The comprehensive initiative conducted by AOAC INTERNATIONAL (formerly the Association of Official Analytical Chemists) and funded by the Department of Homeland Security (DHS) and Department of Defense began in June 2003. Its purpose was to identify reliable analytical methods to enable security, defense, and other federal agencies to make science-based decisions in the event of biological attacks. Additionally, first responders, public health agencies, defense, and security needed validated field-usable methods for detecting agents.
"AOAC has taken the lead in the evaluation and validation of detection methods for biological and chemical threat agents," said James Bradford, PhD, the executive director of AOAC INTERNATIONAL.
This DHS-sponsored project has established an infrastructure to support the development of standards and evaluation of biological and/or chemical threat agent detectors. AOAC INTERNATIONAL and DHS are working jointly to determine which detectors and methods for other chemical and biological agents should be evaluated next.
"The cooperation of many federal agencies, the biodetector industry, the academic and the first responder communities -- all working in concert with AOAC -- was critical in executing this project," said Dr. Bradford.
At this stage, AOAC has just awarded Official MethodsSM status to two methods for use in the laboratory - RAMP Anthrax Test Cartridge by the Response Biomedical Corporation of Canada and MIDI Sherlock Microbial Identification System of Newark, Delaware. Previously, in February 2004, AOAC had granted Official Methods of AnalysisSM status to a confirmation procedure used by the Centers for Disease Control and Prevention (CDC) and the Laboratory Response Network (LRN).
The RAMP test was one of five hand-held assays that underwent an exhaustive AOAC collaborative study in 12 different laboratories. As a rapid screening method, The RAMP test was found to be reliable in detecting anthrax spores at levels of 1 million or more in visible powders. Field-testing studies, still in the planning stage, will determine if any operational parameters related to the use of the RAMP Anthrax Test Cartridge in the field would affect the analytical performance of the assay.
In studies designed by AOAC scientists and implemented at U.S. Army Dugway Proving Grounds in Utah, the RAMP was demonstrated to reliably detect Bacillus anthracis isolates representing a wide variety of geographic sources and physical variants. The specificity of the RAMP was also demonstrated in evaluations to confirm that it would not cross react with non-Bacillus anthracis bacteria. To judge the accuracy of the data generated, AOAC organized 12 laboratories nationwide to assess the RAMP's performance using identical samples. The RAMP test performed well in the collaborative study, and little variation was seen in the data produced by the 12 laboratories.
The second method approved in November by AOAC is a laboratory-only method, commonly referred to as MIDI Sherlock Microbial Identification System, which includes the MIDI BIOTER database version 2.0. The MIDI method was subjected to exhaustive testing of many strains of B. anthracis and of related strains to determine its ability to differentiate among them. The 11 laboratories involved in the study reported an acceptable overall sensitivity for B. anthracis identification of 96.3 percent.
The AOAC INTERNATIONAL has specialized in the validation of methods of analysis for over 120 years. The Association has long-standing relationships with the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, many other federal and state organizations, including now the U.S. Department of Homeland Security, and is best known for its collaborative efforts by volunteer experts that produce standards called AOAC INTERNATIONAL Official Methods of AnalysisSM. The AOAC Research Institute is an AOAC subsidiary created in 1992 to provide conformity assessment services of test kits (hand-held assays). Test kits approved by the AOAC Research Institute are granted Performance-Tested MethodsSM status and are reviewed each year to ascertain continued good standing (see www.aoac.org/testkits/testedmethods.html for test kits in good standing).
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.