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Tag Archives: Instrumentation/instrument product guides

Panelists on viscoelastic and other coag assays

January 2024—Viscoelastic assays and other coagulation tests were front and center when CAP TODAY publisher Bob McGonnagle on Nov. 20 convened seven people in an online roundtable. Oksana Volod, MD, and Eric Salazar, MD, PhD, and five company representatives weighed in on, among other things, appropriate test use, automation, and laboratory-developed tests. What they said begins here.

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People, partners, and platforms at the point of care

September 2023—Point-of-care testing—the requests and the committees that oversee them, the connectivity, what AI might bring. CAP TODAY publisher Bob McGonnagle on July 21 met online with a laboratory operations director and a medical director from large health systems and with company representatives for a look at where things stand today. Their conversation follows.

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The outlook for in-house next-generation sequencing

May 2023—Bringing next-generation sequencing in-house was at the center of a March 27 roundtable led by CAP TODAY publisher Bob McGonnagle, with costs, reimbursement, equity, and the electronic health record part of the conversation. Jeremy Segal, MD, PhD, of the University of Chicago, explains why the Genomics Organization for Academic Laboratories was formed. “By lowering barriers and encouraging cooperation,” he said, “we’ve seen our labs increase the pace of development and the quality of the assays they’re bringing on.”

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In urinalysis, reflex algorithms and other efficiencies

March 2023—Urinalysis was at the heart of a Feb. 7 discussion between CAP TODAY publisher Bob McGonnagle; Ron Jackups Jr., MD, PhD, of Washington University School of Medicine; and Jason Anderson of Sysmex America. “There’s a lot of room to explore what the optimal parameters are to use with the best specificity and sensitivity for a reflex to the sediment analysis or the culture,” Anderson said. Here’s what he and Dr. Jackups said about reflex testing, automation, and middleware.

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Volume? Space? Automation decisions in coagulation

January 2023—Automation and point-of-care, reflex, and viscoelastic testing were some of what came up when a group spoke with CAP TODAY publisher Bob McGonnagle in late November about hemostasis testing. Also tossed in: Results reporting to the EHR, which “can always be improved,” said Eric Salazar, MD, PhD, of University of Texas Health San Antonio. And D-dimer, one of the pandemic’s “health care heroes,” said Nichole Howard of Diagnostica Stago. Here’s what they said about all that and more.

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Purchased for the pandemic? Rethinking instrumentation

October 2022—Who’s doing what with instruments purchased at the peak of the pandemic? That and next-generation sequencing are what CAP TODAY publisher Bob McGonnagle asked Compass Group members about when they met virtually on Sept. 6. The Compass Group is an organization of not-for-profit IDN system laboratory leaders who collaborate to identify and share best practices and strategies.

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Enabling ‘the magic’ in hematology—eyes on what labs need

October 2022—New and better solutions for the hematology laboratory. That was at the center of a Sept. 2 virtual roundtable, led by CAP TODAY publisher Bob McGonnagle. With him were Jonathan Galeotti, MD, of the University of North Carolina School of Medicine, and representatives of Sysmex America, Siemens Healthineers, Beckman Coulter, and CellaVision. “It’s a new era in terms of what can happen in hematological data,” said Fernando Chaves, MD, global head of hematology, Siemens Healthineers.

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How close to patients? Cost, quality, competition

July 2022—Point-of-care versus centralized testing, and automation, IT, and staffing. It all came together as industry executives and a laboratory director and a former medical director met with CAP TODAY publisher Bob McGonnagle on May 25, as CAP TODAY’s list of chemistry and immunoassay analyzers was going together. “I don’t worry much about the machines or reagents,” thanks to good-quality practices, said André Valcour, PhD, MBA, DABCC, of Labcorp, who noted the real focus is quality of information and information transfer. Susan Fuhrman, MD, formerly of OhioHealth, said, “We should always give our clinicians as much information as we can accurately produce and our reports should be as clear as we can make them.” And of the staffing crisis: “We have a perfect storm,” she said. Here is more of what they and the others had to say.

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In next-gen sequencing, aiming for wider access

May 2022—Next-generation sequencing—the worries, the wins, and what’s new. That’s what came up when CAP TODAY publisher Bob McGonnagle led an NGS-focused roundtable on March 14. With him were Jeremy Segal, MD, PhD, of the University of Chicago; Pierre Del Moral, PhD, MBA, and Fiona Nohilly of Illumina; Sohaib Qureshi, PhD, of Thermo Fisher Scientific; and Andy Johnson, DPhil, of Janssen. Here’s what they had to say.

