ADA Recommends A1C as Diagnostic Test for Diabetes
The American Diabetes Association‘s new Clinical Practice Recommendations being published as a supplement to the January issue of Diabetes Care call for the addition of the A1C test as a means of diagnosing diabetes and identifying pre-diabetes. “We believe that use of the A1C, because it doesn’t require fasting, will encourage more people to get tested for type 2 diabetes and help further reduce the number of people who are undiagnosed but living with this chronic and potentially life-threatening disease. Additionally, early detection can make an enormous difference in a person’s quality of life,” said Richard M. Bergenstal, MD, president-elect, medicine & science, American Diabetes Association.
A1C is measured in terms of percentages. The test measures average blood glucose levels over a period of up to 3 months and previously had been used only to determine how well people were maintaining control of their diabetes over time. Under the new recommendations, which are revised every year to reflect the most current available scientific research, an A1C of 5.7% to 6.4% would indicate that blood glucose levels were in the prediabetic range, meaning higher than normal but not yet high enough for a diagnosis of diabetes, which would occur once levels rose to an A1C of 6.5% or higher. To obtain a copy of the “Standards of Medical Care in Diabetes”, contact .
Source: American Diabetes Association
Axis-Shield and Bio-Rad Launch New Anti-CCP Test for BioPlex 2200 System
Bio-Rad Laboratories and and Axis-Shield, an international invitro diagnostics (IVD) company, announced the launch of Bio-Rad’s BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis.
The assay, which will run on Bio-Rad’s BioPlex® 2200 system, measures anti-cyclic citrullinated peptide antibodies (anti-CCP), a novel marker that has been shown to have superior specificity in the diagnosis of rheumatoid arthritis. The BioPlex 2200 Anti-CCP kit is based on Axis-Shield’s proprietary anti-CCP technology. The assay is available for sale in certain countries outside the United States.
“The anti-CCP testing market is one of the fastest-growing markets in autoimmune diagnostics,” said John Goetz, Bio-Rad vice president and group manager of clinical diagnostics. “The addition of this assay will add significantly to our growing menu of autoimmune tests on the BioPlex 2200 system.”
Source: Bio-Rad and Axis-Shield
CLSI Publishes Validation of Automated Systems for Immunohematological Testing
Clinical and Laboratory Standards Institute (CLSI) recently published “Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline” (I/LA33-A). This document provides guidance to laboratory personnel for validating an automated system for immunohematological testing before implementation.
Katharine Appleton Downes, MD, chairholder of the committee that developed the document, says, “I/LA33-A is beneficial to the laboratory because it is comprehensive in design and was developed based on input from a variety of stakeholders. It includes the key elements and tasks of the validation process, including installation qualification, operational qualification, and performance qualification. The appendix is especially practical because it contains easy-to-use templates for the laboratory to apply to meet its needs for data gathering, statistical calculations, and testing of materials.”
Source: CLSI
Wisconsin Researchers Develop Rapid Flu Test
Researchers from the Medical College of Wisconsin, the Children’s Research Institute, and the Children’s Hospital of Wisconsin have developed a rapid, automated system to differentiate strains of influenza.
The report by Beck et al, “Development of a Rapid Automated Influenza A, Influenza B, and RSV A/B Multiplex Real-Time RT-PCR Assay and Its Use During the 2009 H1N1 Swine-Origin Influenza Virus (S-OIV) epidemic in Milwaukee, Wisconsin,” appears in the January 2010 issue of the Journal of Molecular Diagnostics.
A group led by Kelly J. Henrickson, MD, of the Medical College of Wisconsin have developed rapid semi- and fully-automated multiplex real-time RT-PCR assays to detect influenza A, influenza B, and respiratory syncytial virus (RSV). These assays can successfully detect human H1N1, H3N2, and swine-origin H1N1 viruses as well as distinguish these from influenza B and RSV infections. These assays could test large numbers of samples over a very short time, allowing for a significant decrease in both technician and assay time. Beck et al suggest that “this outbreak demonstrates the importance of having rapid, reliable, sensitive, and specific assays that allow clinicians and public health officials to react quickly and effectively during viral outbreaks.”
Source: American Journal of Pathology
Bio-Rad Purchases Certain Biotest AG Diagnostics Businesses
Bio-Rad Laboratories Inc has completed the purchase of certain diagnostics businesses of Biotest AG, including its diagnostics products in the areas of blood transfusion testing, transplantation, and infectious diseases for 45 million euros. Bio-Rad signed a definitive agreement to acquire these diagnostics businesses of Biotest on October 23, 2009.
“We are pleased with the opportunity to expand our product offering in the area of immunohematology,” said Norman Schwartz, Bio-Rad president and CEO. “Integrating Biotest diagnostics products into our current offering will further strengthen Bio-Rad’s position in this area and enable us to provide our customers, including those in the US, with a broader range of products and services.”
Source: Bio-Rad
Cepheid Gets FDA Emergency Approval for H1N1 Assay
Cepheid has been granted Emergency Use Authorization (EUA) from the FDA for its Xpert® Flu A Panel test. The test, which runs on Cepheid’s GeneXpert® System, identifies the 2009 H1N1 influenza virus in less than 1 hour. The FDA has authorized Cepheid’s Xpert Flu A Panel to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform “moderate complexity” (not waived) testing, enabling the test to be performed in hospital near-patient settings.
“Accuracy combined with ease-of-use and the broad testing applicability of the GeneXpert® System offers a helpful unique diagnostic solution in helping to address this healthcare issue,” said John Bishop, Cepheid’s CEO. “Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock. Xpert Flu A Panel combines the convenience and ease-of-use of rapid testing with the performance of PCR, in a test format that maximizes medical value by providing results when they are most needed.
Source: Cepheid
