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A1c Test Kit

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

Assessment Of Stability Of Mail-in Capillary Hemoglobin A1c Test Kit

Assessment Of Stability Of Mail-in Capillary Hemoglobin A1c Test Kit

The purpose of this study is to determine the stability of capillary HBA1c blood samples collected by the participant with this kit and mailed to the laboratory at Children's Mercy Hospital. Participants are given home lab kit for obtaining HbA1c by capillary blood and shipping it to Children's Mercy Hospital and Clinics. They will mail in sample before their next visit and this result will be compared to the HbA1c performed during this visit. Study Type : Observational Actual Enrollment : 23 participants Observational Model: Case-Only Time Perspective: Prospective Official Title: Assessment of Stability and Ease of Use of a Mail-in Capillary Blood Hemoglobin A!c Sample Kit Study Start Date : July 2007 Primary Completion Date : January 2008 Study Completion Date : January 2008 Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Ages Eligible for Study: 1 Year to 17 Years (Child) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Male or female diabetic patients ages 1-17 years who have an A1c test drawn within 24 hours Participants receiving medical care in the Endocrine Clinic at Children's Mercy Hospital Exclusion Criteria: Not meeting above inclusion criteria Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTria Continue reading >>

What Is A1c

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 >>

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 >>

Accubase A1c Test Kit

Accubase A1c Test Kit

The AccuBase A1C Test Kit is a non-fasting method to check for abnormal homoglobins. The test reports an A1C answer and calculates average Glucose in mg/dl units. You simply stick your finger, take the test and mail it in. The entire process is streamlined, fast and accurate. Most doctors recommend people with diabetes test their AIC at least four times a year. It is important to check how your blood sugar is being controlled over an extended period of time. Balanced blood sugar falls within a healthy range, which is the goal of all people with diabetes. If your blood sugar is high, there are steps to take to lower it. Knowing when to lower your blood sugar helps minimize your risk of developing diabetes-related health problems in the future. Your doctor will give you a target A1C. The AccuBase A1C Test Kit monitors the average concentration of glucose in your blood for the past sixty to ninety days. The A1C at home test kit is FDA/OTC approved with no prescription required. Just stick your finger to take a sample then mail it to a CAP participating, CLIA certified diabetes specialty lab. Samples remain stable for 30 days and are sent right away by standard first class mail. Lab results come in within 24 hours of receipt of your sample. The lab reports can be emailed as a PDF file, faxed or mailed. Each AccuBase A1C Test Kit contains instructions for use so you feel confident you’re doing it right. The A1C at home test kit includes a disposable lancet, capillary tube with holder, lab ID form, sample preservative vial, insulator tube, bio-hazard bag and a convenient pre-addressed, postage paid sample mailer. Get accurate information about your blood sugar, when you need it, with the AccuBase A1C Test Kit. Continue reading >>

How To Use An A1c Test Kit

How To Use An A1c Test Kit

Keeping your blood sugar level under control is a key to effectively manage diabetes and prevent serious health problems. It’s crucial to check your blood sugar several times a day and monitor your A1c level periodically. View on healtheo360 What is A1c? An A1c test measures the average blood glucose level over the past 2-3 months. It indicates how well a patient is managing his or her blood sugar level over a period of time. It shows the short-term outcome of certain changes in your diabetes treatment plan. A1c tests are also used to diagnose diabetes before any noticeable symptoms appear. How does an A1c test work? The A1c test measures the percentage of glycated (sugar-coated) hemoglobin, the protein in red blood cells that carries oxygen. The higher the A1c level, the higher the blood glucose level and higher risk of complications. How is an A1c test performed? A doctor or other medical professionals usually administer your A1c test. For patients with diabetes, it is advised to take an A1c test at least every six months. Understanding the numbers For someone without diabetes, the A1c level is normally 5.7% or less. For patients with diabetes, A1c level is usually 6.5% or above. American Diabetes Association recommends an A1c target of 7% or less to reduce the risk of complications caused by diabetes. Difference between a physician-administered A1c test and a home A1c test kit Convenience Diabetes specialists or general practitioners normally take an A1c test every three to six months. For some patients, it’s a long time to wait to see how they’re managing their blood sugar level for the past few months. Over-the-counter A1c test kit could be a good alternative to check your A1c level in between doctor visits and help you to stay on top your diabetes management 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 >>

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 >>

Testing Your Blood Glucose

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 >>

A1c Test Kit

A1c Test Kit

The AccuBase A1c Test Kit is a non-fasting, finger stick, whole blood mail-in test. It is considered a very accurate and comprehensive. This is not a Dried Blood Spot (DBS) test. DBS mail-in tests are know to have temperature, humidity and application problems. The AccuBase test is considered sensitive and specific enough to detect or screen for diabetes. The American Diabetes Association (ADA) recommends that A1c samples be screened for abnormal hemoglobins as part of the screening and/or diagnosing process. The AccuBase A1c Test is the only A1c test that screens for abnormal hemoglobins using HPLC-IE. Abnormal hemoglobins are know to cause interferences in A1c testing. DBS mail-in A1c tests are incapable of detecting abnormal hemoglobins. DTIL has participated in the College of American Pathology (CAP) GH2 surveys for over 15 years. The AccuBase A1c Test Kit does not require any drying time, samples can be collected and mailed within minutes. The kit comes complete with positive patient ID, EDTA sample vial (preserves the sample) and capillary tube device for ease of accurate sample collection. Our analytical method uses the Bio-Rad D-10 method which is approved for diabetes screening and is NGSP certified. Samples are stable for 21 day un-refrigerated once collected. Each test result comes with an estimated Average Glucose (eAG) calculation based on the DCCT Equation: % A1c X 28.7 - 46.7 = eAG in mg/dl. Test results are typically available within 5 to 7 days form mailing. Rapid turnaround can be arranged to provide, next-day, second-day or three day results. Ideal for confidential diabetes screening, DTIL also provides kits that are 100% HIPAA compliant for outreach programs and clinical trails. Kits are available in either English or Spanish and can be private label 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 >>

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 >>

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 >>

Diabetes Screening Comes Home With A1c Testing

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 >>

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 >>

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