利用链置换扩增法检测沙眼衣原体和淋病奈瑟菌以及扩增对照与阴道拭子标本的相关性
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by strand displacement amplification and relevance of the amplification control for use with vaginal swab specimens.
作者信息
Cosentino Lisa A, Landers Daniel V, Hillier Sharon L
机构信息
Magee-Womens Research Institute, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania 15213-3180, USA.
出版信息
J Clin Microbiol. 2003 Aug;41(8):3592-6. doi: 10.1128/JCM.41.8.3592-3596.2003.
Vaginal swab specimens may be preferable to cervical swab or urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae because of the ease of specimen collection and transport. The purpose of this study was to evaluate whether vaginal swab specimens are equivalent to cervical swab specimens for the detection of N. gonorrhoeae and C. trachomatis by the Becton Dickinson strand displacement amplification assay (SDA) with the BDProbeTec ET instrument and then to evaluate the use of the amplification control in a clinical research setting. In the first phase, vaginal and cervical swab specimens were obtained from 455 symptomatic women aged 18 to 40 attending primary health care and sexually transmitted disease clinics. Thirty-nine specimens (8.6%) had true-positive results for N. gonorrhoeae and 37 specimens (8.1%) had true-positive results for C. trachomatis. The sensitivity of SDA was superior to that of culture for the detection of N. gonorrhoeae with vaginal swab specimens and equivalent to that of the Roche PCR for the detection of C. trachomatis with cervical swab specimens. In the second phase of the study, 1,411 consecutively collected vaginal swab specimens were evaluated, with 357 (25.3%) specimens giving indeterminate readings on the basis of the result for the amplification control. The prevalences of sexually transmitted pathogens in vaginal swab specimens with and without use of the amplification control were 6.0 and 5.8%, respectively, for C. trachomatis and 3.1 and 3.0%, respectively, for N. gonorrhoeae. Although, vaginal swab specimens were equivalent to cervical swab specimens for the detection of N. gonorrhoeae and C. trachomatis by SDA with respect to sensitivity, one in four vaginal swab specimens yielded an indeterminate result when the amplification control was used. The amplification control has limited value for use with vaginal swab specimens.
由于标本采集和运输简便，阴道拭子标本在检测沙眼衣原体和淋病奈瑟菌方面可能优于宫颈拭子或尿液标本。本研究的目的是评估阴道拭子标本在通过Becton Dickinson链置换扩增分析（SDA）和BDProbeTec ET仪器检测淋病奈瑟菌和沙眼衣原体方面是否等同于宫颈拭子标本，然后评估在临床研究环境中扩增对照的使用情况。在第一阶段，从455名年龄在18至40岁、到初级卫生保健和性传播疾病诊所就诊的有症状女性中获取阴道和宫颈拭子标本。39份标本（8.6%）淋病奈瑟菌检测结果为真阳性，37份标本（8.1%）沙眼衣原体检测结果为真阳性。对于阴道拭子标本检测淋病奈瑟菌，SDA的灵敏度优于培养法；对于宫颈拭子标本检测沙眼衣原体，SDA的灵敏度与罗氏聚合酶链反应相当。在研究的第二阶段，对1411份连续采集的阴道拭子标本进行了评估，其中357份标本（25.3%）基于扩增对照结果给出不确定读数。使用和未使用扩增对照的阴道拭子标本中，沙眼衣原体的性传播病原体患病率分别为6.0%和5.8%，淋病奈瑟菌分别为3.1%和3.0%。尽管在灵敏度方面，通过SDA检测淋病奈瑟菌和沙眼衣原体时阴道拭子标本等同于宫颈拭子标本，但使用扩增对照时，四分之一的阴道拭子标本会产生不确定结果。扩增对照在阴道拭子标本中的应用价值有限。
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