Chan E L, Brandt K, Olienus K, Antonishyn N, Horsman G B
Virology Section, Department of Clinical Microbiology, Provincial Laboratory, Regina, Saskatchewan, Canada.
Arch Pathol Lab Med. 2000 Nov;124(11):1649-52. doi: 10.5858/2000-124-1649-PCOTBD.
The Becton Dickinson BDProbeTec ET System is a new semiautomated system using strand displacement amplification technology that simultaneously amplifies and detects Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The strand displacement amplification products are hybridized with a fluorescent detector probe and are captured by a chemiluminescent assay in a microwell format. An amplification control is also included to monitor assay inhibition. This study evaluated the performance of the BDProbTec ET system in detecting C trachomatis and N gonorrhoeae in male and female urine specimens, calculated its ability to process large volumes of specimens, and determined the inhibition rate.
Eight hundred twenty-five male and 399 female urine specimens were tested for both C trachomatis and N gonorrhoeae with the BDProbeTec ET system, and results were compared with those of the Roche Amplicor Cobas system. All urine specimens were processed on both assays on the same day they were received, according to the manufacturers' instructions. Discrepant results were resolved by in-house polymerase chain reaction assays. Internal or amplification controls were also used in each specimen assay to monitor inhibition. The throughput of the BDProbTec ET system was further tested with 150 urine specimens on an 8-hour shift for 2 days.
The overall sensitivity, specificity, positive predicative value, and negative predicative value for for detection of chlamydia were 95.3%, 99.3%, 95.9%, and 99.2% for strand displacement amplification and 95.9%, 98.3%, 90.6%, and 99.3% for the Roche Amplicor system. For detection of gonorrhea, these values were 100%, 99.7%, 88.2%, and 100% and 96.7%, 98.9%, 69%, and 99.9%, respectively. The overall inhibition rates for both strand displacement amplification and Roche Amplicor were less than 3.5%. The BDProbTec ET system was able to produce 150 results each for chlamydia and gonorrhea and the internal control within the 8-hour shift.
The performance characteristics of the BDProbeTec ET assay are similar to those of the Roche Amplicor polymerase chain reaction for detection of chlamydia and gonorrhea in male and female urine specimens. The system was able to produce 300 results in an 8-hour shift.
Becton Dickinson BDProbeTec ET系统是一种新型半自动系统，采用链置换扩增技术，可同时扩增和检测沙眼衣原体及淋病奈瑟菌的DNA。链置换扩增产物与荧光检测探针杂交，并通过微孔板格式的化学发光测定法捕获。还包括一个扩增对照以监测测定抑制情况。本研究评估了BDProbTec ET系统在检测男性和女性尿液标本中沙眼衣原体和淋病奈瑟菌方面的性能，计算了其处理大量标本的能力，并确定了抑制率。
用BDProbeTec ET系统对825份男性尿液标本和399份女性尿液标本进行沙眼衣原体和淋病奈瑟菌检测，并将结果与罗氏Amplicor Cobas系统的结果进行比较。所有尿液标本在收到当天按照制造商的说明在两种检测方法上进行处理。不一致的结果通过内部聚合酶链反应测定法解决。每个标本检测中还使用内部或扩增对照来监测抑制情况。用150份尿液标本在8小时轮班期间进行了2天的测试，进一步检测BDProbTec ET系统的通量。
对于衣原体检测，链置换扩增的总体灵敏度、特异性、阳性预测值和阴性预测值分别为95.3%、99.3%、95.9%和99.2%，罗氏Amplicor系统分别为95.9%、98.3%、90.6%和99.3%。对于淋病检测，这些值分别为100%、99.7%、88.2%和100%以及96.7%、98.9%、69%和99.9%。链置换扩增和罗氏Amplicor的总体抑制率均低于3.5%。BDProbTec ET系统在8小时轮班内能够分别产生150份衣原体、淋病和内部对照的检测结果。
BDProbeTec ET检测法在检测男性和女性尿液标本中的衣原体和淋病方面的性能特征与罗氏Amplicor聚合酶链反应相似。该系统在8小时轮班内能够产生300份检测结果。
