Description
Rapid qualitative detection of influenza type A and type B antigens in human nasal specimens for in vitro diagnostic use.
FEATURES
Method: Monoclonal immunochromatographic assay
Specimen: Nasopharyngeal swab
Detection Device: Dipstick
Time to Result: 10 minutes
External Quality Control: Positive influenza A and influenza B control swab
Package: 20 tests/kit
Storage temperature: 15-30℃
CLINICAL PERFORMANCE
Comparison study was conducted in 132 patients with Flu-like symptoms and compared the results of Vstrip® Flu A&B Rapid Test to a FDA-cleared commercial kit.
Influenza A Influenza B
Sensitivity: 94.7% 91.3%
Specificity: 97.9% 100%
Accuracy: 97.0% 98.5%
PPV: 94.7% 100%
NPV: 97.9% 98.2%
ANALYTICAL SENSITIVITY
Among the 14 influenza A strains (H1N1, H3N2, etc.) and 3 influenza B viruses (Victoria, Yamagata), the minimum detectable concentration was follows:
Flu A H1N1 subtype: 1.0x104 TCID50/ml
Flu A H3N2 subtype: 5.0x103 TCID50/ml
Flu B virus : 1.25x105 TCID50/ml
ANALYTICAL SPECIFICITY
The cross reactivity study was evaluated with a total of 15 bacteria strains and 5 viruses strains. None of these tested microorganisms gave a positive result.