Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit
Manufactured by Jiangxi Province JinHuan Medical Instrument Co. Ltd. China, China - http://www.jinhuan123.com/
Device identification number
3085
CE Marking
✓Yes
HSC common list (RAT)
×No
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), Influenza A H1N1, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Pathogens detected
SARS-CoV
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
2022-08-24 09:08:01 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). The analytical components of the test are same as the EU device 2963 (https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2963). However, it has new instructions of use along with new specimen collection methods and respective clinical data.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
1 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.34 % (False positive occurs 1 in 297 cases)
False negatives
4 % (False negative occurs 4 in 100 cases)
Precision
Evaluated
Accuracy
98.7 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Antigen)
Clinical Specificity
99.7 % (Antigen)
Type of antigen
Nucleocapsid protein
Notes
Clone1 binding site: INTNSSP(74-80) Clone2 binding site: GTRNPANN(147-154)
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