PTS DIAGNOSTICS A1CNow2

HbA1c Results in Minutes
Informed conversations at the point of care
 
Disposable after 10 tests
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)
 
Lab Quality Results at the Point of Care
The A1CNow®+ (HbA1c System) by PTS Diagnostics provides healthcare professionals with a fast and easy way of obtaining accurate HbA1c 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.
 
Certifications
National Glycohemoglobin Standardization Program certified
IFCC-traceable
FDA-cleared
CE-marked
 
The A1CNow (HbA1c) system is annually certified by the National Glycohemoglobin Standardization Program (NGSP). Having successfully completed rigorous testing requirements, the A1CNow+ system was awarded a Certification of Traceability to the Diabetes Control and Complications Trial (DCCT) Reference Method. This analyzer was designed to be as accurate as sending blood to a lab, allowing medical professionals to have informed conversations about how patients are managing their diabetes in minutes, not days.
 
What are the advantages of the A1CNow+ (HbA1c) test by PTS Diagnostics?
A1CNow+ is fast, easy, and accurate. It provides HbA1C results in 5 minutes which are 99% laboratory accurate*. These HbA1C 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 HbA1C testing in every exam room. Real-time HbA1C 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 HbA1C 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.
A1CNow+ Venous Comparative Testing
(NGSP-Certified method is the Tosoh A1C 2.2 Plus)
Venous blood was collected from 110 diabetic subjects, and each sample was tested on one of three different lots. Aliquots of the venous samples were also tested by the NGSP-certified method, providing comparative results. Data analysis again consisted of least squares linear regression (x = reference results), bias calculation, and Bland-Altman limits. The data are provided below.
The results showed that the accuracy with venous sampling was, on average, 99.7%. An individual result may differ by -0.8% A1C to +0.7% A1C from the true result. This represents the 95% confidence limits of the Bland-Altman plot. A1CNow+ may be used with either fingerstick (capillary) or venous (heparin-anticoagulated) whole blood samples.1
 
Reference
Professional product insert P/N 90821B.