Double check COVID-19 and Influenza A+B Antigen Rapid Test with CE
| Product Name |
Double check COVID-19 and Influenza A+B Antigen Rapid Test with CE |
| Formats |
Strip(3mm)Device(4mm) |
| Place of Origen |
China |
| Specimen |
swab |
| Read Time |
15 minutes |
| Shelf life |
2 years |
| Package |
25 device/box or 50 strip/Box |
| Storage |
2℃-30℃ |
For professional in vitro diagnostic use only
【INTENDED USE】
The Influenza A+B Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.
Sensitivity, Specificity and Accuracy
The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the Influenza A+B Rapid Test Device (Swab/Nasal Aspirate). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result Nasal Swab Specimen.
Accuracy
A side-by-side comparison was conducted by the results of the test reagent and RT-PCR. 420 clinical swab specimens (including
Ct≤33 and Ct＞33)were evaluated, 111 were positive and 309 were negative. Base on the results from the clinical studies, the
statistical analysis was made as follows:
Clinical sensitivity:98.10% (95% CI: 93.32%~99.48%)
Clinical specificity:99.68% (95% CI: 98.19%~99.94%)
Total Coincidence rate:99.28% (95% CI: 97.89%~99.75%).
Clinical sensitivity:97.30% (95% CI: 92.35%~99.08%)
Clinical specificity:99.68% (95% CI: 98.19%~99.94%)
Total Coincidence rate:99.05% (95% CI: 97.58%~99.63%).
Product Tags:
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Swab 97.7% Influenza AB Test Infectious Disease Rapid Test Kits Images
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