The POC test market expands with demands related to outcomes, efficiency, data management, integration, and regulatory pressures.
By Renee Diiulio
In today’s world, people want the information they seek and they want it now. Thanks to the Internet, wireless technologies, and other advances, that demand is more of an expectation. Whether it’s how to boil water or how to build a CT machine, information seekers can often go online and find what they need—for free.
In medicine, the first part is still true, perhaps even more so. When it comes to a diagnosis or treatment progress report, patients want the information they seek and they want it now. But they have not yet come to expect it immediately—or for free. These inconveniences are tradeoffs for accurate data, which is still provided within a useful timeframe and which can help to direct treatment that results in a positive outcome.
The i-STAT System
The challenge is that, in many instances, immediacy is the most useful timeframe. Enter point-of-care (POC) testing. “The point-of-care market is growing faster than diagnostic laboratory tests—nearly twice as fast for us in the United States and other parts of the world—because people are becoming more aware and more interested in providing reliable results at the patient bedside,” says Peter Farrell, divisional vice president, Abbott Point of Care Inc, Princeton, NJ.
Farrell sees bedside testing happening more in departments such as emergency rooms, operating rooms, and intensive care units. Clinics, physician offices, and at-home testing are other areas where the use of POC tests is increasing. Disciplines include cardiology, coagulation, infectious disease, blood gas, and certain chemistries.
The capabilities of the tests are also expanding, driven by the demands of resource-restricted health care systems. Menus have grown larger, accuracy has gotten better, and features have improved. Speed is a given, and ease of use a new must. But hospitals must continue to carefully evaluate products for specifics as tradeoffs are sometimes still necessary.
|"Laboratory hospital systems are looking to push assays closer to patient care, where it makes sense to provide tools to help providers quickly test and act appropriately.”—Oscar Cateriano, senior product and marketing manager, BD Diagnostics—Diagnostic Systems, San Diego|
It is, naturally, a challenge for manufacturers to reproduce the performance delivered by laboratory tests, which have the benefit of longer incubation times, higher temperatures, and sophisticated instrumentation. “[Point-of-care manufacturers] have to translate all of the complexity at the laboratory level to a simple device that anyone can use, and which can run at room temperature, without the benefit of complex instrumentation, and can deliver the result in a fraction of the time,” says Stephen Lee, PhD, executive vice president and chief scientific officer, OraSure Technologies Inc, Bethlehem, Pa.
Their efforts have been successful, particularly as the concepts have expanded and technology advanced. POC testing does not always mean a lateral-flow test. Some POC systems are instrument-based and have, therefore, been able to provide improved performance over earlier technologies. “The FDA requires these tests to be at least substantially equivalent to their laboratory counterparts, so the tradeoff in performance can’t be too large,” Lee says.
ALL ABOUT OUTCOME
The main concern driving development is patient outcome. “Laboratory hospital systems are looking to push assays closer to patient care, where it makes sense to provide tools to help providers quickly test and act appropriately,” says Oscar Cateriano, senior product and marketing manager for BD Diagnostics—Diagnostic Systems, San Diego.
Cateriano notes that the decision to act can include doing nothing. “If someone has parainfluenza, there is no therapeutic medication, so it is not always a test-and-treat dynamic,” Cateriano says. But the ability to act quickly when a condition is in an earlier, less severe phase can help to improve the outcome and reduce overall cost.
|“The point-of-care market is growing faster than diagnostic laboratory tests—nearly twice as fast for us in the United States and other parts of the world—because people are becoming more aware and more interested in providing reliable results at the patient bedside,” says Peter Farrell, divisional vice president, Abbott Point of Care Inc, Princeton, NJ.|
In this same vein, POC tests are also used to monitor patients with ongoing conditions, such as diabetes or heart disease. The objective is preventive: by keeping the patient’s test results within specific parameters, he or she can reduce, and ideally avoid, associated complications.
Tim Huston, director of marketing for the Physician Office Lab at Roche Diagnostics Corp, Indianapolis, cites studies showing improved outcomes resulting from routine coagulation monitoring of patients on anticoagulants, such as warfarin or heparin. “These patients have been shown to have fewer bleeds, heart attacks, and strokes. A study published in Disease Management in 2006 found that point-of-care monitoring reduced the risk of treatment-related complications by 91% and increased the time the patient spent within the therapeutic range by 97%,” Huston says.
Siemens Healthcare Diagnostics
A healthy patient is a happy patient, and Huston also cites internal patient satisfaction studies that show patients prefer testing with a finger stick versus a lab draw because of the convenience and the immediacy of the result. “ACOs [accountable care organizations] will be measured on patient satisfaction, and so patient experience will be a key to quality measure,” Huston says.
POC testing, however, can help with costs in other ways, particularly by increasing workflow efficiency. “Anybody looking to implement a POC solution is trying to improve the process flow of patients, moving them through the institution more quickly,” Farrell says.
Turnaround time, therefore, is always an issue. “Customers are continually asking for test results as quickly as possible. Getting results in a few minutes can help a clinician make the next-step decision, for example, to send the patient home or for additional diagnostic testing, or perhaps to the ICU,” says Lauren Foohey, senior director of global marketing, urinalysis, and POC diabetes for Siemens Healthcare Diagnostics, Norwood, Mass.
Taking the appropriate next step can help to improve the outcome and the efficiency of the process. Physicians can prescribe the right medication or avoid prescribing an unnecessary one, moves that could be measured in the future. “There are a lot of guidelines pushing to prevent physicians from prescribing unnecessary antibiotics,” Cateriano says.
