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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GenSure COVID-19 Neutralizing Antibody Test (Latex)

Manufactured by GenSure Biotech Inc., China - http://www.gensbio.com 

Device identification number
2112
CE Marking
Yes
HSC common list (RAT)
×No
Physical Support
Latex
Target type
Antibody
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hepatitis C Virus (HCV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
There is a very small possibility of false positives.
False negatives
There is a very small possibility of false negatives.
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.6 %
Clinical Specificity
100 %

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