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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SURE STATUS COVID-19 ANTIGEN CARD TEST

Manufactured by PREMIER MEDICAL CORPORATION PRIVATE LIMITED, India - www.premiermedcorp.com 

Device identification number
2299
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
LOD: 250 pfu/ml ~ 353 TCID50/ml
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
LOD
353 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
3 %
Fn
9 %
Precision
Evaluated
Accuracy
91% SENSTIVITY AND 97% SPECIFICITY In comparison with the RT-PCR
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91 %
Clinical Specificity
97 %
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