EOL Tech Talk: Meters, readers and diagnostics

Edition: July 2012 - Vol 20 Number 07
Article#: 4028
Author: Repertoire

Rapid detection of disease is key to great patient care. Whether physicians are working to prevent the spread of illness or to keep a disease from worsening, they depend on their sales reps for the right tools. Following is a sample of such tools and tips for engaging physician customers.

Selling around diabetes: analyzers and meters

Selling blood glucose testing systems to physicians may call for some teaching on the part of the rep. While meters are very important for monitoring diabetic patients, they are not diagnostic tools and should not be used as such. Blood glucose analyzers are designed specifically to screen, diagnose and monitor patients for diabetes. Point-of-care blood glucose analyzers are similar to blood glucose meters in that both systems are portable and user-friendly. They each include an instrument and disposables. However, blood glucose analyzers rely on a more precise chemistry methodology, and they are designed and FDA-cleared to screen, diagnose and monitor diabetics. Blood glucose analyzers can diagnose at-risk patients for diabetes, including those who are over 65, obese, have hypertension or have a family history of diabetes.

Blood glucose meters are designed to monitor patients’ blood glucose levels after they have been diagnosed as diabetic. Patients can be monitored in the physician’s office, or they can take a blood glucose meter home and monitor their blood glucose level over time for a more precise record. Some important features to consider in a meter include:

• Fast results.

• Small blood sample size.

• Meter size.

• Easy-to-read display.

• Ability to check blood sugar level in other places aside from the finger.

• Ability to track date and time of blood sugar results.

• Cost of supplies and insurance coverage.

• Usability (Some strips and meters may be more user-friendly.)

Physicians and their patients can choose from a variety of blood glucose meters. Traditional systems involve pricking the finger, placing a drop of blood on a test strip and then placing the strip into a meter, which displays the blood glucose level. Other systems include alternate-site testing systems, which permit the user to test the upper arm, forearm, the thumb base or thigh. However, testing at alternate sites may produce results that vary from those obtained from a finger prick. Continuous blood glucose monitoring systems, which are used mainly for research, involve a small plastic catheter, which is inserted just under the skin. The device reportedly collects small amounts of fluid and measures the glucose content over a 72-hour period.

Home blood glucose meters generally measure the glucose in whole blood, while many lab tests measure the glucose in plasma. Glucose levels in plasma tend to be 10 or 15 percent higher than glucose measurements in whole blood. Some meters now provide results as plasma equivalents, enabling patients to compare their home results with those from a lab.

Today, both blood glucose analyzers and blood glucose meters are smaller, faster and require less blood than their earlier counterparts. Some systems use as little as 0.3 micro-liters of blood and work in less than five seconds. If physician customers claim that they do not need to run many of these tests, then they are probably not running enough tests. There are 25.8 million children and adults in the United States – or 8.3 percent of the population – who have diabetes, according to the National Diabetes Association. Yet, only 18.8 million have been diagnosed. Blood glucose screening, diagnosis and monitoring should be a routine part of most patient office visits.

Physicians who may be interested in blood glucose testing systems include:

• Pediatricians.

• Internists.

• General and family practitioners.

• Obstetricians.

• Gynecologists.

• Cardiologists.

• Endocrinologists.

A1c testing

A discussion about diabetics is not complete without ensuring physician customers are equipped with A1c tests. While blood glucose tests enable patients to monitor their daily blood sugar levels, they need an A1c test for a broader picture of how well their diabetes treatment plan is working. Also referred to as a glycated hemoglobin or HbA1, the CLIA-waived A1c provides an overview of the patient’s average blood glucose control for the past two or three months.

Diabetics should have their A1c levels measured when their diabetes is first diagnosed, according to the American Diabetes Association, which recommends that patients have their A1c levels measured at least twice a year. But, in many cases, levels should be measured every three months, particularly when patients begin a new medication or fall short of blood glucose goals.

