Hepatitis C: Completing the Diagnosis with HCV RNA Testing October 22, 2019 | 3-4 pm ET Welcome Carolyn Wester, MD, MPH Director of the Division of Viral Hepatitis (DVH) Speakers Lindsay Jolly MPH, CPH, MLS (ASCP) Tennessee Department of Health Liisa Randall, PhD and Glen Gallagher, MLS(ASCP)CM, PhD Massachusetts Department of Public Health Analysis. Answers. Action. www.aphl.org
Hepatitis C: Completing the Diagnosis with HCV RNA Testing The Association of Public Health Laboratories adheres to established standards regarding industry support of continuing education for healthcare professionals. The following disclosures of personal financial relationships with commercial interests within the last 12 months as relative to this presentation have been made by the speaker(s): Nothing to Disclose Analysis. Answers. Action. www.aphl.org
Hepatitis C: Completing the Diagnosis with HCV RNA Testing Speaker Lindsay Jolly MPH, CPH, MLS (ASCP) Immunoserology Supervisor, Division of Laboratory Services, Tennessee Department of Health Analysis. Answers. Action. www.aphl.org
Hepatiti Hepatitis C: s C: Complet Completin ing the g the Diagnosi Diagnosis s with HCV RNA Testing with HCV RNA Testing A Tale from Tennessee CM | O Linds dsay Jolly, MPH PH, CPH, CPH, MLS S (ASC ASCP) CM Octobe ber 22, 22, 20 2019
Facu culty ty D Disc sclo losu sure • A Tale from Tennessee Lindsay Jolly, MPH, CPH, MLS (ASCP) CM | • October 22, 2019
Objectives Objectives • Describe the HCV testing algorithm • Discuss how HCV RNA testing was implemented at the Tennessee Department of Health, Laboratory Services Division • Demonstrate the effectiveness of collaboration between the PHL and other public health entities
CDC CDC Testing Algorithm Testing Algorithm
HCV HCV in Tennessee in Tennessee- A history A history • CDC identified 41 counties in TN as vulnerable regions in their 2015 Vulnerability Assessment • This assessment indicated that 20% of Tennessee’s population was at risk for an HIV/HCV outbreak. • HCV cases in TN were rising in parallel with opioid addiction
Reported Reported Cases of Acute Cases of Acute HCV in HCV in Tennessee Tennessee 2013 2014 2015 2016 2017 US Case rate 0.7 0.7 0.8 1.0 1.0 Cases 2,138 2,194 2,436 2,967 3,186 TN Case rate 1.5 1.9 2.6 2.3 2.1 Cases 98 123 173 150 142 Rank 6th 5th 4th 6th 6th Sources: Table: CDC 2017 Viral Hepatitis Surveillance – United States Map: TDH Viral Hepatitis 2018 Frozen Dataset
Planning Phase Planning Phase • Regular meetings between the Viral Hepatitis (VH) program and TDHLS • TDHLS researched available HCV testing platforms for both screening and confirmatory assays – Goal was to complete the entire algorithm in-house • CDC Supplemental Funding awarded to the VH program in April 2016 – Planned the pilot study for eastern TN • Informatics Team brought in to work on assay development in LIMS
Pilot Study Pilot Study • Included 3 major Health Departments (HD) – Primarily STD and FP clinics • Specimens were collected over a 5 month period • Lots of considerations – Specimen collection and handling – Risk factor assessment – Post-test counseling and referral to care – Training for HD staff – Reporting of patient results – Staffing requirements
Total Total Study Population Study Population • During June 1–October 31, 2016: 4,753 Patients were tested for HCV Slide credit: TDH Viral Hepatitis Program
Ongoing Testing Ongoing Testing • Pilot was successful • VHP decided to rollout HCV testing statewide – Regions were added in phases – Substance Abuse Pilot-HIV, HBV, HCV – TN Dept of Corrections • Due to increased testing volumes, DLS transitioned from manual HCV NAT to the automated HCV RNA assay on the Hologic Panther. • Validated the HCV Quant Dx for qualitative use.
Funding Funding
Lessons Learned Lessons Learned • Collaboration is essential – TDH Division of Laboratory Services • Laboratory Staff • Informatics Team – Tennessee Viral Hepatitis Program – Regional and Local Health Departments – Community Based Organizations • Lab should anticipate the needs of the programs • Learn from past experiences • Start small
Thank you! Thank you!
