Thomas E E, Puterman M L, Kawano E, Curran M
Department of Pathology, Faculty of Medicine, University of British Columbia, British Columbia's Children's Hospital, Vancouver, Canada.
J Clin Microbiol. 1988 Jun;26(6):1189-93. doi: 10.1128/jcm.26.6.1189-1193.1988.
The performance of seven commercially manufactured rotavirus assays was evaluated with 144 pediatric stool specimens and compared with electron microscopy (EM) findings. The four enzyme-linked immunosorbent assays used were Rotazyme II, Pathfinder, IDL rotavirus immunoassay, and Enzygnost (Behring) rotavirus assay. The three latex tests were Meritec rotavirus detection test, Virogen Rotatest, and Bartels rotavirus latex test. Test outcomes were compared with EM on the basis of sensitivity, specificity, positive-negative predictive value, and the kappa statistic. Relative to EM, Meritec had the highest specificity (97%), followed by Virogen (95%), IDL (91%), Pathfinder (85%), Behring (81%), Bartels (72%), and Rotazyme (71%). The sensitivities were as follows: Rotazyme (92%), Pathfinder (89%), Bartels (86%), Virogen (86%), Behring (82%), Meritec (71%), and IDL (75%). Patient age and sex did not influence test results. Owing to the absence of a true standard, the tests were also compared with each other on the basis of the kappa statistic, the frequency of positive test results, and the frequency of samples in which a test differed from all other tests. Using these measures, the assays could be classified into three groups with progressively decreasing utility: group 1 (Virogen, Meritec, IDL, and EM), group 2 (Pathfinder and Behring), and group 3 (Rotazyme and Bartels). Laboratory criteria were also compared. Latex tests were faster and required less equipment than enzyme-linked immunosorbent assays. The Virogen latex assay showed the best overall performance, which made it our choice for rapid and accurate rotavirus diagnosis. However, in children who have gastrointestinal symptoms with negative rotavirus test results, EM will be useful until such time as immunological tests for other enteric viruses are available.
用144份儿科粪便标本对7种商业生产的轮状病毒检测方法的性能进行了评估，并与电子显微镜（EM）检查结果进行了比较。所使用的4种酶联免疫吸附测定法分别为Rotazyme II、Pathfinder、IDL轮状病毒免疫测定法和Enzygnost（贝林）轮状病毒测定法。3种乳胶试验分别为Meritec轮状病毒检测试验、Virogen Rotatest和Bartels轮状病毒乳胶试验。根据敏感性、特异性、阳性和阴性预测值以及kappa统计量，将检测结果与电子显微镜检查结果进行了比较。相对于电子显微镜检查，Meritec具有最高的特异性（97%），其次是Virogen（95%）、IDL（91%）、Pathfinder（85%）、贝林（81%）、Bartels（72%）和Rotazyme（71%）。敏感性如下：Rotazyme（92%）、Pathfinder（89%）、Bartels（86%）、Virogen（86%）、贝林（82%）、Meritec（71%）和IDL（75%）。患者的年龄和性别不影响检测结果。由于缺乏真正的标准，还根据kappa统计量、阳性检测结果的频率以及某一检测与所有其他检测结果不同的样本频率，将这些检测方法相互进行了比较。采用这些指标，可将这些检测方法分为效用逐渐降低的3组：第1组（Virogen、Meritec、IDL和电子显微镜检查）、第2组（Pathfinder和贝林）和第3组（Rotazyme和Bartels）。还比较了实验室标准。乳胶试验比酶联免疫吸附测定法更快，所需设备更少。Virogen乳胶试验总体性能最佳，这使其成为我们进行快速准确的轮状病毒诊断的选择。然而，对于有胃肠道症状但轮状病毒检测结果为阴性的儿童，在有针对其他肠道病毒的免疫检测方法之前，电子显微镜检查仍将有用。
