DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit
Manufactured by Jiangxi Province JinHuan Medical Instrument Co. Ltd., China - http://www.jinhuan123.com/
Device identification number
2963
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), MERS-CoV, SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
Clone1 binding site: INTNSSP(74-80)
Clone2 binding site: GTRNPANN(147-154)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-10-20 10:13:42 CET
Comments
The device is commercialised in Germany and listed at the BfArM under the test-ID "AT770/21". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770/21 (March 2022).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
1 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.34 % (Nasal swab)
False negatives
4 % (Nasal swab)
Precision
Evaluated
Accuracy
96.56 % (Saliva)
Accuracy
99.07 % (Naso-/oropharyngeal swab (pooled))
Accuracy
98.7 % (Nasal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Nasal swab)
Clinical Sensitivity
97.62 % (Naso-/oropharyngeal swab (pooled))
Clinical Sensitivity
92.16 % (Saliva)
Clinical Specificity
99.7 % (Nasal swab)
Clinical Specificity
99.64 % (Naso-/oropharyngeal swab (pooled))
Clinical Specificity
98.62 % (Saliva)
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