In the eyes of many clinicians as well as healthcare executives, reaping the benefits of rapid blood tests is worth dealing with the resistance to them and the questions about their cost and diagnostic effectiveness.
W. Frank Peacock is one of those proponents. Peacock, a physician and director of clinical operations for the emergency department at the Cleveland Clinic, says that once hospitals' staff members start using the tests, they realize how beneficial they can be. That's what happened at his facility.
"If you took it away, there would be a revolt," he says, referring specifically to a rapid blood test for heart failure that gives results in about 20 minutes and has been used at the Cleveland Clinic for about three years. Before using the rapid test, the clinic sent its blood work for cardiac patients to a central lab, which would take at least an hour. The rapid test from San Diego-based Biosite-the first company to receive Food and Drug Administration approval for a B-type natriuretic peptide, or BNP, test-is the most recent rapid blood assessment added to emergency rooms' arsenal, Peacock says.
Of course, other rapid tests have been helping clinicians reach speedier diagnoses for many years. Such rapid tests now widely used in hospitals measure glucose levels, confirm pregnancies and test for strep throat. New tests targeting more diseases, as well as the next generation of current tests, are expected to come on line within the next year.
New tests, new procedures
Peacock calls his medical center progressive and says many other facilities might not be as quick to adopt new testing procedures for heart failure, citing potential hurdles involving staffing and cost-effectiveness.
Nurse certification for administering the heart-failure test does lead to some cost and work-process issues that hospital executives must address. Going through the certification process pulls nurses from their everyday responsibilities, which will ultimately cost the hospital money, but rapid tests can improve quality of care, reduce wait times and free up bed space in the emergency room, proponents say.
Rapid tests usually cost more than traditional testing. For example, Biosite says its rapid BNP test costs about $20, and Peacock says running the same test through the lab would cost less than $10. However, the trade-off-having patients in ER beds for hours waiting for test results-ultimately makes the rapid tests worth the price, Peacock says.
Still, "there is much resistance" to the acceptance of the new tests, Peacock says. Workers who will be administering the tests may not want to add to their workload; and lab workers may have turf issues and quality concerns because the tests are being taken out of their hands, he says. Some of those worries are valid.
If the tests aren't performed correctly, they can give inaccurate results. However, properly administered rapid tests have proved to deliver accurate results; if they didn't they wouldn't have passed muster with the FDA.
Elissa Passiment, executive vice president of the American Society for Clinical Laboratory Science, a group that represents laboratory service providers, says BNP and other rapid blood tests on the market aren't difficult to administer, but her organization "highly recommends" that hospitals have laboratory technicians in the emergency department watching as the tests are administered. Sometimes caregivers don't understand the ramifications of skipping a step in the testing procedure, she says.
Passiment adds that the rapid tests for heart failure are highly accurate and can speed diagnosis. Before such tests were available, hospitals had to decide whether to admit or monitor patients with chest pains or shortness of breath.
The BNP tests are given to patients who enter the ER with symptoms of heart failure. Nurses prick a patient's finger, draw some blood, place it on a slide and insert the slide into a machine. If there is BNP in the bloodstream, there is a good chance of heart failure since BNP is released from the left heart ventricle when the heart is struggling to pump.
Hospitals are now receiving better reimbursements for the BNP test. Effective Jan. 1, 2003, the CMS raised Medicare reimbursement to about $47 from about $18. Other FDA-approved BNP tests are made by companies such as Roche Diagnostics, Abbott Laboratories and Bayer HealthCare Diagnostics.
Peacock co-authored a study in the May issue of Academic Emergency Medicine that said emergency room workers had results from point-of-care tests for heart failure markers in about one hour, while results that were sent to the laboratory took about two hours.
The study didn't address the economic impact of rapid tests, but Biosite has some ideas on how hospitals can achieve savings with the BNP test. The company says that once staff members are trained, hospitals can cut costs by having to pay fewer lab technicians. The company says a skeleton staff can handle the testing in many situations.
A February New England Journal of Medicine article on a study of BNP tests says administering them can save money and reduce wait times. According to the study, the total mean cost for patients who were given the test was $5,410, compared with $7,264 for patients who weren't given the test. The study says the average time until treatment for patients who underwent the BNP test was 63 minutes compared with 90 minutes for patients who did not undergo the test, and the rate of hospitalization was 10% lower for the group who had the BNP test. Meanwhile, the average length of stay was eight days for patients given the test, compared with 11 days for the group that wasn't tested.
