A1c Test Kit

What Is A1c

A A A Topic Overview A1c is a test that shows the average level of blood sugar over the past 2 to 3 months. People with diabetes need to have this test done regularly to see whether their blood sugar levels have been staying within a target range. This test is also used to diagnose diabetes. Blood for an A1c test can be collected at home or at your doctor's office. Home testing may not be an option for everyone. Check with your doctor. Home testing. Home test kits for A1c are available. Using the kit, you can use a lancet (a small needle) to take a blood sample from a finger. Then, put a few drops of blood on a sample card. Place the card in an envelope and send it to a lab for testing. The lab sends the results of the test to you or your doctor. Doctor's office. Some doctors, particularly endocrinologists, have blood-analysis equipment in their offices that can test hemoglobin A1c blood levels from a finger stick. The doctor can then review the results during the appointment. Laboratory testing. The most accurate measurement of A1c level is done in commercial laboratories. These labs may be run by local hospitals or large health clinics, or they may be independently owned. Lab personnel check their equipment often, calibrate their machines on a regular schedule, and are monitored by federal and state regulatory authorities. A doctor's office sends the blood sample to the lab. How long it takes to get results depends on the lab. You can have the test results reported to you or your doctor. A1c test results show your average blood sugar level over time. The result is reported as a percentage. Your goal is to keep your hemoglobin A1c level as close to the normal level as possible. Studies suggest that the lower the A1c level, the lower the incidence of diabetic complicati Continue reading >>

{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 >>

Glucomen A1c Blood Testing Kit

Most people with diabetes know about the HbA1c test. The GlucoMen A1c performs an A1c test, which is a measurement that can show how well your glucose level has being controlled over a period of months. This can providing you and your care team some ideas as to your long-term blood glucose control and therefore help you to come up with strategies to improve it, if you need to. HbA1c tests under clinical conditions Normally you only get an HbA1c test under clinical conditions. If you attend a hospital, then you’d get the blood get done there. If you attend your local GP, then you would either have to go and get the necessary blood drawn at the local hospital. Alternatively, if your GP offers the service in their surgery, you would have to book up with the phlebotomist and then make an appointment to see your GP a few weeks later, when the results come in. It can all be a bit of a carry-on. Most diabetics are lucky to get this insightful test 3 or 4 times a year. HbA1c test at home Some GPs save costs by not doing these tests. For those who want to know their HbA1c then there is an alternative – you can buy a one-off GlucoMen A1c test. This is an easy to do alternative way of getting this result. You can administer the ‘test’ at home. Instead you need to request this test and it is mailed to you in the post. But this is not a blood test meter. You need to do a finger-prick, then put two blobs of ‘ladybird-sized’ blood onto a special piece of paper in the kit, wait for it to then mail the test back in the pre-paid envelope provided. Either you, or a nominated healthcare professional, will get your result within approximately 48 hours. Available on prescription An GlucoMen A1c test kit should cost around £16.95 from pharmacies – you may need to phone ahead to Continue reading >>

A1c Home Test Kits

Hemoglobin A1C tests are used to screen for and diagnose prediabetes and diabetes. A1C home test kits are a good option if you want to test your A1C at home in between visits to your doctor, whether you have type 1 or type 2 diabetes. An A1C test gives a picture of how well your diabetes treatment is working by showing your average blood sugar level for the past two or three months. This can be very helpful in your diabetes management plan. How A1C Home Test Kits Work All A1C home test kits allow you to provide a small blood sample, about the same as your glucose meter, in the convenience of your home. Depending on the type of kit you purchase, you either get immediate results at home or you send the sample to a lab for analysis. Home A1C tests are not approved for diagnosing diabetes. You need to see a doctor for a diagnosis. Factors That Can Affect Accuracy There are factors that will affect the accuracy of A1C tests, so discuss this with your doctor to ensure you know whether they're appropriate for you. A1C results are affected by hemoglobin variants (such as sickle cell), anemia, transfusion, blood loss, pregnancy, and rheumatoid factor. A1C Results at Home Portable consumer options for immediate results at home are now available at major retailers, with both name brand and house brand versions. A1CNow SELF CHECK was the original FDA-approved brand from Bayer Healthcare. PTS Diagnostics purchased the A1CNow business in 2014 and markets it under the original name, plus they license it for store brand devices. Walmart sells it as ReliOn Fast A1C Test and Walgreens and CVS as At Home A1C Test Kit. This technology received FDA approval and allows you to learn your A1C number in five minutes. It's similar in appearance to your daily glucose meter, but you don't use it o Continue reading >>

