COVID-19 IgG/IgM Rapid Test Cassette (Protective Antibodies)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
4123
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Other ()
Target type
Antibody, IgG, IgM
Antibody type
Monoclonal
Targets
Other (S1 Protein)
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Respiratory Syncytial V (RSV)
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Other
Information on antigen epitope targeted by the antibodies used in the design of the device
BA2.12, BA1.1.529, BA.4, BA.2.75, BA.5
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-10-31 09:34:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
AU
Calibration
Not evaluated
Analytical Sensitivity
83.04 %
Analytical Specificity
98.91 %
Analysis of cross reactivity
Evaluated
False positives
58 %
False negatives
4 %
Precision
Evaluated
Accuracy
89.45 %
Robustness
Evaluated
Clinical Sensitivity
83.04 %
Clinical Specificity
98.91 %
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