State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, No. 79 Qingchun Road, Shangcheng District, Hangzhou 310003, Zhejiang, China.
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, No. 79 Qingchun Road, Shangcheng District, Hangzhou 310003, Zhejiang, China.
Int J Infect Dis. 2019 Apr;81:46-51. doi: 10.1016/j.ijid.2019.01.036. Epub 2019 Jan 24.
The objective of this study was to conduct a multicentre evaluation of the performance of the biochip assay in the rapid identification of mycobacteria in smear-positive sputum specimens.
A total of 1751 sputum specimens were obtained from 7 cities in Zhejiang, China. All of the specimens were used for the discrimination of Mycobacterium species using the biochip assay, and the results were compared to the golden standard method of culture, hsp65, 16S rRNA and rpoB sequence analysis.
In the 1751 sputum specimens, 1685 samples were cultured successfully; among these samples, 1361 were Mycobacterium tuberculosis, 323 were NTM and 1 was Nocadia farcinica. Of the 323 NTM, most of them were Mycobacterium intracellulare(52.5%) followed by Mycobacterium abscessus (20.7%), Mycobacterium avium (11.7%), Mycobacterium kansasii (9.6%) and Mycobacterium fortuitum (1.9%). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the biochip assay to differentiate TB and NTM from AFB positive specimens were 99.8%, 99.7%, 99.9%, 99.1%, 98.8%, 1, 1, and 99.7%, respectively. The concordance between the biochip assay and mycobacterial culture for the identification of NTM species was 95.4%.
The biochip assay is a reliable tool for the rapid identification of most mycobacteria in clinical sputum specimens. This assay can be helpful for physicians in the early diagnosis and treatment of mycobacterium infections.
本研究旨在对生物芯片检测法在快速鉴定痰涂片阳性标本中的分枝杆菌进行多中心评估。
共采集中国浙江省 7 个城市的 1751 份痰标本。所有标本均用于生物芯片检测法区分分枝杆菌种，结果与培养、hsp65、16S rRNA 和 rpoB 序列分析的金标准方法进行比较。
在 1751 份痰标本中，有 1685 份成功培养；其中 1361 份为结核分枝杆菌，323 份为非结核分枝杆菌，1 份为诺卡氏菌。323 株非结核分枝杆菌中，大多数为胞内分枝杆菌（52.5%），其次为脓肿分枝杆菌（20.7%）、鸟分枝杆菌（11.7%）、堪萨斯分枝杆菌（9.6%）和偶发分枝杆菌（1.9%）。生物芯片检测法区分 AFB 阳性标本中的结核分枝杆菌和非结核分枝杆菌的灵敏度、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为 99.8%、99.7%、99.9%、99.1%、98.8%、1、1 和 99.7%，与分枝杆菌培养鉴定非结核分枝杆菌种的一致性为 95.4%。
生物芯片检测法是一种快速鉴定临床痰标本中大多数分枝杆菌的可靠工具。该检测法有助于临床医生对分枝杆菌感染进行早期诊断和治疗。
