COVID-19 In Vitro Diagnostic Medical Device - detail

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

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.617.2 (Delta),

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 %