American Diabetes Association recommends use of A1c for as part of new medical practice standards for the diagnosis of diabetes.

The American Diabetes Association (ADA) announced that the A1c test is considered an important and effective tool in the diagnosis of diabetes. The A1c test represents an efficient/effective means to diagnose Diabetes Mellitus when analyzed by a moderately complex laboratory that uses a method that is free of various interferences (such as Hb S, C, D, E, F and other silent hemoglobin variants. Click the ABC News link below to view news coverage of this important health announcement.

http://abcnews.go.com:80/video/playerIndex?id=7769845

January 1st, 2010- American Diabetes Association (ADA) announced that Point of Care (POC)/CLIA Waived A1c instruments/devices can not be used to screen and/or diagnose diabetes. This includes the A1c Now/InView or A1c SelfCheck device.

Link below to ADA 2010 Medical Standards relating to A1c: http://care.diabetesjournals.org/content/33/Supplement_1/S11.full.pdf

Please note: Page S12 center paragraph and page S13 table for further details.

July 7th, 2010- The Food and Drug Administration (FDA)/CDRH announces that all A1c test manufacturers must re submit their 510 k for a new approval in order to be approved to screen and/or diagnose diabetes. Currently none of the  Point of Care devices are approved by the FDA to screen for diabetes. This includes: the A1c Now/InView, A1c SelfCheck device, or any instrument and/or doctors office A1c instrument. Only moderate complex labs that provide an interference free answer are approved.

Link below to FDA Announcement Letter to A1c manufacturers:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm218389.htm

A recent article from the Washington Post outlines the concern for diabetes screening. 

Link below:

http://www.washingtonpost.com/wp-dyn/content/article/2010/12/06/AR2010120607549.html?hpid=topnews

The ADA position states that only moderately complex laboratories that can provide screening and diagnosis.

If you are interested in providing appropriate diabetes screening, contact DTI Laboratories (DTIL) at 888.872.2443.   DTIL is one of the most highly respected diabetes testing laboratories in the U.S.. Recent article featuring DTIL in the International Journal of Clinical Chemistry and Diagnostic Laboratory Medicine. The labs CAP surveys consistently rank under 2.0% CV.

In order to properly diagnose diabetes according to the ADA/AACC and FDA, it is very important to know if your red blood cells (RBC's) are in a normal range as well as being aware of any abnormal hemoglobin's such as Hemoglobin S, C, F. and any of 850 others known silent variants known to interfere with A1c testing. The new test kit is the only test capable of identifying abnormal hemoglobin's as well as measuring Red Blood Cell disturbances.

Besides these factors, the true level of accuracy is vital to the diagnosis. Companies that claim 99% accuracy may not really be accurate. It really depends on their actual ranking by the College of American Pathologists Glycohemoglobin Survey.  You can view this list of potential A1c tests/devices by name and/or method at   For clinical http://www.ngsp.org/prog/CAPGH2.htm use, and accuracy of test results, test/methods under 2.5% should be a good choice. Tests/methods above this value should be avoided. In may cases, companies claiming 99% accuracy actually fail to achieve acceptable results according to CAP. While many tests are considered certified by the NGSP, they may perform poorly on the CAP survey. This ranking is the true measure of a tests accuracy.

DTI Laboratories, Inc, results for 2010 GH2 CAP Survey:

GH2-01 CAP Target 5.9%  

GH2-01 DTIL Result: 6.0%

GH2-02 CAP Target: 9.8%

GH2-02 DTIL Result: 9.9%

GH2-03 CAP Target: 7.4%

GH2-03 DTIL Result: 7.4%

If you are considering the use of a disposable A1c meter, you should view the article from the American Diabetes Association (Diabetes Care).  You should also be aware that devices like this have know interferences to abnormal hemoglobin such as Sickle cell trait, and have the highest imprecision of all methods tested by the College of American Pathologists.