HbA1c-direct™ from Carolina Liquid Chemistries® Receives NGSP Certification

9 Jul 2014
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Carolina Liquid Chemistries Corp. (CLC) announced today that its new Hemoglobin A1c (HbA1c) test, used on the CLC720™ chemistry analyzer received certification by the National Glycohemoglobin Standardization Program (NGSP). “Our test correlates to the NGSP certified tests used in large-scale diabetes studies,” says CLC Chief Operating Officer Patricia Shugart. “Physicians can now relate their HbA1c results to these studies, providing more relevance.”

“There are other HbA1c tests on the market,” says Patricia Shugart, “but our HbA1c-direct™ is special in two ways. First, it’s a direct test, meaning there is no manual sample pre-treatment. Second, it’s categorized as moderately complex, which avoids the extra cost of a high complexity lab.” The speed and ease of HbA1c-direct™ is made possible by the company’s CLC720™ chemistry analyzer which, unlike most analyzers in its class, automates the lysing step that would otherwise have to be performed manually.

Simple blood glucose tests only measure blood sugar levels at a single point in time. However, HbA1c levels give physicians an indication of average blood glucose levels over the preceeding four to eight weeks. In this way, measuring HbA1c can provide a better indicator of a patient’s glucose control over time.

Diabetes has a significant impact on healthcare costs in the United States. According to the U.S. National Institutes of Health, 25.8 million Americans have diabetes, comprising 8.3% of the total U.S. population. The NGSP notes that diabetes treatment accounts for approximately 20% of all health care spending. According to WebMD.com, people with diabetes should have a HbA1c test every three months.

Carolina Liquid Chemistries Corp. is an ISO certified and FDA regulated repackager/relabeler of chemistry systems. The company specializes in innovative reagent technologies, taking inefficient, complex tests and developing user-friendly applications on clinical chemistry analyzers. As a result, these tests can be performed in physicians’ offices. Carolina Liquid Chemistries offers a broad range of chemistry analyzers, from moderate throughput bench top analyzers to ultra high speed floor models, along with the reagents and service to support the instrumentation.


Image Caption: The new Hemoglobin A1c (HbA1c) test is run on the CLC720™ chemistry analyzer

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.HBA1C
HbA1c-direct™ from Carolina Liquid Chemistries® Receives NGSP Certification