OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method)
Manufactured by Hunan Zhongke Lanhai Biotechnology Co. Ltd., China - www.ojabio.com
Device identification number
1575
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein, ORF1ab polyprotein, ORF1b polyprotein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Beta Coronavirus OC43 (HCoV-OC43), SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
116 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.66 % (11/661)
False negatives
0.28 % (1/350)
Precision
Evaluated
Accuracy
99.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.29 %
Clinical Specificity
99.54 %
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