Performance analysis of high-throughput HPV testing on three automated workflows.

Primary high risk human papillomavirus (hrHPV) DNA testing has been introduced in several countries worldwide, including The Netherlands. The objective of this study was to compare 3 automated workflow procedures for hrHPV testing of which the hrHPV detection assays meet the international guidelines for HPV testing. To mimic a realistic screening situation, we aimed to process 15,000 residual PreservCyt cervical samples in a period of 3 months. During a 3 months-period, 4 technicians were involved in processing 5,000 specimens per month on 3 automated platforms, 1) Qiagen Digene® HC2 HPV DNA test (HC2, signal amplification); 2) Roche Cobas® HPV test (DNA amplification) and 3) Hologic Aptima® HPV test (RNA amplification). We measured and scored general aspects (time-to-results, hands-on-time (HOT)), maintenance, pre-run, run and post-run aspects, inventory (orders, storage) and number of errors on a scale from 1-10. As determined for 1 complete workflow each, maximum processing capacity and HOT were 296 samples and 2h:55m, 282 samples and 3h:20m and 264 samples and 4h:15m for Aptima, Cobas and HC2, respectively. The mean throughput time per run was 5h:51m for Cobas in which 94 samples could be processed. For Aptima the mean throughput time per run was 6h:30m for 60 samples. Mean throughput time for HC2 is longer since results were provided on day 2. In this study, the fully automated Aptima workflow scores best with a 7.2, followed by Cobas with a score of 7.1 and HC2 with a score of 5.8. Although all HPV tests used in this comparison meet the international test guidelines, the performance (workflow) characteristics of the assays vary widely. A specific choice of a lab for high throughput testing can be different based on the labs demands, but also hands-on-time, time-to-results / # samples, maintenance, pre-run, run and post-run parameters, consumables, technical support and number of errors are important operational factors for the selection of a fully automated workflow for hrHPV testing. This article is protected by copyright. All rights reserved.