SARS-CoV-2 (COVID-19) Antigen Rapid Test is intended for the qualitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen.
This Test is a double antibody-sandwich, qualitative membrane-based immunoassay In-vitro diagnostic medical device. The kit is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal swab from patients who are suspected of being COVID-19 positive. The SARS-CoV-2 antigens present in the specimen react with anti- SARS-CoV-2 antibody-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the pre-coated antibody in the test line region. If the specimen contains SARSCoV-2 antigens, a coloured line will appear in the test line region. If the specimen does not contain SARS-CoV-2 antigens, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Main Features:
- 20 separately packed test cassettes, for single use only
- 20 separately packed reagents in tube with dropper, for single use only
- 20 separately packed sterilised nasopharyngeal swabs, for single use only
- Results in 15 minutes
- Store the kit at room temperature or refrigerated (2-30 °C). Do not freeze the kit. The kit has a shelf-life of 12 months
- High Sensitivity and Specificity standards, when compared to a PCR Methodology
- CE-IVD marked
- Made in EU