Diagnostic accuracy of NS1 ELISA and lateral flow rapid tests for dengue sensitivity, specificity and relationship to viraemia and antibody responses.
Diagnostic accuracy of NS1 ELISA and lateral flow rapid tests for dengue sensitivity, specificity and relationship to viraemia and antibody responses.
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DOI：
10.1371/journal.pntd.0000360
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发表时间：
2009
影响因子：
3.8
通讯作者：
Simmons CP
中科院分区：
文献类型：
--
作者：
Hang VT;Nguyet NM;Trung DT;Tricou V;Yoksan S;Dung NM;Van Ngoc T;Hien TT;Farrar J;Wills B;Simmons CP
登革热是许多国家的公共卫生问题。登革热的快速诊断可以帮助患者分类和管理。登革病毒蛋白NS1的检测代表了登革诊断的新方法。在138名越南儿童和成人中，将Platelia NS1 ELISA检测和NS1侧流快速检测（LFRT）的灵敏度和特异性与金标准参考诊断算法进行了比较。总体而言，在确诊的登革热病例中，Platelia NS1 ELISA的敏感性（82%）略高于NS1 LFRT（72%）。ELISA和LFRT检测法对原发性登革热比继发性登革热更敏感，并且对发病3天内收集的样本（相对于随后的时间点）更敏感。可测量的DENV反应性IgG的存在和在较小程度上IgM在测试样品中与在两种测定中的NS1检测率显著较低相关。NS1阳性与潜在的病毒血症相关，因为NS1阳性样本的病毒血症显著高于与疾病持续时间匹配的NS1阴性样本。血小板和NS1 LFRT是100%特异性的，在所有没有近期登革热证据的发热患者以及肠道热、疟疾、日本脑炎和钩端螺旋体病患者中均为阴性。总的来说，这些数据表明NS1检测值得纳入登革热患者的诊断评估中，但要适当考虑疾病晚期或伴有体液免疫应答的患者的局限性。登革热是一种由蚊子传播的人类病毒感染。登革热在许多发展中国家是一个非常重要的公共卫生问题。最近，已经开发了新的测试来帮助诊断登革热患者。评估这些测试，看看他们在不同国家和不同的医疗保健环境中的表现如何，是一个重要的过程，有助于指导医疗保健政策，这些检测是否可能在诊断中有用，如果是这样，什么时候最好使用它们。我们基于医院的结果，使用两种不同类型的NS1测试诊断登革热，表明这些测试在疾病的前3天使用时最敏感，如果患者患有原发性登革热，则最有可能呈阳性。我们的研究结果还表明，阳性NS1检测结果反映了血液中病毒的数量，因此血液中病毒含量高的患者更有可能是NS1阳性。总的来说，结果表明这些NS1测试值得纳入登革热的诊断方法。
Dengue is a public health problem in many countries. Rapid diagnosis of dengue can assist patient triage and management. Detection of the dengue viral protein, NS1, represents a new approach to dengue diagnosis. The sensitivity and specificity of the Platelia NS1 ELISA assay and an NS1 lateral flow rapid test (LFRT) were compared against a gold standard reference diagnostic algorithm in 138 Vietnamese children and adults. Overall, the Platelia NS1 ELISA was modestly more sensitive (82%) than the NS1 LFRT (72%) in confirmed dengue cases. Both ELISA and LFRT assays were more sensitive for primary than secondary dengue, and for specimens collected within 3 days of illness onset relative to later time points. The presence of measurable DENV-reactive IgG and to a lesser extent IgM in the test sample was associated with a significantly lower rate of NS1 detection in both assays. NS1 positivity was associated with the underlying viraemia, as NS1-positive samples had a significantly higher viraemia than NS1-negative samples matched for duration of illness. The Platelia and NS1 LFRT were 100% specific, being negative in all febrile patients without evidence of recent dengue, as well as in patients with enteric fever, malaria, Japanese encephalitis and leptospirosis. Collectively, these data suggest NS1 assays deserve inclusion in the diagnostic evaluation of dengue patients, but with due consideration for the limitations in patients who present late in their illness or have a concomitant humoral immune response. Dengue is a viral infection of humans that is transmitted by mosquitoes. Dengue is a very important public health problem in many developing countries. Recently, new tests to help diagnose patients with dengue have been developed. Evaluating these tests to see how well they perform in different countries and in different health care settings is an important process that helps to guide health care policy on whether these assays are likely to be useful in making a diagnosis, and if so, when best to use them. Our hospital-based results, using two different types of NS1 tests for diagnosing dengue, indicates that these tests are most sensitive when used during the first 3 days of illness and are most likely to be positive if the patient has primary dengue. Our results also show that a positive NS1 test result is a reflection of the amount of virus in the blood, so that patients with high amounts of virus in the blood are more likely to be NS1 positive. Collectively, the results indicate these NS1 tests deserve inclusion in the diagnostic approach to dengue.
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影响因子：
3.7
作者：
Mackenzie, JM;Jones, MK;Young, YR
通讯作者：
Young, YR
影响因子：
6.7
作者：
Avirutnan P;Zhang L;Punyadee N;Manuyakorn A;Puttikhunt C;Kasinrerk W;Malasit P;Atkinson JP;Diamond MS
通讯作者：
Diamond MS
影响因子：
3.1
作者：
Kumarasamy, V.;Wahab, A. H. Abdul;Chua, K. B.
通讯作者：
Chua, K. B.
影响因子：
6.4
作者：
Libraty, DH;Young, PR;Rothman, AL
通讯作者：
Rothman, AL
影响因子：
6.4
作者：
Avirutnan, P;Punyadee, N;Malasit, P
通讯作者：
Malasit, P