Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+heparin, K
2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
1. Accuracy
1.1 Purpose:
To evaluate the equivalence of COVID-19 IgG/IgM Rapid Test result and clinical diagnosis.
1.2 Method: By testing clinical samples with known results, to evaluate the accuracy of COVID-19 IgG/IgM Rapid Test (Whole blood/Serum/Plasma).
1.3 Material: 1)COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma);
2) Cassette Lot1: 2002155,Lot2:2002156,Lot3:2002157;
3) Clinical samples
1.4 Test Procedure: 1) Prepare specimens: tests were taken to clinical partner to evaluate, totally 113 specimens.
2) Perform the test according to the test procedure in the package insert .
1.5 Result 1) IgM
No Review