diabetestalk.net

Bayer A1c Testing

Study: A1c Now Test Is Crap And So Are Many Doctor Office A1c Tests

Study: A1c Now Test Is Crap And So Are Many Doctor Office A1c Tests

A study published in the January issue of the journal, Clinical Chemistry put eight brands of A1c test kits, including the A1c Now test sold in pharmacies and online, through rigorous testing. The other kits were the ones marketed to doctors for use in their offices. You can read an abstract of this study here: Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria. Erna Lenters-Westra1, and Robbert J. Slingerland. Clinical Chemistry 56: 44-52, 2010. First published November 19, 2009; 10.1373/clinchem.2009.130641 The study concluded only two of the eight kits produced clinically valid results. What is most telling, though, is that the study reports: Because of disappointing EP-10 results, 2 of the 8 manufacturers decided not to continue the evaluation. Their test kits were removed from the study after they completed only one of three CLSI protocols that were planned. CLSI stands for "Clinical and Lab Standards Institute." Since four of the six kits that remained in the study ended up with unacceptable results, but must have had good enough results after the first protocol to encourage their manufacturers to keep them in the study, one can only conclude that the kits removed from the study did abysmally. Which meters were withdrawn from the study after they did very poorly at the first level of testing? A1c Now and Quo-test. Of the six remaining kits that completed all three laboratory test protocols, Only the Afinion and the DCA Vantage met the acceptance criteria of having a total CV <3% in the clinically relevant range. The CV is the "Coeeficient of variation." It is the statistic that represents the ratio of the standard deviation to the mean. It's a measure of how widely scattered data is. The larger it Continue reading >>

Easy And Accurate Diabetes Monitoring At Home Is Available

Easy And Accurate Diabetes Monitoring At Home Is Available

The A1CNow device is the easiest and most accurate way for those of us who have diabetes to check our key blood glucose level at home. But it still has spotty availability. Chex Diagnostics, formerly known at Polymer Technology Systems, started shipping it six months ago after the company had purchased the A1CNow business from Bayer Diabetes Care last year. But many pharmacies don’t have it yet. The good news, however, is that we can get it for less than ever before. The pharmacist at the local Kroger supermarket told me today that he had never heard of a way to check our A1C at home. A pharmacist at the most upscale pharmacy near me remembered that they had sold the A1C test when Bayer made it but didn’t have any record of the Chex Diagnostics or Polymer Systems Technology device. I couldn’t find it on the Rite Aid, Target, or Costco websites. But Chex Diagnostics provides the A1CNow device to two retailers who sell it as house brands. Chex Diagnostics owns the proprietary names under which Walgreens sells as the “Walgreens At-Home A1C Test Kit” and which Wal-Mart sells as the “ReliOn Fast A1C Test.” You can get the two tests in the Walgreens At Home A1C Kit for $32.99, according to the company website. At least I think that’s the price, because much of the “overview” information is wrong. Besides describing what is obviously a blood glucose meter, it refers to a “lover limit of the A1C target.” Don’t you love it! The situation at Wal-Mart stores is much better, although its website hasn’t caught up. It’s not yet on the Wal-Mart website, which shows the Bayer version at $29.88 but as no longer available. But Wal-Mart stores started getting their ReliOn Fast A1C Test kits from Chex Diagnostics about two weeks ago, Chex’s Director of Marke Continue reading >>

