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ment program for diagnostic testing of laboratory animals. A comprehensive program such as this currently does not exist in this country.

The following institutions and companies are presently involved in initiating this effort: Anmed Biosafe, Inc.; Bioreliance; Charles River Laboratories; Harlan Sprague Dawley, Inc.; The National Cancer Institute; and our laboratory at the University of Missouri. This group is not intended to be exclusive. It simply represents institutions and companies that operate research animal diagnostic laboratories and are committed to high-quality testing of laboratory animals.

This group has met on several occasions to set goals, establish priorities, and begin to organize the framework for a comprehensive performance assessment program. The goal of the program is to develop a comprehensive performance assessment program that will distribute unknown specimens to participating diagnostic laboratories for testing. Testing results will then be collected and analyzed by an unbiased external third party. Finally, the testing laboratories will be apprised of expected results for each specimen distributed.

If testing laboratories correctly identify a microbial contaminant or infection, the laboratory is provided additional validation of its testing reagents and methods. If test results do not match expected results, the laboratory is alerted to the problem and can modify its testing procedures.

Several fundamental principles will be emphasized in this program.

  1. The program will be comprehensive and will assess all types of diagnostic test methods including serology, bacteriology, molecular techniques such as polymerase chain reaction-based diagnostics, parasitology, histopathology, and new test modalities as they become available.

  2. Specimens distributed to participating laboratories will be well defined and will be made by experimental infection of rodents with well-characterized microorganisms. Alternatively, specimens may be collected from natural outbreak infections and documented extensively to identify the causative agent. Methods for documentation will include testing by a battery of sensitive and specific tests. For example, serum collected from an outbreak of natural infection will be tested by multiple serologic assays, including enzyme-linked immunosorbent assay, immunofluorescent assay, hemagglutination inhibition assay if appropriate, and Western blot analysis. Only if results of all tests are consistent for a specific etiologic agent or disease will the specimen be distributed to laboratories participating in the PAP.

  3. Distributed specimens will be relevant to infections found in laboratory animals, thus allowing diagnostic laboratories to focus attention on types of microbial infections that they are likely to encounter in laboratory animals. Infectious agents that are currently the most prevalent in laboratory animals will be emphasized. As new emerging agents are identified and diagnostic tests are developed, we anticipate including specimens that will test the ability of diagnostic laboratories to detect these newly recognized agents and infections.



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