PRODUCT NOT INTENDED FOR AT HOME USE.
PRODUCT INTENDED FOR PROFESSIONAL USE.
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FOR THE QUALITATIVE ASSESSMENT OF IgG AND IgM ANTIBODIES TO 2019 NOVEL CORONAVIRUS IN HUMAN SERUM, PLASMA OR WHOLE BLOOD
For In Vitro Diagnostic Use Only
25 Test Cards per Kit
1. QuickProfile™ 2019-nCoV IgG/IgM Test Card
2. Sample Buffer
3. 2 μL Capillary Pipet
4. Instructions for Use
MATERIALS REQUIRED BUT NOT SUPPLIED
Clock or timer, safety lancets, alcohol prep-pad, specimen collection container, centrifuge, biohazard waste container.disposable gloves, disinfectant.
QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood.QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
Coronavirus Disease 2019 (COVID-19) is an acute infectious disease caused by the 2019 novel coronavirus (SARS-CoV-2). The incubation period of the disease is 1-14 days, usually 3-7 days. The incubation period is infectious. Asymptomatic carriers may also be sources of infection. Respiratory droplets and contact are the main routes of transmission. The initial symptoms of the patients are fever, fatigue and cough, and gradually developed dyspnea and other serious manifestations. Most of the patients have a good prognosis, but some of the severe cases may have acute respiratory distress syndrome, septic shock, or even death. At present, there is no specific treatment for the disease.
There are several days of incubation period after being infected by 2019-nCoV. IgM antibodies can be detected soon after incubation period and remain for a short time. IgM positive blood samples can indicate acute infection. IgG antibodies appear after few days of incubation period and remain for a long time. IgG positive blood samples can indicate current or previous infection.
FDA GUIDANCE FOR EMERGENCY USE AUTHORIZATION (EUA) OF TEST SUBMITTED FOR APPROVAL. Authorization Status: NOT FDA Authorized
QP 2019-nCoV IgG/IgM Combo Test Card
QP 2019-nCoV Clinical Sample Study Report