Genedrive’s rapid point of care COV19 testing kit receives CE-IVD certification

genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that further to the announcement of 29 November 2021, its rapid point of care Genedrive® COV19-ID Kit has received CE-IVD certification under the European Communities Council Directive 98/79.  

The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. 

In the case of the new Omicron variant of concern, there were approximately 650 Omicron (B.1.1.529) genome sequences identified within the global reference database as of 7 December 2021, and the Genedrive® COV19-ID Kit was 100% inclusive in detection.

Sensitivity and specificity of the Genedrive® COV19-ID Kit was 98.2% and 98.9% respectively in its clinical validation cohort of 149 samples (58 positives at greater than 500 copies per ml) which were referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. The Genedrive® COV19-ID molecular test offers several orders of magnitude improvement in sensitivity compared to antigen lateral flow devices.

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