InnoScreenTM COVID-19 IgG/IgM Rapid Test Device
Manufactured by Innovation Scientific Pty Ltd., Australia - www.innovationsci.com.au
Device identification number
2565
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Sensitivity, Specificity and Accuracy may vary depending on samples cohort
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.1 % ((less than 0.1%))
False negatives
5 % ((less than 5%))
Precision
Evaluated
Accuracy
90 % ((>90%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 % ((>90%))
Clinical Specificity
99.9 % ((>99.9%))
Type of antigen
Other
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