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GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP swab)
The new CE-IVD marked GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
The tests show diagnostic sensitivity of 93.4% and diagnostic specificity of 99.4%, therefore they meet the WHO performance criteria (sensitivity ≥ 80%; specificity ≥ 97%) for use in the global fight against COVID-19.
For professional in vitro diagnostic use only.
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GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens present in nasopharyngeal swab specimen.
Main Features
• Current mutant strains can be detected (UK, South Africa, Brazil)
• Easy specimen collection: nasopharyngeal swabs
• Fast results in 15 minutes
• Intuitive visual interpretation
• Diagnostic Sensitivity: 93.4% ; Diagnostic Specificity: 99.4%
• Easy to perform: no special equipment needed
• CE-IVD
Test Procedure
Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. Swab over the surface of the posterior nasopharynx 5-10 times.
| SKU | CVAG408A |
|---|---|
| Test principle | Rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimens |
| Analysable samples | Nasopharyngeal swabs |
| Assay time | 15 min |
| No. of tests | 20 |