COVID-19 IgG Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
4109
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B
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
BA.2.12, BA.2.12.1, BA.5, BA.2.75, BA.4, BA.5
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-31 09:28:10 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Immunofluorescence
LOD
AU
Calibration
Not evaluated
Analytical Sensitivity
97.95 %
Analytical Specificity
99.57 %
Analysis of cross reactivity
Evaluated
False positives
14 % (14 false positive result is observed in 324 negative samples confirmed by RT-PCR)
False negatives
12 % (14 false positive result is observed in 324 negative samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.25 %
Robustness
Evaluated
Clinical Sensitivity
97.95 %
Clinical Specificity
99.57 %
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