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Urinalysis: Efficiency, utility, and the ‘movement in the field’

December 2021—Four experts met on an Oct. 12 call to talk with CAP TODAY about urinalysis—the newest platforms, what labs need, labor solutions. CAP TODAY publisher Bob McGonnagle asked the questions. Providing their perspectives were Matthew Rhyner, PhD, MBA, Beckman Coulter; Jason Anderson, MPH, MT(ASCP), Sysmex America; Megan Nakashima, MD, Cleveland Clinic; and Keri Donaldson, MD, MSCE, Solvd Health and Penn State. Here’s what they had to say.

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Close ties: instruments, middleware, and more

July 2021—Laboratory instrumentation from an IT perspective and as one solution to the labor shortage were the topics explored April 27 in a virtual roundtable of instrument vendors and laboratory medical directors, led by CAP TODAY publisher Bob McGonnagle. Part one of their conversation about core labs was published in the June 2021 issue; part two follows.

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Next moves for core labs—panel takes stock

June 2021—Pause and restart, or rethink and reorient? That’s the question CAP TODAY publisher Bob McGonnagle put to instrument vendors and James Faix, MD, and David Grenache, PhD, D(ABCC), about COVID and core labs and the instruments in those labs. What impact the pandemic had on them and their customers was a topic of discussion when they met on an April 27 call during which they talked, too, about antibody testing and the proliferation of SARS-CoV-2 testing labs during the pandemic. What follows is part of their conversation. The rest, on IT and the staffing shortage, will be published in July, as will our guide to chemistry and immunoassay analyzers for mid- to high-volume labs.

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Eyes on faster, cheaper, simpler next-gen sequencing

May 2021—Next-generation sequencing analysis and interpretation, as well as reimbursement, were some of what CAP TODAY publisher Bob McGonnagle asked Illumina and Thermo Fisher executives and Jeremy Segal, MD, PhD, about when they gathered on a March 24 call. McGonnagle asked, too, about variants of unknown significance and for views on what lies ahead for NGS. “Circulating tumor DNA analysis is starting to move wholesale into the academic setting,” along with other applications, says Dr. Segal, of the University of Chicago.

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Rapid ID from positive blood culture: Labs tally gains

March 2021—Fresh from its Dec. 27, 2020 FDA clearance, the Bruker MALDI Sepsityper Kit US IVD promises to provide microbiology laboratories with a universal, rapid sepsis identification solution. With the Bruker MALDI Biotyper platform’s reference library covering 491 organisms, the Sepsityper’s ability to identify pathogens directly from positive blood cultures in suspected bacterial or fungal sepsis cases delivers an “order of magnitude increase” in the number of microorganisms that can be identified through PCR detection, said Wolfgang Pusch, Bruker Daltonics executive vice president of microbiology and diagnostics, in a company statement.

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Coagulation tests and COVID: inside labs, industry

January 2021—COVID-19 and coagulation testing were up for discussion on Nov. 20 when six people joined CAP TODAY publisher Bob McGonnagle to talk about that and laboratory labor, relationships with industry and hospital administration, and the distribution of testing. “We’re working with all the manufacturers to support rapid point-of-care testing to manage hot spots that will pop up once there is a vaccine,” said Orchard Software’s Curt Johnson. With Johnson and McGonnagle on the call were Oksana Volod, MD, of Cedars-Sinai Medical Center; Neil Harris, MBChB, MD, of the University of Florida; Annie Winkler, MD, MSc, of Instrumentation Laboratory; Nichole Howard, MBA, of Diagnostica Stago; and Jason Lam, MBA, MLS, of Siemens Healthineers. Drs. Volod and Harris are members of the CAP Hemostasis and Thrombosis Committee.

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Identifying respiratory pathogens: Pneumonia panel studied against standard of care

December 2020—In an evaluation performed at Washington University in St. Louis and published recently, BioFire’s FilmArray pneumonia panel was found to have strong agreement with standard-of-care methods in identifying viral and bacterial targets in 200 lower respiratory tract specimens (Webber DM, et al. J Clin Microbiol. 2020;58[7]:e00343–20). It was also found to have strong agreement with the BioFire upper respiratory panel for common targets, making it unnecessary to perform both. In comparison to standard-of-care methods, it has the potential to detect more Staphylococcus aureus and Haemophilus influenzae and to detect more antimicrobial resistance, particularly at low organism concentrations or in mixed cultures.

