Shafer M A, Schachter J, Moncada J, Keogh J, Pantell R, Gourlay L, Eyre S, Boyer C B
Department of Pediatric, University of California, San Francisco 94143.
JAMA. 1993 Nov 3;270(17):2065-70.
To evaluate the performances of diagnostic screening tests alone or in combination to detect asymptomatic chlamydial urethral infection in young males.
Comparisons of the performance profiles of the following chlamydia screening strategies were done: urethral culture; identification of polymorphonucleocytes (PMNs) on spun first-void urine (FVU); urinary leukocyte esterase test (LET) on unspun FVU; chlamydial enzyme immunoassay (EIA) applied to FVU sediment; combining LET on unspun FVU followed by EIA with or without direct fluorescent antibody (DFA) confirmation on FVU sediment; and combining PMNs on spun FVU followed by EIA with or without DFA confirmation.
General clinics at a youth detention center, university-based teen clinic, college health service, and a military screening clinic.
A total of 618 males aged 12 to 35 years (mean, 17 years) were recruited as a convenience sample; site participation rates ranged from 50% to 80%. Eligible subjects were sexually active, denied symptoms of urethritis, and had taken no antibiotics in the prior 2 weeks.
Sensitivity, specificity, and positive and negative predictive values of each test strategy's ability to detect Chlamydia trachomatis infection, and cost to confirm each positive case.
With a 7% prevalence of chlamydial infection, tissue culture had a sensitivity of only 61%. However, two strategies yielded significantly better performance profiles compared with the others: EIA confirmed by DFA test with a sensitivity of 84%, a specificity of 100%, and a cost to identify each positive case of $434; and PMNs followed by EIA confirmed by DFA test with a sensitivity of 78%, a specificity of 100%, and a cost to identify each positive case of $199. The LET followed by EIA-DFA had a similar performance profile to the PMN test strategies.
A combination of a nonspecific screening of FVU for PMNs or LET followed by specific testing with EIA with DFA confirmation has superior clinical and cost-effective performance for detecting asymptomatic C trachomatis urethritis in young males compared with other strategies. However, an evaluation of the medical, fiscal, and psychological benefits and risks associated with a specific screening strategy for sexually transmitted diseases must be made before adopting a specific strategy for a particular population.
评估单独或联合使用诊断性筛查试验检测年轻男性无症状衣原体尿道感染的性能。
对以下衣原体筛查策略的性能特征进行比较：尿道培养；首次晨尿（FVU）离心后多形核白细胞（PMN）鉴定；未离心FVU的尿白细胞酯酶试验（LET）；应用于FVU沉淀物的衣原体酶免疫测定（EIA）；未离心FVU的LET联合EIA，FVU沉淀物进行或不进行直接荧光抗体（DFA）确认；离心FVU的PMN联合EIA，进行或不进行DFA确认。
青少年拘留中心的普通诊所、大学附属青少年诊所、大学健康服务中心和军事筛查诊所。
共招募618名年龄在12至35岁（平均17岁）的男性作为便利样本；各地点参与率在50%至80%之间。符合条件的受试者有性活动，否认有尿道炎症状，且在过去2周内未服用抗生素。
每种检测策略检测沙眼衣原体感染的敏感性、特异性、阳性和阴性预测值，以及确认每个阳性病例的成本。
衣原体感染患病率为7%时，组织培养的敏感性仅为61%。然而，与其他策略相比，有两种策略的性能特征明显更好：DFA试验确认的EIA，敏感性为84%，特异性为100%，确认每个阳性病例的成本为434美元；PMN联合DFA试验确认的EIA，敏感性为78%，特异性为100%，确认每个阳性病例的成本为199美元。LET联合EIA-DFA的性能特征与PMN检测策略相似。
与其他策略相比，对FVU进行PMN或LET的非特异性筛查，随后进行EIA并经DFA确认的联合检测，在检测年轻男性无症状沙眼衣原体尿道炎方面具有更好的临床和成本效益。然而，在针对特定人群采用特定筛查策略之前，必须对与性传播疾病特定筛查策略相关的医学、财政和心理益处及风险进行评估。
