Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay)
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
2593
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Card, Lateral flow
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) is intended for the quantitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.73 % (8 of 292)
False negatives
3.89 % (6 of 154)
Precision
Evaluated
Accuracy
96.86 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
97.26 %
Type of antigen
Other
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