STOCS-H Scottish TOC Study HPV test comparison

Transcription

1 STOCS-H Scottish TOC Study HPV test comparison

2 What is entailed? Trial of new HPV tests on residual sample after HC2 result obtained, reported and acted on Complements English Sentinel Sites HPV Multi-test Study, on Triage samples and due to report in September Aim is to provide sufficient comparative data to be able to make recommendations as to which HPV tests are acceptable within CSP Similar process undertaken for new tests in other areas of diagnostic medicine all labs undertaking diagnostic testing free to use whichever CE marked and recommended test best suits their set-up and existing repertoire Similar BBV and Chlamydia/GC test comparisons recently

3 Qiagen Hybrid Capture for HR-HPV DNA detection 2. Rapid Capture System - 1. Manual HC2 Automated solution for high throughput HPV testing FDA approval 2004 Used in Sentinel sites Being made available by Qiagen for TOC Early Implementers at no additional cost provided SHPVRL can find bench space for platform

4 Which HPV tests for STOCS-H? Abbott rthpv uses real-time PCR; detects HPV DNA with limited typing data (HPV 16; HPV 18; HPV other HR ) GenProbe APTIMA HPV broad spectrum HPV mrna detection using transcription-mediated amplification system Hologic Cervista HPV uses Invader chemistry ; detects HPV DNA in 3 wells, typing at species level Roche cobas 4800 HPV - uses realtime PCR; detects HPV DNA with limited typing data (HPV 16; HPV 19; HPV other HR ) Abbott rthpv trialled by SHPVRL for MAVARIC trialin comparison with HC2; Results also used for Phase 1 of Sentinel Multi-test study. Same platform used in Edinburgh for Chlamydia and GC NAATs GenProbe APTIMA HPV tested by SHPVRL in EAS performance comparison with HC2 for detection of CIN2+ in women attending Colposcopy; Platform used for GC confirmation in Edinburgh Hologic Cervista HPV manual version 1 tested by HPV Research Group, reproducibility increased significantly with automated DNA extraction; results also used for Phase 1 of Sentinel Multi-test study Roche cobas 4800 HPV - not yet trialled by SHPVRL, but experience in Lab with same platform for BBV

5 Abbott rt HPV Roche cobas 4800 HPV Qualitative real time PCR technology Detects 14 high risk HPV genotypes Detects HPV16 &18 separately Detects 12 other HR-HPV: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 Qualitative real time PCR technology Detects 14 high risk HPV genotypes Detects HPV16 &18 separately Detects same 12 other HR-HPV Fully automated sample preparation

6 GenProbe APTIMA HPV CE marked and launched in Europe in 2008 Detects 14 high-risk HPV types through mrnas to E6 and E7 that are made in higher amounts when HPV infections progress toward cervical cancer. Designed to run on fully automated, high throughput TIGRIS instrument system and and on the smaller PANTHER instrument not yet available in UK EAS uses GenProbe s semi-automated DTS instrument platform

7 Hologic Cervista HPV HR March 2009: Cervista HPV HR approved by FDA as an in vitro diagnostic for use: To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology to determine the need for referral to colposcopy To screen adjunctively with cervical cytology to assess the presence or absence of high-risk HPV types in women 30 years and older Uses Invader chemistry: a biplex isothermal reaction process

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9 HPV Predictors 2 Study Courtesy of Anne Szarewski, November 2011, SACC, Edinburgh

10 Abbott HPV DNA using real-time PCR HPV DNA 16,18 and 12 others Automated test platform Comparable to HC2 in Predictors No sample processing front end Conclusions GenProbe HPV mrna using TMA Semi-Automated and automated test platforms Comparable to HC2 in Predictors Broad spectrum detection, no typing No sample processing front end Hologic HPV DNA using Invader chemistry Full sample processing front end Fits with Scottish LBC systems Automated test platform HPV DNA Species 9, 7 and 5/6 (16,31,33,35,52,58); (18,39,45,59,68); (51,56,66) No UK Comparisons with HC2 yet Roche HPV DNA using real-time PCR Full sample processing front end HPV DNA 16,18 and 12 others Automated test platform Well established platform but no local HPV experience as yet