SARS-CoV-2 Antigen Rapid Detection Kit(Nasal Swab Test)
Description
Device identification number：
2152
CE Marking：
✓Yes
HSC common list：
✓Yes
Format：
Near POC / POC
Physical Support：
Card, Cassette, Strip
Target type：
Antigen
Targets：
nucleocapsid protein,
Specimen：
Nasopharyngeal swab, Oropharyngeal 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), Human Metapneumovirus (HMPV), MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4
Lineages detected：
Commercial Status：
Commercialised
Last Update：
2021-12-08 06:30:08 CET
Comments：
SARS-CoV-2 Antigen Rapid Detection Kit is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasopharyngeal swab or oropharyngeal swab specimen.
Assay Type：
Immuno-Antigen
Rapid Diagnostic：
Yes
Reader Required：
No
Method：
Immunochromatography
Measurement：
Qualitative
Time：
15 minutes
Detection Principle：
Colloidal gold
LOD：
34 AU
Calibration：
Evaluated
Crossreactivity：
Evaluated
Fp：
1.9 %
Fn：
0.5 %
Precision：
Evaluated
Accuracy：
98.8 %
Reproducibility：
Evaluated
Robustness：
Evaluated
Clinical Sensitivity：
98.1 %
Clinical Specificity：
99.5 %
Type of antigen：
Nucleoprotein
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