SARS-CoV-2 Antigen Detection Kit (Sampling by gargle or oropharyngeal wash)
Manufactured by PerGrande BioTech Development Co. Ltd., China - www.pergrande.com.cn
Device identification number
2121
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Throat secretion
Cross-reactivity (pathogens tested)
SARS-CoV
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
No
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
LOD
40 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
2.5 %
Precision
Evaluated
Accuracy
99.14 % (（95.28%-99.85%）)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 % ( （87.12%-99.56%）)
Clinical Specificity
100 % (（95.19%-100%）)
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