Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Nasal Swab)
Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - http://www.chemtronbio.com/
Device identification number
2512
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % without false positive compared with RT-PCR in clincal datas
False negatives
0.5 % (without false negative compared with RT-PCR in clincal datas)
Precision
Evaluated
Accuracy
97.07 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.09 % ((Antigen))
Clinical Specificity
100 % ((Antigen))
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