INTENDED USE For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection. FEATURES Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2. Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva. Easy to use, easy results interpretation by naked eyes. Test result available within 15minutes. TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit. RESULTS INTERPRETATION Positive: A red line appears on the test line (T) and the control line (C). NOTE: A positive result does not rule out co-infections with other pathogens. Negative: Only the control line (C) appears, and no red line appears on the test line (T). NOTE: A negative result does not exclude infection. Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again. CLINICAL PERFORMANCE SARS-CoV-2 Antigen Test Kit Comparator Method (NTA) Positive Negative Total Positive 97 0 97 Negative 3 100 103 Total 100 100 200 - Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%) - LoD: 1.5�??102 TCID50 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% CI): 97/100, 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%). [Product Name]: SARS-CoV-2 Antigen Test [Product Code]: Cat# FP-318 [Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva [Detection Method]: Colloidal Gold [Reaction Time]: Within 15min [Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1. [Storage Conditions]: 2*C ~ 30*C [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/99/2021.