Comparison of the Diagnostic Accuracy of Three Rapid Tests for the Serodiagnosis of Hepatic Cystic Echinococcosis in Humans.
Comparison of the Diagnostic Accuracy of Three Rapid Tests for the Serodiagnosis of Hepatic Cystic Echinococcosis in Humans.
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DOI：
10.1371/journal.pntd.0004444
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发表时间：
2016-02
影响因子：
3.8
通讯作者：
Brunetti E
中科院分区：
文献类型：
--
作者：
Tamarozzi F;Covini I;Mariconti M;Narra R;Tinelli C;De Silvestri A;Manzoni F;Casulli A;Ito A;Neumayr A;Brunetti E
囊型包虫病(CE)的诊断主要基于成像，特别是腹部CE的超声，当成像结果不清楚时，辅之以血清学。在农村流行地区，由于缺乏实验室设备，超声方面的专业知识可能匮乏，传统的血清学技术不可用，因此快速诊断检测(RDT)很有吸引力。我们评价了3种商用RDTs诊断肝CE的准确性。用RDTS VIRapid HYDATIDOSIS(西班牙Vircell)、DIGFA(UniBiotest，中国)、ADAMU-CE(ICST，日本)和RIDASCREEN棘球绦虫Ig G酶联免疫吸附试验(R-BIOPAM，德国)对59例超声分期明确(金标准)的单发肝CE囊肿患者和25例非寄生虫囊肿患者的血清进行了分析。敏感度、特异度和ROC曲线比较采用McNemar和t检验。用Spearman‘s系数评价VIRapid和DIGFA半定量结果与ELIOD值的相关性。用Cohen‘s Kappa系数对随机选择的16份血清进行重复性评价。VIRapid(74%，96%)和ADAMU-CE(57%，100%)的敏感性和特异性与EL ISA(69%，96%)无差异，而DIGFA(72%，72%)与EL ISA(72%，72%)有差异(p=0.045)。与ELISA法相比，ADAMU-CE诊断活动性包囊的敏感性显著降低(p=0.019)，而DIGFA的特异性显著降低(p=0.014)。所有试验诊断非活动性囊性病变的敏感性均较低(33.3%的EL ISA和ADAMU-CE，42.8%的DIGFA和47.6%的VIRapid)。所有RDT的重复性都很好--非常好。VIRapid和DIGFA的条带强度与ELISAOD值呈正相关(r=0.76和r=0.79，P均<0.001)。在资源匮乏的环境中，RDT可能是有用的，以补充不确定病例中CE的超声诊断。VIRapid测试似乎是被检查的试剂盒中表现最好的，但所有的测试在存在不活跃的包囊时灵敏度都很低，这可能会给准确诊断带来问题。囊型包虫病是一种在世界范围内流行的寄生虫性人畜共患病，特别是在经济困难的畜牧业地区。寄生虫囊肿最常发生在肝脏，主要通过超声诊断。血清学有助于诊断，特别是在超声特征不清楚的情况下。不幸的是，在服务不足的流行农村地区，可能缺乏超声诊断CE的专业知识，而且由于缺乏实验室设备，无法使用传统的血清学技术。在这些情况下，快速诊断测试(RDT)可能非常有用。在这项工作中，我们评估了三种RDTs的诊断性能，并将它们与我们诊断实验室常规使用的商业ELISA法进行了比较。我们的结果表明，在明确分期的肝脏CE诊断中，RDTS总体上与ELISA法具有可比性，尽管它们之间存在显著差异。如果在更大的队列中得到证实和扩展，这些结果将支持在CE的诊断中使用RDT而不是常规技术来补充成像。
The diagnosis of cystic echinococcosis (CE) is based primarily on imaging, in particular with ultrasound for abdominal CE, complemented by serology when imaging results are unclear. In rural endemic areas, where expertise in ultrasound may be scant and conventional serology techniques are unavailable due to lack of laboratory equipment, Rapid Diagnostic Tests (RDTs) are appealing. We evaluated the diagnostic accuracy of 3 commercial RDTs for the diagnosis of hepatic CE. Sera from 59 patients with single hepatic CE cysts in well-defined ultrasound stages (gold standard) and 25 patients with non-parasitic cysts were analyzed by RDTs VIRapid HYDATIDOSIS (Vircell, Spain), Echinococcus DIGFA (Unibiotest, China), ADAMU-CE (ICST, Japan), and by RIDASCREEN Echinococcus IgG ELISA (R-Biopharm, Germany). Sensitivity, specificity and ROC curves were compared with McNemar and t-test. For VIRapid and DIGFA, correlation between semiquantitative results and ELISA OD values were evaluated by Spearman’s coefficient. Reproducibility was assessed on 16 randomly selected sera with Cohen’s Kappa coefficient. Sensitivity and Specificity of VIRapid (74%, 96%) and ADAMU-CE (57%, 100%) did not differ from ELISA (69%, 96%) while DIGFA (72%, 72%) did (p = 0.045). ADAMU-CE was significantly less sensitive in the diagnosis of active cysts (p = 0.019) while DIGFA was significantly less specific (p = 0.014) compared to ELISA. All tests were poorly sensitive in diagnosing inactive cysts (33.3% ELISA and ADAMU-CE, 42.8% DIGFA, 47.6% VIRapid). The reproducibility of all RDTs was good-very good. Band intensity of VIRapid and DIGFA correlated with ELISA OD values (r = 0.76 and r = 0.79 respectively, p<0.001). RDTs may be useful in resource-poor settings to complement ultrasound diagnosis of CE in uncertain cases. VIRapid test appears to perform best among the examined kits, but all tests are poorly sensitive in the presence of inactive cysts, which may pose problems with accurate diagnosis. Cystic echinococcosis (CE) is a parasitic zoonosis prevalent worldwide, especially in economically poor livestock raising areas. Parasitic cysts develop most commonly in the liver and are diagnosed primarily by ultrasound. Serology helps with diagnosis, particularly when ultrasound features are unclear. Unfortunately, in underserved endemic rural areas, expertise in ultrasound diagnosis of CE may be scant, and conventional serology techniques are unavailable due to the lack of laboratory equipment. In these circumstances, Rapid Diagnostic Tests (RDTs) may be very useful. In this work, we evaluated the diagnostic performance of three RDTs and compared them with a commercial ELISA test routinely used in our diagnostic laboratory. Our results show that RDTs have overall comparable performances to ELISA in the diagnosis of hepatic CE in well-defined stages, although significant differences exist among them. If confirmed and expanded on a bigger cohort, these results would support the use of RDTs instead of conventional techniques to complement imaging in the diagnosis of CE.