Coronavirus Ag Rapid Test Cassette (Swab)
Manufactured by Shandong ThinkLab Biotechnology Co. Ltd., China
Device identification number
2154
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Adenovirus Subtype C, Coronaviruses (HCoV), Influenza A H1N1, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The coronavirus AG rapid detection box (swab) is an in vitro immunochromatographic test for qualitative detection of the SARS-CoV-2 nuclear capsimal hemoglobin antigen in nasopharyngeal and nasal swab samples directly or to the viral transport medium of individuals whose health care providers suspect carrying COVID-19.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.8 %
False negatives
1.7 %
Precision
Evaluated
Accuracy
96.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.2 %
Clinical Specificity
98.3 %
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