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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Actim SARS-CoV-2

Manufactured by Actim Oy, Finland - https://www.actimtest.com/ 

Device identification number
2245
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Dipstick
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Instructions for use available at: https://www.actimtest.com/wp-content/uploads/2021/06/Kayttoohje-Actim-SARS-CoV-2_AOACE35522_LR.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
200 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % 0/149
Fn
15 % (15/100)
Precision
Evaluated
Accuracy
99 % (Ct values < 33)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (Ct values < 25)
Clinical Sensitivity
96 % (Ct < 30)
Clinical Specificity
100 %
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