遺伝子検査(3)

ヒト遺伝子検査(白血病 CML 検査項目)
の外部精度評価の実施

石　川　　　博*1　引　地　一　昌*2　山　口　敏　和*3
高　野　昇　一*4　福　田　節　也*5　山　森　俊　治*6
奥　泉　仁　一*7　堀　　　友　繁*8　奥　山　典　生*9
　　　　　　　　　　　　　　　　　　　　　　
External Quality Assessment of the Genetic Testings for Hematopoietic Tumor, CML

Hiroshi ISHIKAWA*1, Kazumasa HIKIJI*2, Toshikazu YAMAGUCHI*3,Shoichi TAKANO*4,
Setuya FUKUDA*5, Shunji YAMAMORI*6, Jinichi OKUIZUMI*7,
Tomoshige HORI*8 and Tsuneo OKUYAMA*9

Genetic testings are commonly employed in various fields of clinical medicine and the test items performed at clinical laboratories are increasing rapidly in number. They are utilized to make early and/or definite diagnoses of infectious diseases, leukemia, cancers and molecular inherited diseases and also to monitor the progress of the diseases. However, these genetic testings except for infectious diseases have been developed independently at each clinical laboratory and the test results obtained at each laboratory are not always compatible each other.
Under these situations it is widely expected to construct advanced genetic testing systems that can supply standardized data at any of domestic and international clinical laboratories. For the period from April, 1999 to March, 2002 three major clinical laboratories, SRL, Inc., BML, Inc. and MBC, Inc., were consigned by JBA(Japan Bioindustry Association) to collaborate in standardizing the evaluation methods for genetic testing systems among the clinical laboratories. The aim of the study is to develop the standardized genetic testing systems and to propose them as international standard operational procedures to the ISO/TC212 working group.
Although one of the most important issues for standardization is the external quality assessment, they have not been carried out in reality. In this study we evaluated the difference of the genetic testing results obtained during the year of 2000 and 2001 among the clinical laboratories. The genetic testings for hematopoietic tumor, CML were selected to be evaluated since they are widely accepted as clinically useful tests.
[Rinsho Byori 50 : 1117〜1123, 2002 ]
*1SRL, Inc. Hino 191-0002

【Key Words】standardization of genetic testing(遺伝子検査の標準化)，external quality assessment(外部精度評価)，fluorescence in situ hybridization：FISH(螢光インサイチューハイブリダイゼーション)，Southern blot analysis(サザンブロット解析)，real-time PCR(リアルタイム PCR)

*1,2�潟Gスアールエル(〒191-0002 日野市新町5-6-50)
*3,4�潟rー・エム・エル(〒350-1101 川越市的場1361-1)
*5,6�且O菱化学ビーシーエル(〒174-8555 東京都板橋区志村3-30-1)，
*7,8(財)バイオインダストリー協会(〒104-0032 東京都中央区八丁堀2-26-9 グランデビルディング8F)
*9東京都立大学 名誉教授(〒243-0206 厚木市下川入99-7)

E-mail :hishikaw@srl.srl-inc.co.jp