SARS-CoV-2 Ag Rapid Test
Manufactured by AUTOBIO DIAGNOSTICS. Ltd., China - https://www.autobio.com.cn/
Device identification number
2538
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-10-05 02:12:13 CET
Comments
This assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in nasal swab specimens. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.45 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.94 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.55 %
Clinical Specificity
100 %
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