This product is suitable for the qualitative detection of novel coronavirus in sputum samples. It provides an aid in the diagnosis of infection with novel coronavirus.
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.
- Test Card
- Sample Extraction Tube
- Tube Cap
- Paper Cup
- Sputum Dropper
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.
WARNINGS AND PRECAUTIONS
- Read the instructions for use carefully before using this product.
- This product is for professional use ONLY.
- This product is applicable to sputum Using other sample types may cause inaccurate or invalid test results.
- Sputum rather than saliva is the type of sample recommended by WHO. Sputum comes from the respiratory tract while saliva comes from the mouth.
- Please make sure that a proper amount of sample is added for testing. Too much or too little sample amount may cause inaccurate results.
- If the test line or control line is out of the test window, do not use the test card. The test result is invalid and retest the sample with another one.
- This product is disposable. DO NOT recycle used components.
- Dispose of used products, samples, and other consumables as medical wastes under relevant regulations.