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%).
