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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgG II CLIA Microparticles

Manufactured by Autobio Diagnostics Co., Ltd, China - https://www.autobio.com.cn/ 

Device identification number
919
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Near POC / POC
Target
Antibody, IgG
Specimen
Plasma, Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-16 04:43:59 CET
Comments
No cross-reaction with Influenza A, Influenza B,RSV, Adenovirus, Enterovirus 71, Coxsackie virus B, Chlamydia pneumonia, M. pneumoniae IgG, L. pneumophila, Toxo IgG, Rubella IgG, CMV IgG, HSV IgG, RF.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other
Method
CLIA
Measurement
Qualitative
Time
40 minutes
Subclass
Other
Detection Principle
Chemiluminescence
Crossreactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (≥15days after infection:100%(51/51), 8-14days after infection:79.3%(23/29),≤7days after infection:26.9%(7/26))
Clinical Specificity
99 % ((1063/1074))
Notes
Rapid diagnostic test Not found Chemiluminescence

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