COVID-19 Antigen Rapid test

Covid-19 Antigen Rapid Test-Nasal Swab

[PRINCIPLE]

The Covid-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains a conjugate formed by binding to a monoclonal antibody against SARS-CoV-2 nucleocapsid protein;the reaction membrane contains the secondary antibodies for Nucleocapsid protein protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

[WARNINGS AND PRECAUTIONS]

· For in vitro diagnostic use only.

· For healthcare professionals and individuals trained in point of care settings.

· Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

· Do not use this product after the expiration date.

· Please read all the information in this leaflet before performing the test.

· The test cassette should remain in the sealed pouch until use.

· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

· The used test cassette should be discarded according to federal, state and local regulations.

Nasal Swab Specimen Collection step 

1. While gently rotating the swab, insert swab about 2.5 cm (1 inch) into nostril until resistance is met at turbinates.

1. Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.

   packing list : 

   1pc /box , 43.5*47.5*55.5cm , 480boxes /carton 

   5pcs/box , 46*44*51cm , 180boxes/carton , 900pcs/carton