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 >>

The High Costs of Diabetes Kills: RIP, Shane Patrick Boyle

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 >>

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 >>

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 >>

Testing Your Blood Glucose

Testing your blood glucose, also known as Self-Monitoring of Blood Glucose (SMBG), is a method of checking how much glucose (sugar) is in the blood using a glucose meter -- anywhere, anytime. Here, you'll learn some basics about: Blood sugar targets for adults How your doctor tests your blood The importance of self-testing When to test and what to look for How to share results with your doctor Blood glucose targets for non-pregnant adults* Before meal After meal 80-120 mg/dL Less than 180 mg/dL How your doctor tests your blood -- the A1C test† Your doctor uses what is called an A1C (Glycosylated Hemoglobin) test to see what your average blood glucose level has been over the last two to three months. Used for both Type 1 and Type 2 diabetes, it gives you and your doctor an indication on how well you are responding to your treatment regimen, and if any adjustments are necessary. The goal is to keep your level below seven percent (7%).* The A1C test is sometimes referred to as the hemoglobin A1c, HbA1c or glycohemoglobin test. The connection between A1C and average blood sugar levels.† Your A1C test result will not show the daily effects of food choices and your activity. A blood glucose meter is the best way to observe and track the immediate effects of food choices and activity on your blood glucose levels. This allows you to take immediate action to bring your glucose levels within range if needed. Your doctor will also rely upon your blood glucose meter results to assess and adjust your treatment regimen. When to test and what to look for – a practical guide Use this simple chart to remind you when to test and what to observe to help you manage your blood glucose level on a daily basis. When to test What to look for First thing in the morning, before you eat How Continue reading >>

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 >>

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. Discover the world's research 14+ million members 100+ million publications 700k+ research projects Join for free Jea Continue reading >>

Diabetes Screening Comes Home With A1c Testing

BioIQ Offers Comprehensive Diabetes Screening Solutions for Individuals, Employers and Institutions. Santa Barbara, Calif. – July 28, 2009 – BioIQ is offering turn-key A1c screening programs to help people assess their risk for diabetes, a devastating disease that impacts tens of millions of Americans. BioIQ’s A1c test kits can be distributed at an employer wellness event or shipped directly to people’s homes for self-use. Click here for a complete guide to using A1c as part of a corporate wellness program that includes simple blood tests for diabetes and heart disease. Doctors at the American Diabetes Association’s 69th annual conference cited numerous advantages of the A1c test over plasma glucose measurement, including greater stability, accuracy, convenience, and correlation to the risk of developing retinopathy. The American Diabetes Association (ADA), the International Diabetes Federation (IDF), and the European Association for the Study of Diabetes (EASD) recently concurred that the A1c test can be effectively used for screening, diagnosing, and monitoring diabetes.1 According to Richard Kahn, Ph.D., Chief Scientific and Medical Officer of the American Diabetes Association, the A1c test can be conducted at any time of day without fasting. A1c values vary less than fasting plasma glucose (FPG) values and offer a picture of a patient’s average blood glucose level over the preceding two to three months. “The A1c level is a reliable indicator of diabetes, and can be monitored over time to gauge the effectiveness of patient treatment regiments,” Dr. Kahn said. BioIQ’s test kits enable employees and dependents to conduct diabetes tests themselves by supplying a few drops of blood to a home test kit and dropping it in the mail for processing by a certi Continue reading >>

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 >>

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 >>

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 >>