A1CNow+ System

A1CNow®+

 

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.  

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
  • Available in multiple test count configurations
  • No maintenance
  • Available with IFCC (mmol/mol)
The A1CNow+ system has demonstrated accuracy equivalent to clinical laboratory analyzers.

References
1. Summary of 2017 Evaluations Comparing the A1CNow+ System to Clinical Lab Analyzers. Data on file.
2. http://www.ngsp.org/bground.asp

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A Valuable Resource in a Value-Based World

Value-based medicine is a new healthcare model to shift physician focus from the quantity of services and revenue generated to the quality and value of healthcare provided. Point-of-care A1C testing can maximize patient and provider engagement by obtaining results in real-time which allows for effective communication, healthy discussion and improved healthcare.

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Controls

Although PTS Diagnostics does not currently manufacture A1CNow control solution, there are several A1C control solution options on the market that can be used with the A1CNow+ System.  The following links will take users to websites where control solutions for the A1CNow+ system may be purchased: 

Bio-Rad

Reference Numbers: 

  • 740
  • 740x
  • 171
  • 172
  • 172x
  • 173

  • Thermo Scientific

    Reference Number:

  • DBCL-MP

  • Nova-One-Diagnostics

    Reference Numbers:

  • NOD13111-100
  • NOD13122-100

  • Nova-One Diagnostics Control Instructions for A1CNow System

    NGSP Information

    NGSP to IFCC Conversion Chart

    Results Labels

    A1CNow Results Labels

    Proficiency Testing 

    PTS Diagnostics Proficiency Testing Overview & FAQ

    Customer Notification: Proficiency Testing 2018

    Control Log

    A1CNow System Control Log

    What are the advantages of the A1CNow+ test by PTS Diagnostics?

    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 and certified by the National Glycohemoglobin Standardization Program (NGSP).

    * 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.1

    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.2

    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.3