Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ArtTest™ COVID-19 Express Kit

Manufactured by ArtBioTech LLC, Belarus - https://smartpcr.com/ 

Device identification number
2957
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Direct RT-PCR method is used
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
N.A.
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
60 minutes
LOD
980 copies/ml (4.9 copy/test)
Positive control
SARS-CoV-2 N gene and the human RNase P gene
Negative control
Nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
Delta (100 %) Omicron (100 %) Alpha (100 %) Beta (100 %) Gamma (100 %)

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