Chua K B, Mustafa B, Abdul Wahab A H, Chem Y K, Khairul A H, Kumarasamy V, Mariam M, Nurhasmimi H, Abdul Rasid K
National Public Health Laboratory, Ministry of Health, Sungai Buloh, Selangor, Malaysia.
Malays J Pathol. 2011 Jun;33(1):13-20.
A prospective study was carried out to evaluate the sensitivity of dengue NS1 antigen-capture ELISA in comparison with dengue virus isolation, conventional RT-PCR and real-time RT-PCR for laboratory confirmation of acute dengue based on single-acute serum samples. Four primary healthcare centres were involved to recruit patients with clinical diagnosis of dengue illness. Patient's demographic, epidemiological and clinical information were collected on a standardized data entry form and 5 ml of venous blood was collected upon consent. In the laboratory, six types of laboratory tests were performed on each of the collected acute serum sample. Of the 558 acute serum samples collected from 558 patients with clinical diagnosis of dengue from mid-August 2006 to March 2009, 174 serum samples were tested positive by the dengue NS1 antigen-capture ELISA, 77 by virus isolation, 92 by RT-PCR and 112 by real-time RT-PCR. A total of 190 serum samples were tested positive by either one or a combination of the four methods whereas, only 59 serum samples were tested positive by all four methods. Thus, based on single-acute serum samples, 190 of the 558 patients (34.1%) were laboratory-confirmed acute dengue. The overall test sensitivity was 91.6%, 40.5%, 48.4% and 58.9% for dengue NS1 antigen-capture ELISA, virus isolation, conventional RT-PCR and real-time RT-PCR respectively. Statistically, dengue NS1 antigen-capture ELISA was the most sensitive and virus isolation was the least sensitive test for the laboratory confirmation of acute dengue based on single-acute serum specimens. Real-time RT-PCR was significantly more sensitive than the conventional RT-PCR.
开展了一项前瞻性研究，以评估登革热NS1抗原捕获酶联免疫吸附测定（ELISA）与登革热病毒分离、传统逆转录聚合酶链反应（RT-PCR）和实时RT-PCR相比，用于基于单份急性血清样本对急性登革热进行实验室确诊的敏感性。四个初级医疗保健中心参与招募临床诊断为登革热疾病的患者。使用标准化数据录入表格收集患者的人口统计学、流行病学和临床信息，并在患者同意后采集5毫升静脉血。在实验室中，对每份采集的急性血清样本进行六种实验室检测。在2006年8月中旬至2009年3月期间从558例临床诊断为登革热的患者中采集的558份急性血清样本中，174份血清样本通过登革热NS1抗原捕获ELISA检测呈阳性，77份通过病毒分离检测呈阳性，92份通过RT-PCR检测呈阳性，112份通过实时RT-PCR检测呈阳性。共有190份血清样本通过这四种方法中的一种或多种检测呈阳性，而只有59份血清样本通过所有四种方法检测呈阳性。因此，基于单份急性血清样本，558例患者中有190例（34.1%）被实验室确诊为急性登革热。登革热NS1抗原捕获ELISA、病毒分离、传统RT-PCR和实时RT-PCR的总体检测敏感性分别为91.6%、40.5%、48.4%和58.9%。从统计学角度来看，基于单份急性血清样本对急性登革热进行实验室确诊时，登革热NS1抗原捕获ELISA是最敏感的检测方法，而病毒分离是最不敏感的检测方法。实时RT-PCR比传统RT-PCR明显更敏感。
