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

Abstract

Background: 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 preprocessing 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. Methods:Automatically and manual pre-processed specimen results were compared (primary screening population n = 307; triage population n = 169).Results: Excellent agreement of overall hrHPV results (98.1%; k: 0.95) was observed.On average, it takes approximately 1.5 minutes hands-on-time per sample to process manually compared to 45 minutes to aliquot 48 samples using the Freedom EVO 150. Conclusion:The Tecan worktable configuration designed to automate and control preanalytics 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. K E Y W O R D SAbbott M2000, automation, NHS Cervical Screening Programme, pre-analytics, primary human papillomavirus testing, Tecan Freedom EVO | INTRODUC TI ONThe Abbott RealTime (RT) high-risk human papillomavirus (hrHPV) test, a highly automated, qualitative multiplex real-time polymerase chain reaction assay for the detection of DNA from 14 hrHPV genotypes in cervical specimens collected in the two most commonly used liquid-based cytology (LBC) media (BD SurePath and Hologic ThinPrep PreservCyt Solution) is approved by the National Health Service Cervical Screening Programme (NHSCSP) for the purpose of HPV triage of low-grade cytological abnormalities; test-of-cure (ToC) of high-grade disease in, and for HPV primary screening. A number of studies have validated the RT hrHPV | 533 SARGENT ET Al. assay in triage, ToC and primary screening settings, demonstrating clinical sensitivity and specificity of the test at least comparable to that of standard benchmark tests for the detection of hrHPV DNA. 1-4 Since 2013, six sites in England have been piloting HPV as the primary test triaged by cytology, if HPV positive. Review of the data from the pilots has resulted in the UK National Screening Committee recommending national implementation of HPV primary screening to begin in this year. The CSP screens on average 3.3 million s...