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Point of Care diagnostics: South Africa ’s experience

Point of Care diagnostics: South Africa ’s experience. Lesley Scott Department of Molecular Medicine and Haematology University of the Witwatersrand, and the National Priority Program, NHLS Johannesburg, South Africa . POC WHO, IAS satellite 30 th June 2013.

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Point of Care diagnostics: South Africa ’s experience

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  1. Point of Care diagnostics: South Africa’s experience Lesley Scott Department of Molecular Medicine and Haematology University of the Witwatersrand, and the National Priority Program, NHLS Johannesburg, South Africa • POC WHO, IAS satellite 30th June 2013

  2. A perspective on South Africa’s Testing volumes • Total Population over 50 Million at last census • Estimated 5.7 million HIV infected individuals of which 1.9 million are receiving ARV therapy. HIV continues to drive these testing needs. • Currently Conduct approximately ~ 4 million CD4 tests annually, 2 million viral loads and currently 360 000 EID assays • 3rd highest TB cases, 20% worlds reported HIV‐associated TB cases and 4th largest reported numbers of MDR. • over 1.4 million GeneXpert tests (2012), smear microscopy load ~5 million smears in 2012, 1.2 million TB cultures in 2012 • 30-40% of all public health sector laboratory expenditure for HIV and TB • Universal testing for HIV and screening for TB – the primary objectives being to ensure that all citizens know their HIV and TB status, and to prevent new HIV and TB infections (NSP: 2012/2013-2016/2017) . Increase testing requirements • NSP, 2012 http://www.doh.gov.za/docs/stratdocs/2012/NSPsum.pdf

  3. 256 NHLS labs ~80% population (public sector) • NDOH Healthcare Facilities • Over 7636 health facilities • 54 different categories of facility • 45% urban, 45% rural, 0.7% peri-urban • Over 3515 ARV clinics • New guidelines: • On ART: CD4 only at 12 months • Pre-ART: CD4 every 6 months • 2013/2014: • 14 million HCT – 2,166 855 (14%) expected HIV positive and require CD4. • Target to initiate 500 000, thus 1 CD4 at 12 months. • Residual 1,666 855 with CD4 >350c/ul will be monitored 6 monthly (ie 3,333 711 CD4 tests). • Total CD4 for 2013/14 = 6,000 566: significant scale up

  4. Evaluations of POC CD4 Count Within Comprehensive Interventions: linkage to care!! • Recently completed pilot evaluations (no comparison arms): • HBCT-Plus(Home based counseling and testing, POC CD4 count, facilitated referrals, and follow up home visits) • 86% initiated ART ≤ 3months in rural KZN [16] • RAP(“Rapid Initiation of Antiretroviral Therapy in Pregnancy”) • 97% initiated ART (91% on same day) in Cape Town [17] • Randomized controlled trials now underway • Grand Challenges Canada RCT(“Investigating the feasibility of implementation of multi-disciplinary point-of-care testing in an HIV treatment clinic using a randomised controlled trial”) • RapIT(“Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa”) • Others? Courtesy Syndey Rosen, NDoH/NHLS POC workshop Pretoria, 24-15th June 2013

  5. Feasibility of implementing multi-disciplinary point-of care (POC) testing in an active HIV treatment clinic ( PI: Wendy Stevens ) Grand Challenges Canada (POC implementation award, 2011-2014) • CD4, Creatinine, ALT, Hb, TB (VL, CryAG) • Develop a “POCT package” • Perform randomized controlled trial (POC vs SOC “2010 guidelines”) • Determine costing • Recommend policy

  6. Findings • Clinic space to perform “multiple POCT” is variable and limited. • POCT requires its own checklist within quality ISO, CLSI and SANAS guidelines : pre-analytical, analytical and post analytical; equipment, safety, storage, waste, test QC, EQA, operator certification, training. • SOP’s to include quick reference charts. • Training both central and “on-site” test witnessing: more emphasis placed on computer literacy (GeneXpert experience) • A “starter kit” (measuring cylinder, squeegee bottle, spill kit, order charts etc to introduce GCLP into clinics. • Health system strengthening required for daily clinic workflow issues • 69% HIV patients require multiple POCT (>3/visit).

