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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Test

Manufactured by Baicare(Tianjin) Biotechnology Co,. Ltd., China - http://www.bai-care.com/index.php?catid=27 

Device identification number
2602
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-03 01:51:50 CET
Comments
Sensitivity:nasal samples and oropharyngeal samples: 93.18% , nasopharyngeal samples:93.75% Specificity:nasal samples and oropharyngeal samples: 99.32%, nasopharyng99.32% Accuracy:nasal samples and oropharyngeal samples:97.57%, nasopharyngeal samples: 97.73%eal samples:
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
30 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.7 % (A total of 617 clinical samples (176 positive and 441 negative), with 3 false positives.)
Fn
2.49 % (A total of 617 clinical samples (176 positive and 441 negative), with 11 false negatives.)
Precision
Evaluated
Accuracy
97.57 % ((Antigen) Nasal swab)
Accuracy
97.73 % (Nasopharyngeal swab)
Accuracy
97.57 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.75 % (Nasopharyngeal swab)
Clinical Sensitivity
93.18 % (Oropharyngeal swab)
Clinical Sensitivity
93.18 % ((Antigen) Nasal swab)
Clinical Specificity
99.32 % ((Antigen) Nasal swab)
Clinical Specificity
99.32 % (Oropharyngeal swab)
Clinical Specificity
99.32 % (Nasopharyngeal 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