BIOSYNEX COVITOP
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
2947
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), 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
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
TCID50/ml 22,7 TCID50/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.31 % (1 false positive among 321 tested samples)
False negatives
6.02 % (5 false negative among 83 tested samples - Nasopapharyngeal swab)
False negatives
18.07 % (15 false negative among 83 tested - Nasal swab)
Precision
Evaluated
Accuracy
Not evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.98 % (Antigen - Nasopharyngeal sample)
Clinical Sensitivity
81.93 % (Antigen - Nasal sample)
Clinical Specificity
99.69 % (Antigen)
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