結核菌抗原ESAT‐6およびCFP‐10を用いた結核感染診断法QuantiFERON TB‐2Gの基礎的検討

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タイトル別名
  • BASIC CHARACTERISTICS OF A NOVEL DIAGNOSTIC METHOD (QuantiFERON TB-2G) OF LATENT TUBERCULOSIS INFECTION WITH A USE OF MYCOBACTERIUM TUBERCULOSIS-SPECIFIC ANTIGENS, ESAT-6 AND CFP-10
  • ケッカクキン コウゲン ESAT 6 オヨビ CFP 10 オ モチイタ ケッカク カンセン シンダンホウ QuantiFERON TB 2G ノ キソテキ ケントウ

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[Purposes] To determine the optimum cut-off level of a newly developed method for diagnosing tuberculosis infection based on whole-blood interferon-gamma measurement, and to study the basic characteristics of the method.<BR>[Study Subjects] 1) A total of 220 young, healthy individuals having no apparent exposure to tuberculosis infection, most of whom have had a vaccination with BCG vaccine. 2) One hundred eighteen tuberculosis patients who were diagnosed by positive Mycobacterium tuberculosis on culture. 3) A group of 75 youngsters exposed to an infectious tuberculosis patient and who showed a strong tuberculin reaction (with erythema diameter of 30 mm or more).<BR>[Method] Whole-blood specimens of donors were stimulated with antigens, i.e., ESAT-6 and CFP-10, and then cultured. Plasma concentrations of interferon-gamma discharged were then determined with QuantiFERON ®-CMI. Correlation between interferon-gamma concentrations in response to ESAT-6 and CFP-10, and their correlation with Mantoux test results were analyzed for various categories of donors. The Receiver Operating Characteristics analysis was performed considering the loss due to misclassification.<BR>[Results and Discussion] The optimum cut-off level was determined as 0.35 IU/ml for both ESAT-6 and CFP-10. This gave the test a sensitivity of 89.0% and specificity of 98.1% in detecting tuberculosis infection. The correlation of interferongamma response with tuberculin tests among BCG-vaccinated individuals was low, which suggested that the test was not influenced by previous BCG vaccination. The low correlation between ESAT-6 and CFP-10 tests suggested that the simultaneous use of the two tests was beneficial. As in the case of clinical tests in general, the cut-off should be set at a lower level when the test is applied to high prevalence situation and vice versa.

収録刊行物

  • 結核

    結核 79 (12), 725-735, 2004

    一般社団法人 日本結核病学会

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