{"title":"BD MAX MDR-TB 检测法在临床环境中的性能及其对肺结核患者临床病程的影响:一项前后回顾性研究。","authors":"Sung Jun Ko, Kui Hyun Yoon, Sang Hee Lee","doi":"10.12701/jyms.2024.00024","DOIUrl":null,"url":null,"abstract":"Background\nMissing isoniazid (INH) resistance during tuberculosis (TB) diagnosis can worsen the outcomes of INH-resistant TB. The BD MAX MDR-TB assay (BD MAX) facilitates the rapid detection of TB and INH and rifampin (RIF) resistance; however, data related to its performance in clinical setting remain limited. Moreover, its effect on treatment outcomes has not yet been studied.\n\n\nMethods\nWe compared the performance of BD MAX for the detection of INH/RIF resistances to that of the line probe assay (LPA) in patients with pulmonary TB (PTB), using the results of a phenotypic drug sensitivity test as a reference standard. The treatment outcomes of patients who used BD MAX were compared with those of patients who did not.\n\n\nResults\nOf the 83 patients included in the study, the BD MAX was used for an initial PTB diagnosis in 39 patients. The sensitivity of BD MAX for detecting PTB was 79.5%. The sensitivity and specificity of BD MAX for INH resistance were both 100%, whereas these were 50.0% and 95.8%, respectively, for RIF resistance. The sensitivity and specificity of BD MAX were comparable to those of LPA. The BD MAX group had a shorter time interval from specimen request to the initiation of anti-TB drugs (2.0 days vs. 5.5 days, p=0.001).\n\n\nConclusion\nBD MAX showed comparable performance to conventional tests for detecting PTB and INH/RIF resistances. The implementation of BD MAX as a diagnostic tool for PTB resulted in a shorter turnaround time for the initiation of PTB treatment.","PeriodicalId":74020,"journal":{"name":"Journal of Yeungnam medical science","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Performance of the BD MAX MDR-TB assay in a clinical setting and its impact on the clinical course of patients with pulmonary tuberculosis: a retrospective before-after study.\",\"authors\":\"Sung Jun Ko, Kui Hyun Yoon, Sang Hee Lee\",\"doi\":\"10.12701/jyms.2024.00024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background\\nMissing isoniazid (INH) resistance during tuberculosis (TB) diagnosis can worsen the outcomes of INH-resistant TB. The BD MAX MDR-TB assay (BD MAX) facilitates the rapid detection of TB and INH and rifampin (RIF) resistance; however, data related to its performance in clinical setting remain limited. Moreover, its effect on treatment outcomes has not yet been studied.\\n\\n\\nMethods\\nWe compared the performance of BD MAX for the detection of INH/RIF resistances to that of the line probe assay (LPA) in patients with pulmonary TB (PTB), using the results of a phenotypic drug sensitivity test as a reference standard. The treatment outcomes of patients who used BD MAX were compared with those of patients who did not.\\n\\n\\nResults\\nOf the 83 patients included in the study, the BD MAX was used for an initial PTB diagnosis in 39 patients. The sensitivity of BD MAX for detecting PTB was 79.5%. The sensitivity and specificity of BD MAX for INH resistance were both 100%, whereas these were 50.0% and 95.8%, respectively, for RIF resistance. The sensitivity and specificity of BD MAX were comparable to those of LPA. The BD MAX group had a shorter time interval from specimen request to the initiation of anti-TB drugs (2.0 days vs. 5.5 days, p=0.001).\\n\\n\\nConclusion\\nBD MAX showed comparable performance to conventional tests for detecting PTB and INH/RIF resistances. The implementation of BD MAX as a diagnostic tool for PTB resulted in a shorter turnaround time for the initiation of PTB treatment.\",\"PeriodicalId\":74020,\"journal\":{\"name\":\"Journal of Yeungnam medical science\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2024-04-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Yeungnam medical science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.12701/jyms.2024.00024\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Yeungnam medical science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12701/jyms.2024.00024","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
背景在结核病(TB)诊断过程中漏诊异烟肼(INH)耐药性会加重INH耐药结核病的治疗效果。BD MAX MDR-TB 检测试剂盒(BD MAX)有助于快速检测结核病、INH 和利福平(RIF)耐药性;然而,有关其在临床环境中表现的数据仍然有限。我们比较了 BD MAX 与线探针检测法(LPA)在肺结核(PTB)患者中检测 INH/RIF 耐药性的性能,并将表型药敏试验的结果作为参考标准。对使用 BD MAX 和未使用 BD MAX 的患者的治疗结果进行了比较。结果 在纳入研究的 83 名患者中,39 名患者使用 BD MAX 进行了 PTB 初步诊断。BD MAX 检测 PTB 的灵敏度为 79.5%。BD MAX 对 INH 耐药性的敏感性和特异性均为 100%,而对 RIF 耐药性的敏感性和特异性分别为 50.0% 和 95.8%。BD MAX 的敏感性和特异性与 LPA 相当。结论BD MAX在检测PTB和INH/RIF耐药性方面的表现与传统检测方法相当。将 BD MAX 作为 PTB 诊断工具可缩短开始 PTB 治疗的周转时间。
Performance of the BD MAX MDR-TB assay in a clinical setting and its impact on the clinical course of patients with pulmonary tuberculosis: a retrospective before-after study.
Background
Missing isoniazid (INH) resistance during tuberculosis (TB) diagnosis can worsen the outcomes of INH-resistant TB. The BD MAX MDR-TB assay (BD MAX) facilitates the rapid detection of TB and INH and rifampin (RIF) resistance; however, data related to its performance in clinical setting remain limited. Moreover, its effect on treatment outcomes has not yet been studied.
Methods
We compared the performance of BD MAX for the detection of INH/RIF resistances to that of the line probe assay (LPA) in patients with pulmonary TB (PTB), using the results of a phenotypic drug sensitivity test as a reference standard. The treatment outcomes of patients who used BD MAX were compared with those of patients who did not.
Results
Of the 83 patients included in the study, the BD MAX was used for an initial PTB diagnosis in 39 patients. The sensitivity of BD MAX for detecting PTB was 79.5%. The sensitivity and specificity of BD MAX for INH resistance were both 100%, whereas these were 50.0% and 95.8%, respectively, for RIF resistance. The sensitivity and specificity of BD MAX were comparable to those of LPA. The BD MAX group had a shorter time interval from specimen request to the initiation of anti-TB drugs (2.0 days vs. 5.5 days, p=0.001).
Conclusion
BD MAX showed comparable performance to conventional tests for detecting PTB and INH/RIF resistances. The implementation of BD MAX as a diagnostic tool for PTB resulted in a shorter turnaround time for the initiation of PTB treatment.