SmartAmp SARS-CoV-2 RNA detection test kit
Manufactured by LLC EMG- Evotech Mirai Genomics, Russia - evotech-mg.com/en/
Device identification number
1951
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SmartAmp® SARS-CoV-2 Detection Kit combines reverse transcription and SmartAmp® DNA amplification in a single step, together with Eprobe® mediated real-time monitoring of amplification. SmartAmp is an isothermal DNA amplification technology which was developed by the group of Yoshihide Hayashizaki at the RIKEN institute, Japan. The test detects a highly conserved region within the Nsp15 gene, coding for endonuclease NSP15. An in vitro synthesized fragment of human RNA (RPP30 gene) is used as internal control of the extraction, reverse transcription and amplification reaction.
Assay Type
Nucleic acid-Other
Reader Required
Yes
Measurement
Qualitative
Time
40 minutes
LOD
10000 cpu
Positive control
in vitro synthesized fragment of SARS-CoV-2 coronavirus RNA
Negative control
PCR grade water
Clinical Sensitivity
100 %
Clinical Specificity
98.7 %
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