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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



CareStart(TM) COVID-19 Antigen

Manufactured by Access Bio, Inc., United States - www.accessbiodiagnostics.com 

Device identification number
2572
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 P.1 (Gamma), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Reference number: RCMM-02072 Kit contents - 20, test device - 20, extraction buffer vial and cap - 20, anterior nasal swab - 1, positive control swab - 1, negative control swab - 1, instructions for use
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
2 AU ((NP swab))
Fp
5 AU ((Anterior nasal swab))
Fn
1 AU ((NP swab))
Fn
0 AU (Anterior nasal swab)
Precision
Evaluated
Accuracy
98.33 % ( (NP swab))
Accuracy
94.57 ( (Anterior nasal swab))
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
93.75 % ( (NP swab))
Clinical Sensitivity
87.18 % ( (Anterior nasal swab))
Clinical Specificity
99.32 % ( (NP swab))
Clinical Specificity
100 % ((Anterior nasal swab))
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