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    Harmonization of Biological Testing Methodology: A Performance-Based Approach

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    The latitude provided in many written biological test methods, including ASTM standard practices, is such that different laboratories can produce widely varying test results on the same test materials while in technical compliance with the “method.” One obvious solution to this problem is to standardize upon more tightly controlled, less flexible testing procedures. This approach, while widely accepted in the field of chemistry, has been strongly resisted by the biological testing community. This paper presents an alternative approach to achieving comparability of testing data among laboratories while retaining a high degree of flexibility for the individual laboratory. The keys to this approach are (1) the development and routine use of standard reference materials for test system calibration and control, (2) the development of “reference standard methods” that are sufficiently controlled that responses of the test systems to known test materials are predictable and reproducible, and (3) participation in external performance evaluation programs. Recommendations for implementation of a performance-based method evaluation program are offered.


    aquatic biology, test methods, biological test methods, test method performance, method equivalency, method evaluation, standard methods, and reference materials

    Author Information:

    Williams, LR
    Research biologist, Environmental Monitoring Systems Laboratory, U.S. Environmental Protection Agency, Las Vegas, NV

    Committee/Subcommittee: E47.08

    DOI: 10.1520/STP33580S