COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)
Manufactured by Safecare Biotech (Hangzhou) Co. Ltd, China - www.safecare.com.cn
Device identification number
1035
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Pathogens detected
SARS-CoV
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines), C.37 (Peru), B.1.616 (France), B.1.526.1 (USA), B.1.526.2 (USA),
Commercial Status
Commercialised
Last Update
2021-07-27 12:32:38 CET
Comments
LOD: 10-time diluted of internal reference material
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
10 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
% 9.19%
Fn
% 15.09%
Precision
Evaluated
Accuracy
90.19 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
84.91 %
Clinical Specificity
91.81 %
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