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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit

Manufactured by DNA-Technology R&D LLC, Russia - site.dna-technology.ru/ 

Device identification number
1109
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://site.dna-technology.ru/files/images/instructions_eng/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf; samples: RNA extracted from nasopharynx and oropharynx swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum http://site.dna-technology.ru/eng/new/1/32.html
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
40 minutes
LOD
10 copies/reaction
Positive control
Positive control included. It is a cloned part of the virus genome.It is produced with genetic engineering techniques and characterized by automatic sequencing. The kit includes the Internal control (RNA-IC). RNA-IC is intended to assess the quality of t
Negative control
Physiological saline solution can be used as a negative control sample in volumes indicated in supplied instructions. A negative control sample should go through all stages of RNA extraction.
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 %
Notes
information provided by manufacturer +website (http://site.dna-technology.ru/files/images/instructions_eng/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf)

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