Accuracy of clinical criteria and an immunochromatographic strip test for dengue diagnosis in a DENV-4 epidemic
Accuracy of clinical criteria and an immunochromatographic strip test for dengue diagnosis in a DENV-4 epidemic
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DOI：
10.1186/s12879-016-1368-7
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发表时间：
2016-01-29
影响因子：
3.7
通讯作者：
Daumas, Regina Paiva
中科院分区：
文献类型：
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作者：
Buonora, Sibelle Nogueira;Lambert Passos, Sonia Regina;Daumas, Regina Paiva
背景：登革热感染的早期诊断对于决策和及时实施治疗措施非常重要。虽然快速NS 1检测已用于登革热诊断自2008年以来，其性能在DENV-4 cases尚未得到充分assessed.Methods：我们评估了NS 1 Bioeasy（TM）免疫层析试纸条测试和三个临床标准的准确性登革热诊断。在2013年里约热内卢DENV-4流行期间，在急性发热性疾病72小时内在急诊中心就诊的患者连续入组进行临床和实验室评价。我们根据WHO 2009、WHO 1997和INI-FIOCRUZ三个临床标准将患者分为疑似登革热或非疑似登革热。通过使用RT-PCR的RNA检测确定登革热诊断，并且阴性病例对所有登革热血清型和Platelia（TM）NS 1 ELISA均为阴性。结果：325例患者中148例DENV-4 RT-PCR检测阳性，其中148例为阴性。NS 1 Bioeasy（TM）与WHO 2009、WHO 1997和INI-FIOCRUZ标准的阳性似然比、灵敏度和特异性分别为22.6（95% CI 7.2-70.6），40.6%（95% CI 32.3-49.3）和98.2%（95% CI 94.9-99.6）; 18.3（95% CI 6.8-49.2），44.2（95% CI 35.8-52.9），97.6（95% CI 94.0-99.3）; 26.2（95% CI 6.5-106.5），29.7（95% CI 22.4-37.8），98.9（95% CI 96.0-99.9）。WHO 1997年临床诊断标准对排除疾病的敏感性高，但特异性极低。INI-FIOCRUZ有中等的敏感性和特异性，并可以针对一组更具体的test.Conclusions：虽然假阴性结果使用NS 1 Bioeasy（TM）快速检测建议对它的使用分流（排除）的目的，在DENV-4流行病的大比率，它可以被用作床边算法的确认工具。
Background: Early diagnosis of dengue infection is important for decision-making and timely implementation of therapeutic measures. Although rapid NS1 assays have been used for dengue diagnosis since 2008, their performance in DENV-4 cases has not yet been fully assessed.Methods: We evaluated the accuracy of NS1 Bioeasy (TM) immunochromatographic strip test and of three clinical criteria for dengue diagnosis. Patients presenting at an emergency care center within 72 h of an acute febrile illness during the 2013 DENV-4 epidemic in Rio de Janeiro were consecutively enrolled for clinical and laboratory evaluation. We classified patients as suspected dengue or not according to three clinical criteria: WHO 2009, WHO 1997, and INI-FIOCRUZ. Dengue diagnosis was defined by RNA detection using RT-PCR and the negative cases were negative for all dengue serotypes and also Platelia (TM) NS1 ELISA. We obtained accuracy indices for NS1 Bioeasy (TM) alone and in combination with the clinical criteria.Results: RT-PCR for DENV-4 was positive in 148 out of 325 patients. Positive likelihood ratio, sensitivity, and specificity of NS1 Bioeasy (TM) with WHO 2009, WHO 1997, and INI-FIOCRUZ criteria were 22.6 (95 % CI 7.2-70.6), 40.6 % (95 % CI 32.3-49.3), and 98.2 % (95 % CI 94.9-99.6); 18.3 (95 % CI 6.8-49.2), 44.2 (95 % CI 35.8-52.9), 97.6 (95 % CI 94.0-99.3); 26.2 (95 % CI 6.5-106.5), 29.7 (95 % CI 22.4-37.8), 98.9 (95 % CI 96.0-99.9), respectively. WHO 1997 clinical criteria presented high sensitivity to rule out disease, but extremely low specificity. INI-FIOCRUZ had moderate sensitivity and specificity, and could target a group to a more specific test.Conclusions: Although the large rates of false negative results using NS1 Bioeasy (TM) rapid test advise against its use for triaging (rule out) purposes in DENV-4 epidemics, it could be used as a confirmatory tool in a bedside algorithm.