COVID-19 IgG/IgM Rapid Test Dipstick
Manufactured by Hangzhou AllTest Biotech Co. Ltd., China - www.alltests.com.cn
Device identification number
1382
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Dipstick
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
similar to 674 but name a bit different (on website same as 674: 2019-nCoV IgG/IgM Rapid Test Dipstick)
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
False positives
2 % IgG
False positives
3 % IgM
False negatives
0.1 % IgG (<0.1% )
False negatives
9.1 % IgM
Accuracy
98.4 % IgG
Accuracy
95.9 % IgM
Clinical Sensitivity
99.9 % IgG (>99.9)
Clinical Sensitivity
90.9 % IgM
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