항결핵제 감수성검사를 위한 AdvansureTM MDR-TB Genoblot Assay Kit의 수행능 평가
Performance Assessment of Advansure™ MDR-TB Genoblot Assay Kit for Anti-tuberculosis Drug Susceptibility Test
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배경: 화학요법과 조혈모세포이식을 받은 다발골수종 환자는 혈청 면역고정전기영동검사에서 다수의 올리고클론띠와 동형전환이 관찰된다는 보고들이 있다. 본 연구에서는 화학요법과 자가조혈모세포이식을 받은 한국인 다발골수종 환자에서 나타난 올리고클론띠와 다발골수종 재발과의 관계를 알아보고, 혈청 유리형경쇄비가 비정상적인 단백띠의 감별진단에 도움이 될 수 있는지를알아보고자 하였다. 방법: 화학요법과 자가조혈모세포이식 치료를 받은 16명의 다발골수종 환자들을 대상으로 혈청 면역고정전기영동과 유리형 경쇄비에 대한 후향 분석을 실시하였다. 결과: 다발골수종 환자 11/16예(68.8%)에서 자가조혈모세포이식후에 올리고클론띠가 관찰되었으며 동형전환이 함께 나타난 경우도 있었다. 올리고클론띠가 처음으로 출현한 시점의 중앙값은 자가조혈모세포이식 후 2.0개월이었다. 비록 통계적인 유의성은 없었지만(P = 0.299), 올리고클론띠가 나타나는 환자에서는 재발하거나 단세포군감마글로불린병증이 지속되는 빈도가 낮게 관찰되었다(27.3% vs. 60.0%). 그리고 자가조혈모세포이식 후에 올리고클론띠가 관찰되고 재발하지 않은 8예의 환자들은 혈청 유리형 경쇄비가 정상 참고치 범위 이내였지만, 올리고클론띠가 관찰되면서 골수에서 형질세포가 증가한 1예 환자의 혈청 유리형 경쇄비는 지속적으로 증가하였다. 결론: 자가조혈모세포이식 치료를 받은 한국인 다발골수종 환자들 중 올리고클론띠를 보인 환자들과 보이지 않은 환자들 사이에재발하거나 단세포감마글로불린병증이 지속되는 비율에는 통계적으로 유의한 차이가 없었으므로 올리고클론띠는 불량한 예후인자가 아닐 가능성을 보여준다. 또한 혈청 유리형 경쇄비는 이러한 환자들에서 다발골수종의 재발 예측에 유용한 보조 지표로 생각된다.
Abstract
Background: Because of the long time required for conventional drug susceptibility test (DST) for rifampin and isoniazid, development of rapid DSTs is necessary. Recently, the AdvanSure™ MDR-TB GenoBlot Assay kit (LG Life Science, Korea), using reverse hybridization line blot assay, was developed. We compared this kit with Genotype® MTBDRplus (HAIN Lifescience, Germany) and conventional DST. Methods: Of the DNAs preserved after performing DST by using Genotype®, we selected 144 samples having conventional DST results. The experiments with both the kits were performed according to the manufacturers’ instructions. For the samples for which discrepant results were obtained,sequencing was performed if the DNA was available. Conventional DST was performed at the Korean Institute of Tuberculosis by using the absolute concentration method. Results: For rifampin, the findings obtained using both the kits were the same with concordance rates of 98.6% (142/144) compared to conventional DST. Of the 2 discrepant findings, one was very major error and the other was major error. For isoniazid, compared to conventional DST, concordance rates of AdvanSure™ and Genotype® were 95.8%(138/144) and 95.1%(137/144) respectively. Of the 6 discrepant findings between conventional method and Advansure™, 5 were very major error and one was major error. All the 7 discrepant findings between conventional method and Genotype® were very major error. Conclusions: The findings obtained using AdvanSure™ showed high concordance with those obtained using Genotype® and conventional DST. This kit has a higher rate of detection of isoniazid resistance because it includes probes for an additional target (ahpC).
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