Iwen P C, Walker R A, Warren K L, Kelly D M, Hinrichs S H, Linder J
Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, USA.
J Clin Microbiol. 1995 Oct;33(10):2587-91. doi: 10.1128/jcm.33.10.2587-2591.1995.
A nucleic acid-based test (Gen-Probe PACE 2C System) was evaluated for the ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae from endocervical specimens in a single assay. Three swab samples, randomized for collection order, were obtained from each patient and tested by N. gonorrhoeae and C. trachomatis culture and by the PACE 2C probe assay. Fifty of 395 specimens were culture positive for N. gonorrhoeae (17 specimens), C. trachomatis (26 specimens), or both (7 specimens), of which PACE 2C testing detected 48 specimens. The PACE 2C assay was positive for 56 specimens, including 8 specimens not positive by culture. Of the total of 10 discrepancies between culture and PACE 2C results, resolution testing yielded four false-negative culture, four false-positive PACE 2C, and two false-negative PACE 2C results. The sensitivity, specificity, and positive and negative predictive values for PACE 2C after reevaluation were 96.3, 98.8, 92.9 and 99.4%, respectively. The overall sensitivities for C. trachomatis and N. gonorrhoeae culture were 89.2 and 88.9%, respectively. The prevalence rate for C. trachomatis was 9.4%, and that for N. gonorrhoeae was 6.8%. The Gen-Probe PACE 2C System is a reliable alternative for screening endocervical specimens for both C. trachomatis and N. gonorrhoeae in a single assay.
对一种基于核酸的检测方法（Gen-Probe PACE 2C系统）进行了评估，以确定其在单次检测中从宫颈标本中检测沙眼衣原体和淋病奈瑟菌的能力。从每位患者处获取三个拭子样本，按随机顺序收集，并通过淋病奈瑟菌和沙眼衣原体培养以及PACE 2C探针检测法进行检测。395份标本中有50份淋病奈瑟菌培养阳性（17份标本）、沙眼衣原体培养阳性（26份标本）或两者均阳性（7份标本），其中PACE 2C检测法检测出48份标本。PACE 2C检测法对56份标本呈阳性，包括8份培养结果为阴性的标本。在培养结果与PACE 2C结果的总共10处差异中，重新检测得出4例假阴性培养结果、4例假阳性PACE 2C结果和2例假阴性PACE 2C结果。重新评估后，PACE 2C的敏感性、特异性、阳性预测值和阴性预测值分别为96.3%、98.8%、92.9%和99.4%。沙眼衣原体和淋病奈瑟菌培养的总体敏感性分别为89.2%和88.9%。沙眼衣原体的患病率为9.4%，淋病奈瑟菌的患病率为6.8%。Gen-Probe PACE 2C系统是一种可靠的替代方法，可在单次检测中对宫颈标本进行沙眼衣原体和淋病奈瑟菌的筛查。
