Abbott Launches New A1c Test Cleared for Diabetes Diagnosis

Interview by Steve Halasey

Beth McQuiston, MD

Beth McQuiston, MD

It has been 5 years since an international expert committee first suggested that testing for hemoglobin A1c could be a better method of diagnosing diabetes than more commonly used alternatives such as fasting glucose tests. In the time since then, both specialty societies and government agencies have been busy setting clinical standards and protocols to ensure that HbA1c tests intended for diagnostic use would meet provider expectations.

In April, Abbott Laboratories, Abbott Park, Ill, announced that FDA had cleared its HbA1c test on the company’s Architect c8000 analyzer for diagnostic applications, making it one of just a few such tests to receive the agency’s authorization for that intended use. To find out more about the importance of the new test for healthcare professionals and patients, CLP spoke with Beth McQuiston, MD, a registered dietitian and medical director for diagnostics at Abbott.

CLP: Clinical perspectives on the diagnosis of diabetes have changed in recent years. How have those changes influenced the range of Abbott’s product offerings?

Beth McQuiston, MD: Traditionally, clinicians have used a fasting blood glucose test to diagnose diabetes. But in 2009, an international expert committee including representatives from the American Diabetes Association, the European Association of Diabetes, and the International Diabetes Federation, determined that an FDA-approved hemoglobin A1c test could be used for the diagnosis of diabetes. In line with that determination, we pursued developing an assay to fit with that need.

The benefit of our new hemoglobin A1c test is that you can test patients that just show up at a hospital—without the preparation of fasting—and you can figure out what their blood sugar looks like over time. It’s a very convenient assay.

CLP: Also in line with the recommendations of the international expert committee, FDA has recently revised its guidances for the use of blood glucose monitors in both professional and home-use contexts. How important are these changes?

McQuiston: Abbott follows all FDA guidances and professional organization recommendations very closely, and keeps those in mind. It’s easy to see why they came about.

Over 79 million people in the United States are prediabetic. They’re walking around right now and they have abnormal blood sugars, and they have no idea. In addition, half the people walking around with diabetes don’t know it. In the United States, we have approximately 19 million diagnosed diabetics, 7 million that are undiagnosed, and 2 million cases diagnosed as new each year.

I appreciate FDA very much both as a physician and as a patient. The guidances that FDA offers are to keep us safe and on track, which is why Abbott pursued FDA clearance for the intended uses of both the diagnosis and monitoring of diabetes for our new hemoglobin A1c test. It’s very important to have an assay that can accurately measure hemoglobin A1c.

CLP: How does the new emphasis on HbA1c change the way that healthcare professionals will diagnose and treat diabetes?

McQuiston: There are two types of tests that are typically used for diabetes. The first is a blood glucose test, which is a measure of blood sugar. Clinicians can obtain that measurement from a composite blood test when it is sent into the lab. There are also point-of-care devices that measure glucose as well. Both really provide a snapshot in time of what someone’s blood sugar looks like.

The hemoglobin A1c is more like a video over time, showing for a period of 2 to 3 months what the patient’s blood sugar looked like. And there are different hemoglobin A1c tests on the market.

In the past, what we’ve had is a hemoglobin A1c test that  FDA cleared for monitoring diabetics. This new test is cleared for both monitoring and diagnosis, and that is very exciting to me as a physician.

CLP: Are there certain settings where diagnosis by means of an HbA1c test offers particular benefits not previously in the professional users’ armamentarium?

McQuiston: When a person comes in to the emergency room, it may be very important to have access to a test for the diagnosis of diabetes. That’s a role that Abbott’s new HbA1c test can play.

The patient doesn’t need to be fasting. The test can be performed at any time of day, and it provides a picture of what the patient’s blood sugars looked like for approximately the past 2 to 3 months.

That’s a big advantage when you’re working in an emergency room and someone who is sick comes in, and perhaps they haven’t been eating well, or they have an infection. When you just get the regular blood glucose measurement, you can’t necessarily be sure what it means. Is the patient’s blood glucose elevated because they’re sick, or perhaps they were just given some medications, such as steroids, that elevate blood sugar? Is it lower than it normally would be because they haven’t been feeling well and they haven’t eaten for days? In these circumstances, using an FDA-cleared hemoglobin A1c test can be a big help.

Having an HbA1c test is extremely useful in figuring out what’s going on with such patients. Obviously, it’s not very practical to have them stay for a fasting glucose test, and you’re not going to give everyone in your emergency department a glucose tolerance test. But you can give them a hemoglobin A1c test.

CLP: What about the clinical and economic outcomes from having a test like this?

McQuiston: Having this test available on the market enables us to do some very meaningful health economics and outcomes research. When people come into an emergency room and are diagnosed with diabetes, 10% of them already have some sort of kidney injury, and 20% will have some sort of eye problem from their diabetes. If we can catch them earlier and make the proper intervention—the right treatment, the right diet—that would help tremendously.

