A. Description

This kit is only used for the in vitroqualitative detection of 2019-nCoV S-RBD IgG antibody and S-RBD IgM antibody from human serum,plasmaor whole blood.

This kit is intended for the detection of neutralizing antibody against COVID-19, which can better monitor herd immunity and protective immunity, and evaluate the efficacy of vaccines during clinical trials as well as after mass vaccination. The results are for clinical reference only.

This kit is intended for people aged 18-59 years who have received the COVID-19 vaccine.

This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques in the field ofin vitrodiagnostic procedures.

B. MAIN COMPONENTS

1. Test cards are sealed together with desiccant in aluminum foil pouch.

2. Do not mix use different batches of test cards and sample diluent.

C. TEST PROCEDURE

1.Remove the test card by opening the aluminum foil pouch from tear notch and lay it flat.

2.Serum or plasma: Load 10μL into the sample well (S) of the test card.

3.Whole blood: Load 20μL into the sample well (S) of the test card.

4.Add 2 drops (approximately 80 μL) of sample diluent into the sample well (S) of the test card.

5.Please read the chromogenic results in the detection zone between 15~20 minutes to ensure proper test performance. Do not read results after 30 minutes. Results read after 30 minutes are invalid.