Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma(EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider.

Specification

1T/Kit,20T/Kit

Kit components

Features&advantages

■ Coated with carefully selected specific Nucleocapsid and Spike protein antigen.

■ Detection for IgM and IgG antibodies simultaneously.

■ Simple operation, easy result interpreted.

■ Rapid test within 15 minutes.

Performances

- Positive Percent Agreement(PPA)=91.07%(153/168)(95% Cl:85.70%-94.92%).

- Negative Percent Agreement(NPA)=95.37%(103/108)(95% Cl:89.53%-98.48%).

- Overall Rates of Agreement(ORA)=92.75%((153+103)/(168+108))(95% Cl:89.03%-95.52%).

Storage

1.The test device is sensitive to humidity and as well as to heat.

2. Store kit components at 2-30℃ and do not use after the expiry date on the box outer label.