GSD NovaGen SARS-CoV-2 (COVID-19) Antigen Rapid Test (100x20)
The GSD NovaGen SARS-CoV-2 (COVID-19) Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 antigens from nasopharyngeal samples within 15 minutes.
The tests show diagnostic sensitivity of 92.6% and diagnostic specificity of 98.6%, therefore they meet the WHO performance criteria (sensitivity ≥ 80%; specificity ≥ 97%) for use in the global fight against COVID-19.
The GSD NovaGen SARS-CoV-2 (COVID-19) Antigen Rapid 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 swabs from patients who are suspected of being COVID-19 positive.
• Fast and reliable results in 15 minutes
• Sample material: nasopharyngeal swabs
• Cost-effective and easy to use; no additional special equipment required
• Transportation and storage at room temperature
• Diagnostic Sensitivity: 92.6% ; Diagnostic Specificity: 98.6%
After sample collection, insert the swab into the tube containing the buffer solution. Rotate the swab for one
minute and close the lid. Use the dropper to transfer 3 drops (approximately 100 μL) of the specimen with
reagent to the specimen well (S) of the cassette, and start the timer.
|Test principle||Double antibody-sandwich, qualitative membrane-based immunoassay - In-vitro diagnostic medical device|
|Analysable samples||Nasopharyngeal swabs|
|Assay time||15 min|
|No. of tests||100x20|