COVID-19 ANTIGEN RAPID TEST CASSETTE
Manufactured by BIO GROUP MEDICAL SYSTEM, Italy - www.biogms.it
Device identification number
2122
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Antigen Rapid Test) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal/orophayngeal/nasal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
See IFU
False negatives
See IFU
Precision
Evaluated
Accuracy
96.2 % ( (95%CI*: 91.3%~98.7%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.9 % ( (95%CI*: 84.1%~97.6%))
Clinical Specificity
99.9 % (＞99.9% (95%CI*: 94.0%~100%))
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