The SARS-CoV-2 Antigen Test is intended for the qualitative detection of the nucleacapsid protein antigen from SARS-CoV-2 in nasopharyngeal(NP) and nasal (NS) swab, and saliva specimens directly from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.

Specification

1T/Kit,2T/Kit

Kit components

Features&advantages

■ Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2;

■ Various specimen applied; Nasopharyngeal(NP) swab, Nasal(NS) swab and Saliva;

■ Easy run, easy to interpretation by naked eyes;

■ Test result will be present within 15minutes.

Performances

-LoD:1.5×10²TClD₅₀ for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.

-Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.

-No cross reactions with various bacteria, viruses and fungi normally available in respiratory track.

-Positive Agreement(95% Cl):30/31   96.8% (83.3%-99.9%)

-Negative Agreement(95% Cl):80/80  100.0%(95.5%-100%).

Storage

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

2. Store kit components at 2-30°C, out of direct sunlight. Kit components are stable until the expiration date printed on the outer box.

3. After unsealing the aluminum foil bag, the test cassette should be used as soon as possible within Two hours.

4. Do not freeze.