Hemoglobin, which is found inside red blood cells, carries oxygen from the lungs to all of the cells in the body. As with all proteins, hemoglobin links up with sugars, such as glucose. Patients with uncontrolled diabetes have too much sugar in their bloodstream. The extra glucose enters the red blood cells and links up – or glycates – with molecules of hemoglobin. As excess glucose builds up in the bloodstream, more hemoglobin is glycated. Diabetic patients on medication may find that one week their blood sugar levels are too high, and the next week they return to normal. But, the red blood cells carry a “memory” of the first week’s high blood glucose in the form of extra A1c, according to the American Diabetes Association.

As old blood cells in the body die and new ones with fresh hemoglobin replace them, the record of A1c levels changes. The amount of A1c in the blood reflects blood sugar control for the last 120 days, or the lifespan of the red blood cells. Compared with a non-diabetic patient who has approximately 5 percent of all hemoglobin glycated, a diabetic whose blood sugar levels have been out of control for a long time may have levels as high as 25 percent, according to the American Diabetes Association.

Distributor reps can find a market for A1c POC tests in physicians’ offices and clinics where patients with diabetes are diagnosed and treated, including family and general practitioners, endocrinologists, internists, cardiologists, pediatricians and others. The tests are ready to use and require no daily controls, calibration, maintenance or refrigeration for up to four months. By placing a small patient blood sample into a sampler body and shaking well, and then inserting the sampler into a monitor, the physician can read the test results with 99 percent accuracy.

Distributor reps should ask potential physician customers how they presently are getting A1c results for patients. Some follow-up questions should include the following:

• “Doctor, have you done any in-office A1c POC testing in the past, or are you considering doing so?”

• “What do you find effective about the way you currently do A1c testing?”

• “What, if anything, would you change about the way you do A1c testing?”

In spite of the quick results using the A1c POC test, some physicians still prefer to send their tests to a lab. Distributor reps should remind customers that rapid test results create an opportunity to provide patients with immediate treatment decisions in the office, as well as educate and counsel them to better manage their disease. There are no follow-up calls to a lab to track down results, no phone-tag trying to connect with patients and no need to schedule follow-up office appointments.

In addition to administering blood-glucose checks and A1c tests, doctors must monitor patients’ blood pressure and cholesterol level. Some tests necessary to monitor diabetes include the following:

Urine tests for Ketones. Ketones in the urine is a sign the body is using fat for energy instead of glucose, because not enough insulin is available to use glucose. The ADA does not recommend using urine tests for glucose unless blood testing is not possible.

Lipids (LDL, Triglycerides, HDL). Lipids tests are important for monitoring patients’ cholesterol levels, which indicate the amount of fat in the blood. Blood vessels leading to the heart can become partially or totally blocked by fatty deposits. A heart attack occurs when the blood supply to the heart is restricted or cut off.

Echocardiograms. These tests use ultrasound to produce images of the heart and blood vessels on a screen.

Electrocardiogram (ECG or EKG). These tests provide information on heart rate and rhythm, and show whether there has been damage or injury to the heart muscle.

Exercise stress test. These tests, which involve using an ECG in conjunction with a treadmill test, help find heart disease that is exhibited only during physical activity.

Holter monitor. Patients wear Holter monitors for a continual stress test reading after leaving the doctor’s office.

Blood pressure cuffs. High blood pressure, or hypertension, can lead to heart attack, stroke, eye problems and kidney disease. Since diabetics already are at risk for these complications, they have a lower blood pressure target than the general public.

Microalbumin test. Albumin is a protein produced in the liver. Although it is present in high concentrations in the blood, when the kidneys are functioning properly, almost no albumin is permitted to leak into the urine. Microalbumin tests measure tiny amounts of albumin that the body begins to release into the urine several years before significant kidney damage becomes apparent.

Creatinine test. Creatinine is a waste product produced by muscle metabolism. Because healthy kidneys excrete almost all creatinine, blood levels indicate how well – or poorly – the kidneys are working.

