SARS-CoV-2 IgG/IGM Rapid t
Manufactured by Taizhou ZECEN Biotech Co., Ltd, China - http://www.zechengbio.com
Device identification number
2649
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-09-23 01:15:49 CET
Comments
Antibody test, no antigen
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.3 (Test 153 negative samples, 2 results are postive;)
Fn
3.63 (Test 55 postive samples, 2results are negative;)
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
98.7 %
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