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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 + Actim Influenza A&B

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

Device identification number
2969
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Dipstick, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Herpes Simplex (HSV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
For performance data, please see the last pages of the IFU: https://www.actimtest.com/wp-content/uploads/2021/11/IFU-Actim-SARS-CoV-2-Influenza-AB-1.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
See IFU in additional information.
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
See IFU in additional information.
False negatives
See IFU in additional information.
Precision
Evaluated
Accuracy
94 % (SARS-CoV-2 Nasopharyngeal (Antigen), nasal 95(Antigen). Influenza A 97 (Antigen), Influenza B 98(Antigen).)
Accuracy
98 % (Influenza B (Antigen))
Accuracy
97 % (Influenza A (Antigen))
Accuracy
95 % (SARS-CoV-2 Nasal (Antigen))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
85 % (SARS-CoV-2 Nasopharingeal (Antigen))
Clinical Sensitivity
89 % (SARS-CoV-2 Nasal (Antigen))
Clinical Sensitivity
86 % (Influenza A (Antigen))
Clinical Specificity
100 % (Antigen)
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