Improving laboratory workflow through automated pre-processing of SurePath specimens for human papillomavirus testing with the Abbott RealTime assay.

Abstract

Cervical specimens collected in liquid-based cytology (LBC) are used for cervical screening in the UK. The Abbott RealTime high-risk human papillomavirus (hrHPV) assay for the detection of 14 hrHPV types is approved by the English NHS Cervical Screening Programme (NHSCSP). As per manufacturer's instructions, pre-analytic processing of LBC involves a manual vortex and liquid transfer into a secondary tube. In high-throughput settings, hands-on time for pre-processing is considerable and poses the potential for human error. Implementation of hrHPV primary screening planned for 2019 accompanied by centralisation of services is a major change for the NHSCSP, increasing the demand for availability of automated pre-analytics. This study evaluated a custom-configured work-table setup of the Tecan Freedom EVO designed to automate pre-processing of BD SurePath LBC prior to HPV testing on the Abbott m2000. Automatically and manual pre-processed specimen results were compared (primary screening population n=307; triage population n=169). Excellent agreement of overall hrHPV results (98.1%; k: 0.95) was observed. On average, it takes approximately 1.5minutes hands-on-time per sample to process manually compared to 45minutes to aliquot 48 samples using the Freedom EVO 150. The Tecan worktable configuration designed to automate and control pre-analytics required for preparing SurePath LBC samples for HPV testing using Abbott RealTime resulted in assay performance comparable to that following the manufacturer validated manual process. It significantly reduces hands-on-time and allows for complete specimen identification tracking and documentation of process control.