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用于急性登革病毒感染实验室诊断的商用登革热NS1抗原捕获酶联免疫吸附测定法的评估

Evaluation of a commercial dengue NS1 antigen-capture ELISA for laboratory diagnosis of acute dengue virus infection.

作者信息

Kumarasamy V, Wahab A H Abdul, Chua S K, Hassan Z, Chem Y K, Mohamad M, Chua K B

机构信息

Makmal Kesihatan Awam Kebangsaan (National Public Health Laboratory), Kementerian Kesihatan, Lot 1853 Kg. Melayu, 47000 Sungai Buloh, Selangor, Malaysia.

出版信息

J Virol Methods. 2007 Mar;140(1-2):75-9. doi: 10.1016/j.jviromet.2006.11.001. Epub 2006 Nov 30.

DOI:10.1016/j.jviromet.2006.11.001
PMID:17140671
Abstract

A commercial dengue NS1 antigen-capture ELISA was evaluated to demonstrate its potential application for early laboratory diagnosis of acute dengue virus infection. Dengue virus NS1 antigen was detected in 199 of 213 acute serum samples from patients with laboratory confirmation of acute dengue virus infection but none of the 354 healthy blood donors' serum specimens. The dengue NS1 antigen-capture ELISA gave an overall sensitivity of 93.4% (199/213) and a specificity of 100% (354/354). The sensitivity was significantly higher in acute primary dengue (97.3%) than in acute secondary dengue (70.0%). The positive predictive value of the dengue NS1 antigen-capture ELISA was 100% and negative predictive value was 97.3%. Comparatively, virus isolation gave an overall positive isolation rate of 68.1% with a positive isolation rate of 73.9 and 31.0% for acute primary dengue and acute secondary dengue, respectively. Molecular detection of dengue RNA by RT-PCR gave an overall positive detection rate of 66.7% with a detection rate of 65.2 and 75.9% for acute primary dengue and acute secondary dengue, respectively. The results indicate that the commercial dengue NS1 antigen-capture ELISA may be superior to virus isolation and RT-PCR for the laboratory diagnosis of acute dengue infection based on a single serum sample.

摘要

对一种商用登革热NS1抗原捕获酶联免疫吸附测定法(ELISA)进行了评估,以证明其在急性登革热病毒感染早期实验室诊断中的潜在应用价值。在213份经实验室确诊为急性登革热病毒感染患者的急性血清样本中,有199份检测到登革热病毒NS1抗原,但在354份健康献血者的血清样本中均未检测到。登革热NS1抗原捕获ELISA的总体灵敏度为93.4%(199/213),特异性为100%(354/354)。急性初次登革热的灵敏度(97.3%)显著高于急性二次登革热(70.0%)。登革热NS1抗原捕获ELISA的阳性预测值为100%,阴性预测值为97.3%。相比之下,病毒分离的总体阳性分离率为68.1%,急性初次登革热和急性二次登革热的阳性分离率分别为73.9%和31.0%。通过逆转录聚合酶链反应(RT-PCR)对登革热RNA进行分子检测,总体阳性检出率为66.7%,急性初次登革热和急性二次登革热的检出率分别为%和75.9%。结果表明,基于单份血清样本,商用登革热NS1抗原捕获ELISA在急性登革热感染的实验室诊断中可能优于病毒分离和RT-PCR。

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