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
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.
Guidelines for A1c testing in patients with diabetes
The goal of therapy is to achieve an A1c as close to the non-diabetic range as possible without severe hypoglycemia
3. IDF, http://www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf
- American Diabetes Association. Executive Summary: Standards of Medical Care in Diabetes-2009. Diabetes Care, 32 (S1) 2009, pp. S6-S7.
DCCT A1c levels and the risk of complications in type 1 diabetes
Adapted from DCCT. Diabetes 1995;44:968-43.
Therefore, any improvement in A1c levels is likely to reduce the risk of diabetic complications. 
Lowering A1c levels reduces the risk of diabetes complications in people with type 2 diabetes
UKPDS: 21% risk reduction per 1% absolute decrease in A1c levels (p<0.0001)
Slide from: http://www.dtu.ox.ac.uk/generic/slides.php
- DCCT. Diabetes 1995;44:968–83.
- UKPDS 35. BMJ 2000;321:405–12.
The Guidelines and Treatment Algorithm emphasize[1,2]
- Importance of achieving and maintaining normal glycemic goals
- Initial therapy with lifestyle modifications and metformin
- Rapid addition of medication and transition to new regimens when glycemic goals are not achieved or sustained
- Early addition of insulin therapy in patients who do not meet glycemic goals.
- The guidelines acknowledge the important role of SMBG, particularly to help achieve glycemic goals with the latter two treatment regimens
Lifestyle intervention and metformin
b Although three oral agents can be used, initiation and intensification of insulin therapy is preferred based on effectiveness and expense.
c See algorithm for initiation and adjustment of insulin.
Nathan D, et al. Diabetes Care 2006;29:1963–72. Reproduced with permission.
- Nathan et. al. "Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for Initiation and Adjustment to Therapy", Diabetes Care 2006, 29 (8), pp. 1963-1973.
- Inzucchi Ctal "Management of Hyperglycemia in Type 2 Diabetes: A Patient Centered Approach", Diabetes Care 2012, 35: 1364-1379
To convert (mmol/mol) A1c units (IFCC traceable) to (%)A1c (DCCT traceable) use the following equation(%A1c=(0.09148*A1c mmol/mol) + 2.152 .
- Nathan, DM, Kuenen, Borg, R, Zheng, H, Schoenfeld, D, Heine, RJ. "Translating the A1C Assay Into Estimated Average Glucose Values" Diabetes Care Volume 32 (8), August 2008.
- NGSP Website: http://www.ngsp.org/ifcc.asp
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English (NGSP -%A1C)
Spanish & Portuguese (NGSP - %A1C)
English (UK), German, French & Italian (NGSP - %A1C)
Dutch, Spanish, Portuguese & Polish (NGSP - %A1C)
English & French (Canadian) (NGSP - %A1C)
English, German, French & Italian (IFCC - mmol/mol)
Dutch, Spanish, Portuguese & Polish (IFCC - mmol/mol)
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While PTS Diagnostics does not manufacture A1CNow control solution, there are several manufactures of A1C Control solution that can be used with the A1CNow+ Systems. The following link will take users to Nova-One Diagnostics website where control solutions for the A1CNow+ system may be purchased
Nova-One Diagnostics Control Instructions for A1CNow System
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A1CNow+ is fast, easy, and accurate. It provides A1c results in 5 minutes which are 99% laboratory accurate*. These A1c tests are for use in a doctor's office. Providing real-time results outside of the laboratory, A1CNow+ is a hand-held, portable monitor which allows A1c testing in every exam room. Real-time A1c results allow for timely decisions on therapy changes when needed. The product requires no maintenance. Office staff no longer have to prepare and refrigerate lab samples. Obtaining A1c results during the patient office visit eliminates follow-up phone calls to discuss results and possible therapeutic changes. Our A1CNow® System is CLIA waived.
* 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.
How does the A1CNow+ test work?
The single-use test provides quantitative results from a single drop of blood. Lance the finger for an adequate drop of blood. Touch the blood drop with the tip of the blood collector. Insert the blood collector into the open end of the sampler body and shake. Insert the cartridge into the A1CNow+ monitor. Deliver the sampler body into the cartridge. Your result will display after 5 minutes. Results are 99% laboratory accurate*.
*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.
What is the National Glycohemoglobin Standardization Program (NGSP)?
The NGSP standardizes glycated hemoglobin test results so that clinical laboratory results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established. A key component of the program is the Reference Laboratory Network. The network interacts with manufacturers of glycohemoglobin methods to assist them first in standardizing their methods and then in providing comparison data for certification of traceability to the DCCT.
What is the Clinical Laboratory Improvements Amendment (CLIA)?
Clinical Laboratory Improvements Amendment (CLIA) is an act of Congress that established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. 
What does CLIA waived mean?
A CLIA waived test has been reviewed by the Food & Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS). It is defined as simple laboratory examinations and procedures that are cleared by the FDA for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
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