COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
1891
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
A rapid test for the qualitative detection of COVID-19, Flu A&B Antigen, Respiratory Syncytial Virus (RSV) in Nasopharyngeal swab
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % No false positive result is observed in 324 negative samples confirmed by RT-PCR
False negatives
% 2 false negative results are observed in 40 positive samples confirmed by RT-PCR
Precision
Evaluated
Accuracy
99.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
Clinical Specificity
99 % ((＞99.9))
Type of antigen
Nucleoprotein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements