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).

A Two-Site Analytical Evaluation of the BD Viper System with XTR Technology in Nonextracted Mode and Extracted Mode with Seeded Simulated Specimens

“…This higher time measurement is consistent with the measurement determined by Felder et al 5 ''Hands-on'' timing measurements in the Extracted Mode were relatively consistent between both institutions and ranged between 29.8 and 34.2 min. There was a 5.8e7.9-min increase in the total amount of ''hands-on'' time necessary for processing swabs in the Extracted Mode compared with Nonextracted Mode at both testing facilities.…”

“…Eluate is then neutralized to buffer conditions optimal for real-time amplification, achieved by SDA. 5 There were two objectives in this study design: to measure the time-related efficiencies of the Viper XTR in Extracted Mode to that in Nonextracted Mode in terms of overall ''hands-on'' time and total processing time (TPT), and to correlate the accuracy of performance of Viper XTR in Extracted Mode to Nonextracted Mode at spike levels of CT and GC organisms indicative of low analytical loads of these pathogens.…”

Time-Motion Analysis of Four Automated Systems for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Nucleic Acid Amplification Testing

“…There are few timemotion studies reported in the literature that have evaluated the characteristics of these new platforms, particularly for CT/NG testing. [3][4][5][6][7] Head-to-head evaluations that assess multiple systems using a standardized approach provide critical information to laboratories considering adoption of a new platform. In this study, four automated systems routinely used for the detection of CT/NG were assessed for total run time, hands-on and available walk-away time associated with a run, and ease of instrument set up, operation, and maintenance.…”

Workflow and Maintenance Characteristics of Five Automated Laboratory Instruments for the Diagnosis of Sexually Transmitted Infections

“…With clearance by the U.S. Food and Drug Administration and other regulatory agencies in Europe and elsewhere of several systems, automated molecular testing has become routine in clinical laboratory practice, ensuring diagnostic accuracy and improved result turnaround time (TAT). Studies have been published assessing clinical performances of molecular assays (2)(3)(4)(5)(6)(7)(8), and workflow and maintenance characteristics of automated instruments (9)(10)(11)(12)(13)(14)(15)(16). In addition to performance and instrumentreagent costs, hands-on time required for testing and maintenance, in-process interaction, and time to results and test capacity are key metrics that should be considered because they can influence efficiency and labor costs.…”