Hepatitis C: Completing the Diagnosis with HCV RNA Testing Speakers Liisa Randall, PhD Director, Office of Health Care Planning, Massachusetts Department of Public Health Glen Gallagher, MLS(ASCP)CM, PhD Division Director of Molecular Diagnostics and Virology, Massachusetts Public Health Laboratory Analysis. Answers. Action. www.aphl.org
Massachusetts Department of Public Health Bureau of Infectious Disease and Laboratory Sciences Strengthening Testing and Linkage for Hepatitis C in Massachusetts Liisa M. Randall, PhD Director, Office of Health Care Planning Glen Gallagher, PhD Director, Molecular Diagnostics and Virology Hepatitis C: Completing the Diagnosis with HCV RNA Testing October 22, 2019
Context & Goals • Program • Public Health Laboratory • Surveillance
Enabling Environment • Policy • Administration – State appropriations – Bureau organization • 3rd party billing – Integrated procurement, • Retained revenue contract management, and – Universal coverage capacity building • No treatment restrictions • Operation – Opioid response – Specimen submission to SPHL – Co-testing – Reflex testing
Confirmed and Probable HCV Cases by Year and Age Group, Massachusetts, 2007-2018 Data current as of 3/25/19 and are subject to change Data source: Massachusetts Department of Public Health, Bureau of Infectious Disease and Laboratory Sciences.
HCV Laboratory Testing Cascade: Massachusetts 2014-2016 Vo, Quynh, et al. “The Massachusetts Hepatitis C Testing Cascade, 2014-2016.” Microbiology Insights, vol. 12, 21 June 2019, pp. 1-6.
Integrated HIV/HCV/STI/TB Testing Programs MA SPHL 48 partner agencies 120+ locations CBOS CHCs Hospitals DOC HOCs SSPs SUD/OTP Mobile
Syringe Services Programs as of September 2019, n=33 https://www.mass.gov/info-details/syringe-service-program-locator 25
HIV/HCV/Syphilis Testing Volume, MA SPHL 2013 – 2019 Automated Ab HCV Reflex (July) HIV/HCV co-testing (April) Discontinue HIV RT (October) Data Source: BIDLS/MDPH. Current as of 10/17/19
HCV Infections Identified, MA SPHL 2013 – 2019 HIV/HCV co-testing (April) HCV Reflex (July) Data Source: BIDLS/MDPH. Current as of 10/17/19
Outcomes • Uptake of HCV testing – 228% increase in HCV test volume - 2013 and 2018 – PWID • 637% increase in HCV test volume - 2013 and 2018 • 19% of all tests; 77% HCV+ in 2019 YTD – Project approximately 38,000 HCV tests in 2019 • Identification of Infection – 776 % Increase in HCV+ btw 2013 and 2018 – With reflex 12% HCV+ – 19% are new diagnoses Data Source: BIDLS/MDPH. Current as of 10/17/19
Coordinated Approach to HCV NAAT Implementation Lab Capacity Lab Evaluation HCV Test Choice NAAT Epi Program Test Implementation
Lab Capacity Evaluation HCV Antibody chemiluminescent microparticle HCV POC Rapid test NAAT immunoassay (CMIA) Automated No HCV HCV RNA HCV NAAT NAAT Manual HCV NAAT • Current testing infrastructure will guide decisions for implementation
Lab Capacity Evaluation • Current lab structure HCV NAAT – Available equipment – Space requirements Budget – Personnel – Testing schedule • Multiple Procurement options – Instrument purchase – Reagent rental agreement – Lease
Test Choice Evaluation of current testing system and HCV NAAT available test platforms – Patient population served • Prevalence and risk • Platform performance sensitivity/ specificity – Sample types • Serum vs Plasma – Processing requirements • Centrifugation timing – Shipping • Current logistics structure (ambient vs frozen) • Package insert requirements • May need sample stability study
Test Implementation Component Responsible Parties Considerations HCV Method comparison or Lab Administration - New instruments NAAT verification study - New testing method Personnel training, Lab administration - Previous experience competency, proficiency with molecular testing techniques - Environmental monitoring Reporting CLIA or Lab Directors / IT - Reporting to labs /Surveillance - Reporting to epidemiologists Messaging and training Program / Lab - Sample collection and shipping providers Administration /Surveillance - Results interpretation Messaging to Clinicians Program / Lab - Clinical management Administration/ guidance Surveillance - Results interpretation
Future • Further expansion with SSP, opioid prevention investments • Data-driven enhancements – Targeting to address gaps in access/uptake – Focused capacity building on LTC – Laboratory, provider capacity • Ongoing submitter education/TA
Thanks for Joining! For any questions contact Anne.Gaynor@aphl.org
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