COVID-19 and M.pneumoniae IgG Combo Rapid Test
Manufactured by Hangzhou AllTest Biotech Co. Ltd., China - www.alltests.com.cn
Device identification number
1386
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.alltests.com.cn/EN/Prodetail.asp?newsid=1788&cclassid=2&classid=51
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Calibration
Not evaluated
False positives
2 % IgG (5.4% IgG (M.pneumoniae))
False negatives
0 % 7.8% IgG (M.pneumoniae)
Robustness
Not evaluated
Clinical Sensitivity
100 % IgG (+ (Mycoplasma pneumoniae= 92.2% IgG ))
Clinical Specificity
98.6 % IgG (+ (Mycoplasma pneumoniae = 93.7% IgG ))
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