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Volume 15, Number 3—March 2009

Evaluation of Commercially Available Anti–Dengue Virus Immunoglobulin M Tests

Elizabeth A. Hunsperger, Sutee Yoksan, Philippe Buchy, Vinh Chau Nguyen, Shamala D. Sekaran, Delia A. Enria, Jose L. Pelegrino, Susana Vázquez, Harvey Artsob, Michael Drebot, Duane J. Gubler, Scott B. Halstead, María G. Guzmán, Harold S. Margolis, Carl-Michael Nathanson, Nidia R. Rizzo Lic, Kovi E. Bessoff, Srisakul Kliks, and Rosanna W. PeelingComments to Author 
Author affiliations: Centers for Disease Control and Prevention, San Juan, Puerto Rico, USA (E.A. Hunsperger, K.E. Bessoff); Mahidol University, Bangkok, Thailand (S. Yoksan); Institut Pasteur, Phnom Penh, Cambodia (P. Buchy); Cho Quan Hospital, Ho Chi Minh City, Vietnam (V.C. Nguyen); University of Malaya, Kuala Lumpur, Malaysia (S.D. Sekaran); Instituto Nacional Enfermedades Virales Humanas Dr. Julio I. Maiztegui, Buenos Aires, Argentina (D.A. Enria); Instituto Medicina Tropical Pedro Kouri, Havana, Cuba (S. Vázquez, M.G. Guzmán, J.L. Pelegrino); Public Health Agency of Canada, Winnipeg, Manitoba, Canada (H. Artsob, M. Drebot); University of Hawaii, Honolulu, Hawaii, USA (D.J. Gubler); Pediatric Dengue Vaccine Initiative, Seoul, South Korea (S.B. Halstead, H.S. Margolis, S. Kliks); World Health Organization, Geneva, Switzerland (C.-M. Nathanson, N.R. Rizzo, R.W. Peeling)

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Table 2

Characteristics of 9 tests used for detection of IgM against dengue virus*

Test name Dengue IgM capture Pathozyme dengue M Pathozyme dengue M capture Dengue fever virus IgM capture DxSelect Dengue IgM capture
Company, location Panbio Diagnostics, Windsor, Queensland, Australia Omega Diagnostics, Alva, UK Omega Diagnostics Focus Diagnostics, Cypress, CA, USA Standard Diagnostics, Kyonggi-do, South Korea
Detection method IgM capture Indirect IgM detection IgM capture IgM capture IgM capture
Format 12 strips of 8 wells 12 strips of 8 wells 12 strips of 8 wells 12 strips of 8 wells 12 strips of 8 wells
No. tests/package 96 96 96 96 96
Antigen Recombinant DENV 1–4 Purified DENV 2 DENV 1–4 DENV 1–4 DENV 1–4
Sample volume, μL 10 10 20 10 10
Total incubation time 130 min at 37°C 120 min at 37°C 110 min at 37°C 240 min at room temperature 130 min at 37°C
Storage conditions, °C
Rapid diagnostic tests
Test name Dengue duo cassette Hapalyse dengue-M PA kit Dengucheck WB SD dengue IgG/IgM
Company, location Panbio Diagnostics Pentax, Tokyo, Japan Zephyr Biomedicals, Panaji, India Standard Diagnostics
Assay principle Lateral flow Particle agglutination Lateral flow Lateral flow
Target antibody IgM and IgG IgM IgM and IgG IgM and IgG
Format Cassette 12 strips of 8 wells Cassette Cassette
No. tests/package 25 96 25 25
Antigen Recombinant DENV 1–4 DENV 1–4 Recombinant DENV (serotype not specified) Recombinant DENV 1–4 envelope protein
Specimen type Serum, plasma, or whole blood Serum or plasma Serum, plasma, or whole blood Serum or plasma
Volume of sample required, μL 10 1 5 5
Duration of test, min 15 90 15 15–20
Storage conditions, °C 2–30 2–8 4–30 1–30
Additional equipment required No Yes (e.g., micropipette) No No

*Ig, immunoglobulin; DENV, dengue virus.

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Page created: December 07, 2010
Page updated: December 07, 2010
Page reviewed: December 07, 2010
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.