Things you need to
know about A1c methods
The DTIL A1c
uses a unique and highly specialized multi-method laboratory
analysis (HPLC-IE/BA) to evaluate your A1c/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 A1c
value free of possible interferences including chemically
approach provides the most comprehensive evaluation of individual
hematology surrounding A1c as the most recent inference
of glycemic control by any laboratory or method available in the
A proper HbA1c
determination should include the evaluation of the individuals Red
Blood Cells at the time of HbA1c measurement. The
AccuBase A1c multi-method analysis does this and more.
Healthcare professional and patients alike should remember to:
"Treat the patient not just the A1c number"
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
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 A1c
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 A1c
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 A1c answer
and each sample should be screened for the presence of DEK.
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 A1c method
and/or disposable monitoring device has CV's (coefficient of
variation) greater than 2.0% or can not detect an abnormal
method and/or monitoring device with a CV of 7.0 % could mean
that if your actual HbA1c 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 A1c value that the
particular method or device is incapable of detecting.
Each AccuBase A1c
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
The graph below
(left) demonstrates a normal chromatogram with no hemoglobin
variants present and a normal A1c level.
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.