Gosbell I B, Sullivan E A, Maidment C A
Department of Microbiology and Infectious Diseases, South Western Sydney Area Health Service, Liverpool, Australia.
Pathology. 1999 Nov;31(4):398-402. doi: 10.1080/003130299104800.
Traditional tests for detection of syphilis are labour intensive and costly. Enzyme immunoassays (EIAs) are readily automated and cost effective if large numbers of tests are performed. Four experiments were devised to evaluate a syphilis EIA test kit where resources are limited: (1) testing antenatal patients; (2) testing refugees; (3) testing a high prevalence population; and (4) testing "problem sera" (containing autoantibodies or antibodies to other infective agents). Forty-one available syphilitic sera from antenatal patients were tested to evaluate sensitivity. Specificity was determined through testing sera determined to be nonreactive with rapid plasma reagin and Treponema pallidum hemagglutination tests, calculating the sample size (456) on the confidence interval (CI) required. Two runs were performed on antenatal sera, giving sensitivities of 32% (95% CI: 20%, 47%) and 37% (95% CI: 24%, 52%) and specificities of 92% (95% CI: 89%, 94%) and 90% (95% CI 87%, 92%), respectively. We present a method to evaluate a serological test where resources are limited. Unexpectedly, the test kit performed poorly as a screening test. New serological tests need to be evaluated in-house prior to adoption.
传统的梅毒检测方法劳动强度大且成本高。如果进行大量检测，酶免疫测定法（EIA）易于自动化且具有成本效益。设计了四项实验来评估在资源有限的情况下一种梅毒EIA检测试剂盒：（1）检测产前患者；（2）检测难民；（3）检测高患病率人群；（4）检测“问题血清”（含有自身抗体或针对其他感染因子的抗体）。对41份来自产前患者的现有梅毒血清进行检测以评估敏感性。通过检测经快速血浆反应素和梅毒螺旋体血凝试验确定为无反应性的血清来确定特异性，并根据所需的置信区间（CI）计算样本量（456）。对产前血清进行了两次检测，敏感性分别为32%（95%CI：20%，47%）和37%（95%CI：24%，52%），特异性分别为92%（95%CI：89%，94%）和90%（95%CI：87%，92%）。我们提出了一种在资源有限的情况下评估血清学检测的方法。出乎意料的是，该检测试剂盒作为筛查检测表现不佳。新的血清学检测在采用之前需要在内部进行评估。
