InnoScreenTM COVID-19 Antigen Rapid Test Device
Manufactured by Innovation Scientific Pty Ltd., Australia - www.innovationsci.com.au
Device identification number
2566
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
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-Antigen
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Calibration
Evalauted
Analysis of cross reactivity
Evalauted
False positives
0.1 % ((less than 0.1%))
False negatives
5 % ((less than 5%))
Precision
Evalauted
Accuracy
90 % ((>90%))
Reproducibility
Evalauted
Robustness
Evalauted
Clinical Sensitivity
95 % ((>95%))
Clinical Specificity
99.9 % ((>99.9%))
Type of antigen
Nucleocapsid protein
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