サイトメガロウイルス (CMV) の核酸同定検査における精度管理試料の有用性

概要

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In recent decades, molecular diagnostic tests mainly for infectious diseases have been introduced to many clinical laboratories. However, the tests have sometimes caused unexpected false-negative or -positive results due to the complicated procedures for extracting nucleic acids from various materials and a large number of amplifications of nucleic acids by polymerase chain reactions (PCR). There have not been suit-able control materials to guarantee the quality of genetic tests such as for the identification or quantitative detection of Cytomegalovirus (CMV) DNA. The authors, therefore, made quality control materials, consisting of human embryonic lung cells (HEL) infected with AD-169 strain (CMV), and delivered them at under -20℃ to 13 clinical laboratories. Moreover, we had the materials measured to assess their reliability for CMV DNA assay and evaluate their usefulness as control materials. This study revealed that the inter-laboratory differences among assay values of CMV DNA were smaller than we expected. The quality control materials were also stable when frozen at -80℃ for a long period of more than 6 months and useful for keeping test data stable, and for reducing variations of assay values among the laboratories.
香川県立保健医療大学の論文