Xpert MTB/RIF Ultra 在诊断结核性淋巴结炎方面优于 Xpert 检测：一项前瞻性头对头队列研究。

Xpert MTB/RIF Ultra outperformed the Xpert assay in tuberculosis lymphadenitis diagnosis: a prospective head-to-head cohort study.

机构信息

National Clinical Laboratory on Tuberculosis, Beijing Key Laboratory for Drug-resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing, China.

Tuberculosis Department, Beijing Chest Hospital, Capital Medical University, Beijing, China.

出版信息

Int J Infect Dis. 2022 Sep;122:741-746. doi: 10.1016/j.ijid.2022.07.039. Epub 2022 Jul 22.

DOI:10.1016/j.ijid.2022.07.039

PMID:35872095

Abstract

OBJECTIVES

Xpert Mycobacterium tuberculosis/rifampin (MTB/RIF) Ultra (Xpert-Ultra) has shown better sensitivity in comparison with Xpert MTB/RIF (Xpert) in extrapulmonary tuberculosis (TB), whereas the head-to-head comparison of these methods in TB lymphadenitis had barely been performed.

METHODS

Patients with undiagnosed lymphadenopathy were recruited prospectively and consecutively, and fine-needle aspiration (FNA) biopsy or lymph node tissue was collected. The specimen was subjected to smear, culture, Xpert, and Xpert-Ultra assays. Culture and/or smear for acid-fast bacilli (AFB) or AFB observed on histopathology were performed as a reference.

RESULTS

A total of 106 participants were recruited, including 41 confirmed TB, 33 probable TB, and 32 non-TB lymphadenopathies. The head-to-head comparison for MTB detection showed that Xpert-Ultra produced the highest sensitivity when compared with smear, culture, and Xpert (75.7% vs 5.4 %, 13.5%, and 48.7%). When Xpert-Ultra outcomes were integrated for diagnosis, the percentage of confirmed TB lymphadenitis cases increased from 55.4% (41/74) to 85.1% (63/74). The sensitivities of Xpert-Ultra and Xpert on tissue were 73.6% (95% CI: 59.4-84.3) and 39.6% (95% CI: 26.8-54.0), respectively. The sensitivity of Xpert-Ultra on FNA samples (81.0%, 95% CI: 57.4-93.7) was higher than that of Xpert (71.4%, 95% CI: 47.7-87.8).

CONCLUSION

Xpert-Ultra detected significantly more TB lymphadenitis cases than Xpert or culture. This superiority was particularly distinct using lymph node tissue than FNA detection.

摘要

目的

与 Xpert MTB/RIF（Xpert）相比，Xpert 分枝杆菌/利福平超敏（Xpert-Ultra）在肺外结核病（TB）中显示出更好的敏感性，而这两种方法在 TB 淋巴结炎中的头对头比较几乎没有进行过。

方法

前瞻性连续招募诊断不明的淋巴结病患者，并采集细针抽吸（FNA）活检或淋巴结组织。对标本进行涂片、培养、Xpert 和 Xpert-Ultra 检测。进行抗酸杆菌（AFB）培养和/或涂片，或进行组织学观察到的 AFB 作为参考。

结果

共纳入 106 名参与者，包括 41 例确诊 TB、33 例疑似 TB 和 32 例非 TB 淋巴结病。MTB 检测的头对头比较显示，与涂片、培养和 Xpert 相比，Xpert-Ultra 的敏感性最高（75.7%比 5.4%、13.5%和 48.7%）。当整合 Xpert-Ultra 结果进行诊断时，确诊的 TB 淋巴结炎病例比例从 55.4%（41/74）增加到 85.1%（63/74）。Xpert-Ultra 和 Xpert 在组织上的敏感性分别为 73.6%（95%CI：59.4-84.3）和 39.6%（95%CI：26.8-54.0）。Xpert-Ultra 在 FNA 样本中的敏感性（81.0%，95%CI：57.4-93.7）高于 Xpert（71.4%，95%CI：47.7-87.8）。