COVID-19 IgG Rapid Test Cassette(Whole blood/Serum/Plasma)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - www.biotests.com.cn
Device identification number
5744
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG
Antibody type
Monoclonal
Targets
Other (Antibody)
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), 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)
ORF1b protein
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), Other (BA.4, BA.5), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-31 09:24:17 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
AU
Calibration
Not evaluated
Analytical Sensitivity
97.95 %
Analytical Specificity
99.57 %
Analysis of cross reactivity
Evaluated
False positives
97.95 % (14 false positive result is observed in 683 samples confirmed by RT-PCR)
False negatives
99.57 % (12 false negative results are observed in 2807 positive samples confirmed by RT-PCR negative)
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