SARS-CoV-2 Ag Rapid Test Kit
Manufactured by Zhejiang Hongyu Medical Commodity Co. Ltd., China - http://www.cnhongyu.cn/
Device identification number
2309
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Specimen
Anterior nasal swab, Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum, Stool
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, 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
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LOD of the SARS-CoV-2 Ag Rapid Test Kit is 5 pg/mL SARS-COV-2 nucleocaspid protein.
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
5 AU (pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
9.5 % (NP swab)
False negatives
3.7 % (Stool )
False negatives
6 % (Sputum/oropharyngeal saliva)
False negatives
9 % (Front Nostril)
False negatives
8.6 % (OP swab)
Precision
Evaluated
Accuracy
97 % ((Sputum/oropharyngeal saliva)；)
Accuracy
98.15 % ((Stool)；)
Accuracy
95.25 % ((NP swab)；)
Accuracy
95.5 % ((Front Nostril)；)
Accuracy
95.7 % ((OP swab)；)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.5 % ((NP swab))
Clinical Sensitivity
91.4 % ((OP swab))
Clinical Sensitivity
91 % ((Front Nostril))
Clinical Sensitivity
94 % ((Sputum/oropharyngeal saliva))
Clinical Sensitivity
96.3 % ((Stool))
Clinical Specificity
100 % ((NP swab))
Clinical Specificity
100 % ((OP swab))
Clinical Specificity
100 % ((Front Nostril))
Clinical Specificity
100 % ((Sputum/oropharyngeal saliva))
Clinical Specificity
100 % ((Stool))
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