COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test
Manufactured by Acro Biotech Inc., United States - www.acrobiotech.com
Device identification number
1697
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
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
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU ((IgG))
False positives
4 AU ((IgM))
False negatives
0 AU (IgG)
False negatives
15 AU ((IgM))
Precision
Evaluated
Accuracy
98.6 % IgG (98.6 (COVID-)
Accuracy
92.9 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
85 % 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