应用各种标本的结核分枝杆菌 RT-PCR 检测对淋巴结结核的快速诊断：一项诊断准确性研究。
Clinical application of Mycobacterium RT-PCR assay using various specimens for the rapid detection of lymph node tuberculosis: A diagnostic accuracy study.
机构信息
Zhejiang Tuberculosis Diagnosis and Treatment Center, Affiliated Hangzhou Chest Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Department of Hospital Infection, Affiliated Hangzhou Chest Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
出版信息
Medicine (Baltimore). 2023 Feb 22;102(8):e33065. doi: 10.1097/MD.0000000000033065.
To evaluate the diagnostic accuracy of the Capital Bio Mycobacterium real-time polymerase chain reaction assay Capital Bio assay for lymph node (LN) tuberculosis (LNTB), and to further compare the effect of different types of LN specimens on the detection capability of the test. We retrospectively analyzed the medical records of LNTB patients who met the inclusion criteria. The sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve of Capital Bio assay were calculated to evaluate its diagnostic accuracy compared with the final clinical diagnosis as reference standard. Three hundred sixty-four patients were included in the study. The overall sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve of the Capital Bio assay for LNTB were 74.4%, 100.0%, 100.0%, 34.9%, and 0.87, respectively. For the pus specimens, these values for Capital Bio assay were 93.2%, 100.0%, 100.0%, 27.3%, 0.97, respectively. For the core needle biopsy specimens, these values were 65.9%, 100.0%, 100.0%, 33.3%, and 0.83, respectively. For the fine-needle aspiration specimens, these values were 60.0%, 100.0%, 100.0%, 53.9%, and 0.80, respectively. For the tissue, these values were 59.3%, 100.0%, 100.0%, 33.3%, 0.80, respectively. The Capital Bio assay had good effective for the diagnosis of LNTB. Compared to LN fine-needle aspiration and core needle biopsy specimens and tissue specimens, pus specimens were more suitable for molecular testing and had the best diagnostic efficacy.
为了评估 CapitalBio 实时聚合酶链反应检测试剂盒（CapitalBio 检测）对淋巴结（LN）结核病（LNTB）的诊断准确性，并进一步比较不同类型的 LN 标本对检测试验的检测能力的影响。我们回顾性分析了符合纳入标准的 LNTB 患者的病历。采用最终临床诊断作为参考标准，计算 CapitalBio 检测的敏感性、特异性、阳性预测值、阴性预测值和曲线下面积，以评估其诊断准确性。共纳入 364 例患者。CapitalBio 检测对 LNTB 的总体敏感性、特异性、阳性预测值、阴性预测值和曲线下面积分别为 74.4%、100.0%、100.0%、34.9%和 0.87。对于脓液标本，CapitalBio 检测的这些值分别为 93.2%、100.0%、100.0%、27.3%、0.97。对于核心针活检标本，这些值分别为 65.9%、100.0%、100.0%、33.3%和 0.83。对于细针抽吸标本，这些值分别为 60.0%、100.0%、100.0%、53.9%和 0.80。对于组织标本，这些值分别为 59.3%、100.0%、100.0%、33.3%和 0.80。CapitalBio 检测对 LNTB 的诊断具有良好的效果。与 LN 细针抽吸和核心针活检标本和组织标本相比，脓液标本更适合分子检测，诊断效果最佳。
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