VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit
Manufactured by CerTest Biotec S.L, Spain - www.certest.es
Device identification number
2371
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test is designed for the qualitative detection of RNA from genetic mutations in the S gene (P681R, L452R and E484Q) from positive SARS-CoV-2 nasopharyngeal samples. The assay uses a human housekeeping gene as an endogenous Internal Control (IC) (human RNase P gene) to monitor the extraction process and/or discard the inhibition of the polymerase activity
Assay Type
Unknown
Method
RT-PCR
Measurement
Qualitative
Positive control
Yes
Negative control
Yes
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