SARS-CoV-2 VoCs RT-qPCR Multiplex Kit
Manufactured by ChemGenes Corp., United States - https://www.chemgenes.com/
Device identification number
2849
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Hello European Commission, We are hoping to pivot our SARS-CoV-2 Variants of Concern Multiplex Kit from Alpha + Delta to Omicron + Delta due to the increasing interest in such, as done by companies such as ThermoFisher, due to Alpha and Omicron having the same S69-70 deletion which is the target for our probe. We are currently looking for Omicron clinical samples and would be happy to provide sample kits if you have any clinical sites with Omicron samples to test the kit's capabilities yourselves. Regardless, with both the prevalence of Delta and the possible issues with Omicron we hope to talk with you on how to get a CE Mark. We have a production capability in the tens of millions weekly if given proper notice. Thank you for our time and I'm happy to address any questions, clear up any issues or provide further information if desired. We hope our kit can be used to mitigate this health crisis, both in the EU and globally.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
60 minutes
LOD
25 cpu
Positive control
N2
Negative control
RP1
Clinical Sensitivity
100 %
Clinical Specificity
97.3 %
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