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Urinalysis: ‘a field with the potential to do more’: pathologist, two companies talk about urinalysis now and what’s needed

December 2020—What could improve urinalysis operations in your laboratory? That’s a question CAP TODAY publisher Bob McGonnagle asked Megan Nakashima, MD, of the Cleveland Clinic when she talked in October with him and two others: Carl Trippiedi of Sysmex and Matt Rhyner, PhD, MBA, of Beckman Coulter. Their conversation took place as CAP TODAY’s 2020 product guide to urinalysis instrumentation was taking shape. What they had to say follows.

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IT in a pandemic year, now and what’s ahead: interfaces, analytics, telepathology—seven weigh in

November 2020—Information technology from a COVID-19 perspective. What has been the impact on IT, and what change is yet to come? That is what seven people who met virtually on Sept. 10 talked about with CAP TODAY publisher Bob McGonnagle. They are James Harrison, MD, PhD, of the University of Virginia; J. Mark Tuthill, MD, of Henry Ford; Stephen Hewitt, MD, PhD, of the National Cancer Institute; Bob Dowd of NovoPath; Michelle Del Guercio of Sunquest; Curt Johnson of Orchard; and Brian Gunderson of Roche. You will see here, in the conversation that follows, where their focus is as the crisis continues.

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A panel’s take on instruments, connectivity, COVID

July 2020—Has the pandemic changed your thinking or that of your customers? That’s one of the questions CAP TODAY publisher Bob McGonnagle put to seven representatives of five companies and two other panelists in a May 13 roundtable on chemistry/immunoassay analyzers and testing. But first up were other topics: scalability, connectivity, standardizing platforms across health systems, consistent sourcing of antibodies, and open automation.

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POC panel talks diabetes care, data management, CGM

March 2020—Data management, diabetes care, the demand for continuous glucose monitoring, and device cleansing were up for discussion when CAP TODAY publisher Bob McGonnagle led a point-of-care glucose testing roundtable in January. Joining him were Todd Cullen of Arkray, Corinne Fantz, PhD, DABCC, of Roche, and Susan Fuhrman, MD, of OhioHealth Laboratory Services. Here is what they said.

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Panel explores urinalysis solutions, rules, POC testing

December 2019—What do users of urinalysis systems want? According to those in the know, the answer is instruments that are scalable and modular, maximize automation, reduce hands-on time, improve workflow, and more. CAP TODAY publisher Bob McGonnagle convened a panel in October to discuss these topics and other aspects of urinalysis testing. On the panel were Megan Nakashima, MD, of Cleveland Clinic; Michelle Dumonceaux, of Beckman Coulter; Maya Daaboul, of Siemens Healthineers; and Jason Anderson, MPH, MT(ASCP), of Sysmex. What they said follows.

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HemoCell workcell approach brings efficiencies to coag

November 2019—Total laboratory automation solutions, with their integrated, comprehensive approach, have meshed well with the goals of many central labs. But with HemoCell, the first lab automation solution designed for hemostasis testing, Instrumentation Laboratory has shifted gears toward a more specialized solution: a workcell to improve quality and efficiency through process standardization. IL’s HemoCell integrates the company’s ACL Top 750 LAS testing systems, HemoHub Intelligent Data Manager, and HemosIL reagents with Thermo Fisher Scientific’s TCAutomation track. The company’s initial customer base for HemoCell has been in Europe, Asia (particularly China), and South America. Now IL hopes to bring the benefits of HemoCell to more U.S. labs.

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Hematology panel: bridging gaps, staffing, Lab 2.0

October 2019—Automation, the workforce shortage, manual review rates, and Laboratory 2.0 were some of what came up in CAP TODAY’s latest gathering of hematology experts for a roundtable on what’s new, pressing, and in play. CAP TODAY publisher Bob McGonnagle convened a panel in August consisting of Cordelia Sever, MD, of TriCore Reference Laboratories; Olga Pozdnyakova, MD, PhD, of Brigham and Women’s Hospital; Danette Godfrey and Simon Shorter of Sysmex; and Matt Rhyner, PhD, MBA, and Rachel Burnside, PhD, MBA, of Beckman Coulter. What they said follows.

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Chemistry and immunoassay testing: Standardizing platforms, ranges, interfaces—panel weighs in

July 2019—One vendor or two. Automating esoteric testing. The desire for more smart systems. The need for analytics. Seven people spoke with CAP TODAY publisher Bob McGonnagle in May about chemistry and immunoassay testing. They are David Alter, MD, DABCC, of Emory University; Nina Babic, PhD, DABCC, of Medical University of South Carolina; Denise Pastore of Siemens Healthineers; Timothy Lenz, PhD, of Randox; Delena Carite of Roche Diagnostics; and Jessica Tubman, MPH, MT(ASCP), and Stephen Ishii, MT(ASCP), of Beckman Coulter. What follows is what they told us.

