SARS-CoV-2 Antigen Test Kit
Manufactured by Procomcure Biotech GmbH, Austria - procomcure.com
Device identification number
2080
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 %
Clinical Specificity
99 %
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