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Microbial Status and Genetic Evaluation of Mice and Rats: Proceedings of the 1999 US/Japan Conference (2000)
Institute for Laboratory Animal Research (ILAR)

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. "Factors Causing Difficulties in Uniformity of Results Among Testing Facilities in Microbiologic Monitoring of Laboratory Animals." Microbial Status and Genetic Evaluation of Mice and Rats: Proceedings of the 1999 US/Japan Conference. Washington, DC: The National Academies Press, 2000.

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Microbial Status and Genetic Evaluation of Mice and Rats: PROCEEDINGS OF THE 1999 US/JAPAN CONFERENCE

antibody positive. All animal experiments were immediately stopped and the animals destroyed. Later we were asked to test the samples, and the results were negative. Testing was performed using basically the same method except for a slight modification to inhibit nonspecific reactions; however, the results were different.

The results in the testing facility of the university were considered positive at an antibody titer of 1:16. They took the position of stating only that there was a positive reaction and deferring to the client to decide whether there was an infection, even though they were experts in this field. When we obtained results showing that antibody titers were in the 1:20 to 1:100 range (so-called low antibody titer) in the IFA test, we reported these results to the client while continuing the testing process. Inasmuch as there was little possibility of real infection, we collected blood samples after 1 week for retesting because generally in contaminated facilities, both the prevalence and antibody titer increase when retesting is performed. We have performed Hantavirus antibody tests on several thousand samples a year and have found only about 10 samples showing such low antibody titers. However, these samples were all found to be negative using immunoblot analysis.

The discrepancy between our test results and those of the university appeared to be caused by differences in the basic position of the testing facility when submitting the test results to the client. There are two different positions: One is simply to hand over the test results, and the other is to consider countermeasures after obtaining the results and assuring highly accurate test results. We naturally take the latter position.

CONCLUSION

The reasons for discrepancies in culture results include difficulty in accurate identification of isolates and differences in sample collection sites and tests for identification of bacteria. For the several test methods available in antibody tests, it is necessary to confirm the advantages and disadvantages of each method and select the method based on an overall evaluation of the factors. The position taken by the testing facility concerning its level of responsibility when submitting test results will also influence the results.

I am well aware that test methods are in a constant state of development, test facilities take pride in their techniques, and it is very difficult to achieve uniform test methods. I want to stress that simply listing the test items is not sufficient for international harmonization of microbiologic testing of laboratory animals. The test items must include the test method as well as a recommendation of usefulness. Even when there are no major differences in test methods, there are cases in which different results are presented to the client. These differences probably depend on the philosophy adopted by each testing facility.

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Front Matter (R1-R16)
Opening Remarks, Judith Vaitukaitis (1-3)
Opening Remarks, Shin-Ichi Ota (4-5)
Introductory Comments on Microbiologic Testing of Laboratory Mice and Rats: Uniformity of Results (6-6)
Development of a Performance Assessment Program for Research Animal Diagnostic Laboratories and Defining Microbiologic Testing Standards (7-10)
Standardization of Rodent Health Surveillance: Regulation Versus Competition (11-15)
Factors Causing Difficulties in Uniformity of Results Among Testing Facilities in Microbiologic Monitoring of Laboratory Animals (16-20)
Necessity of Reexamining the Pathogenicity and Elimination of Parasites in Rats and Mice (21-26)
Emerging (and Reemerging) Viruses of Laboratory Mice and Rats (27-34)
Emerging Infections as a Cause of Concern (35-39)
Emerging Diseases in Mice and Rats (40-43)
Survey of Heliobacter Species in Laboratory Mice and Gerbils in Japan (44-46)
Genetic Evaluation of Outbred Rats (47-50)
Genetic Evaluation of Outbred Rats from the Breeder's Perspective (51-64)
Concept for Establishment of Rat Outbred Global Standard Strains (65-76)
Necessity of Genetic and Microbiologic Quality Network from the Pharmaceutical Industry's Perspective (77-84)
International Harmonization of Laboratory Animals (85-96)
Rat Genetics and Toxicology (97-104)
A Phenotype-driven Approach to the Molecular and Functional Analysis of the Mouse Genome (105-115)
Evaluation of Targeted Mutations (116-118)
Defining Behavioral Phenotypes in Transgenic and Knockout Mice (119-129)
Defining Phenotype in Genetically Engineered Mice (130-131)
Development of the Mouse Model Dramatype for Human Clinical Benefit (132-136)
Concluding Remarks (137-137)
Implication of Wild-derived Genes, Mitochondria, and Chromosomes in the Genetic Background of Mouse Models for Diseases and Biologic Functions (138-141)
Concluding Comments, John Strandberg (142-143)
Concluding Remarks, John Vandenbergh (144-146)
Appendix A (147-148)
Appendix B (149-150)