INFO Covid-19 Ag Test
Manufactured by Türklab Tibbi Mal. San. ve Tic. A.S., Turkey
Device identification number
2584
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Influenza A, Influenza A H1N1, Influenza A H3N2, MERS-CoV, Mycoplasma Pneumoniae, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
5 AU
False negatives
43 AU
Precision
Evaluated
Accuracy
97.14 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.71 %
Clinical Specificity
99.54 %
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