MANASSAS, Va., Oct. 10 /PRNewswire/ -- In April 2005, nearly 4,000 proficiency test panels sent to clinical laboratories were recalled because they contained an influenza virus H2N2 subtype to which a large portion of the human population has no immunity. While the reasons for its inclusion in the panels are complex, the H2N2 virus posed significant public health risks had the test panels been mishandled by laboratory technicians.
The H2N2 recall illustrates the importance of using traceable and properly characterized microorganisms in proficiency panels in response to these critical health system risks. ATCC(R) (American Type Culture Collection) has developed the Proficiency Testing Standards Program to provide authenticated bioreagents for use in the manufacture of laboratory proficiency test panels.
"The public health ramifications of the H2N2 scare prompted ATCC to find a way to offer to the proficiency testing system its expertise in handling, storing, authenticating and distributing microorganisms," said Joseph Perrone, ATCC Vice President for Standards & Certification. "Laboratory personnel are not properly informed about the microbes they are handling in proficiency panels and therefore cannot know the full safety implications. Laboratory directors and technicians should always ask themselves, 'Where do my test panel's microbes come from?'"
Under current practices, microorganisms in proficiency panels are often subjected to excessive subculturing, have unknown pedigrees, and are misidentified, contaminated or stored under variable conditions. These factors can degrade the quality of the proficiency testing system or expose lab personnel to undue hazards.
The program improves the current situation in four ways. First, ATCC will work with proficiency test providers and manufacturers to select strains for the panels prior to manufacture, ensuring that microorganisms are vetted for appropriate biosafety level before they are sold. Second, the program prevents contamination and misidentification by testing the sample microbes' authenticity. Third, to improve year-to-year consistency, manufacturers will acquire new strains each year and destroy remaining material when panel assembly is complete. Fourth, serial numbers on each vial allows microbes to be traced individually.
"The ATCC Proficiency Standards Program will improve the validity and safety of proficiency testing by using characterized reference microbes in test panels," said Perrone, adding, "Authenticated microorganisms bring consistency to the tests and allow results to be meaningfully compared among a group of laboratories." These features are absent if such reference material is not available for the panels and clinical isolates are used instead.
The ATCC Proficiency Standards Program is now available to proficiency test providers and manufacturers throughout the United States. For more information, please visit the standards page at http://www.atcc.org or email standards@atcc.org.
About ATCC
Since 1925, ATCC has set the standard for authentication and distribution of biological reference materials for life science research in the public and private sector. ATCC's mission is to acquire, authenticate, preserve, develop, and distribute biological materials, information, technology, intellectual property, and standards for the advancement, validation, and application of scientific knowledge.
ATCCCONTACT: Leslie Valenza, Media Liaison, +1-202-973-1320, orlvalenza@levick.com, for ATCC
Web site: http://www.atcc.org/