A1cnow®+ System

A1cnow®+ System

Lab Quality Results at the Point-of-Care The A1CNow+ system provides healthcare professionals with a fast and easy way of obtaining accurate A1C results with just a fingerstick. This innovative technology enables clinicians to communicate face-to-face with patients about their diabetes control in minutes, not days. In addition, the A1CNow+ system is fully reimbursable. More Efficient than the Lab Portable - use in multiple exam rooms Easy to use - minimal training required Certifications​ FDA-cleared CE References: 1. PTS Diagnostics A1CNow+ System Professional Procedure Guide PN 91078 Rev. B. March 2014. 2. Relative to TOSOH certified reference method. PTS Diagnostics A1CNow+ System Preliminary Performance Data, May 30, 2014. Data on file. 3. Exhibits a linear dynamic range and precision that meets current NGSP standards. PTS Diagnostics A1CNow+ System Preliminary Performance Data, May 30, 2014. Data on file. 4. Excellent Precision of 2.15% CV and 4.3% CV at the Normal (5.7% HbA1c) and High (8.9% HbA1c) ends of the spectrum. PTS Diagnostics A1CNow+ System Preliminary Performance Data, May 30, 2014. Data on file. Complimentary Whitepaper Download Point-of-Care Alternatives to A1C Testing ​Ease-of-use point-of-care medical devices provide an advantage in measuring HbA1c in situations where clinical laboratory analyzers are unavailable to provide physicians with real-time information to better manage diabetes. The purpose of this whitepaper is to help healthcare professionals understand the viability of portable, point-of-care A1C monitors. What you will learn from this whitepaper: How point-of-care devices are viable alternatives to sending blood to laboratory testing Point-of-care A1C device accuracy evaluations relative to three clinical laboratory HbA1c analyzers Continue reading >>

Bayer’s A1cnow

Bayer’s A1cnow

Bayer’s A1CNow SELFCHECK, cleared by the Food and Drug Administration last year, is the first and only system of its kind with at-home results in five minutes. It enables patients to more closely watch their A1C level in between doctor visits so they may have a more informed discussion with their healthcare provider to ensure their diabetes plan is working. Measuring A1C levels is important for diabetes management, as even a one-percent point reduction in A1C may lower the risk of complications by up to 40 percent.(1) “A1C testing is an important measure of long-term diabetes management,” said Olivier Jarry, Chief Operating Officer for Bayer Diabetes Care. “Bayer’s A1CNow SELFCHECK provides patients with a new way to partner with their healthcare providers to help meet their blood sugar goals over time.” A1CNow SELFCHECK complements the healthcare provider-administered A1C test but is not intended to replace it or routine blood glucose testing. Bayer’s A1CNow SELFCHECK, when used in conjunction with blood glucose meters, such as Bayer’s CONTOUR® or BREEZE®2 blood glucose meters, lets people with diabetes know where they stand with respect to their treatment goals. A1CNow SELFCHECK comes as a 2-test-kit for a suggested sale price of $29.99. For more information or to find out where you can buy this meter, visit These websites also contain valuable educational information for patients to help them better understand and track their A1C progress. About A1C (5, 6, 7) A1C is a measure of how much sugar is attached to hemoglobin – a protein inside the red blood cells. The more sugar there is in the blood, the more will stick to hemoglobin, which increases a patient’s A1C level. Once it sticks, sugar remains on the hemoglobin for the life of the red blood Continue reading >>

A1cnow At Home

A1cnow At Home

Today Bayer Diabetes Care launched the A1CNow SELFCHECK that we can use to check our A1C level at home. Finally. Many of us have been waiting for years. In September 2006 I wrote here that we would have it “soon.” Then, a year ago at last year’s convention of the American Diabetes Association in San Francisco a Bayer spokesperson told me that next year they plan to sell it over-the-counter in three-packs. Now that the SELFCHECK is finally available online, the two-pack version is even better for us. Until now, if you wanted to use the A1CNow, you had to buy the commercial version. The problem with that version is that we don’t need to use all of its 10 cartridges within their one-year expiration date. Since the A1C test measures our average blood glucose level over the previous two to three months, our doctors generally recommend two to four A1C tests each year. “Some patients will skip having their A1C tested because they’re worried about what their healthcare provider will say if their A1C levels are not good,” said Steve Edelman, MD, founder and director of Taking Control of Your Diabetes. “A1CNow SELFCHECK is a new tool that allows people with diabetes to test their A1C level in the comfort and privacy of their own home, to get the information they need to manage their disease in-between health-care provider visits.” Just as important, Bayer finally got the A1CNow certified. Last month the NGSP (formerly the National Glycohemoglobin Standardization Program) certified the A1CNow as having documented traceability to the Diabetes Control and Complications Trial reference method, which established relationships between A1C levels and risk for complications of diabetes. The DCCT method is the gold standard for reliable A1C testing. For more information, Continue reading >>