  7. Nurses perform multiple POC, daily QC and EQA as accurately as laboratory testing. • Multiple POC’s (CD4, Hb, ALT, Creat) could be performed accurately on 1 finger stick (8% required >1 finger stick). • 100% of patients said they prefer either one (65.5%) or two finger sticks (34.5%) over a venepuncture specimen. • 68.8% would be willing to have up to 3 finger sticks before having a blood draw. • Earliest time a POCT performed was 09:30, (median11:00 and the latest 12:24). • Median time taken from the time the nurse started the first POCT to the time taken to start the last POCT varied depending on the number and type of tests requested. • When CD4 requested, tests took ~1hr47min, • No CD4 requested, ~6min - 14minutes. These time measurements did not include acting on result or any connectivity.

  8. POC DUTIES (pre-analytical, analytical, post-analytical) • Additional finger prick/venepuncture • Sample labelling • Instrument QC testing • Instrument maintenance • Testing: • ALT, Creat, lactacte, Hb: <2minutes • PIMA = 20 minutes • Xpert MTB/RIF =2 hours • Result recording/printing/reporting • External quality assessment (EQA) • Infection control • Spill cleaning • Waste disposal • Additional skills: • Phlebotomy • Testing performed from blood tubes (pipetting skills) • Additional duties: • Operator certification and on-going monitoring • Managing test failures, instrument downtime • Stock control • Specimen storage Human resources • CLINIC DUTIES • Patient registration • History taking • Physical exam • Counselling • Rapid testing (HIV, pregnancy) • Phlebotomy – lab tests • Treatment • Return visit booking • + Who will perform POCT? Task Shifting – management of task shifting from lab staff to clinical staff Regulation and certification around scope of work?

  9. N=3000 RCT at 3 remote PHC HCT/PICT Consent and Finger-stick x1 N=1000 HIV Positive HIV Negative N=480 Venipuncture: HIV test confirmation +PIMA in POC N=480 POC participants SOC participants Venipuncture PIMA TB screening N=316 CD4> 350 CD4< 350 Use stored blood from tests above Adherence counseling TB screening (questionnaire) Creatinine ALT Hemoglobin Return in one week Negative Positive CD4>350 CD4<350 N=50 GeneXpert Sputum Adherence counseling Adherence counseling N=316 N= 288 ART start (same day) ART start 1-4 weeks later Follow up for 6 or 12 months

  10. GCC RB Osih Outcome measures • Primary: Proportion of patients retained in care at 6/12 and 12/12 • Secondary: • Time taken from HCT to initiation of ART in both arms • Proportion of patients in each arm experiencing an OI (including TB) in the follow-up period • Proportion of patients experiencing treatment interruptions in each group • Determine cost effectiveness of POC testing vs Standard of Care (SOC) Preliminary results before study end (dedicated staff)

  11. TAT: 3 clinics North West Province 75% of specimens are collected (once/day courier) from the clinic and received at laboratory within one day; Patient initiated SOC 85% lab tests completed by lab within one day; 72% printed results stamped in the clinic within one day. Without connectivity in clinics, POCT will lose National data • Patient initiated day 1 with POC , same day 72% lab results returned to clinic • POC placement with staff versus treatment guideline timeline change to initiate day 1 or day 7 to compliment clinic work flow.

