Evaluation of capture ELISA and rapid immunochromatographic test for the determination of IgM and IgG antibodies produced during dengue infection

S.K Lam , P.L Devine
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引用次数: 95

Abstract

Background: Rapid diagnosis of dengue infection is essential to patient management and disease control. The development of a rapid (5 min) immunochromatographic test and a 2 h commercial capture enzyme linked immunosorbent assay (ELISA) for anti-dengue IgM and IgG antibodies may lead to more rapid and accurate testing in peripheral health settings and diagnostic laboratories.

Objectives: Evaluate two new commercial tests for dengue serology (Dengue Rapid test and Dengue Duo ELISA; PanBio, Brisbane, Australia).

Study design: The sensitivity and specificity of the tests were compared with in-house dengue IgM ELISA and hemagglutination-inhibition (HAI) assays using known positive and negative dengue specimens, as well as specimens from non-dengue cases.

Results: Both assays showed excellent sensitivity in the diagnosis of both primary and secondary dengue infection (100%). In both assays, IgG levels showed excellent correlation with hemagglutination-inhibition (HAI) assay, and these could be used to distinguish between primary and secondary dengue infections (92 and 97% of patients correctly classified in the rapid test and Duo ELISA, respectively). Specificity in both assays was 89% when sera from patients, with no apparent dengue infection, typhoid, leptospirosis and malaria, were tested.

Conclusions: These tests should be a useful aid in confirming the clinical diagnosis of dengue infection. The rapid test will be particularly valuable in peripheral health settings, while the ELISA has a place in central testing laboratories.

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捕获ELISA和快速免疫层析法测定登革热感染过程中产生的IgM和IgG抗体的评价
背景:快速诊断登革热感染对患者管理和疾病控制至关重要。针对登革热IgM和IgG抗体的快速(5分钟)免疫层析检测和2小时商用捕获酶联免疫吸附测定(ELISA)的发展,可能会导致在周边卫生机构和诊断实验室进行更快速和准确的检测。目的:评价两种新的登革热血清学检测方法(登革热快速检测和登革热双酶联免疫吸附试验);PanBio,布里斯班,澳大利亚)。研究设计:使用已知的登革热阳性和阴性标本以及来自非登革热病例的标本,将这些试验的敏感性和特异性与内部登革热IgM酶联免疫吸附试验和血凝抑制(HAI)试验进行比较。结果:两种检测方法对原发性和继发性登革热感染的诊断均具有良好的敏感性(100%)。在这两种检测中,IgG水平与血凝抑制(HAI)检测显示出良好的相关性,并且这些可用于区分原发性和继发性登革热感染(在快速检测和Duo ELISA中分别有92%和97%的患者正确分类)。当检测无明显登革热感染、伤寒、钩端螺旋体病和疟疾的患者血清时,两种检测方法的特异性均为89%。结论:这些检测对登革热感染的临床诊断具有重要的辅助作用。快速检测在外围卫生机构尤其有价值,而酶联免疫吸附试验则在中心检测实验室占有一席之地。
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