Testing for flu

People infected with flu often can spread the disease to others a day before symptoms develop and five to seven days after becoming sick, according to the Centers for Disease Control and Prevention (CDC). Children may pass the virus for longer than seven days. In addition, patients suspected of having flu may benefit from treatment with an antiviral agent, particularly if given within the first 48 hours of the onset of illness. By determining whether the patient is infected with influenza A or influenza B, appropriate preventive intervention can be taken. Rapid point-of-care tests are available to detect influenza A and B in patients early, enabling physicians to make recommendations while the patient is still in the office, thereby limiting the spread of illness.

Diagnostic tests available for influenza include rapid immunoassay, immunofluorescence assay, polymerase chain reaction (PCR), serology and viral culture. At least one newer CLIA-waived product available today is a chromatographic immunoassay designed to detect influenza A or B nucleoprotein antigens from respiratory specimens of symptomatic patients, with results in approximately 10 minutes. These tests reportedly provide more objective results than traditional lateral flow tests. They are said to be easy to use and offer cutting-edge adaptive read technology and high sensitivity standards. In many cases, physicians who purchase the test can break even after testing about 142 patients. On average, they test 450 patients each flu season.

Distributor sales reps can engage their physician customers in a discussion about the value of adding flu tests by asking a few probing questions, such as the following:

• “Doctor, what are you doing to increase efficiency in diagnosing your patients who complain of flu-like symptoms and ensure they do, indeed, have flu?”

• “What do you like about your current testing method?”

• “What about your current testing method is not working well? What would you change if you could?”

• “Have you looked into CLIA-waived instrumental readers that provide objective, high-performance rapid test results?”

In some cases, physicians may object to the cost of purchasing a test reader. However, a reader only costs about 10 cents per test over its lifespan, according to experts – a small price to pay for a system that can help confirm a clinical diagnosis. Newer readers are designed to provide up to 3,000 tests – or about 22 months of use. And, many vendors will refund the physician’s money if he or she is not satisfied within 30 days of purchasing the product.

A discussion about flu products is not complete without inquiring whether physician customers require additional protective wear products, such as gloves, masks, as well as alcohol-based hand sanitizers and surface disinfectants. The disease commonly spreads through droplets generated when people cough, sneeze or talk, according to the CDC. When infected droplets land in others’ nose or mouth, or are inhaled into the lungs, the disease can be passed along. In other cases, people become infected by influenza by touching infected surfaces or objects, and then touching their nose or mouth. One of the best ways for people to avoid spreading or getting the illness is by washing their hands with soap and water, or using alcohol-based hand rubs.

The CDC also recommends that people receive a flu vaccination each flu season, whether via seasonal flu shot or a nasal-spray vaccine. The CDC recommends that everyone six months and older be vaccinated, particularly individuals who are at high risk for developing flu-related complications (e.g., pregnant women; children younger than five years; adults 65 years and older; people with medical conditions, including asthma, neurological and neuro-developmental conditions, chronic lung disease, heart disease, weakened immune systems, or people with blood, kidney, endocrine, liver or metabolic disorders).

Prothrombin time testing

For many people, a cut to the skin is minor. For some, however, it can present dangerous – if not life-threatening – health issues. Typically, when the body sustains a wound, the blood clots. Under normal circumstances, this is a healthy response, as clotting helps the body heal itself. But under certain circumstances (e.g., atrial fibrillation, deep vein thrombosis, pulmonary embolism, mechanical heart valves, etc.), this same mechanism can cause a life-threatening clot or “thrombus” to form. Patients with these conditions must take oral anticoagulants, which decrease the clotting ability of the blood. Anticoagulants are considered to have a narrow therapeutic index, and the response to a standard dose varies widely both between patients and within patients over time. Changes in patient health, lifestyle or diet can affect changes in the action of anticoagulants. That’s why patients taking them must be tested frequently to make sure they are taking the proper level of anticoagulants.

Prothrombin time (PT) is a blood test designed to measure how long it takes a patient’s blood to clot. The test may be used to check for bleeding problems, or to evaluate the effectiveness of blood thinning drugs, such as Coumadin. Coumadin is one of the more commonly used anticoagulants, which helps inhibit the formation of blood clots. The PT test helps physicians monitor how well Coumadin is maintaining a balance between clot prevention and excessive bleeding.

