SARS-CoV-2 Antigen Test Kit
Manufactured by FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd., China - www.fcy-medical.com
Device identification number
2597
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Saliva
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.617.1 (Kappa)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Test Kit is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in anterior nasal (AN) swab or saliva (SA) specimens directly collected from individuals, based on the principle of latex immunochromatographic immunoassay. It is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection, professional use only.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.24 % (100/105 (95% CI, 89.33%~97.95%))
Clinical Specificity
99.44 % (353/355, (95% CI, 97.97%~99.85%))
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