AnyLab COVID-19 Ag Nasal Test Kit
Manufactured by Z Biotech Inc., South Korea - http://zetbio.com/
Device identification number
2912
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, 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 H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Last Update
2022-08-24 09:08:01 CET
Comments
Not Applicable
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1150 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Not Applicable
False negatives
Not Applicable
Precision
Evaluated
Accuracy
100 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Antigen)
Clinical Specificity
100 % (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