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GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal swab)
The new CE-IVD marked 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 in nasal swab specimens 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 93.5% and diagnostic specificity of 99.3%, 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.
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 nasal swab specimen.
Main Features
• Fast and reliable results in 15 minutes
• Sample material: nasal swabs
• Cost-effective and easy to use; no additional special equipment required
• Transportation and storage at room temperature
• Diagnostic Sensitivity: 93.5% ; Diagnostic Specificity: 99.3%
• CE-IVD
Test Procedure
Insert a sterilized swab less than one inch (about 2 cm) into a nostril. Rotate the swab 5-10 times against the nasal wall and repeat in the second nostril.
SKU | CVAG408B |
---|---|
Test principle | Rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimens |
Analysable samples | Nasal swabs |
Assay time | 15 min |
No. of tests | 20 |