《使用福尔马林固定、石蜡包埋组织评估 MeltPro MTB 检测在耐药结核病诊断中的性能》
Performance of the MeltPro MTB Assays in the Diagnosis of Drug-Resistant Tuberculosis Using Formalin-Fixed, Paraffin-Embedded Tissues.
机构信息
Department of Pathology, Key Laboratory of Head and Neck Molecular Diagnosis Pathology, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
Department of Pathology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.
出版信息
Am J Clin Pathol. 2021 Jun 17;156(1):34-41. doi: 10.1093/ajcp/aqaa203.
OBJECTIVES
The MeltPro MTB assays for detection of resistance to antituberculosis (TB) drugs perform well in genotypic drug susceptibility testing (DST) of clinical samples, but their effectiveness with formalin-fixed, paraffin-embedded (FFPE) tissues is unknown.
METHODS
FFPE tissues were obtained from 334 patients with TB. Susceptibility to rifampicin (RIF), isoniazid (INH), and fluoroquinolones was examined using the MeltPro MTB assays, with Xpert MTB/RIF (Xpert) and/or phenotypic DST (pDST) results as references. Samples with discordant results were analyzed by multiplex polymerase chain reaction-targeted amplicon sequencing (MTA-seq).
RESULTS
With pDST as the reference, the MeltPro MTB assays sensitivity for RIF, INH, levofloxacin (LVX), and moxifloxacin (MXF) was 95.00%, 96.00%, 100%, and 100%, respectively, and the specificity was 95.15%, 95.92%, 94.69%, and 89.92%, respectively. Concordance was 99.08% between the MeltPro MTB and Xpert (κ = 0.956) for RIF and 95.12% (κ = 0.834), 95.93% (κ = 0.880), 95.12% (κ = 0.744), and 90.24% (κ = 0.367) between the MeltPro MTB and pDST for RIF, INH, LVX, and MXF, respectively. MTA-seq confirmed the discordancy between the MeltPro MTB and pDST for 26 (89.66%) of 29 samples.
CONCLUSIONS
The MeltPro MTB assays rapidly and efficiently predict Mycobacterium tuberculosis resistance to the main first- and second-line anti-TB drugs in FFPE tissues.
目的
MeltPro MTB 检测试剂盒在临床样本的基因耐药性检测（DST）中表现良好，但对于福尔马林固定、石蜡包埋（FFPE）组织的效果尚不清楚。
方法
从 334 例结核病患者中获取 FFPE 组织。采用 MeltPro MTB 检测试剂盒检测利福平（RIF）、异烟肼（INH）和氟喹诺酮类药物的敏感性，以 Xpert MTB/RIF（Xpert）和/或表型 DST（pDST）结果为参考。对结果不一致的样本进行多重聚合酶链反应靶向扩增子测序（MTA-seq）分析。
结果
以 pDST 为参考，MeltPro MTB 检测试剂盒检测 RIF、INH、左氧氟沙星（LVX）和莫西沙星（MXF）的敏感性分别为 95.00%、96.00%、100%和 100%，特异性分别为 95.15%、95.92%、94.69%和 89.92%。MeltPro MTB 与 Xpert 检测 RIF 的一致性为 99.08%（κ=0.956），与 pDST 检测 RIF、INH、LVX 和 MXF 的一致性分别为 95.12%（κ=0.834）、95.93%（κ=0.880）、95.12%（κ=0.744）和 90.24%（κ=0.367）。MTA-seq 确认了 MeltPro MTB 与 pDST 之间 26 份（89.66%）样本的不一致性。
结论
MeltPro MTB 检测试剂盒可快速、有效地预测 FFPE 组织中结核分枝杆菌对主要一线和二线抗结核药物的耐药性。
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