorate rapidly to acute respiratory distress syndrome, septic shock, irreversible metabolic acidosis and blood coagulation dysfunction. It should be noted that severe and critical COVID-19 patients might have no obvious fever throughout the course. Cases infected by symptomatic patients were also reported.
DETECTION PRINCIPLE
Hecin COVID-19 IgM Antibody Rapid Test Kit is an IgM capture solid-phase immunochromatographic assay and can be used for the detection of COVID-19 specific IgM in whole blood, serum, plasma and fingertip blood. The quality control (C) line is pre-coated with anti-rabbit IgG antibodies, and the detection (T) line is pre-coated with COVID-19 antigen. The gold pad is coated with colloidal gold-labeled anti-human IgM antibodies. COVID-19 specific IgM antibodies in sample will combine with colloidal gold-labeled anti-human IgM antibodies and form a gold-labeled antibody-antigen complex. The complex will then move along the detection card and react with the pre-coated COVID-19 antigen on the detection line (T-line) and form the “anti-IgM-IgM-antigen” complex, then a visible pink/purple band will appear at the test line (T) after assay. In addition, colloidal gold-labeled rabbit IgG antibodies which can be recognized by immobilized anti-rabbit IgG antibodies were used as a control for proper function of the reagents. A pink/purple band in the control line (C) should bevisualized.
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