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

Williams, James A.; Eddleman, L; Pantone, A; Martínez, Regina Martínez; Young, Stephen; Pol, Barbara Van Der

doi:10.1177/2211068213511245

Cited by 8 publications

(6 citation statements)

References 6 publications

(7 reference statements)

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“…When a batch of 96 tests was run, results were available 6 h 11 min from the start, confirming two previous reports of 6 h 20 min (7,16). The total hands-on time, including daily maintenance for a 96-test run, was approximately 1 h, which was longer than the 43 min reported by Williams et al (16). A second run of 96 tests doubled the total hands-on time and increased the mandatory visits to four, with results from the second run extended into the next work shift ( Fig.…”

Section: Discussionsupporting

confidence: 84%

“…The Abbott m2000 two-unit batch system allowed a maximum of 93 specimens with 3 controls to be processed in a run and required two return visits per run. When a batch of 96 tests was run, results were available 6 h 11 min from the start, confirming two previous reports of 6 h 20 min (7,16). The total hands-on time, including daily maintenance for a 96-test run, was approximately 1 h, which was longer than the 43 min reported by Williams et al (16).…”

Section: Discussionsupporting

confidence: 81%

“…Batched results for a 96-test run were available 3 h 31 min from the start, which is 1 h less than reported previously (16). Our study indicated the total hands-on time, including daily maintenance was 1 h 41 min for 96 tests.…”

Section: Discussioncontrasting

confidence: 58%

“…Our observations are consistent with a previous report (11) that the Tigris required minimal hands-on time for the throughput achieved. The Tigris instrument was recently compared to the same three instruments with batches of 96 tests and was deemed easiest to operate (16). That comparison failed to record times on the Tigris for the same number of specimens to enable a proper comparison (109 and 132 tests on Tigris versus 96 tests on the other three instruments).…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

mentioning

confidence: 99%

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

et al. 2014

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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. A utomated instruments offer standardized processing technology for specimen extraction, specimen amplification, and detection of molecular targets (1). Minimal operator interaction is required, improving workflow, test throughput, and overall efficiency of laboratory operations. 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 (2-8), and workflow and maintenance characteristics of automated instruments (9-16). 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. In this respect, workflow studies provide quantifiable and objective data to assist in choosing a system that is best suited for a given laboratory.This study was conducted to determine the relative workflow and maintenance characteristics of five automated instruments commonly used for the diagnosis of sexually transmitted infections. For this purpose, the respective second-generation assays for C. trachomatis and N. gonor...

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Section: Discussionsupporting

confidence: 84%

Section: Discussionsupporting

confidence: 81%

Section: Discussioncontrasting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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

et al. 2014

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Type-specific detection of herpes simplex virus type 1 and type 2 using the cobas® HSV 1 and 2 test on the cobas® 4800 platform

Pol

2016

Expert Review of Molecular Diagnostics

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HSV-1 and HSV-2 are among the most common causes of sexually transmitted infections (stis) globally. these infections are strongly associated with increased risk of hiv acquisition and rare, but devastating, neonatal disease. available treatment options can reduce HSV transmission and improve quality of life. accurate diagnosis early in disease can improve patient management. Areas covered: This paper describes the clinical manifestations of HSV infection often used for clinical diagnostic purposes. The paper then describes the evolution of laboratory diagnostic assays. Serology, culture and molecular diagnostics are described since all are currently in use. The features and performance characteristics of the cobas 4800 HSV1 and HSV2 Test (cobas HSV) on the cobas 4800® system (cobas 4800) are described in detail. Expert commentary: Diagnosis of HSV has historically been unreliable or technically difficult, but the availability of molecular assays such as the cobas HSV test for detection and typing of herpes can improve our ability to correctly manage this disease. Utilization of tools such as the cobas HSV assay may help shorten the time to accurate diagnosis and treatment thus potentially reducing the risk of transmission and the global burden of HSV.

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Profile of the triplex assay for detection of chlamydia, gonorrhea and trichomonas using the BD MAX™ System

Pol

2017

Expert Review of Molecular Diagnostics

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Chlamydia, gonorrhea and trichomonas are the most common curable STI. improved access to testing could reduce infection rates and prevent sequelae. nucleic acid amplification tests are the recommend class of diagnostic assay for these infections which are often asymptomatic. Areas covered: A description of the BD MAX™ System (MAX) and the BD MAX CT/GC/TV assay is provided along with data from a large US clinical trial. The capacity of the system for other tests and for lab developed assays is also described. Expert commentary: The CT/GC/TV assay on the MAX is a triplex PCR assay suitable for use with female urine and vaginal or endocervical swab samples. Male urine can be tested by ordering the CT/GC results but has not yet been evaluated for trichomonas. The assay performance characteristics are similar to those of assays run on high-throughput platforms with sensitivity ≥91.5% and specificity ≥98.6% for all analytes. Screening with the CT/GC/TV assay can be combined with testing for vaginitis which would provide a greater depth of coverage for common co-infections. The throughput is moderate (1-48 samples per 8-hour shift) but the menu includes assays beyond STI pathogens making this a suitable platform for moderate volume laboratories.

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

Cited by 8 publications

References 6 publications

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

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

Type-specific detection of herpes simplex virus type 1 and type 2 using the cobas® HSV 1 and 2 test on the cobas® 4800 platform

Profile of the triplex assay for detection of chlamydia, gonorrhea and trichomonas using the BD MAX™ System

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