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Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems

It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web.

The report is titled “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing.”  This report can be immediately downloaded and viewed by visiting the web site.

Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing

The report evaluates the productivity of five competing immunoassy (IA) and infectious disease (ID) systems. It is authored by an industrial engineering company that provides process improvement services to clinical laboratories and lab industry vendors. The study was funded by one of the major in vitro diagnostics (IVD) manufacturers.

Criteria used to select the IA and ID analyzers evaluated in this report were:

  • Ability to perform complete routine testing with minimal staff involvement including repeats, auto-dilations, and reflex testing
  • Provide significant walk-away (10 minutes minimum)
  • Be operationally easy to use
  • Enable reduction in FTEs (full-time employees)
  • Able to support the typical sample volumes, related IA and ID tests, and turnaround time (TAT) protocols of hospitals.

Each analyzer in the study uses automation to accomplish these tasks. Interestingly, all of the analyzers evaluated in this study used automated features in different ways. The five competitive systems that were tested include:

Another interesting aspect to this study is that the analyzers were evaluated in real, day-to-day use. Each IA or ID system was put into a healthcare system or clinical laboratory. Three U.S.-based medical laboratories and one non-U.S.-based clinical laboratory collaborated in the study. Each participating laboratory represented the mid-volume segment IA system, performing an annual volume of between 50,000 and 100,000 ID tests each year.

Demographically, the labs represented Northeast and Southeast U.S. community hospitals, Southeast U.S. medium-sized university health centers, and non-U.S. community hospitals.

The labs’ staffs evaluated each system for two days, during which the consulting firm conducted direct observations and interviews. The consulting firm compiled detailed study data and operator comments. The firm also recorded the daily work list of patient samples and ordered tests. The firm then interviewed lab management and staff, and collated the resulting data into a theoretical model of each participating labs’ ideal system.

One key subject of the study was how each IA or ID analyzer system could be used in ways that optimized use of each laboratory’s staff knowledge and manpower resources to produce increased productivity. Another study topic was whether use of each analyzer might trigger an increase in staff hours or a reduction in services. The study assumed that each analyzer could provide similar testing accuracy, so qualitative results were not examined. Nor was the individual cost of each system taken into consideration, since it was determined that cost was not an overriding factor in deciding which system to purchase.

The criteria for evaluating each system include:

Operator ease of use
Access analyzer for start-up and maintenance
Load/unload samples, reagents, and consumables
Complete solid/liquid waste disposal
Control analyzer via user interface

Analyzer features assisting in labor efficiency
Enables visual observation of all key processes
Performs routine tasks automatically
Broad assay menu
Inventories onboard consumables to minimize restocking cycles
Has high level of reliability

Productivity enhancements
Minimizes total manual labor time
Maximizes ease of use/ergonomics
–Visual, Audio, Reach, Weight
Allows for operator to walk away from an analyzer for more than 10 minutes at a time
Communicates “problems” to operator
–When near analyzer
–When in walk-away status
Provides optimal testing throughput

Significantly, all of the analyzers tested produced effective outcomes. It was the “value added” features of each instrument system where medical laboratories will find the ability to improve their productivity while maintaining the accuracy of the lab test results produced by the respective IA/ID testing system.

The report “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing” was produced by industrial engineers evaluating these different immunoassy (IA) and infectious disease (ID) lab testing systems during normal operation in a clinical laboratory. For this reason, the information in the report can be useful for any pathologist or clinical laboratory manager actively considering the purchase or acquisition of IA and ID instrument systems for their laboratory.

For its part, Dark Daily and The Dark Report believe that publication of this “Consumer Report” type of assessment is useful because it makes allows the entire clinical pathology laboratory testing profession to gain access to information that might otherwise have very limited distribution. As a free PDF, downloadable immediately, this report is one more example of how the Internet is expanding access to important information.

Clinical laboratory managers and pathologists who wish to read the entire report can download it now here. (Or copy and paste this URL: . We encourage readers of this publicly-accessible report to email us with their comments and opinions concerning its usefulness and value.

Related Information:

Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing

From Digital Pathology to Clinical Laboratory Automation, White Papers Are Available for Medical Laboratory Professionals

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