Business
CE-IVD certification for Point-of-Care kit
CE-IVD certification for Point-of-Care kit.
About this update from Genedrive Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 0049V\n Genedrive PLC\n 08 December 2021\n \n \n \n \n genedrive plc\n \n \n (\"genedrive\" or the \"Company\")\n \n \n \n \n \n \n \n \n CE-IVD certification for Point-of-Care Genedrive®COV19-ID kit \n \n \n \n \n \n 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. \n \n \n \n \n \n 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. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without viral extraction. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants. 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.\n \n \n \n \n \n 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. The clinical cohort included five confirmed SARS-COV2 Delta variants, which were all detected by the Genedrive® COV19-ID test. The sensitivity and specificity of the assay on the entire cohort met the current requirements of the UK's MHRA Target Product Profile for a SARS-CoV-2 Point of Care molecular diagnostic test. \n \n \n \n \n \n Information about the new Genedrive®COV19-ID Kit can be found at \n \n \n \n \n http:/...