Process Evaluation of a Fully Automated Molecular Diagnostics System

Abstract

Molecular diagnostics presents challenges to clinical laboratories that are under pressure to consolidate and automate. There is a need to evaluate molecular automation for process efficiency and suitability for high-throughput environments in core laboratories. A fully automated molecular instrument platform (the BD Viper System with XTR Technology in extracted mode [BD Viper System with XTR]), was evaluated for automation efficiency, labor requirements, and system robustness. System productivity was predicted using time and motion studies as well as process simulation. Preanalytical steps required 15 min of skilled operator time. The BD Viper System with XTR fully automated DNA extraction, amplification, and analysis of 368 specimens (736 results for Chlamydia and Gonorrhea). Time and motion studies estimated that the total hands-on full time employee (FTE) burden was approximately 35 min per run, of which 41% was high complexity, 29% medium complexity and 29% relatively unskilled labor. A skilled operator can easily operate four instruments for 8.5 h and generate data on 2944 results (four runs on each instrument for a total of 1472 clinical specimens) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) analysis. Based on mean time between intervention data, the BD Viper System with XTR was estimated to be capable of operating for more than 1000 runs without system malfunction. We determined that fully automated molecular analysis of GC and CT is possible in a core laboratory facility with significant throughput and minimal impact on labor demand using a fully automated and robust molecular diagnostics platform (such as the BD Viper System with XTR).