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            Diabetes Specialty Reference Testing Laboratory

DTI Laboratories, Inc., (DTIL) Is a nationally recognized CLIA certified National Reference Laboratory specializing in diabetes and related diagnostic evaluation such as glycated proteins (A1c and/or GHb). DTIL offers the most comprehensive approach available from any reference laboratory in the U.S. relating to the analysis of A1c and/or Total Glycated Hemoglobin (GHb). DTIL has been recognized as the "best practices" in the reporting of hemoglobin A1c out of the top seven reference laboratories in the U.S according to the International Journal of Clinical Chemistry and Diagnostic Laboratory Medicine (see lab review button at bottom of key selection).

DTIL is a leading reference laboratory for Human and Animal studies including diabetes and pre-diabetes screening, routine A1c diabetes monitoring, detection of hemoglobinopathies, clinical and research studies in mice, rats and primates.

The laboratory currently supports on-going clinical/research studies relating to diabetes and metabolic syndrome studies in large and small pharmaceutical companies, universities, cancer institutes as well as many wellness and diabetes screening companies.

Besides our specialty in glycated hemoglobin (A1c and GHb) the laboratory is fully certified to analyze any clinical analyte that we choose to perform. The company specializes in mail-in testing of several analytical Bio-Metric tests.

DTIL is also nationally certified to provide on-site diagnostic wellness screening and is actively involved in such health/diabetes/anemia screening and health assessment programs as Head Start and corporate wellness programs.

The DTIL focus has continued to be focused on diabetes and it related potential complications such as kidney, eye, cardiovascular and nerve disease which includes loss of protective sensation in the foot. We offer a 5.07/10gram level monofilament that is FDA approved. 

Understanding the significance of smoking and complications associated with smoking and diabetes the laboratory is now offering Cotinine testing to detect tobacco and second hand smoke exposure. 

If you are interested in any number of analytical tests available from DTIL simply contact us at 888.872.2443. DTIL also offers private label A1c/GHb testing kits at very affordable prices.

 

Things you need to know about A1c methods

and/or devices......

The DTIL A1c Test 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 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.

Text Box: Increased levels of Hemoglobin F may represent an increased risk for SIDS in infants, and may represent as association in various types of leukemia and/or solid tumors. Mothers that smoke or have been exposed to environmental pollution during pregnancy may have a much higher level of       Hb F in the baby which may increase the risk of SIDS in the newborn.

          

The AccuBase A1c Test Kit has several unique advantages, call us for further details...

888.872.2443