AccuBase A1c
Test Kit
FDA approved for
over-the-counter (OTC) use
Things you need to know about A1c methods
and/or
devices......
The
AccuBase A1c Test
uses a unique and highly specialized
multi-method
laboratory analysis
(HPLC-IE/BA)
to evaluate your HbA1c/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 modified derivatives.
This
multi-method 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 U.S.
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"
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 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 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 A1c 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 A1c method and/or disposable monitoring device has CV's (coefficient of variation) greater
than 2.0% or can not detect an abnormal hemoglobin"
"An
HbA1c 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 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.
