抗酸菌検査施設に対する結核菌薬剤感受性試験外部精度評価 EXTERNAL QUALITY ASSESSMENT OF DRUG SUSCEPTIBILITY TESTING FOR MYCOBACTERIUM TUBERCULOSIS

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著者

    • 御手洗 聡 MITARAI Satoshi
    • 結核予防会結核研究所抗酸菌レファレンスセンター細菌検査科 Bacteriology Division, Mycobacterium Reference Centre, Research Institute of Tuberculosis Japan Anti-Tuberculosis Association (JATA)

抄録

〔目的〕日本結核病学会抗酸菌検査法検討委員会は検査センターおよび病院検査室を対象として薬剤感受性試験外部精度評価を施行した。〔方法〕薬剤感受性試験を実施している23の検査センターおよび25の病院検査室に耐性既知の結核菌20株を送付し,各施設で感受性試験を実施し,結果を標準判定と比較した。〔結果〕参加施設の検査精度は,INH・RFPで感度・特異度が平均95%を超えており,すべての薬剤で一致率平均が90%を超えていた。しかし,検査センターではINHの感度・特異度・一致率・再現性のすべてが100%であったのに対し,病院検査室では感度90%以下の施設が2施設(8%)認められた。同様にRFPに関しては感度が90%を下回る施設が検査センターで1施設(4.3%),病院検査室で3施設(12%)認められた。2003年度に精度改善のため現地での調査・検討を行った2施設では,いずれも今回精度の改善を認めた。〔考察〕病院検査室間の結果のばらつきは検査センターに比べて大きく,同じ範囲内であっても病院検査室の検査精度は検査センターに比べて低い傾向にあった。また,外部精度評価に基づく検査法の改善は精度の向上に有効であった。

[Objective] The Committee for Mycobacterial Examinations has planned and implemented the third external quality assessment of drug susceptibility testing for <I>Mycobacterium tuberculosis</I> to the hospital and private laboratories.<BR>[Method] The Committee delivered 20 <I>M. tuberculosis</I> strains, exactly pairs of 10 strains, which were evaluated and standardized for the drug resistance pattern in the WHO/ IUATLD supra-national laboratory network (SRLN). The agreement of the majority of SRLN laboratories was considered as the gold standard of susceptibility result for each strain tested. Each laboratory performed the drug susceptibility testing (DST) with its own routine method. The sensitivity to detect drug resistance, the specificity for susceptible strain, the efficiency of overall agreement, the reproducibility for each pair, and kappa coefficient were calculated to evaluate their performance. DST was performed for isoniazid (INH), rifampicin (RFP), streptomycin (SM) and ethambutol (EB).<BR>[Results] A total of 48 results has been collect ed. The overall sensitivity, specificity, efficiency, reproducibility and kappa coefficient for each anti-tuberculosis drug tested were as follows respectively; 100%, 99. 0% (62. 5-100), 99. 6% (85. 0-100), 99. 6% (90-100) and 0. 991 for INH; 97. 7% (83. 3-100), 100%, 98. 6% (90-100), 99. 0% (90-100) and 0. 972 for RFP; 87. 5% (66. 7-100), 99. 0% (87. 5-100), 92. 1% (80-100), 97. 5% (70-100) and 0. 84 for S M; 99. 5% (75. 0-100), 97. 9% (75. 0-100), 98. 5% (85. 0-100), 97. 9% (70-100) and 0. 97 for EB. Regarding private laboratories, all indicators showed 100% for INH but 2 hospital laboratories showed less than 90% in sensitivity. As for RFP, one private laboratory (4. 3 %) and 3 hospital laboratories showed less than 90% in sensitivity. The major difference between private and hospital laboratories was seen in EB. One hospital laboratory (4. 0%) showed less than 90% in sensitivity and three (12. 0%) showed less than 90% in specificity, compare d to none in private laboratories. Additionally, six hospital laboratories (24. 0%) showed less than 90% in reproducibility. As for quality improvement, two private laboratories that showed poor performance in 2003 have improved their quality up to 100% in 2004.<BR>[Discus sion] The overall efficiency by private and hospital laboratories satisfied WHO criteria. However, it diverged in each category of laboratories and hospital laboratories tended to show poor performance compared to the private ones. The reason for the difference was not clear, but the routine workload, allocated time and cost for the panel testing might contribute to it. The sensitivity of SM was relatively low compared to the other drugs as it was observed in 2003. It was mainly due to two strains to which the participating laboratories showed poor agreement to the gold standard. The difference of critical drug concentration for SM in Löwenstein-Jensen and in 1% Ogawa medium might contrib ute to the discrepancies. As for quality improvement, two private laboratories with poor performance in 2003 have shown marked improvement after on-site evaluation. The results indicated the usefulness of external quality assessment for the maintenance and improvement of the quality of the test.

収録刊行物

  • 結核  

    結核 81(8), 501-509, 2006-08-15 

    JAPANESE SOCIETY FOR TUBERCULOSIS

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各種コード

  • NII論文ID(NAID)
    10018335650
  • NII書誌ID(NCID)
    AN00073442
  • 本文言語コード
    JPN
  • 資料種別
    ART
  • ISSN
    00229776
  • NDL 記事登録ID
    8066276
  • NDL 雑誌分類
    ZS21(科学技術--医学--内科学)
  • NDL 請求記号
    Z19-133
  • データ提供元
    CJP書誌  CJP引用  NDL  J-STAGE 
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