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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Test Kit

Manufactured by Surge Medical Inc., China - www.surgemedical.cn 

Device identification number
1942
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
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
In addition to the European Union's CE certification, our products have also passed the German government's "BfArM" and "PEI" certification and the British government's "DHSC" testing certification.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
N.A.
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
100000 AU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (99 % clinical specificity)
False negatives
6.67 % (93.33% clinical sensitivity)
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.33 %
Clinical Specificity
97.69 %
Type of antigen
Nucleoprotein
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