Evaluation of Six Commercial Point-of-Care Tests for Diagnosis of Acute Dengue Infections: the Need for Combining NS1 Antigen and IgM/IgG Antibody Detection To Achieve Acceptable Levels of Accuracy

被引：137

作者：

Blacksell, Stuart D. ^{[1
,2
]}

Jarman, Richard G. ^{[3
]}

Bailey, Mark S. ^{[4
]}

Tanganuchitcharnchai, Ampai ^{[1
]}

Jenjaroen, Kemajittra ^{[1
]}

Gibbons, Robert V. ^{[3
]}

Paris, Daniel H. ^{[1
,2
]}

Premaratna, Ranjan ^{[5
]}

de Silva, H. Janaka ^{[5
]}

Lalloo, David G. ^{[6
]}

Day, Nicholas P. J. ^{[1
,2
]}

机构：

[1] Mahidol Univ, Fac Trop Med, Mahidol Oxford Trop Med Res Unit MORU, Bangkok 10400, Thailand

[2] Univ Oxford, Churchill Hosp, Ctr Trop Med, Oxford OX3 7LJ, England

[3] Armed Forces Res Inst Med Sci, Bangkok 10400, Thailand

[4] Royal Ctr Def Med, Dept Mil Med, Birmingham B15 2SQ, England

[5] Univ Kelaniya, Dept Med, Fac Med, Ragama, Sri Lanka

[6] Univ Liverpool Liverpool Sch Trop Med, Clin Res Grp, Liverpool L3 5QA, Merseyside, England

来源：

CLINICAL AND VACCINE IMMUNOLOGY | 2011年 / 18卷 / 12期

基金：

英国惠康基金;

关键词：

LINKED-IMMUNOSORBENT-ASSAY; VIRUS-INFECTION; HUMAN SERUM; BLOOD; LAOS;

D O I：

10.1128/CVI.05285-11

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Six assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen-and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.

引用

页码：2095 / 2101

页数：7

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