AccuBase A_1c Test Kit

FDA approved for over-the-counter (OTC) use

Things you need to know about A1c methods

and/or devices......

The AccuBase A_1c Test uses a unique and highly specialized multi-method laboratory analysis           (HPLC-IE/BA) to evaluate your HbA_1c/eAG level. The two (2) step process includes a screening step to detect hemoglobin variants and/or disturbed erythrocyte kinetics (DEK) by HPLC-Ion Exchange (IE). The second step includes the use of an interference -free procedure HPLC-Boronate Affinity (BA),   that provides an A_1c value free of possible  interferences including chemically modified derivatives.

This multi-method approach provides the most comprehensive evaluation of individual hematology surrounding A_1c as the most recent inference of glycemic control by any laboratory or method available in the U.S.

A proper HbA_1c determination should include the evaluation of the individuals Red Blood Cells at the time of HbA_1c measurement. The AccuBase A_1c multi-method analysis does this and more.  Healthcare professional and patients alike should remember to:

"Treat the patient not just the A_1c number"

Treating the patient includes evaluating red blood cells and screening for any possible          hemoglobin variants. The linearity of the AccuBase A1c Test is from 3.0 - 30.0%. The AccuBase A1c Test was recently named "best medical practices"  by the Journal of International Clinical Chemistry and Laboratory Diagnostic Medicine.

Method linearity is an important aspect of A1c method and/or device.  Most dried blood spot (DBS) technologies, have linearity limits between 5.0% and 11.0% considered a "medical error". In addition many if not all of the DBS A1c kits also have serious humidity and temperature stability problems once the blood sample is applied to the paper. You should always demand to see the temperature and humidity studies that was or should have been submitted to the FDA (or should we say that was not submitted to the FDA). Another issue with DBS technology is the fact that the sample continues to glycate once the sample is applied to the filter paper. High temperatures and humidity all have serious effects in obtaining the correct A1c answer.

The AccuBase A_1c Test Kit is a highly accurate test (CV's < 1.0%) capable of detecting abnormal and/or silent hemoglobin variants such as hemoglobin S, and C and F and over 850 others.  Each sample is first screened for presence of abnormal hemoglobins and/or disturbed erythrocyte kinetics (abnormal age or volume of red blood cells) Example; anemia (which can falsely lower the A_1c value).

Individuals with long-standing diabetes may present with a condition called erythropoietin (EPO) deficiency.  EPO deficiency and/or anemia are considered serious conditions requiring appropriate medical intervention. DEK can adversely affect the A_1c answer and each sample should be screened for the presence of DEK.

Estimates report that over 650,000 Black Americans with diabetes are know to have the Sickle Cell Trait (Hb "S,  C or F") 

"Don't be fooled by claims of accuracy when an A_1c method and/or disposable monitoring device has CV's (coefficient of variation) greater than 2.0% or can not detect an abnormal hemoglobin"

"An  HbA_1c method and/or monitoring device with a CV of 7.0 %  could mean that if your actual HbA_1c level was 6.5% it could be reported anywhere from 5.0% to 8.0% providing false and/or misleading therapeutic information," not to mention the impact of an abnormal hemoglobin on the    A_1c value that the particular method or device is incapable of detecting.

Each AccuBase A_1c sample is analyzed by an HPLC-IE procedure with resulting printed  chromatogram as shown below. Our laboratory staff is available to discuss individual chromatograms with your physician and/or medical personnel.

The graph below (left) demonstrates a normal chromatogram with no hemoglobin variants present  and a normal A1c level.

The Chromatogram to the (right) demonstrates an highly elevated level of hemoglobin F (25.6%).   This elevated level of  Hb F resulted in a sub-normal HbA1c value  of 3.2%.  Normal range of HbA1c assay (4.2% - 6.0%).

Unless you have been screened for hemoglobin variants you would not know you carry the hereditary persistent variant, or be aware of its associated impact on your HbA1c level.

The AccuBase A_1c Test Kit has several unique advantages, call us for further details...

888.872.2443

When Accuracy Counts, Count on the AccuBase A_1c Test Kit