{diabetes Management} Home A1c Test Fail

{diabetes Management} Home A1c Test Fail

I’ve been curious about the home A1c tests. We have an A1c done in office every three to four months, but sometimes I wish I could check in between to see if changes we’ve made are making any difference. (And, yes I know the A1c is only one measurement of how well diabetes is being managed.) I saw the Bayer A1cNow Selfcheck kits on sale and decided that it was worth it to buy a box and check it out. That evening I pulled it out and did the test and was absolutely SHOCKED at the number that popped up. There is NO WAY that Q’s A1c was 10.5. That would indicate an average BG of 255. I don’t think so! So not only was I totally upset and discouraged, but I was perplexed. I wrote it off as inaccurate and decided to wait until our next endo appointment and use the second test in the box to compare. In the meantime I saw two other bloggers use the home kit and they each seemed to think that the test was accurate enough. Our next endo appointment rolled around. I have been struggling with Q’s A1c’s (both literally and emotionally) because they are higher than I would like them to be and we made some changes in the past couple of months that we really thought would bring it down. In fact her A1c dropped 0.5, a much appreciated improvement. We still have a little way to go, but we made a couple more changes to I:C ratios and correction factors that I think will help. We also talked about doing the iPro again. (Unfortunately this clinic requires three separate visits: putting it on, taking it off, and discussing results with the doctor in person. It’s 90 minutes each way for us.) Armed with an A1c taken in the endo’s office (finger prick, not blood draw), I pulled out the home A1c test to check it’s accuracy. It was 1.8 HIGHER than the result at the endo. FAIL. I Continue reading >>

A1c Self Test Kit From Bayer

A1c Self Test Kit From Bayer

Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community If anyone is interested in self-testing their HbA1C level, then Bayer make an easy I have one of these. One thing you should be aware of is that the test packs expire - mine expire 10 months after the purchase date, so I will have to test monthly to get the full use. I paid 110 on ebay to a kit with 10 tests. I had a quick look around the net and the kits seem a bit thin on the ground at the moment. I just wish my Pharmacy would start it's proposed trial of doing the test. Where did you get it from as I have been looking? It's not the cost of the kit that's got me puzzled, it's the cost of the consumables... and I've not been able to locate any refills for it which is worrying... you'd think that supplier would carry them as well... There are no refills. You have to buy an additional set of testers. In the US, drugstores sell two-test kits. You get one meter, and two test kits. The meter can only be used for two tests. Utilizing micro-optical technology that's integrated into a proprietary reusable monitor with single use cartridges, the Monitor will expire after the programmed number of tests have been run (10 or 20). in this day and age, that is just criminal that the meter becomes useless after the pre-programmed number of tests have been performed and no refill kits are available... what a waste of resources making those electronics and the plastic housing. in this day and age, that is just criminal that the meter becomes useless after the pre-programmed number of tests have been performed and no refill kits are available... what a waste of resources making those electronics and the plastic housing. The 'meter' is just a bit of plastic that's a co Continue reading >>

