nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)
Manufactured by HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd., China - http://www.lysunbio.com/
Device identification number
2141
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % IgM (0 of 102)
False positives
1.96 % IgG ((2 of 102))
False negatives
4.55 % IgM ((2 of 44))
False negatives
0 % IgG (0 of 102)
Precision
Evaluated
Accuracy
98.6 % IgM ((95%CI:96.7%~100%))
Accuracy
98.7 % IgG ((95%CI:97.0%~100%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.5 % IgM ((95%CI:89.3%~100%))
Clinical Sensitivity
100 % IgG ((95%CI:99.7%~100%))
Clinical Specificity
100 % IgM ((95%CI:99.8%~100%))
Clinical Specificity
98 % IgG ((95%CI:95.4%~100%))
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