COVID-19 and M.pneumoniae IgG/IgM Combo
Manufactured by Hangzhou AllTest Biotech Co. Ltd., China - www.alltests.com.cn
Device identification number
1385
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU 0
Calibration
Not evaluated
False positives
2 % IgG (+ M.pneumoniae IgG: 5.4%; M.pneumoniae IgM: 5.2%)
False positives
4 % IgM
False negatives
0 % IgG + M.pneumoniae IgG: 7.8%; M.pneumoniae IgM: 8.5%
False negatives
15 % IgM
Robustness
Not evaluated
Clinical Sensitivity
100 % IgG (+92.2(Mycoplasma pneumoniae IgG); 91.5(Mycoplasma pneumoniae IgM))
Clinical Sensitivity
85 % IgM
Clinical Specificity
98.6 % IgG (+ 93.7(Mycoplasma pneumoniae IgG); 93.7(Mycoplasma pneumoniae IgM))
Clinical Specificity
92.9 % IgM
Notes
Rapid diagnostic test lateral flow
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