C-166. Comparison of Workflow and Analytical Sensitivity with Urine Samples between the BD ProbeTec™ ET System and the BD Viper™ System in Extracted Mode

J. E. Petrilli, C. D. Welborn, B. G. Towns, J. T. Kendall;
Becton Dickinson, Sparks, MD.

Background: The BD ProbeTec™ ET System is a platform for amplification and detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA from swab and urine specimens. Manual specimen processing for this system requires significant hands-on time and urine specimens involve prewarm, centrifugation, decant/resuspension and heat lysis in addition to capping and uncapping. The BD Viper™ System in extracted mode alleviates this workload by automating cell lysis and DNA extraction along with the use of pierceable caps. The purpose of this study was to characterize the functional performance and throughput of the fully automated BD Viper System in extracted mode compared with that of the BD ProbeTec ET System. Methods: Urine samples were spiked with 15 CT Elementary Bodies and 50 GC particles/mL and processed either manually for the BD ProbeTec ET System or with the ferric oxide-based DNA extraction technology of the BD Viper System. Processed specimens were amplified using the assay chemistries appropriate for each platform and results were evaluated against predetermined thresholds. Hands-on time and time-to-results were determined for both systems based on processing of 96 samples and controls. Results: The results from testing spiked urine samples on the BD ProbeTec ET and BD Viper Systems are shown below:

 

% Positive

BD ProbeTec ET System

BD Viper System

CT

83.3%

100%

GC

100%

100%

The workflow for the BD ProbeTec ET System required 207 minutes of technologist time to process 96 samples and controls prior to running the assays. The hands-on time required for this number of samples on the BD Viper System in extracted mode totaled 31 min. Time-to-results for the BD ProbeTec System was 327 minutes, whereas for the BD Viper System it was 191 minutes. Conclusions: The enhanced automation of the BD Viper System in extracted mode allows for equivalent or better analytical performance in the detection of CT and GC while providing significant labor release for processing of urine specimens when compared with the BD ProbeTec ET System. * Product not for sale, for investigational use only in the US.

130/C. Specimen Collection, Transportation and Processing

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