KSMART COVITOP
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
3113
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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.1.617.1 (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
In development
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
Yes
Method
Immunochromatography
Time
20 minutes
LOD
22.7 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.29 % (1 false positive among 341 tested samples (nasopharyngeal swab))
False negatives
0.57 % (6 false negative among 1041 tested samples (nasopharyngeal swab))
Precision
Evaluated
Accuracy
not available
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.2 %
Clinical Specificity
99.7 %
Type of antigen
Nucleocapsid protein
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