Within the Abbott medical affairs group, we do have a health economics and outcomes research team, and that is absolutely something that we consider. In my role at Abbott—as a physician, as a registered dietitian, and as someone who worked in a dialysis center for 5 years—I’ve seen the long-term effects of diabetes on patients. It really is essential to catch it early so that you can intervene as appropriate.

CLP: Once somebody has been diagnosed with diabetes, can the new HbA1c test also be used in monitoring?

McQuiston: The Abbott hemoglobin A1c test that was recently cleared by FDA can be used for diagnosis as well as monitoring. It’s very important to have ongoing monitoring. When I worked as a registered dietitian, people would bring in the records of what food they had eaten, together with logs of their blood sugar measurements—2 or 3 times a day, or whatever their prescribed regimen happened to be—in order to make monitoring possible. That’s important. In addition, a hemoglobin A1c test will essentially capture that video of levels over time, if you will, of the red blood cell and how much sugar was floating around in the bloodstream. When you check a hemoglobin A1c level, it provides that long-term picture of what the patient’s blood sugar looks like.

CLP: Diabetes is often called a “silent killer,” because the symptoms develop subtly over a period of time, and sometimes go unnoticed. How can the HbA1c test help with that?

McQuiston: The beauty of such a test is that when people present with symptoms of diabetes, one simple blood test can show how their blood sugar has looked over the past 2 to 3 months. That’s very convenient.

Symptoms of diabetes can go unnoticed. People can be walking around thinking they’re fine, and they actually have diabetes. Some symptoms can be vague, so perhaps people don’t notice them. Those could be things like frequent urination, excessive thirst, increased hunger, weight loss, tiredness, lack of interest or concentration, and perhaps frequent infections, or slow-healing wounds. These signs can be subtle—and they can be missed.

CLP: For all of those reasons, is this the kind of test that physicians may order as part of an annual physical or regular checkup?

McQuiston: The hemoglobin A1c test is very important. It’s up to the physician and the patient’s particular medical history and condition whether it should be ordered. But if the physician thinks there are any symptoms consistent with prediabetes or diabetes, the decision will likely be yes.

For type 2 diabetes, there are certain things that increase people’s risk, including family history, being overweight, and inactivity. These things help the physician or healthcare provider determine the patient’s risk.

So there are really three buckets for determining when or how frequently to perform a diabetes hemoglobin A1c test. First, for a person who has already been diagnosed as a diabetic, the A1c level is generally tested 2 to 4 times per year. Second, it should be tested whenever signs or symptoms indicate possible diabetes. And third, it should be tested as part of the health checkup when the patient is at high risk of developing diabetes.

CLP: Is HbA1c testing equally applicable to both type 1 and type 2 diabetics?

McQuiston: The American Diabetes Association recommends HbA1c monitoring for both type 1 and type 2 diabetics. For type 1 diabetics, and for some type 2 diabetics, use of point-of-care home glucose monitoring is also recommended.

CLP: What do you see as the future for managing diabetes, and how will the role of clinical laboratories and laboratorians change as a result?

McQuiston: The prevalence of diabetes is increasing dramatically. Worldwide, the number of cases is staggering—371 million people—and half of those are undiagnosed. For laboratorians, capturing these diagnoses is essential. We can definitely do better than a 50% rate of diagnosis.

We know that the prevalence and incidence of diabetes increases as countries become more Westernized and as peoples’ weights begin to increase. But in order to manage the disease, you have to be able to diagnose the disease. Only then can physicians adequately advise patients on what to do, and hopefully minimize the untoward effects of the disease.

CLP: What are the benefits of running the new HbA1c test on Abbott’s Architect platform?

McQuiston: Abbott’s new hemoglobin A1c test offers a number of key attributes. It diagnoses and monitors diabetes, and uses whole blood application without manual pretreatment. It’s certified by the National Glycohemoglobin Standardization Program (NGSP), compliant with standards of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and it has high precision.

When you have a good lab, a test such as Abbott’s hemoglobin A1c assay provides increased efficiency, minimized hands-on time, and essentially all of the things that laboratorians want. The standardization of an FDA-cleared and commercialized product elevates confidence in the results.

It is very important for physicians to know what they’re ordering, because not all hemoglobin A1c tests are the same. And when clinicians have confidence in the results, they can make clinical decisions appropriately.

It’s important that people understand why diabetics need to be diagnosed. Over the long term, diabetes can cause such significant complications as eye problems, kidney problems, cardiovascular disease, and neuropathy. But excellent blood glucose control can prevent or delay the onset of complications.

It’s important to remember why we’re doing the testing in the first place. The goal is to help people live happy and healthier lives.

Steve Halasey is chief editor of CLP.