Intended Use
This product is suitable for the qualitative detection of novel coronavirus in nasopharyngeal swab or sputum samples. It provides an aid in the diagnosis of infection with novel coronavirus.
Principle
The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, the complex of the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-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 effect has occurred.
Storage and stability
Store the product package at temperature 2-30°C or 38-86°F, and avoid exposure to sunlight. The kit is stable within the expiration date printed on the labeling.
Once an aluminum foil pouch is opened, the test card inside should be used within one hour. Prolonged exposure to hot and humid environment may cause inaccurate results.
The lot number and the expiration date are printed on the labeling.
Price and lead time:
Depending on volume and other requirements, contact us if interested: inquiries@ad-medical-supplies.com
