GA CoV-2 Antigen Rapid
Manufactured by GA Generic Assays GmbH, Germany - www.genericassays.com
Device identification number
1580
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
in instruction manual: Limit of detection: 100 pg/ml of the recombinant protein
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
70 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3.6 % (It was compared with results of the RT-PCR reference method and found a sensitivity 96.4%)
False negatives
0.8 % (It was compared with results of the RT-PCR reference method and found a specificity 99.2%)
Precision
99 % (>99%)
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
99.2 %
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