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Xpert in the diagnostic algorithm of pulmonary TB in adult patients who are neither high risk for HIV, nor high risk for MDR-TB. Preparations for the global consultation DEWG core team meeting, Berlin 10 Nov 2010
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Xpert in the diagnostic algorithm of pulmonary TB in adult patients who are neither high risk for HIV, nor high risk for MDR-TB Preparations for the global consultation DEWG core team meeting, Berlin 10 Nov 2010 Jacob Creswell, Knut Lönnroth, Ikushi Onozaki, Salah Ottmani, Suvanand Sahu, Mukund Uplekar
Group work in the consultation • Operationalize STAG recommendations – develop implementation road map: • HIV (high HIV prevalence settings / people suspected of HIV) • MDR-TB (high MDR-TB prevalence settings / MDR risk groups) • DOTS expansion and enhancement (settings and individuals where HIV and MDR-TB are of lesser concern). • Three topics for discussion • Proposed algorithm(s) • Implementation issues • Operational research • Preparations for group 3: • Small ad hoc group in Secretariat have done preliminary work • Discussion in DEWG core team 10 Nov • Mini task force to finalise draft for the consultation
STAG-TB supports Expert Group guidance that: • Xpert MTB/RIF should be used as the initial diagnostic test in individuals suspected of MDR-TB or HIV-associated TB (strong recommendation); • Xpert MTB/RIF may be used as a follow-on test to microscopy in settings where MDR and/or HIV is of lesser concern, especially in smear-negative specimens (conditional recommendation, recognising major resource implications).
Group 3 algorithms - assumptions • The issue is not only to find the appropriate place of Xpert in the current algorithm, but also to re-consider the whole algorithm, including potentially changed role of microscopy and X-ray for screening, diagnosis and case categorization. • The priority is algorithms for "passive" case finding. Additional algorithms may have to be developed for "active" case findings in TB risk groups other than people with HIV. • The algorithms need to be linked to / integrated with / consistent with algorithms for people at high risk of MDR-TB and people with HIV, which have not yet been finalized. • The recommendation to use Xpert "as the initial diagnostic test" for people at high risk of HIV or MDR-TB, does not necessarily mean first screening test
Different algorithms are required for at least two different levels of the health system: • Facilities with smear microscopy but no X-ray • Facilities with X-ray • The algorithms should work in both high and low MDR prevalance / HIV prevalance settings • The first step is to identify the most effective and cost-effective approach. Affordability and feasibility issues are considered under implementation challenges.
Legend/Guide TB SUSPECT Option 1: Diagnostic algorithm for passive case finding in a facility with microscopy and no CXR Start Process/Action HIV- or Unknown Is HIV+? Microscopy Result Decision HIV+ Follow HIV Algorithm Referral for CXR SS- Endpoint Result SS+ CXR Abnormal CXR Normal XPERT YES MDR Risk Factors? TB+ No Res Result NO No TB TB+ Rif Res FLD FLD SLD Further Clinical Management • Not HIV clinic • Not TB cases failing treatment • Not contact investigation • Not active case findings
Legend/Guide Option 2a: Diagnostic algorithm for passive case finding in facilities with CXR Start TB SUSPECT Process/Action CXR Result Decision CXR Abnormal CXR Normal XPERT Endpoint Result TB+ No Res No TB **Note - Use of culture and DST will be necessary in parallel with GeneXpert use TB+ Rif Res FLD SLD Further Clinical Management
Legend/Guide Option 2b: Diagnostic algorithm for passive case finding in facilities with CXR Start TB SUSPECT Process/Action CXR Result Decision CXR Abnormal CXR Normal XPERT Endpoint Result TB+ No Res No TB **Note - Use of culture and DST will be necessary in parallel with GeneXpert use TB+ Rif Res FLD SLD Further Clinical Management ss- Smear? ? ss+
Algorithm- Issues to discuss during consultation • Detailed technical discussion on proposed algorithms • Can we use the same algorithm in both low- and high MDR-TB / HIV settings? • How to link with algorithms for people at risk of HIV and MDR-TB? • Can we use the same algorithm in high and low TB prevalance settings? • Do we need to change the definition of a TB case and method for monitoring treatment outcomes (if sputum smear microscopy is no longer essential for diagnosis)?
Implementation • Considerations for NTPs, partners, and donors: • Should we develop an interim algorithm for settings that are already planning to purchase Xpert, or discourage general use until results from further research findings? • If interim algorithm, should we prepare an operational research protocol that should be used in all sites? • Where is the appropriate place of Xpert in the health system? • What are the capacity strengthening needs for Xpert, X-ray, R&R, etc? • What are the health systems pros and cons of different algorithms (e.g. improving X-ray capacity is beneficial for diagnosis of many other conditions)
Strategy for Xpert use in the private sector • Should private providers engaged in PPM schemes have access to Xpert at reduced cost? • Should the be an agreement with Sepheid to only sell Xpert to private providers on condition of report to NTP where Xpert has been purchased as well as mandatory reporting/notification of diagnosed cases? • Accreditation / certification? • Need to update ISTC? • Should NTPs accept cases diagnosed with Xpert in the private sector (need to change case definition)?
Research needs • What recommendations for the evaluation of Xpert in the FIND sites, concerning cases that are neither HIV-positive, nor high risk for MDR? • Use sputum smear microscopy, Xpert, X-ray, and culture for all suspects in order to fully assess sensitivity and specificity of all permutations? • Full assessment of risk factor profile for MDR and TB (HIV, smoking, diabetes, etc) among all suspects in order to assess differences in yield and precision across risk groups • Operational research questions and protocol; which operational question?