Multicenter evaluation of the BDProbeTec ET system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs
Multicenter evaluation of the BDProbeTec ET system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs
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DOI：
10.1128/jcm.39.3.1008-1016.2001
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发表时间：
2001-03-01
影响因子：
9.4
通讯作者：
Jones, RB
中科院分区：
文献类型：
--
作者：
van der Pol, B;Ferrero, DV;Jones, RB
Becton Dickinson BD Probe Tec ET System Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assay（BD Biosciences，Sparks，Md.）在一项多中心研究中进行了评价。样本收集自2，109名男性和女性，有或没有症状，参加性传播疾病，计划生育和妇产科诊所。采集拭子和尿液样本，并将从4，131份标本中获得的结果与培养和LCx核酸扩增试验（Abbott Industries，Abbott Park，III.）的结果进行比较，用PCR和细胞离心涂片直接荧光抗体染色法判定衣原体培养阴性结果，计算有无扩增对照（AC）的敏感性和特异性，结果无明显差异。trachomatis和N.宫颈拭子和妇女尿液中淋病的检出率分别为92.8%和96.6%，淋病的检出率分别为80.5%和84.9%; trachomatis和N.男性尿道拭子淋病敏感性分别为92.5%和98.5%，男性尿液淋病敏感性分别为93.1%和97.9%。该扩增DNA系统用于同时检测衣原体和淋球菌感染，与衣原体培养物相比具有上级灵敏度，并且具有与用于这些生物体的其他市售核酸检测试剂相当的性能特征。
The performance of the Becton Dickinson BDProbe Tec ET System Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays (BD Biosciences, Sparks, Md.) was evaluated in a multicenter study. Specimens were collected from 2,109 men and women, with or without symptoms, attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. Both swab and urine samples were collected, and the results obtained from 4,131 specimens were compared to those from culture and the LCx nucleic acid amplification test (Abbott Industries, Abbott Park, III.), PCR and cytospin of the culture transport medium with chlamydia direct fluorescent antibody staining were used to adjudicate chlamydia culture-negative results, Sensitivity and specificity were calculated both,vith and without use of the amplification control (AC), with little apparent difference in the results, Without the AC result, sensitivity for C. trachomatis and N. gonorrhoeae were 92.8 and 96.6%, respectively, for cervical swabs and 80.5 and 84.9% for urine from women, C. trachomatis and N. gonorrhoeae sensitivities were 92.5 and 98.5%, respectively, for male urethral swabs and 93.1 and 97.9% for urine from men. This amplified DNA system for simultaneous detection of chlamydial and gonococcal infections demonstrated superior sensitivity compared to chlamydia culture and has performance characteristics comparable to those of other commercially available nucleic acid-based assays for these organisms.