Tools to help manage testing volume quickly, efficiently, and cost-effectively are in demand
BY: RENEE DIIULIO
As the volume of hemostasis testing has increased, coagulation has become a part of the core lab. With continued growth expected, tools that help to manage this routine volume quickly, efficiently, and cost-effectively are in demand.
Over the past 2 decades, coagulation has transitioned from a laboratory island to a main staple of the core lab. And, according to a market report published by TriMark Publications LLC, New York, the segment will continue to be one of the more important within the in vitro diagnostics market for the foreseeable future.
|“Right now, the current need in [coagulation] testing includes easy and reliable tests for routine requests, like PT, aPTT, D-dimer, and fibrinogen. Flexibility is key, particularly in a world where standardization is an increasing goal for laboratories.” ~Jackie Hauser, US director of Hemostasis Marketing, Siemens Healthcare Diagnostics
The report, titled “Coagulation Testing Markets,” forecasts that the market as a whole will climb to more than $1.9 billion by 2018 and, in US laboratories, to $971 million. (The total market incorporates physician office and point-of-care testing as well.) A portion of these revenues will be generated by routine testing. The most frequently performed laboratory tests within US labs include PT prothrombin time (PT) and activated partial thromboplastin time (aPTT), estimated at annual test volumes of 65.9 million and 45.6 million, respectively.
The numbers are not necessarily surprising. The impact of the aging Baby Boomer population has long been expected by the medical community. The real cause for alarm is that the recent statistics may portend even greater test increases. Today’s Baby Boomers, who made up 26.1% of the US population in 2010, are less healthy than their counterparts of an earlier generation, despite having a longer life expectancy.1
|The CoaguChek XS Plus System from Roche Diagnostics, a point-of-care anticoagulation monitor, provides PT/INR results within roughly 1 minute and with a 97% correlation to lab analyzer results.
According to a research letter published in a recent issue of JAMA Internal Medicine, only 13.2% of members of a 2007 to 2010 group of Baby Boomers (average age 54.1 years) reported “excellent” health versus 32% of individuals in a cohort from 1988 to 1994 (average age 54.5 years).1 When compared to the previous generation, today’s Baby Boomers used a walking assist device more frequently, were limited in work more often, reported more functional limitations, were more obese, exercised less, and drank more (on a moderate level)—although they did smoke less. Hypertension was more common (43.0% in the 2007 to 2010 group versus 36.4% in the 1998 to 1994 group), hypertension medications were taken by more patients (35.4% versus 23.2%), and hypercholesteremia was diagnosed more frequently (73.5% versus 33.8%).
“Baby Boomers are entering their 60s and 70s now, and that—combined with the fact that people are living longer—means there are a lot of older people joining the patient population. “This aging population translates to more patients with cardiac conditions, increasing the need for anticoagulant medications and monitoring,” says Jackie Hauser, US director of Hemostasis Marketing, Siemens Healthcare Diagnostics, Tarrytown, NY.
Clinical laboratories are looking for solutions to help them manage this volume quickly, efficiently, and cost-effectively across the range of tests; PT and aPTT are not the only tests routinely offered. Others can include fibrinogen, D-dimer, and heparin levels. “Specialty coagulation labs also have the ability to perform compete thrombophilia and bleeding workups, and some offer molecular components,” Hauser says.
|The ACL TOP 300 CTS Hemostasis Testing System from Instrumentation Laboratory offers full testing process automation for low-to-medium volume, routine or specialty hemostasis labs, or as an adjunct to other installed ACL TOP systems.
“Right now, the current need in [coagulation] testing includes easy and reliable tests for routine requests, like PT, aPTT, D-dimer, and fibrinogen,” Hauser says. Flexibility is key, particularly in a world where standardization is an increasing goal for laboratories.
“As customers move toward IDNs [integrated delivery networks] and ACOs [accountable care organizations], they tend to want to standardize their processes and vendors so they can share the same reference ranges, therapeutic ranges, and algorithms. This enables physicians to seamlessly move across facilities. Reagents and vendor contracts are also easily managed in such a system,” Hauser says.
Siemens’ newest line of coagulation analyzers offers options designed to assist smaller laboratories with specific needs, whether it includes routine and/or specialty coagulation testing. The Sysmex CA-620 analyzer is best suited to laboratories conducting basic clotting tests; the Sysmex CA-660 analyzer also offers additional chromogenic and immunoassay testing (including the Innovance Antithrombin Assay and the Innovance D-Dimer Assay. Either system can operate as a routine analyzer for a small-volume laboratory or as a backup for a larger-volume laboratory.
