HPV PCR Testing – 2016 planning Shane Byrne Components of Project    Try and define potential volume in new algorithm Establish project team drawn from both departments Examine requirements for – Pre-Analytic component • Processing from LBC vials to instrument input (de-cap and re-cap) o o o – Analytic Requirements • Based on volume and known throughput of available instruments o o o – Number of analysers required FTE requirements based on TAT required Space requirements for instrumentation and location Post-Analytic component • • • •  Direct from Vial Aliquot to other tube SRA: Where and how vs current Storage of LBC vials, including dangerous goods/volume aspects Reflex to cytological examination post HPV assay for positives and how this is controlled Determine expected volume of reflex LBC for Cytology Reporting – Neg and Pos wrt guidelines Risks – Timing of implementation • • Pre or post Bowen Hills move – require two ‘plans’ to be worked up to cover contingencies Taringa o Space considerations • Bowen Hills • Managing the transition and ramp up/ramp down in the departments o o Departments on different floors, handling/logistics of LBC vials Cross skilling of existing cytology staff? HPV testing Platforms Update  Available Platforms – Now – – – – – – Roche Cobas 4800 Hologic Panther Hologic Tigris QIAGEN QIASymphony/RCS BD Onclarity (Viper LT) Abbott m2000  Available Platforms 2016 – – – – – – Roche Cobas 6800/8800 Abbott MQ Hologic Panther Hologic Tigris QIAGEN QIASymphony/RCS BD Onclarity (Viper LT) PreAnalytic Systems Update  Pre-analytics available  Required to deal with volume of Thinprep jars – Direct test from Thinprep jar • De-cap/re-cap • Storage of cap during testing – Aliquot from Thinprep/SurePath to other tube  Currently available Pre-Analytics – – – – Roche p480 Hologic Tomcat Qiagen ‘QIAEnsemble’ ?available BD “Totalys” Roche p480 PreAnalytic for 4800 Hologic Tomcat Preanalytic  Hologic TOMCAT Qiagen QIAensemble PreAnalytic  Qiagen ‘ENSEMBLE’ BD Surepath Totalys PreAnalytic  BD Totalys(TM) MultiProcessor automated instrument that integrates the pre-processing for the BD SurePath(TM) Liquid-based Pap Test with a molecular aliquot Instrument/Assay Comparisons Roche 4800  4800  Current SNP platform Roche 6800/8800  6800/8800 – 6800 300/8hr – 8800 1000/8hr Hologic/GenProbe Panther  Panther Hologic/GenProbe Tigris  Tigris Abbott  m2000  MQ (confidential at present) BD  Viper LT Qiagen  RCS Test Volume Prediction  Predictions of test Volume – Tracey Bessell: 55 000/yr ->1.2M/yr • = ~25x • SNP 7500 tests currently = 180,000 HPV tests • = 47,000 positives -> reflexed LBC Test Volume Prediction  Predictions of test Volume – [PAP/yr] x 2 then ÷ 5 • July 2014 = 15249 paps • 183000 x 0.4 = 73,200 HPV tests • Cytology LBC workload: 19,144 reflexed – Other Calcs/SNP internal modelling? – Will be more at the start/transition – Need additional 3 x 4800 and 2-3 x p480 preanalytics Workflow options? No Preanalytic Positives: Workflow options? Preanalytic p480 Positives: Workflow options? Direct Vial Testing Positives: Renewal Algorithms  Algorithms Renewal Algorithms  Algorithms