Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs : round 3 (2010-2011)

This Summary presents an overview of the results of the first, second and third rounds of WHO Product Testing of malaria antigen-detecting RDTs completed in 2008, 2009 and 2011 respectively, and is published in conjunction with the release of the results of Round 3. The results of the three rounds of testing should be considered as a single data set. Concerning products re-submitted for evaluation, the results of earlier rounds are replaced by subsequent rounds and therefore only one set of results per product feature in this summary. Separate full reports of all rounds should be consulted for further detail on product performance, and on the interpretation and use of these results.Acknowledgements -- Abbreviations -- 1. Summary peformance of malaria RDTs: WHO product testing : Rounds 1-3 -- 2. WHO malaria RDT product testing: Round 3 executive summary -- 3. Background -- 4. Objective -- 5. Materials and methods -- 6. Data management -- 7. Quality assurance -- 8. Ethical considerations -- 9. Data analysis -- 10. Laboratory versus field-based malaria RDT evaluations -- 11. Results -- 12. Heat stability -- 13. Ease of use description -- 14. Discussion of key findings -- 15. Using these results to ensure quality of diagnosis in the field -- 16. Conclusions -- 17. References -- -- Annex 1: Characteristics of rapid malaria tests in Round 3-- Annex 2: Malaria RDT guide to results interpretation -- Annex 3: Phase 1 results -- Annex 4: Phase 2 results -- Annex 5a: Selection of an appropriae RDT -- Anneex 5b: RDT format review and ease of use assessment -- Annex 6: Introducing RDT-based malaria diagnosis into national programmesThe evaluation described in this report was a joint project of the Global Malaria Programme (GMP), the Foundation for Innovative New Diagnostics (FIND), TDR, Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO and the US Centers for Disease Control and Prevention (CDC), under the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND, the Australian Agency for International Development (AusAID), the United States Agency for International Development (USAID), the UK Department for International Development (DFID) and TDR. The project would not have been possible without the cooperation and support of the specimen collection sites, and the specimen characterization laboratories mentioned herein, and acknowledges the technical advice from many malaria diagnostic manufacturers and developers in the development of the programme. This report on Round 3 of WHO Malaria RDT Product Testing was compiled by Jane Cunningham (Special Programme for Research and Training in Tropical Diseases (TDR), Switzerland) and David Bell (Foundation for Innovative New Diagnostics (FIND), Switzerland.Mode of access: World Wide Web as an Acrobat .pdf file (7.53 MB, 124 p.).Includes bibliographical references (p. 54)

Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008)

1. Executive summary -- 2. Background -- 3. Objectives -- 4. Data management -- 5. Materials and methods -- 6. Quality assurance -- 7. Ethical considerations -- 8. Data analysis -- 9. Laboratory versus field-based malaria RDT evaluations -- 10. Results -- 11. Heat stability -- 12. Ease of use description -- 13. Discussion of key findings -- 14. Additional measures to ensure quality and utility of RDT testing -- 15. Conclusions -- 16. References -- -- Annex 1: Characteristics of rapid malaria malaria tests in the evaluation -- Annex 2: Malaria RDT guide to results interpretation -- Annex 3: Phase 1 results -- Annex 4: Phase 2 results -- Annex 5: Example algorithm for selecting a malaria RDT -- Annex 6: Introducing RDT-based malaria diagnosis into national programmesThis report, which presents the results of the first round of WHO product testing of malaria antigen-detecting RDTs, was completed in November 2008 in collaboration with FIND, the US Centers for Disease Control and Prevention (CDC) ...--P. 1.Also available online at: as an Acrobat .pdf file (2.77 MB, 110 p.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

<p>Abstract</p> <p>Background</p> <p>Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.</p> <p>Discussion</p> <p>Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.</p> <p>The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.</p> <p>Conclusion</p> <p>Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?</p

Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs : round 2 (2009)

