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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 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