  12. Beyond the LIS: Our experience at POC: Manual entry transcription errors Both clinic sites had transcription errors (1%; n=5/480): Incorrect assay result recorded Assay result recorded under incorrect test. Laboratory information system (LIS): instant data stream to central “powerhouse data repository” Result reporting Billing • National data Program M&E Central data warehouse

  13. Increasing access to results:SMS printers • SMS printers to improve turn-around-time of results back to facilities from the labs • Beneficial in remote, far-reaching areas where no internet access is available • SMS is automatically generated from the lab’s LIS • Result printed on paper and to be stored in patient’s file • Initial roll-out in 2009: • Currently 1990 SMS printers in the field nationwide (~4500 DoH facilities) • Services available for: CD4 Count, HIV VL, EID, GeneXpert TB and TB Microscopy. Dashboard

  14. Host LIS/HIS Centralised data for decentralised testing Bi-directional Communication HL7/ASTM/POCT1-A Universal POC Devices Interface Program / Data Management System POCT1-A Proprietary ASTM HL7 POC Device #1 POC Device #2 POC Device #3 POC Device #4

  15. Feasibility of multi-disciplinary Point-of-Care Testing

  16. Available Options for Connectivity • Instrument and Data Management • Patient Management

  17. Middleware Dashboard • PIMA modem required for FTP-PUSH • LIS mechanism can be developed to interface results from CSV file • Two components: Dashboard and Middleware Solutions • Dashboard contains a small subset of the full features of the middleware solutions • Dashboard is unlinked from patient information • Dashboards are instrument / manufacturer specific • Middleware solutions are vendor & instrument neutral. PIMA connectivity:

  18. Cepheid/NHLS Remote Monitoring • Operational dashboard for real-time monitoring of results, errors, resistance and positivity rates • Pre-configured on all newly installed GeneXperts User Workshop held 5-9th November to improve usability and facilitate design changes, Johannesburg

  19. National policy Roll out March 2011, testing at smear microscopy labs >1mil tests to date. Gx at POC: NTCM=too costly, 2 ½ staff required for 15 patients same day treatment Current GeneXpert Placements Phase 2 Phase 3 Testing centres: 175 Analysers: 242 Clinic placements: 20 Gx4: 77 Gx16-8: 1 Gx16: 162 GX48: 1 GX80-48: 1

  20. POCT not an easy decision for South Africa • Both a national policy and legal framework required. • NDoH/NHLS combined POCT workshop (24-25th June 2013): output to form a national advisory body to focus on POCT. • POCT “an extension of the lab tiered network” • Focus on CD4, Cryptococcal antigen testing <100CD4 cells/ul • Investigate POCT for NCD’s • Determine the place of VL • Address lack of regulation issues • Address connectivity as a critical component for quality POCT • Combine efforts on modeling the place and cost for POCT. • Address gaps in research – especially linkage to care (HIV and TB) and improve health systems.

  21. www.mapplace.co.uk Totally Centralised model (4hr) Models for implementation Decentralised model (1hr) Solution: 15 Labs No POC Solution: 127 Labs 190 POC

  22. In the interim: 62 CD4 labs – current footprint Proposed CD4 service delivery model • NHLS CD4 testing laboratories (Red), • Proposed community laboratories (Green), • POC/mini-lab sites (Yellow) • in reference to the NDOH clinics (blue)

  23. Is South Africa ready for (multiple) POCT? • Clinic space is varied and limited • Nurses can perform multiple POCT duties but time is limited. Need a new cadre of POCT staff • More studies needed: • Full economic costing • Cost-effectiveness (incl. multiple POCT) • Cost of deployment and logistics • Cost of quality assurance • Address economic scale and new guidelines: Hb, ALT, cr, CD4 at once for 7 day initiation • Same day initiation impact (HCT + adherence + LTH + HIV resistance) yet unknown: takes more than a rapid CD4 count

  24. Acknowledgments • National Department of Health • NHLS National Priority Program staff (led by Prof Wendy Stevens and Dr. Leigh Berrie • NHLS POCT working group • GCC team and clinical partners • Funders: Clinton Foundation, CDC, PEPFAR, Grand Challenges Canada • Professor Scott and R&D Development team • South African Cryptococcal Screening Programme: NeleshGovender • HERO: Professor Sydney Rosen, Dr. Lawrence Long, Kate Schnippel • Connectivity working group (Brad Cunningham) • CD4 working team (Prof. Debbie Glencross), viral load (Dr. Sergio. carmona) • Special thanks to Trevor Peter, Maurine Murtagh, Rosanna Peeling, Tim Tucker, • IleshJani. Mozambique program

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