INTENDED USE

A Rapid test for the qualitative detection of novel coronavirus antigens, influenza A&B virus, respiratory syncytical virus, adenovirus in nasal swab. For self-testing use.

INTRODUCTION

RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test is an in vitro diagnostic test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein antigen, Influenza A&B (Flu A&B) nucleoprotein antigen, Respiratory Syncytical Virus (RSV) F antigen and Adenovirus (ADV) hexon protein in nasal swab within 7 days of onset of symptoms, as an aid for diagnosis of COVID-19, within 4 days of onset of symptoms, as an aid for diagnosis of Influenza A/B, within 6 days of onset of symptoms, as an aid for diagnosis of RSV within 6 days of onset of symptoms, and as an aid for diagnosis ofADV, using the rapid immunochromatographic method. This kit is intended forlayperson’s home use in a non-laboratory environment. (This product is not intended for children under three years old.)

PRINCIPLE

The RSV, Adv, Flu A/B & Covid-19 Rapid Antigen Combo Test is a lateral flow immunoassay based on the principle of the double antibody sandwich technique. A monoclonal Covid-19/Flu A&B/RSV/Adv antibody conjugated with colored microparticles and sprayed onto the conjugation pad is used as a detector. During the test, the Covid-19/Flu A&B/RSV/Adv antigen in the sample interacts with the Covid-19/Flu A&B/RSV/Adv antibody conjugated with colored microparticles, creating an antigen-antibody labeled complex. This complex migrates on themembranebycapillaryactionuptotheTestlinewhereitiscaptured bythe pre-coatedmonoclonalCovid-19/Flu A&B/RSV/Adv antibodies. A colored test line (B/A/Cov/Adv/Rsv) would be visible in the each result window if Covid-19/Flu A&B/RSV/Adv antigens are present in the sample. The absence of the T line indicates a negative result. The control line (C) is for procedural control and should appear whenever the test procedure is being performedproperly.