Ratnam Sam, Jang Dan, Gilchrist Jodi, Smieja Marek, Poirier Andre, Hatchette Todd, Flandin Jean-Frederic, Chernesky Max
Division of Community Health and Humanities, Memorial University, St. John's, Newfoundland and Labrador, Canada Department of Oncology, McGill University, Montreal, Quebec, Canada.
St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
J Clin Microbiol. 2014 Jul;52(7):2299-304. doi: 10.1128/JCM.03549-13. Epub 2014 Apr 16.
The choice of a suitable automated system for a diagnostic laboratory depends on various factors. Comparative workflow studies provide quantifiable and objective metrics to determine hands-on time during specimen handling and processing, reagent preparation, return visits and maintenance, and test turnaround time and throughput. Using objective time study techniques, workflow characteristics for processing 96 and 192 tests were determined on m2000 RealTime (Abbott Molecular), Viper XTR (Becton Dickinson), cobas 4800 (Roche Molecular Diagnostics), Tigris (Hologic Gen-Probe), and Panther (Hologic Gen-Probe) platforms using second-generation assays for Chlamydia trachomatis and Neisseria gonorrhoeae. A combination of operational and maintenance steps requiring manual labor showed that Panther had the shortest overall hands-on times and Viper XTR the longest. Both Panther and Tigris showed greater efficiency whether 96 or 192 tests were processed. Viper XTR and Panther had the shortest times to results and m2000 RealTime the longest. Sample preparation and loading time was the shortest for Panther and longest for cobas 4800. Mandatory return visits were required only for m2000 RealTime and cobas 4800 when 96 tests were processed, and both required substantially more hands-on time than the other systems due to increased numbers of return visits when 192 tests were processed. These results show that there are substantial differences in the amount of labor required to operate each system. Assay performance, instrumentation, testing capacity, workflow, maintenance, and reagent costs should be considered in choosing a system.
为诊断实验室选择合适的自动化系统取决于多种因素。比较性工作流程研究提供了可量化的客观指标,以确定样本处理与加工、试剂准备、回访与维护期间的人工操作时间,以及检测周转时间和通量。运用客观的时间研究技术,在m2000 RealTime(雅培分子公司)、Viper XTR(贝克曼库尔特公司)、cobas 4800(罗氏分子诊断公司)、Tigris(豪洛捷基因探针公司)和Panther(豪洛捷基因探针公司)平台上,使用沙眼衣原体和淋病奈瑟菌的第二代检测方法,确定了处理96项和192项检测的工作流程特征。需要人工操作的操作步骤和维护步骤相结合的情况表明,Panther的总体人工操作时间最短,Viper XTR最长。无论处理96项还是192项检测,Panther和Tigris都显示出更高的效率。Viper XTR和Panther得出结果的时间最短,m2000 RealTime最长。Panther的样本制备和加样时间最短,cobas 4800最长。处理96项检测时,仅m2000 RealTime和cobas 4800需要强制回访,而且由于处理192项检测时回访次数增加,这两者所需的人工操作时间都比其他系统多得多。这些结果表明,每个系统的操作所需人工量存在显著差异。选择系统时应考虑检测性能、仪器设备、检测能力、工作流程、维护和试剂成本。