COVID-19 Ag Rapid Test Cassette
Manufactured by MedicalSystem Biotechnology Co. Ltd., China - https://en.nbmedicalsystem.com/en/
Device identification number
2049
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Latex
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva, Throat swab
Lineages detected
A.23.1
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N.A.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
150 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.33 %
False negatives
7.33 %
Precision
Evaluated
Accuracy
90 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.67 %
Clinical Specificity
98.67 %
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