Feldman R A, Deeks J J, Evans S J
Department of Epidemiology and Medical Statistics, London Hospital Medical College at Queen Mary Westfield College, UK.
Eur J Clin Microbiol Infect Dis. 1995 May;14(5):428-33. doi: 10.1007/BF02114899.
The performance of eight commercially available EIA kits in detecting antibody to Helicobacter pylori was evaluated by a panel of 17 laboratories using serum from 59 patients selected from endoscopy clinics in Belgium, Ireland, Italy, the Netherlands and Switzerland. Each laboratory received a randomly numbered set of sera and was ignorant of the culture results of the patients. The performance of the kits was assessed in terms of diagnostic accuracy compared to culture (measured by sensitivity and specificity), the inter-laboratory variability in diagnostic accuracy and the number of laboratories that experienced problems in using the kits. Grey zone results, which are routinely used to highlight the uncertain interpretation of results that lie near the cut-off point between positive and negative diagnoses, were accounted for in the analysis. Laboratories experienced practical problems in using some kits, whilst other kits were found to have high inter-laboratory variation or low diagnostic accuracy. There was no single kit that performed better on every criterion than the others. The Orion kit was a good all-round performer, whilst the Roche kit was excellent at detecting positive results, although it had a slightly raised false-positive rate.
由来自比利时、爱尔兰、意大利、荷兰和瑞士等国内镜检查诊所选取的59例患者的血清，组成了一个包含17个实验室的小组，用以评估8种市售酶免疫分析（EIA）试剂盒检测幽门螺杆菌抗体的性能。每个实验室收到一组随机编号的血清样本，且对患者的培养结果不知情。根据与培养结果相比的诊断准确性（通过敏感性和特异性衡量）、诊断准确性的实验室间变异性以及在使用试剂盒过程中遇到问题的实验室数量，对试剂盒的性能进行评估。分析中考虑了灰区结果，该结果通常用于突出介于阳性和阴性诊断分界点附近结果的不确定解释。一些实验室在使用某些试剂盒时遇到了实际问题，而其他试剂盒则被发现具有较高的实验室间变异性或较低的诊断准确性。没有一种试剂盒在所有标准上都比其他试剂盒表现更好。奥立安试剂盒是一个表现出色的全能选手，而罗氏试剂盒在检测阳性结果方面表现出色，尽管其假阳性率略有升高。