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Automated molecular platforms: 3 companies on what’s new and next

October 2018—CAP TODAY’s updated guide to the automated molecular platform market begins on page 45. Thirty-four platforms are profiled, with one new one: Hologic’s Panther Fusion. Writer Valerie Neff Newitt talked with three of the 20 companies about what they introduced this year, what’s to come, and more. “This is a dynamic and competitive industry. We are always asked to go faster, and that is what we are trying to do in terms of development,” says Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular. Others seem to be doing the same.

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POC glucose: views on volume, critical care, ACOs

April 2018—Test volume, limitations on devices used in critical care, consolidation, and population health is what CAP TODAY asked about when it spoke in March with the makers of three bedside glucose testing systems. Their systems and those of two other companies are profiled on pages 44-49. “The customers are more aware than ever of the limitations that are in the package inserts from the glucose manufacturers,” says Corrine Fantz, PhD.

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AP-LIS vendors talk reports, interfaces, protocols

February 2018—Customer demand, cancer protocols, and consolidation of pathology practices are some of what CAP TODAY asked about when it spoke in January with four anatomic pathology computer system companies. Their AP systems and those of 17 other companies are profiled in the anatomic pathology computer systems interactive product guide. “It’s a really good time for our market right now,” says Joe Nollar of Xifin, “and systems providers need to be creative in helping their clients get the solutions they need to be scalable, competitive, and profitable.” Here is more of what they told writer Anne Ford.

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Sigma analysis, role and limitations: development of a QC program for the Beckman Coulter AU5812

October 2017—The challenge for all clinical laboratories is to produce the highest quality in vitro diagnostic results in the most efficient manner. Fortunately, high quality and high efficiency are not mutually exclusive, and the direct correlation between the two is well documented.1,2 As the quality of processes increases, so does process efficiency, which ultimately drives down costs.

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Volume, value, technology steering 2017 instrument buys

July 2017—For at least some laboratories, economic conditions and capital flows are calling for a cautious approach to purchasing new laboratory instruments. As one analyst of the clinical laboratory services industry was heard to say recently: “Because of tight capital, nobody is buying anything unless it breaks.” But laboratory executives and medical directors at some of the nation’s largest health systems in the Northeast, West, and Midwest take a different view.

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Guide to urinalysis instrumentation

December 2015—Not everyone shares Lauren Foohey’s idea of a good time, and she knows it. “Performing urine sediment analysis under a microscope—I thought it was fun,” Foohey says with a laugh. She spent 10 years in the laboratory before ultimately becoming senior director of global marketing for point-of-care urinalysis and diabetes at Siemens Healthcare, Point of Care Diagnostics.

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A step-by-step process to 95% autoverification

December 2015—Many laboratories have yet to reap the benefits of autoverification even though there is clear evidence of its benefits. During a recent internal study at Labsco, we discovered that more than 70 percent of our customers have not yet implemented AV. Of the customers who did perform AV, the highest percentage seen was about 60 percent (primarily in hematology and coagulation).

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Leveraging urinalysis for value-based health care

November 2015—Tim Skelton, MD, PhD, knows a fair amount about how to enhance the clinical value of urinalysis. It’s a subject that, as medical director of the core laboratory and laboratory informatics at Lahey Hospital and Medical Center in Burlington, Mass., he’s been focused on for the past three years. But he didn’t exactly set out to become an expert in that particular area. He was mainly trying to figure out why his laboratory was experiencing repeated urinalysis quality assurance failures.

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Automated molecular platforms — the latest on two dozen

October 2015—CAP TODAY’s automated molecular platforms product guide begins on page 31 and features 26 platforms from 18 companies. Faster turnaround times and higher throughput are among the capabilities that manufacturers are touting. New to the market is BioMérieux’s EasyStream, which was first installed in Europe in 2014 and sold in the U.S. this year. EliTech Group, new to the product guide, introduced its Elite InGenius this year.

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Laboratory automation: more than moving from here to there

August 2015—Move it, monitor it, manage it: Hardware and middleware, modules, and interfaces dominate the developments from at least five manufacturers of systems in this year’s product guide to laboratory automation systems and workcells—Beckman Coulter, Siemens, Sarstedt, Inpeco, and Cerner. The guide also includes four systems from a company new to the guide—IDS in Kumamoto, Japan—and additions from Aim Labs, Ortho-Clinical Diagnostics, Roche, and Beckman Coulter.

