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 (RAT)
×No
Format
Lab-based, Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
1.7 % (A total of 617 clinical samples (176 positive and 441 negative), with 3 false positives.)
False negatives
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