Heather Alexander, PhD

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1 Xpert MTB/RIF: An Opportunity to Strengthen Laboratory Systems and Bridge the Laboratory-Program Gap Heather Alexander, PhD International Laboratory Branch Division of Global HIV/AIDS Centers for Disease Control and Prevention Conference on TB and HIV Diagnostics in Adult and Pediatric Populations 29 June 2011 Center for Global Health Division of Global HIV/AIDS

2 Outline TB diagnostic pathway and WHO endorsement Implementing new TB diagnostic tests Xpert MTB/RIF as a piece of the TB control puzzle Implementation, collaboration, and operational research

3 TB Diagnostic Test Pathway Stop TB New Diagnostics Working Group: A blueprint for the development of TB Diagnostics, 2009

4 WHO TB Diagnostics Policy Formulation Identifying the need for policy change Reviewing the evidence Convening an Expert Group Assessing policy proposal and recommendations Formulating and disseminating policy WHO strategic monitoring of country needs Partners (researchers, industry, etc) Body of evidence available Commissioning of systematic reviews QUADAS or other diagnostic accuracy tool Meta-analyses (where feasible) Experts, methodologists, end-users Guidelines Review Committee GRADE process for evidence synthesis Strategic and Technical Advisory Group Endorsement/revision/addition Advise WHO to proceed/not with policy Guidelines Review Committee Dissemination to Member States Promotion with stakeholders & funders Phased implementation & scale-up plan Courtesy WHO/GLI

5 Implementation of New Technologies Decided by Ministries of Health Coordination of partners and funding mechanisms Avoid duplication of efforts Maximize resources Phased approach In the context of national strategic plans Laboratory strengthening Management of TB, MDR TB and HIV-associated TB Linked to drug access and programmatic capacity Based on local epidemiology

6 Courtesy WHO and FIND

7 The Assay is Only Part of the Answer Suspect Identification Specimen Collection Specimen Transport Laboratory Testing Result Reporting Treatment Initiation Treatment Monitoring

8 Xpert MTB/RIF: Suspect Identification Recommended initial diagnostic test Individuals with suspected HIV-associated TB Individuals with suspected MDR TB Programmatic considerations Clinician (refresher) training Intensified TB case finding (ICF)* Risk factors for MDR TB Human resource capacity Access to suspects Community outreach workers *WHO guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource constrained settings

9 Xpert MTB/RIF: Specimen Collection Programmatic considerations Number of specimens and time of collection 2 versus 3 Spot-spot, spot-morning, spot-morning-spot, etc. Specimen quality Supervised collection Mouth rinsing

10 Transport Xpert MTB/RIF: Specimen Transport Collection to receipt at laboratory < 24 hours Temperature Biosafety Storage 35 C up to 3 days 4 C up to 10 days

11 Placement Xpert MTB/RIF: Laboratory Testing (I) District and sub-district hospitals Central /Reference laboratories for support, training and quality assurance Use close to operating capacity (12-20 per day) Infrastructure Temperature control Cartridge storage (2-28ºC) Testing (max 30ºC) Stable power supply UPS, generator, or batteries Minimal biosafety Security Adequate waste management

12 Laboratory algorithm Parallel testing Smear microscopy Culture Splitting specimens Confirmatory testing Molecular method Phenotypic method Reflex testing Xpert MTB/RIF: Laboratory Testing (II) First and second-line DST WHO Rapid Implementation of the Xpert MTB/RIF Diagnostic Test

13 Xpert MTB/RIF: Laboratory Testing (III) Method validation Quality assurance/proficiency testing Inventory and supply management systems Maintenance/calibration

14 Xpert MTB/RIF: Result Recording and Reporting?

15 Xpert MTB/RIF: Treatment Initiation Case definitions Interpretation of results Capacity for treatment scale-up Availability of quality first- and second-line anti-tb drugs Access to patients Treatment of Xpert-confirmed RIF-resistant cases* PPV > 90% where prevalence of RIF resistance > 15% Risk assessment If at risk Initiate MDR TB treatment Collect sputum specimen for culture and 1 st and 2 nd line DST *WHO Rapid Implementation of the Xpert MTB/RIF Diagnostic Test

16

17 Xpert MTB/RIF: Treatment Monitoring Not indicated for monitoring treatment outcome Sputum smear microscopy and culture required Health systems and laboratory systems considerations are not eliminated

18 Summary Xpert MTB/RIF highlights laboratory systems and clinic-laboratory interface needs Country-level interest in Xpert MTB/RIF provides a unique opportunity for systems strengthening and operational research Considerations are not unique to specific tests or disease areas How can we best collaborate and learn from previous diagnostic implementation initiatives?

19 Resources GLI Roadmap for TB Laboratory Strengthening WHO Policy Framework for Implementing TB Diagnostics GLI Laboratory Tool Set WHO Rapid Implementation of the Xpert MTB/RIF Diagnostic Test USG Phased Implementation and Evaluation of Xpert MTB/RIF (in review) The findings and conclusions in this presentation have not been formally disseminated by [he Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.

20 Acknowledgements CDC Anand Date Mark DeZalia Michael Iademarco Bess Miller John Nkengasong Eric Pevzner Thomas Shinnick Angela Starks USAID Amy Piatek OGAC Bill Coggin WHO Chris Gilpin Karin Weyer FIND Rick O Brien

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