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Pressing questions in POC glucose testing

April 2015—Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, DC. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

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Paths to validating, using urine sediment analyzers

March 2015—Before Lahey Hospital and Medical Center’s clinical laboratory brought an automated urine sediment analyzer on board last November, it had been doing manual microscopy on positive dipstick specimens only. A review of that practice uncovered problems with quality, including patient misdiagnosis, says Tim Skelton, MD, PhD, medical director of the core laboratory and laboratory informatics at the tertiary care medical center in Burlington, Mass.

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Coagulation analyzers: Recently released and soon to be seen

January 2015—CAP TODAY’s 2015 guide to coagulation analyzers begins here. Diagnostica Stago last year released rivaroxaban and apixaban calibrators and controls (research-use only) for automated anti-Xa activity assessment. It expects in the coming months to submit them for 510(k) clearance, says Nichole Howard, Stago’s communications specialist. The company will soon release the automated ecarin chromogenic assay for dabigatran (RUO).

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Full speed ahead through tight corners

December 2014—Like sailing ships, laboratories hope for fair winds as they chart their business plans. But smooth sailing is never a sure bet; rough sea conditions are an ever-present possibility that can make ships hard to steer. Perhaps the tide is with the vessel but the winds are against it. That’s a situation that could aptly describe a health care system facing a growing patient population at the same time that hospital admissions and reimbursement are in decline.

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Latest lineup of chemistry analyzers for low-volume settings

August 2014—This year’s guide to chemistry analyzers for low-volume laboratories consists of information supplied by 17 companies on 33 analyzers, three of which are new to this guide. Vital Diagnostics, an ElitechGroup Company, launched the Eon 300 Clinical Chemistry system. The system is sold exclusively by McKesson Medical Surgical to small to midsize physician offices and satellite and hospital laboratories.

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New analyzers, assay applications, and tools, tests, and solutions to come

July 2014—In this year’s roundup of chemistry analyzers for mid- and high-volume laboratories, three appear in our guide for the first time. Randox received FDA clearance this year for the latest edition of its RX series, the RX Daytona Plus, a fully automated, random-access benchtop analyzer that’s capable of running 270 photometric tests per hour or 450 tests per hour with the optional ion selective electrode unit.

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New analyzers, connectivity, tests, and software features

June 2014—Cleared in April by the FDA is Nova’s newest—the Stat Profile Prime, which features Zero maintenance cartridges and MicroSensor technology. The Zero maintenance cartridge technology consists of individual cartridges for biosensors, calibrators, and liquid QC. The design optimizes the life of each cartridge, improves analyzer uptime, and eliminates the waste, downtime, and higher costs associated with older systems, says Rick Rollins, Nova marketing specialist. Stat Profile Prime analyzers deliver a 10-test profile—pH, PCO2 , PO2 , Na, K, iCa, Cl, Hct, glucose, and lactate—in 60 seconds.

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Laboratory automation possibilities give lift to labs

March 2014—Tracks, modules, rules, consolidations, connections. Marketers of lab automation systems and workcells are busy turning out and fine-tuning what labs of all sizes need in the face of staff shortages, belt-tightening, growing workloads, and the need to implement a new set of best practices as payment shifts from volume-based to value-based. “Automation systems that provide answers to these challenges will help fulfill the original promise of laboratory automation and become the new standards of automation innovation,” says Jeremy Kiger, marketing manager for lab automation and IT, Roche Diagnostics.

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Coagulation analyzers:
New analyzers, assays, controls, and PEP

January 2014—With the new year come fresh offerings from coagulation analyzer manufacturers, of which at least two have launched entirely new testing systems. Instrumentation Laboratory’s ACL AcuStar hemostasis system has been “met with great enthusiasm for its speed, accuracy, and comprehensive line of high performance chemiluminescent assays,” says Venita C. Shirley, director of marketing for commercial operations in North America.

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Hematology lineup gets year-end look

December 2013—They say change is never easy, but Sysmex seems to be making a downright habit of it: “We have replaced almost 80 percent of our portfolio within the past year,” says Alan Burton, the company’s director of IVD product marketing. Coincidentally or not, Sysmex has seen much success in the last 12 months with its introduction of the XN-Series of automated hematology analyzers. “Already there have been well over 500 XN modules installed across North America,” Burton reports.

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