Reduction in cycle time for a rapid polymerase chain reaction diagnostic test at the point of care

Abstract

Rapid testing facilitates safe and effective diagnosis, but the true speed of the process is the time from collection of a sample to delivery of an accurate and reliable test result - 'end-to-end' time. Transport, unpacking and relaying of information can extend this time considerably beyond the minimum laboratory turnaround times as stipulated by PCR testing protocols. This study aimed to minimise time needed to ascertain SARS-CoV-2 status prior to treatment in a UK Dental Hospital using a novel, mobile, direct to polymerase chain reaction (PCR) workflow. Process flow analysis and PDSA (Plan, Do, Study, Act) cycles for rapid continuous improvement were employed in a service improvement programme. Primerdesign™ q16 rapid PCR instruments and PROmate® COVID-19 direct assays were used for molecular testing. We showed a reduction in real-world end-to-end time for a diagnostic test from 240min to 85min (65% reduction) over a 4-week period. New rapid technologies have become available that reduce analytical time to under 90min, but the real-world clinical implementation of the test requires a fully integrated workflow from clinic to reporting.