Report for the assessment of the effects caused by the false replacement of the fungal strains designated for use in JIS Z 2911 (2000) Methods for Antifungal Tests
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Fungal strains of NBRC, Aspergillus niger NBRC 6341 and NBRC 6342, had been specified and used for the Methods for Antifungal Tests: JIS Z 2911 (2000). However, the gene analyses which were implemented as part of the quality management system by NBRC revealed that these strains had been mistakenly replaced by the strains of the same species before they were deposited to IFO, the predecessor collection of NBRC.
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Therefore, NITE disclosed this fact on March 13, 2009 and, in cooperation with AIST, which has been distributing the strains of the same origin as those of NBRC, established an investigation committee (Chairperson: Dr. Kosuke Takatori, Chairperson of Center for Fungal Consultation) including outside experts to evaluate carefully the effect of the replacement of the strains to the data for antifungal tests.
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The committee compared NBRC 6341(Series B), NBRC 6342 (Series A) with the newly obtained strains from ARS (NRRL), USDA, NBRC 105649 (Series A, = NRRL 334) and NBRC 105650 (Series B, = NRRL 3536), for the basic characteristics, growth properties, and product deterioration, etc. by practically examining these tests.
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After the careful assessment, the committee concluded as follows:
Although small differences were found in the basic characteristics and growth profiles, these four strains did not show any significant differences so far as in the antifungal tests such as JIS Z 2911, so that the results of the tests using any of these strains can be designated as equivalent.
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NBRC has been offering the alternative strains, NBRC 105649 and NBRC 105650, to those customers who purchased the culture of NBRC 6341 or NBRC 6342 before.
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NBRC will make sincere effort to improve the quality management system to prevent a recurrence of such an incident.
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Now the strains NBRC 105649 (Series A, =NRRL 334) and NBRC 105650 (Series B, =NRRL 3536) are available as the tester strains for the Antifungal Tests from NBRC culture collection.
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| Keiichiro Okuda, Director-General
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| Department of Biotechnology, NITE
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| 26 May, 2009
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For further information, please contact to:
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Attn: A. Nakagiri or I. Okane
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NITE Biological Resource Center
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Department of Biotechnology
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National Institute of Technology and Evaluation (NITE)
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2-5-8, Kazusakamatari, Kisarazu, Chiba 292-0818, Japan
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Tel 0438-20-5763AFax 0438-52-2329
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e-mail@collection@nbrc.nite.go.jp
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