National Clinical Laboratory on Tuberculosis, Beijing Key Laboratory on Drug-resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing, China.
Department of Orthopedics, Beijing Bone and Joint Tuberculosis Diagnosis and Treatment Center, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing, China.
Emerg Microbes Infect. 2018 Jun 20;7(1):109. doi: 10.1038/s41426-018-0114-1.
Early diagnosis of spinal tuberculosis (TB) is hampered by the flaws of conventional tests. The aim of this study was to assess the value of new and existing molecular tests in a prospective, head-to-head cohort study. Specimens were consecutively collected from spinal TB suspects in four hospitals in Beijing, China. Smear, culture, histopathology, Xpert MTB/RIF (Xpert), and MeltPro TB assays were performed in parallel using the same specimen from each patient. Drug-susceptibility testing (DST) was conducted on the isolates recovered. In total, 438 suspects were recruited; 319 of them were diagnosed with spinal TB according to the composite reference standard (CRS), which was composed of clinical, laboratory, histopathological, and radiological examinations and 18 months of follow-up. Based on conventional testing, 74.29% of patients were classified as confirmed cases, which increased to 90.6% when Xpert outcomes were integrated. Further, 76.60% of probable and 45.71% of possible cases were re-classified as confirmed cases with Xpert. Xpert (85.27%) produced higher sensitivity than histopathology (73.04%), MeltPro TB (57.68%), culture (51.72%) and smear (24.45%) (all P <0.001). Xpert was 100% concordant with phenotypic DST regarding rifampicin resistance detection. The sensitivity and specificity of MeltPro TB for rifampicin resistance detection were 100% and 97.96%, respectively, and 95.00% and 93.88% for isoniazid resistance detection. New molecular tests demonstrated excellent efficiency for spinal TB diagnosis in this cohort study, so their application as initial diagnostic tools would greatly increase the proportion of confirmed cases and dramatically reduce the delay of appropriate treatment. An updated laboratory testing algorithm of the disease is desirable.
早期诊断脊柱结核（TB）受到常规检测方法的缺陷所阻碍。本研究旨在通过前瞻性、头对头的队列研究评估新的和现有的分子检测方法的价值。连续采集来自中国北京四家医院脊柱 TB 疑似患者的标本。对每位患者的同一样本同时平行进行涂片、培养、组织病理学、Xpert MTB/RIF（Xpert）和 MeltPro TB 检测。从分离株中进行药敏试验（DST）。共招募了 438 名疑似患者；其中 319 名根据复合参考标准（CRS）诊断为脊柱 TB，该标准由临床、实验室、组织病理学和影像学检查以及 18 个月的随访组成。根据常规检测，74.29%的患者被归类为确诊病例，当整合 Xpert 结果时，这一比例增加到 90.6%。此外，76.60%的可能病例和 45.71%的疑似病例通过 Xpert 重新归类为确诊病例。Xpert（85.27%）的灵敏度高于组织病理学（73.04%）、MeltPro TB（57.68%）、培养（51.72%）和涂片（24.45%）（均 P<0.001）。Xpert 与表型 DST 检测利福平耐药性的一致性为 100%。MeltPro TB 检测利福平耐药性的灵敏度和特异性分别为 100%和 97.96%，异烟肼耐药性检测分别为 95.00%和 93.88%。新的分子检测方法在本队列研究中对脊柱 TB 诊断具有优异的效率，因此作为初始诊断工具的应用将大大增加确诊病例的比例，并大大减少适当治疗的延迟。理想情况下，需要更新疾病的实验室检测算法。