Feds Say “no” To Finger-stick A1c: Health Screening Compliance

Feds Say “no” To Finger-stick A1c: Health Screening Compliance

Afew months ago, my company was engaged in a RFP process for one of our most valued municipal clients of over 3 years. As part of that process, our client asked us to provide pricing for “point of care” (a.k.a. finger-stick) Hemoglobin A1c testing. As we began to explain that, practically speaking, there is no compliant solution available for finger-stick A1c, we were surprised to hear that other health screening vendors were proud to offer this test. To provide some background, finger-stick A1c products were developed to help people who have already been diagnosed with diabetes monInterlinitor their blood sugar levels. Over time screening companies began to use these Hemoglobin A1c tests in the field. A few years ago, the FDA issued a letter to manufacturers of finger-stick A1c test kits clarifying that the tests are only approved for monitoring and that no A1c test had been cleared to diagnose diabetes. Now, understand that health screening vendors do not diagnose, we screen. Screened individuals who show a likely condition are referred to a physician for formal diagnosis. Therefore, health screening vendors continued to offer finger-stick A1c under the assumption that as long as the test was used to screen, not diagnose participants, it would comply with the intended restriction. However, in 2013, manufacturers of finger-stick A1c solutions began discontinuing their lines of finger-stick A1c products, including Bayer who then manufactured a product labeled A1cNow+®. The A1cNow+® product is now manufactured by PTS for its intended purpose of monitoring the blood sugar levels of people already diagnosed with diabetes. The manufacturer’s insert clearly states “This test is NOT for the screening or diagnosis of diabetes” under the section labeled “Limitatio Continue reading >>

Multi-test A1c System

Multi-test A1c System

Bayer’s A1CNow+provides you with a fast and easy way of obtaining accurate A1C results in your office. This innovative technology enables you to communicate face-to-face with your patients about their blood sugar control. PRACTITIONERS ORDER HERE SELFCHECK CLICK HERE More Efficient Than The Lab Results in 5 Minutes Small (5μL) Blood Sample Portable – Use in Multiple Exam Rooms Easy to Use – Minimal Training Required No Maintenance Key Features 99% Lab Accuracy* NGSP Certified CLIA Waived Reimbursable Ideal For Medical Doctors Naturopathic Doctors Certified Diabetic Educators Nurse Practitioners Nutritionist / Dietitians Real-time results. Better outcomes. A1CNOW+® PROCEDURE A1CNow+ is a fast, easy and accurate way to perform in-office A1C testing. The simple process requires less than one minute of hands-on time and results are ready in just five minutes. The portable, hand held A1CNow+ monitor also empowers physicians' offices to perform parallel tests, greatly increasing workflow efficiency. * Study results with healthcare professionals showed that the accuracy of A1CNow+ with fingerstick samples was, on average, 99%. This means that, on average, a true 7.0% A1C could read approximately 6.9% A1C. An individual A1CNow+ result may differ by as much as -1.0% A1C to +0.8% A1C from the true result. This represents the 95% confidence limits of a Bland-Altman plot. 1. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2003. 2. Standards of Medical Care in Diabetes - 2008. Diabetes Care, Volume 31, Supplement 1, January 2008. 3. Daniels, E. et al, Point of C Continue reading >>

Home A1c Testing Vs. The Lab

Home A1c Testing Vs. The Lab

So it was time again for my A1C and other blood tests last week. Over-time, in fact. You know how I hate going in to the lab when I have to be fasting for lipid tests and can't even have a latte on the way over in the morning. Ugh! And who ever said diabetics don't mind needles?! Anyway, I'd been saving the review unit A1c Now SelfCheck pack I got from Bayer a few weeks ago for just this occasion. What better way to test the accuracy of home a A1C testing kit? I don't mind admitting I had very little faith in the thing. My endo had some of these in her office last year, and we tried them several times. The results were always differed wildly from the A1C I got at the hospital lab. She thought her packs might be too old, although the date on the box seemed OK. So after dragging my behind to the hospital that day, and then enjoying a lovely post-needle cafe breakfast with my husband, I went home and snipped the seal on my A1C Now pack. Inside were all the trimmings for two tests, along with a lot of documentation and a mini-CD that's supposed to explain how to use it — which I didn't watch of course. I figured I'd be representative of the "average patient" who is too lazy to watch the CD. (Not to mention that I have ZERO patience myself and ripped right into the thing without thinking ;) ) Lucky for me, the little fold-out Reference Guide with photos did the trick. It told me what to open first, how to prick my finger for the blood (not more than a usual BG test!), and what to open only "AFTER blood collection!" And I must have done it right, because wouldn't you know, I got 6.3 on the Bayer test, and a 6.4 reported back from the hospital lab. Pretty impressive! (Yes, for those science guys but also for me -- under 6.5, Baby!) So I got to experience the "5-minute home A Continue reading >>

