Avacta: Paul Hill discusses the Clinical validation of their AffiDX Lateral Flow Test.
Episode 181, Apr 20, 2021, 08:23 AM
Avacta: Paul Hill discusses the Clinical validation of their AffiDX Lateral Flow Test.
Avacta #AVCT Group plc
Avacta #AVCT Group plc
("Avacta" or "the Group" or "the Company")
Clinical validation of AffiDX® SARS-CoV-2 Antigen Lateral Flow Test
98.0% clinical sensitivity for samples with PCR Ct values[1] up to 31
Completing the technical data set for self-declaration of a CE mark for professional use in early May, followed immediately by commercial launch in Europe
Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce positive data from the clinical validation of its AffiDX® SARS-CoV-2 antigen lateral flow test. Data from the clinical study conducted in Europe on 98 positive COVID-19 samples demonstrate excellent performance in identifying the SARS-CoV-2 virus across a broad range of viral loads. These data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.
The clinical evaluation of Avacta's lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR. The study tested 98 positive samples (31 with Ct<26; 65 with Ct 26-30 and 2 with Ct 30-31). Avacta's rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads. Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%.
Lateral flow rapid antigen tests are intended to provide a low cost means of identifying individuals with a high viral load that means they are more likely to infect others. Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure. However, there is a growing consensus that a viral load as measured by PCR of Ct<27 should be considered as infectious. The clinical data for Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.