"This Summary presents an overview of the results of the first and second rounds of WHO product testing of malaria antigen-detecting RDTs completed in 2008 and 2009 respectively, and is published in conjunction with the release of the results of Round 2. The results of the two rounds of testing should be considered as a single data set, and the full reports of both Rounds 1 and 2 consulted for further detail on product performance, and on the interpretation and use of these results." - p. 1Acknowledgements -- Abbreviations -- 1. Summary peformance of malaria RDTs: WHO product testing : Rounds 1 and 2 -- 2. WHO malaria RDT product testing: Round 2 executive summary -- 3. Background -- 4. Objective -- 5. Materials and methods -- 6. Data management -- 7. Quality assurance -- 8. Ethical considerations -- 9. Data analysis -- 10. Laboratory versus field-based malaria RDT evaluations -- 11. Results -- 12. Heat stability -- 13. Ease of use description -- 14. Discussion of key findings -- 15. Using these results to ensure quality of diagnosis in the field -- 16. Conclusions -- 17. References -- -- Annex 1: Characteristics of malaria rapid diagnostic tests in the evaluation -- Annex 2: Malaria RDT guide to results interpretation -- Annex 3: Phase 1 results -- Annex 4: Phase 2 results -- Annex 5: Example algorithm for selecting a malaria RDT -- Annex 6: Introducing RDT-based malaria diagnosis into national programmes"DOI: 10.2471/TDR.09.978-924-1599467""The RDT evaluations summarized here were performed as a collaboration between WHO, TDR, FIND, the US Centers for Disease Control and Prevention (CDC) and other partners."Mode of access: World Wide Web as an Acrobat .pdf file (5.4MB, 100 p.).Includes bibliographical references (p. 46)

Malaria rapid diagnostic test performance: summary results of WHO malaria RDT product testing: rounds 1-3 (2008-2011)

"The RDT evaluations summarized here were performed as a collaboration between WHO, TDR, FIND, the US Centers for Disease Control and Prevention (CDC) and other partners. All companies manufacturing under ISO 13485:2003 Quality System Standard were invited to submit up to 3 tests for evaluation under the programme. In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites, while 29 products from 13 manufacturers were evaluated in Round 2. In Round 3, 50 products were evaluated from 23 manufacturers, including 23 products re-submitted from earlier rounds (Table S3). Of these 120 total products, 118 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after two months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. Of the 118 fully evaluated products, 25 have been evaluated in more than one round. Of the 95 unique products tested by the programme, 29 detect P. falciparum alone, 57 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species specific), 8 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. Where the same products4 have been re-submitted in subsequent rounds of testing, the latter results replace results published from the earlier round. Thus, the performance of many tests in the results below differ from those published in the Round 1 and Round 2 reports. The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement decisions of WHO and other UN agencies and national governments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad implementation of reliable malaria diagnosis in areas where malaria is prevalent. A fourth round of product testing began in June 2011." - p. 1"TDR/RDT/11.1.

Assessing the use of an essential health package in a sector wide approach in Malawi

<p>Abstract</p> <p>Background</p> <p>The sector wide approach (SWAp) used in many developing countries is difficult to assess. One way is to consider the essential health package (EHP) which is commonly the vehicle for a SWAp's policies and plans. It is not possible to measure the impact of an EHP by measuring health outcomes in countries such as Malawi. But it is possible to assess the choice of interventions and their delivery in terms of coverage. This paper describes an attempt to assess the Malawi SWAp through its EHP using these available measures of technical efficiency.</p> <p>Methods</p> <p>A burden of disease model was used to identify the priority diseases and their estimated incidence. Data from the health management information system (HMIS) were used to measure the coverage of these interventions. A review of the cost-effectiveness of the chosen and potential interventions was undertaken to assess the appropriateness of each intervention used in the EHP. Expenditure data were used to assess the level of funding of the EHP.</p> <p>Results</p> <p>33 of the 55 EHP interventions were found to be potentially cost-effective (<$150/DALY), 12 were not so cost-effective (>$150/DALY) and cost-effective estimates were not available for ten. 15 potential interventions, which were cost-effective and tackling one of the top 20 ranked diseases, were identified.</p> <p>Provision had increased in nearly all EHP services over the period of the SWAp. The rates of out patient attendances and inpatient days per 1000 population had both increased from 929 attendances in 2002/3 to 1135 in 2007/08 and from 124 inpatient days in 2002/03 to 179 in 2007/08.</p> <p>However, by 2007/08 the mean gap between what was required and what was provided was 0.68 of the estimated need. Two services involving the treatment of malaria were overprovided, but the majority were underprovided, with some such as maternity care providing less than half of what was required.</p> <p>The EHP was under-funded throughout the period covering on average 57% of necessary costs. By 2007/08 the funding paid by SWAp partners including the government of Malawi to fund the EHP was at US$13.5 per capita per annum, which was almost half of the revised EHP estimated required expenditure per capita per annum.</p> <p>Discussion</p> <p>The SWAp had invested in some very cost-effective health interventions. In terms of numbers of patients treated, the EHP had delivered two thirds of the services required. This was despite serious under-funding of the EHP, an increase in the population and shortage of staff.</p> <p>Conclusions</p> <p>The identification of interventions of proven effectiveness and good value for money and earmarked funding through a SWAp process can produce measurable improvement in health service delivery at extremely low cost.</p