Another Diabetes Device Bites The Dust

Another Diabetes Device Bites The Dust

has learned that Bayer BAYRY +0% will be closing the production facility for its A1CNow product and cease all production by the end of the year. For those new to the wacky world of diabetes, back in 2006 Bayer acquired privately held Metrika, the makers of the A1CNow. Back in the day the A1CNow was the only at home A1C test on the market and the acquisition was generally viewed as a positive step for Bayer. Yet as so often happens in the wacky world of diabetes devices great products get ruined by inept management. Before Bayer ran Metrika into the ground, something that’s normally the domain of Abbott (NYSE:ABT) who has run not one but two glucose monitoring companies into the ground, the possibility existed that sales of the A1cNow could also drive sales of test strips for Bayer’s line of conventional glucose monitors. Before this disaster unfolded Diabetic Investor was very public with our belief that an A1C result was the simplest test result for a patient to understand, a result of 7 or below was good, above 7 not as good. Heck, even the geniuses who ran Bayer should have been able to see that. The thought was Bayer with their scale, yes at one time the company did have scale in the BGM market, could use the A1CNow as an engagement tool for patients who weren’t testing their glucose or weren’t testing as often as they should. Basically the A1CNow would be the patient’s baby step into testing their glucose on a regular basis. As Diabetic Investor noted on more than one occasion with the proper marketing effort Bayer could have educated patients as to the correlation between regular glucose monitoring and A1C. Yet once again the company never had a clear strategy for what do with the A1CNow and without a strategy wound up running in circles going nowhere in Continue reading >>

Evaluation Of An Over-the-counter Glycated Hemoglobin (a1c) Test Kit

Evaluation Of An Over-the-counter Glycated Hemoglobin (a1c) Test Kit

Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C. Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject’s blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material ± DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey. A total of 110 subjects with (n = 93) and without (n = 17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results (R2 = 0.93 for both). The average within-subject coefficient of variation was 4.57% (n = 74). The FTF rates with and without instructional DVD were 11.3% (n = 56) and 39.6% (n = 54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were “very” to “extremely” likely (93.5%) to discuss their home A1C results with their HCP. Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately. Keywords: A1CNow, diabetes, glycated hemoglobin A1c, in vitro diagnostic for home use, over-t Continue reading >>

Bayer Diabetes Care Launches A1cnow(r) Selfcheck, A New A1c Monitor For At-home Use

Bayer Diabetes Care Launches A1cnow(r) Selfcheck, A New A1c Monitor For At-home Use

Through Self A1C Testing, New Monitor Enables Diabetes Management Between Physician Visits TARRYTOWN, N.Y., June 2 /PRNewswire/ -- Bayer Diabetes Care announced today the launch of A1CNow(R) SELFCHECK, a new A1C monitor that enables people with diabetes to check their A1C level at home. Measurement of A1C provides an average assessment of blood sugar levels over the past three months -- and is an indicator of how well diabetes is being managed. The U.S. Food and Drug Administration recently cleared Bayer's A1CNow SELFCHECK which enables patients to more closely watch their A1C level in between healthcare provider visits so they may modify their diet and exercise, or have a more informed discussion with their healthcare provider based on the results. A1CNow SELFCHECK, which is now available without a prescription and through leading online pharmacies, provides at-home results within five minutes, has an easy-to-use design and delivers lab accuracy. Measuring A1C levels is important for consistent diabetes management, as even a one-percent reduction in A1C reduces the risk of serious complications by 40 percent(1). "A1C testing is an important measure of long-term diabetes management, however, some patients will skip having their A1C tested because they're worried about what their healthcare provider will say if their A1C levels are not good," said Steve Edelman, MD, founder and director, Taking Control of Your Diabetes. "A1CNow SELFCHECK is a new tool that allows people with diabetes to test their A1C level in the comfort and privacy of their own home, to get the information they need to manage their disease in-between healthcare provider visits." At the healthcare provider's office patients can be tested with Bayer's A1CNow+ monitor, which provides results within five m Continue reading >>

