Evaluation of commercially available anti-dengue …

1 Diagnostics Evaluation SerieDiagnostics Evaluation SeriesNo. 3 Evaluation of commercially available anti - dengue virus immunoglobulin M testsSpecial Programme for Research & Trainingin Tropical Diseases (TDR) sponsored byUNICEF/UNDP/World Bank/WHOS pecial Programme for Research & Trainingin Tropical Diseases (TDR) sponsored byUNICEF/UNDP/World Bank/WHOWHO Library Cataloguing-in-Publication Data : Evaluation of commercially available anti - dengue virus immunoglobulin M tests.(Diagnostics Evaluation series, 3) - diagnosis. - immunology. virus - immunology. M - blood. M - immunology. , Viral - blood. immunosorbent assay. kits, Diagnostic. Bank/WHO Special Programme for Research and Training in Tropical Diseases.

2 dengue Vaccine Initiative. ISBN 978 92 4 159775 3 (NLM classification: WC 528)Copyright World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009 All rights use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical information product is not for sale.

3 The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO.

4 Including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or views expressed in this health information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard.

5 Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information in the PhilippinesContact:Dr Rosanna W. PeelingAccessible Quality Assured DiagnosticsUNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)World Health Organization20, Avenue Appia1211, Geneva 27 SwitzerlandTel: (+41) 22 791-3742E-mail: copies please write to:TDR/World Health Organization20, Avenue Appia1211 Geneva 27 SwitzerlandFax.

6 (+41) 22 Evaluation of commercially available anti - dengue virus immunoglobulin M testsAcknowledgementsTDR is indebted to the members of the dengue diagnostics evaluations steering group, Drs Harvey Artsob, Duane Gubler, Maria Guzman, Elizabeth Hunsperger, Harold Margolis, Rosanna Peeling and Sutee Yoksan for their valuable input into the development of the dengue diag-nostics Evaluation scheme. Without them, this work would not have been possible. TDR would like to acknowledge the excellent work of the principal investigators and staff at the Evaluation laboratories, in particular, the staff of the reference laboratories for validating the qualification panels, repackaging and sending out the tests to all the sites and performing the reproducibility testing.

7 The excellent assistance of Michael Drebot with the coordination of the proficiency testing, of Mary Cheang with data analysis, of Nidia Rizzo with technical coordination, and of Isabela Suder-Dayao with contract administration is much appreciated. This report was prepared by Jos Luis Pelegrino and Carl-Michael main findings from this evalution has been published in Emerging Infectious Diseases. Hunsperger EA, Yoksan S, Buchy P, et al. Evaluation of commercially available anti dengue virus immunoglobulin M tests. Emerg Infect Dis. 2009; 15:436-40. DOI: Evaluation of commercially available anti - dengue virus immunoglobulin M tests iAbbreviations AFRIMS Armed Forces Research Institute of Medical Sciences CDC Centers for Disease Control CI confidence interval DENV dengue virus EIA enzyme immunoassay ELISA enzyme-linked immunosorbent assay ERC ethical review committee GCLP good clinical laboratory practice HRP horse radish peroxidase IgG immunoglobulin G IgM immunoglobulin M MAb monoclonal antibody MAC-ELISA IgM antibody capture ELISA OD optical density PCR polymerase chain reaction PDVI Pediatric dengue Vaccine Initiative QA quality assurance RDT rapid diagnostic test RFA request for application

8 RNA ribonucleic acid SE sensitivity SPC specificity TDR Special Programme for Research and Training in Tropical Diseases WHO World Health Organizationii Evaluation of commercially available anti - dengue virus immunoglobulin M testsTable of contents Objectives ..1 Background .. 21. Evaluation plan .. Tests under Evaluation .. Evaluation sites .. Evaluation Site preparation .. Ethical considerations ..93. Evaluation .. Before Performing the tests general procedures .. Performing the tests specific Duo Cassette (DuoCassette) Panbio Diagnostics, Hapalyse dengue -M PA Kit (HapalyseM) Pentax Corporation, Bioline dengue IgG/IgM (SD Bioline) Standard Diagnostics, Republic of WB (Dengucheck) Zephyr Biomedicals, India.

9 15 dengue Fever virus IgM Capture DxSelect (DxSelect) Focus Diagnostics, United States of America ..16 Evaluation of commercially available anti - dengue virus immunoglobulin M tests iiiDengue IgM Capture ELISA (Pb IgMCap) Panbio Diagnostics, dengue M (Pathozyme M) Omega Diagnostics Ltd., United dengue M Capture (Pathozyme MCap) Omega Diagnostics Ltd., United dengue IgM Capture ELISA (SD IgMCap) Standard Diagnostics, Republic of Results .. Rapid Tests .. Cross-reactions .. Test reproducibility and Conclusion ..34 Annexes .. 37iv Evaluation of commercially available anti - dengue virus immunoglobulin M testsAccessible Quality-Assured Diagnostics is a unit within the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) aimed at promoting and facilitating the development, Evaluation and deployment of diagnostic tools appropriate for use in developing dengue Vaccine Initiative (PDVI) was established to raise awareness and work with public and private part-ners in the North and South to accelerate the development and introduction of dengue vaccine(s) that are affordable and accessible to poor children in endemic countries.

10 Evaluation of commercially available anti - dengue virus immunoglobulin M tests 1 Objectives1 To assess the performance and operational character-istics of commercially avail-able IgM antibody detection tests for the diagnosis of To provide data on test performance to WHO member states3 To provide advice on the inclusion of tests in the WHO Bulk Procurement Scheme2 Evaluation of commercially available anti - dengue virus immunoglobulin M testsBackgroundThe arthropod-borne flavivirus dengue virus (DENV) is found mostly in tropical and subtropical regions. Four distinct serotypes (DENV 1-4) cocirculate in many of the dengue -endemic regions of the world. Approximately billion people live in areas at risk for acquiring dengue .