Modarress K J, Cullen A P, Jaffurs W J, Troutman G L, Mousavi N, Hubbard R A, Henderson S, Lörincz A T
Digene Corporation, Silver Spring, Maryland 20904, USA.
Sex Transm Dis. 1999 May;26(5):303-8. doi: 10.1097/00007435-199905000-00012.
The Digene Hybrid Capture II (HC II) CT/GC Test (Digene Corp., Beltsville, MD) is a new nucleic acid signal amplification-based test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in specimens from the genital tract. For optimal results, the HC II CT/GC Test employs a special conical shaped brush for cervical specimen collection from nonpregnant women and swabs from pregnant women.
To validate a protocol for HC II C. trachomatis and N. gonorrhoeae testing of specimens collected for the GenProbe PACE 2 System.
Specimens were collected from 1,746 patients with a swab and placed in GenProbe transport media according to the manufacturer's recommended procedure. The specimens were first tested at two clinical laboratories by the PACE 2 system, and then blindly tested by HC II CT/GC using an adjusted cutoff value. Discrepant specimens were adjudicated by polymerase chain reaction (PCR), and the result common to two of the three testing methods (HC II, PACE 2, and PCR) was defined as the consensus result.
Combining the data from both sites, the relative sensitivity of the HC II Test compared with the consensus result for the detection of 1,761 specimens for C. trachomatis and 1,750 specimens for N. gonorrhoeae was 100% for both organisms. The relative specificities for C. trachomatis and N. gonorrhoeae detection were 99.8% and 99.7%, respectively. The relative sensitivities of the PACE 2 CT and GC Systems were 86.5% and 87.1%, respectively, with relative specificities of 99.9% and 100%. The difference in sensitivity between HC II and PACE 2 for C. trachomatis detection was significant (P < 0.016).
The HC II CT/GC Test can be performed using specimens collected in GenProbe transport media and has a significantly greater sensitivity for C. trachomatis detection than the PACE 2 System.
Digene杂交捕获二代（HC II）CT/GC检测法（Digene公司，马里兰州贝尔茨维尔）是一种基于核酸信号放大技术的新型检测方法，用于检测生殖道标本中的沙眼衣原体和淋病奈瑟菌。为获得最佳结果，HC II CT/GC检测法采用一种特殊的锥形刷子从非孕妇宫颈采集标本，从孕妇采集拭子。
验证针对为GenProbe PACE 2系统采集的标本进行HC II沙眼衣原体和淋病奈瑟菌检测的方案。
用拭子从1746例患者采集标本，并按照制造商推荐的程序置于GenProbe运输培养基中。标本首先在两个临床实验室用PACE 2系统进行检测，然后用HC II CT/GC以调整后的临界值进行盲法检测。对有差异的标本通过聚合酶链反应（PCR）进行判定，三种检测方法（HC II、PACE 2和PCR）中两种方法得到的相同结果定义为一致结果。
综合两个研究地点的数据，HC II检测法相对于1761份沙眼衣原体标本和1750份淋病奈瑟菌标本的一致结果的相对灵敏度，两种病原体均为100%。沙眼衣原体和淋病奈瑟菌检测的相对特异性分别为９９.８％和９９.７％。PACE 2 CT和GC系统的相对灵敏度分别为86.5%和87.1% , 相对特异性分别为99.9%和100%。HC II和PACE 2在沙眼衣原体检测灵敏度上的差异具有统计学意义（P < 0.016）。
HC II CT/GC检测法可使用在GenProbe运输培养基中采集的标本进行，并且在沙眼衣原体检测方面比PACE 2系统具有显著更高的灵敏度。
