One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold)
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
2589
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Lateral flow
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), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Herpes Simplex (HSV), Influenza B, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold) is intended for in vitro qualitative detection of SARS-CoV-2 total antibody and circulating neutralizing antibody in serum, plasma or whole blood samples. The test is only used for professional and laboratory use, not for home testing.
Assay Type
Unknown
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
99.5 % ((total antibody))
Accuracy
99.3 ((neutralizing antibody))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.2 ((total antibody))
Clinical Sensitivity
98.5 % ((neutralizing antibody))
Clinical Specificity
99.6 ((total antibody))
Clinical Specificity
99.6 % ((neutralizing antibody))
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