At Home A1c Testing Systems & Kits: Review

At Home A1c Testing Systems & Kits: Review

The A1C, a Glycated hemoglobin, is a form of hemoglobin that is measured primarily to identify the three-month average blood glucose concentration. The A1C test is limited to a three-month average because the lifespan of a red blood cell is only four months. In other words, it’s the indication of your blood sugar level for a three-month period. Typically, your doctor will test your A1C levels every 90 to 180 days depending on how well your blood sugar levels have been managed. In basic terms, the A1C test checks to see how much glucose is attaching to your red blood cells. You can work to keep your A1C within your target range using a recommended diabetes management regimen along with a well-managed diet, exercise routine and other healthy lifestyle . Normal a1C Prediabetes a1C Diabetic a1c Under 5.7 5.7 to 6.4 6.5 and above A1C Test Features and Pricing While most hospital conducted A1C tests cost around $86 per test (depending on your co-pay), you can now buy the A1C self-check home kit for around $40. Each kit includes one test with two strips, but you can buy a double test kit as well. The kits are not reusable so once you use your two lancets, you must buy another kit. Use Most people use this test every 30 days instead of waiting 90 days to be seen by the doctor. This helps patients have a more accurate reading on where their levels fall throughout the month. Insurance Coverage Most insurances will cover 1 or 2 tests per year and some hospitals will have a sample take-home A1C test that you can ask for. However, not all hospitals do so you may still need to buy over the counter kits depending on how many results a year you want to have or how many your doctor requires. Pros and Cons of Home Testing The A1C at home kit needs four large drops of blood which is eas Continue reading >>

Rip, A1cnow

Rip, A1cnow

The rumored end to Bayer Diabetes’ production of A1cNow speaks volumes about the new math of the business of diabetes care. According to a Forbes article published recently by Diabetic Investor editor David Kliff, Bayer will stop producing it’s A1cNow SelfCheck kits by the end of 2013. If true, it may offer a cautionary tale about what can happen when outfits like Bayer Diabetes venture into the over-the-counter world, especially when the prescription device space is already under siege due to reduced test strip reimbursements from Medicare and other insurers. A1cNow seemed like an idea whose time had come when it debuted in 2008. Dr. Steve Edelman, renowned founder of the non-profit Taking Control of Your Diabetes, was an early spokesman for the product, and when I helped his organization produce the Extreme Diabetes Makeover video series in 2010, we gave A1cNow tests to our group of patient participants for periodic checkups of their A1c progress. A1cNow brought a lot of joy to the show’s participants. I specifically recall how delighted and proud Tim Smith, a Type 2 on insulin, was to see his progress with A1cNow. He began the Makeover program with an A1c of 11.7, but just six weeks into the program, it was 6.3. What a moment! All of the Makeover participants looked forward to their next A1cNow test. It was a measure of how far they had brought themselves, and it was there for all to see. Bayer used some of the video footage featuring A1cNow from Extreme Diabetes Makeover (including Tim’s Shining Moment) in product presentations at the American Association of Diabetes Educators conference that summer. The diabetes educators were enthusiastic. At a suggested retail price of about $30 to $40, it seemed like a tool that could help motivate people to test more fr Continue reading >>

More in diabetes