Instrumentation Laboratory (IL), Bedford, Mass, also recently released a new analyzer for small- to medium-volume laboratories that perform routine and/or specialty testing. The ACL TOP® 300 CTS Hemostasis Testing System is ideal for processing 50 to 100 patient samples per day with full testing process automation. Other systems in the series are designed for larger-volume laboratories. Advanced features shared by all include the ability to access samples, reagents, and cuvettes at any time, as well as to run STAT samples in any position (and at any time).
The future may hold further improvements that help to reduce operator involvement and shorten turnaround times. A newer analyzer within the Siemens line, which was recently released in Europe but is not yet available in the United States—but perhaps provides a glimpse into coagulation’s crystal ball—is intended for high-volume laboratories. Its promise is enabling these operations to achieve first-run accuracy through the identification and management of unsuitable test specimens prior to analysis.
The company cites statistics that suggest that preanalytical errors and unsuitable samples, such as underfilled tubes or hemolytic samples, account for up to 70% of mistakes within the laboratory. Automating sample management steps can minimize the amount of operator time spent dealing with these issues through manual inspection of specimens, which can add up significantly over time as volume increases. With cap-piercing technology, a wide optical spectrum, and onboard capacity of up to 100 samples and up to 40 reagents, the as-yet-unapproved system has the potential to deliver extended walkaway time to streamline workflow.
Future demands could also potentially include more routine testing solutions for the new hemostasis drugs hitting the market (and receiving airplay on television), such as rivaroxaban (Xarelto) by Janssen Pharmaceuticals Inc, Titusville, NJ; dabigatran etexilate (Pradaxa) by Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Conn; and apixaban (Eliquis) by Pfizer and Bristol-Myers Squibb, both in New York. One of the advantages touted by these new medications is that regular monitoring is no longer required; FDA approval was given without the restriction.
“In some cases, however, physicians are finding they would like a test that identifies the medication’s presence in the body because there is often no way to reverse the effects outside of waiting for the drug to be processed by the body, and some of the medications have a long half-life,” Hauser says. The demand for such testing at present is low, but Hauser says she believes manufacturers will develop tests that offer solutions for these potential needs.
|Siemens Sysmex CA-600 Systems provide an economical coagulation package for smaller laboratories needing a robust stand-alone system or larger labs that need a powerful backup analyzer.
Connectivity, however, is a definite demand, one that is fairly common today and therefore one with many solutions in the marketplace. “Laboratories are looking for middleware solutions that offer consolidation and results verification, so operators can run and report the tests accurately and easily,” Hauser says.
The demand for data integration also extends to point-of-care devices, and the easier the process, the better. Roche Diagnostics, Indianapolis, was granted CLIA-waived status last year for the CoaguChek XS Plus System. The point-of-care anticoagulation monitor provides PT/INR [international normalized ratio] results within roughly 1 minute and with a 97% correlation to lab analyzer results, according to the company. The fifth-generation device also offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities, or through the POCT1A standard data transfer protocol.
The new features are designed to address the need to streamline workflow and integrate information into the electronic medical record as well as to assist with regulatory compliance. Automated record-keeping improves the ability of a laboratory to produce necessary documentation and data quickly and accurately, whether needed for an internal review or for an external audit.
In general, any service that can assist with the growing need for documentation and information management is a boon for today’s laboratories, and manufacturers are expanding their service offerings to address common challenges, such as those presented by continued education and competency requirements.
Today’s technologists are often cross-trained and may be responsible for performing and/or managing coagulation testing along with testing from other disciplines, such as chemistry and hematology. “There is also a lot of changeover as more employees retire and new staff are brought in. Laboratories want to be confident that anyone can run the analyzer,” Hauser says.
To assist with this goal, Siemens introduced the Personalized Education Plan or PEP, a virtual competency-based learning system that combines formal instruction, interactive training, and expert insight—along with the company’s state-of-the-art technology. Currently, the company offers more than 700,000 learning opportunities annually through its Customer Care division.
“PEP allows individuals to complete the modules they need, whether hemostasis, chemistry, and/or other available disciplines, and to obtain the same training as their peers,” Hauser says. “New technologists can be brought up to speed, and existing technologists made current with necessary skills. As a web-based tool, it offers the ability to manage continuing education and competency tracking all in one place.
1. King DE, Matheson E, Chirina S, Shankar A, Broman-Fulks J. The status of baby boomers’ health in the United States: The healthiest generation? JAMA Intern Med. 2013;173(5):385-386.
Renee Diiulio is a contributing writer for CLP. For more information, contact Editor Judy O’Rourke, j[email protected]
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