PT testing is performed for several other reasons as well, including the following:

• To check for low levels of blood clotting factors, a condition that can cause hemophilia.

• To check for low levels of vitamin K, which is needed to make prothrombin and other clotting factors.

• To see if the liver is functioning properly.

• To see if the patient’s body is using up its clotting factors too quickly, preventing the blood from clotting (disseminated intravascular coagulation).

Traditionally, the physician practice would send the patient’s blood sample to a commercial lab for testing, and the patient would not receive results for one or two days. This delayed any necessary follow-up treatment and introduced potential problems to the blood sample, due to handling and transportation.

In recent years, however, rapid CLIA-waived tests have been available for physician offices. These newer devices rely on a small blood sample from a fingerstick, and results can be achieved in about five minutes. Patients do not have to wait several days and then return to the doctor’s office for follow-up instructions and treatment. In-office testing ensures that anticoagulant therapy can be modified during the patient’s initial visit if necessary.

This shift away from lab testing extends to patients testing at home as well, because recent expansions in Medicare coverage have enabled more patients on Coumadin therapy to become involved in self-testing. And technology is helping to make this continuum of care more seamless. For example, patients can now use the same meter technology that their healthcare providers use, which helps maintain consistency in results and simplifies training. Patient self-testing support services, known as Independent Diagnostic Testing Facilities (IDTFs), allow patients to call in their results or enter them online. The IDTFs then flag out-of-range results that need to be reported to physicians.

Because normal values can vary from one test site to the next, a method of standardizing prothrombin test results, called the international normalized ratio (INR) system, was developed. The INR system enables doctors to understand and interpret the PT test universally, ensuring that anticoagulant therapy is the same no matter who prescribes it.

INR Ranges

Below 2.0 Danger

2.0-3.0 Optimal

3.0-4.0 Caution

Above 4.0 Danger

However, certain factors, such as the following, can affect the test results:

• Antibiotics, aspirin, barbiturates, birth control pills, hormone replacement therapy, cimetidine and vitamin K supplements can affect how well blood thinners work.

• Severe diarrhea or vomiting, which may lead to dehydration, can make the prothrombin time longer.

• Consumption of foods high in vitamin K, such as beef liver, pork liver, green tea, broccoli, chickpeas, kale, turnip greens and soybean products can influence test results.

• Excessive alcohol consumption can affect test results.

• Laxatives, and some herbal products or natural remedies can affect test results.

Certain patient populations greatly benefit from in-office PT testing, particularly patients on anticoagulant therapy. Patients taking Coumadin or another anticoagulant generally include:

• Individuals over the age of 50 years.

• Most individuals who have had a serious illness (such as deep vein thrombosis or atrial fibrillation, among others) or medical procedure.

• Some individuals who have hearing or vision loss.

• Some patients with reduced mobility.

A variety of practices and specialties can benefit from offering the PT test. Such practices include:

• Cardiology

• Internal medicine

• General practice

• Family practice

PT testing, can also play an important role in nursing homes and long-term-care facilities. By providing results faster, point-of-care PT testing helps ensure they can be immediately reported to the physician in charge, who can quickly adjust the patient’s medication if necessary. In the case of a patient who is bleeding profusely, this can be a life-saving decision. Even in nursing homes, where administrators are under constant pressure to reduce costs, as the price point of the machines used to run the tests has come down, the PT test has become more affordable.

When approaching potential customers, distributor reps should talk to them about how they currently treat and manage patients on Coumadin or warfarin. Do they prescribe Coumadin to any of their patients? If so, reps should find out how often they perform PT testing. Do they offer this test in-office, or are they referring it to a commercial reference lab? Are they aware of recent improvements in INR? Once distributor reps have a better understanding of their physician customers’ practice and patient populations on Coumadin, they can present prothrombin time testing products that work best with their practices’ needs.

Editor’s note: Repertoire would like to thank Roche Diagnostics for its assistance with PT testing.