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Moving forward in the diagnosis of infectious diseases in developing countries: a focus on malaria Forum organized by Fondation Mérieux & the Roll Back Malaria Partnership 22 June 2009 Dr Sergio Spinaci Global Malaria Programme Estimated number of cases and deaths Approximately 250 million cases per year: 85% in Africa, 9% in South-East Asia Approximately 900 000 deaths: 91% in Africa, 85% in children under 5 years of age Source: World Malaria Report, 2008 Cases (millions) Deaths (thousands) % deaths under 5 Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific 212 3 8 0 21 2 801 3 38 0 36 4 88% 29% 76% 0% 35% 40% World 247 881 85% 2 | GLOBAL MALARIA PROGRAMME Laboratory-confirmed diagnosis of malaria 100 Malaria patients with confirmed diagnosis (%) 80 60 40 20 0 Africa 3 | Western Pacific Eastern Mediterranean South-East Asia Americas GLOBAL MALARIA PROGRAMME Europe District health system in Ghana District level District hospital District health management teams (DHMT) patient referral supervision patient referral Sub-district level Sub-district health management teams (SDHMT) ... Health centres in sub-district Health centres in sub-district patient referral supervision patient referral supervision ... patient referral supervision Community level Community health committees CHPS zones with community support systems ... 4 | CHPS zones with community support systems CHPS zones with community support systems GLOBAL MALARIA PROGRAMME CHPS zones with community support systems ... Trend of malaria cases compared to total OPD in Sene District, 2005–2008 60 000 Number of malaria cases Malaria cases Total OPD cases 40 000 20 000 0 2005 5 | 2006 2007 2008 GLOBAL MALARIA PROGRAMME Trend of laboratory-confirmed malaria cases in the Sene District, 2005–2008 6000 Number of laboratory-confirmed malaria cases 5463 5000 4183 4000 3000 2000 1484 1000 0 6 | 2005 2006 2007 GLOBAL MALARIA PROGRAMME 2008 Reduction in prescription of antimalarials after RDT implementation A mean of 6-fold decrease in ALu consumption was observed (range: 2–26) in intervention facilities and 1.7-fold decrease in control health facilities Proportion of patients tested negative who were still prescribed antimalarials decreased from 67% to 7% Fever patients tested for malaria increased from 73% to 90% 7 | GLOBAL MALARIA PROGRAMME Mean test positivity rates in intervention and control health facilities Routine microscopy: 41% in hospitals; 49% in health centres; 65% in dispensaries (range: 13–90%) Routine RDTs: 7% in hospitals; 10% in health centres; 9% in dispensaries (range: 6–12%) Malaria test positivity rate before and after RDT implementation 2006 8 | 2007 GLOBAL MALARIA PROGRAMME 2008 New development in 2007–2009 Malaria decrease due to effective control Systematic review: 24 studies conducted between 1989 and 2005 in 15 different African countries including 15 331 patients Proportion of malaria among fevers highly variable: 2% to 81% Median parasite rate = 26% D'Acrémont et. al. (2009). PLoS Med, 6 (1): e252 Median PfPR 1985-19992-10 = 37% Median PfPR 2000-20072-10 = 17% 9 | GLOBAL MALARIA PROGRAMME New development in 2007–2009 Evidence of benefits of health outcomes 1887 patients studied in Zanzibar in non randommized four-centre clinical trial with weekly cross-over validation comparing RDT-aided malaria diagnosis with symptom-based clinical diagnosis (CD) RDT was associated with lower prescription rates of antimalarial treatment than CD alone, 361/1005 (36%) compared with 752/882 (85%). Prescriptions of antibiotics were higher after RDT than CD alone, i.e., 372/1005 (37%) and 235/882 (27%); re-attendance due to perceived unsuccessful clinical cure was lower after RDT 25/1005 (2.5%), than CD alone 43/882 (4.9%). Total average cost per patient was similar: US$ 2.47 and 2.37 after RDT and CD alone, respectively Msellem et. al. (2009). PLoS Med, 6 (4): e1000070 10 | GLOBAL MALARIA PROGRAMME Debate on abandoning presumptive antimalarial treatment for febrile African children Time to move to laboratory confirmed diagnosis Proportion of fevers due to malaria has become significantly lower We now have reliable RDTs (comparable to expert microscopy) Risk of false negative test is smaller than risk of patient dying due to another severe disease because of the focus on malaria D'Acrémont V et. al. (2009). PLoS Med, 6 (1): e252 11 | Against rapid abandoning of presumptive treatment Health systems and health workers not ready for this change – Prescription of antimalarial to negative – Problematic drug supply system – No resources for treating other causes of non-malaria fevers Pre-requirements – More data on local epidemiology – Improved implementation in > 5 years – Evidence of safety of new policy English M et. al. (2009). PLoS Med, 6 (1): e1000015 GLOBAL MALARIA PROGRAMME New diagnostics at different levels of the health system Drug resistance surveillance Reference labs Regional labs District level Sub-district level Community level Specimen bank Recombinant panel LAMP iLED PCWs TB Malaria HAT Malaria RTD lot testing RDT lot testing Malaria LAMP Improved RDTs Infant HIV Dx Malaria HAT TB TB Malaria HAT FIND: Foundation for innovative new diagnostics 12 | GLOBAL MALARIA PROGRAMME Conclusions The quality of routine microscopy was as poor in hospitals and health centres as in dispensaries Routine RDT implementation minimized over-diagnosis and significantly reduced ALu consumption Without appropriate diagnosis the true burden of disease cannot be estimated Well-trained clinicians with adequate supportive supervision comply with RDT results and improve on practice RDTs should be used as first-line diagnostic tool for malaria in all settings and all health facility levels, including hospitals where the potential for saving lives is the greatest 13 | GLOBAL MALARIA PROGRAMME