Guidelines and regulations have a large impact on the use of point-of-care testing. Regulations have become more stringent over time with new requirements published in the past 5 years by agencies such as the FDA, the Centers for Medicare and Medicaid Services (CMS), and The Joint Commission. As a result, hospitals and other health care providers have new concerns, such as ensuring meaningful use, secure data, and positive metrics.
|BD Diagnostics' Flu BD A+B test is
FDA-cleared and CLIA-waived for
use in physician offices.
POC test manufacturers have responded with features designed to assist health care providers with meeting these new requirements. Newer items on the market have expanded functionality to include operator data and quality control management, remote instrument monitoring and maintenance, patient identification, and digital data transfer (sometimes wirelessly).
Point-of-care coordinators and managers are often challenged by scale. “These professionals can be managing thousands of operators across many sites, and sometimes, there is a lot of geography involved,” Foohey notes.
POC managers want to be able to block an operator who hasn’t completed the competency training or lock out an instrument where quality control has not been run or QC
has failed, and they want to be able to do it from their desk. “It makes their lives easier and workflow more productive
to be able to remotely dial in to monitor equipment,” Foohey
Foohey predicts that eventually this functionality will be available for use on tablet and smart phone technologies. In general, manufacturers are working toward the wireless world in demand by customers.
“Hospitals need to gather and have available all of the information on patients as they move through the spectrum of the health care environment. And if the hospital is trying to become an ACO, it will need to send that information to CMS for reimbursement,” Huston says.
The ability to integrate with other data systems is therefore a frequent demand of customers, and manufacturers must rise to the challenge of developing equipment that is compatible with all—or at least as many as possible.
Another frequent demand is ease of use, and manufacturers find themselves consistently being asked for simpler systems that can be run by all—or at least nonlaboratorians in a medical setting. “This allows organizations to expand the testing that can be done, whether in a clinic or doctor’s office,” Lee says.
Simple, accurate, fast, connected, compliant. These are the demands POC customers have, and as the market expands, these are the features manufacturers are focused on because today, people want the information they seek, and they want it now.
Abbott Point of Care Inc offers the i-STAT System to perform a broad menu of critical care tests, including cardiac markers, blood gases, chemistries/electrolytes, coagulation, lactate, and hematology. The handheld device weighs 18 ounces, uses just a few drops of blood, and delivers results within minutes. Its newest feature is wireless capability that allows immediate transmission of test results to the EMR [electronic medical record].
BD Diagnostics – Diagnostic Systems offers a POC diagnostic platform as well as rapid tests. Its RSV and Flu A+B have been cleared by the FDA for use in clinical settings. The Flu A+B test has also been FDA-cleared and CLIA-waived for use in physician offices; the results have been designed to eliminate subjectivity. “We timed the procedure from the opening of the box through processing to the result and found the entire process took less than 10 minutes,” says Oscar Cateriano, BD senior product and marketing manager.
OraSure Technologies Inc introduced the OraQuick In-Home HIV Test in October, after receiving FDA approval in July. The test is both the first HIV at-home test and the first for infectious disease, according to Stephen Lee, PhD, executive vice president and chief scientific officer for the company. Use is simple: the sample is collected with an oral swab, and results on both HIV-1 and HIV-2 are available in roughly 20 minutes. The company offers customer support via a Web site and 24/7 telephone service line. For the professional market, OraSure launched the OraQuick HCV Rapid Antibody Test, with FDA approval and CLIA waiver. The results, with an accuracy greater than 98%, are available in 20 minutes.
Roche Diagnostics Corp received FDA clearance for its ACCU-CHEK Inform II system in October. The next-generation blood glucose monitoring system offers improved accuracy along with real-time wireless data transfer. Similar features have been added within the coagulation POC line. The CoaguChek XS Plus system received CLIA waiver in September; the device offers connectivity with data management solutions or EMR systems. The CoaguChek XS Pro (available for professional use or patient self-testing) adds an integrated bar code scanner to assist with patient and operator identification. For coagulation therapy and result management, Roche has introduced CoaguChek Link, a Web-based application designed to track a patient’s INR value. Patients can enter self-test results from home, allowing physicians to track progress from their office (or other location). “This further allows for immediate therapy adjustments, which can potentially improve outcomes,” says Tim Huston, director of marketing for the Physician Office Lab division at Roche.
Siemens Healthcare Diagnostics released a new lactate assay for its RAPIDPoint 500 system, an easy-to-use POC system that delivers results in roughly 60 seconds. Outside the United States, Siemens achieved a CE mark for the same system to perform pH testing on pleural fluid. Siemens has also achieved CE marks for its DCA HbA1c test kit (for use on the DCA Vantage and DCA 2000 analyzers) as an aid to diagnose diabetes and identify patients at risk for developing the disease, and for the Clinitek Novus Automated Urine Chemistry Analyzer. “The instrument is typically used in the central laboratory, but outside the United States, particularly in Asia, we often see it placed in outpatient labs,” says Lauren Foohey, senior director of global marketing, urinalysis, and POC diabetes at Siemens.
Think you might be pregnant? Need to monitor your glucose? Want to watch your cholesterol? Do it at home using a self-administered test purchased over the counter. At-home tests also exist to determine HIV status, check for illegal drug use, confirm suspected urinary tract infections, indicate ovulation, and verify a low sperm count. Health care consumers willing to mail in a sample and wait a few days can also obtain results on paternity, steroid use, and longer-term drug use (hair tests). And the options are expected to expand.
Renee Diiulio is a contributing writer for CLP. For more information, contact Editor Judy O'Rourke, at firstname.lastname@example.org