In the pipeline
Many other companies are busy developing tests that will target other critical conditions. Among them:
A test by Ischemia Technologies, Arvada, Colo., can be used to determine if patients are at immediate risk for a heart attack. The test provides results in about 30 minutes, but blood samples for the test need to be analyzed in a lab. Robin Daigh, senior vice president of commercial operations, says the company should have a test applicator that can be administered by ER workers on the market within the next five years.
Another rapid test that is awaiting FDA approval can be used to diagnose appendicitis. The test has been developed by DMI BioSciences, Englewood, Colo., and provides results in about 20 minutes by testing the urine of patients who have stomach pains. The company hopes to have it on the market by mid-2005.
Biosite says it has a test in clinical trials for diagnosing a stroke. Kim Blickenstaff, the company's president and chief executive officer, says he hopes to have FDA approval for that test in about a year and thinks hospitals would be able to cut costs through its use.
"Hospitalization costs (for stroke victims) are huge and the after-care costs of a stroke are certainly huge," he says.
The company also is working on developing a rapid test for sepsis, a life-threatening infection. Biosite is aiming to start clinical trials on that test during the first half of 2005.
A Germany-based company, Brahms Diagnostica, is marketing a test in Europe that could confirm treatment for bacterial infections. The current test, which must be sent to a lab but can provide results in about 30 minutes, could be available in the U.S. by 2006, says Bill Frank, the company's general manager.
Brahms expects another version of the test, one that gives results in about one hour and 45 minutes, to have FDA approval in the next 90 days. After that, the company is planning to submit a rapid version with results in 30 minutes to the FDA. Both of the tests would cost $15 to $22.
The tests could be used when patients with a high fever enter the emergency department, Frank says. A February article in the British medical journal The Lancet examined the test that is on the market in Europe.
It says the test is useful for distinguishing between bacterial and other infections and could reduce the inappropriate use of antibiotics. The article's authors say too many patients with lower respiratory infections are given antibiotics, a practice that helps create antibiotic-resistant bacteria, which can endanger public health.
The study was conducted on patients who entered the emergency department at University Hospital in Basel, Switzerland, from December 2002 to April 2003. Researchers in the study gave antibiotics only to patients whose blood samples showed signs of a bacterial infection. This practice cut in half the amount of antibiotics prescribed with no signs of adverse effects, the authors said.
Other recently published research has supported rapid HIV tests.
The FDA approved a rapid blood test for HIV in November 2002 and in March approved a rapid test that uses saliva for HIV screening. Both are made by OraSure Technologies, Bethlehem, Pa. The blood test costs $8 to $15 and the oral test will be introduced to the market in September, OraSure says.
The tests provide results in about 20 minutes; previously, it could take a day before patients could learn of their diagnosis. The oral test is also less hazardous to hospital workers because it doesn't require a needle.
HHS has allocated $6.8 million in 2004 for purchasing the tests, which will go to community-based organizations that handle HIV testing and prevention.
An article in the July 14 issue of the Journal of the American Medical Association says OraSure's rapid HIV testing for women in labor delivers "accurate and timely" results. A positive result could lead to earlier treatment, which has been proven to reduce prenatal HIV transmission, according to the study. The article states that this type of test would be "particularly applicable to higher-risk populations."
Although the HIV tests have proven to be more than 99% accurate, for many acute-care hospitals it probably wouldn't be cost-effective to make a complete shift to rapid testing because the FDA requires a confirmation test for every positive result from the rapid HIV test, Passiment says.
Passiment recommends the HIV rapid test for facilities such as community outreach clinics or hospitals where there is a higher likelihood of positive results or for patients who don't have easy access to HIV testing centers, perhaps in rural areas. She also says it would be a good idea to keep rapid tests on hand for testing employees in case of accidents.
"Rapid HIV testing is overall suitable for hospitals if an employee has been stuck (with a needle)," Passiment says.
Oakwood Healthcare System, Dearborn, Mich., uses the rapid HIV test when there's a chance that an employee might have contracted the virus from a patient. Cheryl Okma, director of the laboratory at Oakwood Hospital & Medical Center in Dearborn, Mich., says it would be too costly to use the rapid test all the time.
Although the price of analyzing HIV tests varies for every hospital, Okma says that sending the HIV tests in bulk to its laboratories-which try to get all ER test results in 60 minutes-costs less than giving a rapid HIV test. Passiment says the FDA is close to approving next-generation rapid HIV tests, which would give results just as quickly and at a lower cost.
The Oakwood system uses Biosite's BNP test, but it doesn't have ER workers administering the test as the Cleveland Clinic does. Instead, the samples are sent to the laboratory. The system is studying whether it would be more efficient to have ER staff perform the test, Okma says.
Passiment thinks that taking more tests out of the lab would be beneficial. Doing that "appears to be expensive but pays off down the road," she says.