痰标本中结核分枝杆菌复合群诊断的荧光原位杂交技术

The Fluorescence In Situ Hybridization for Diagnosis of Mycobacterium tuberculosis Complex in Sputum Samples.

作者信息

Yuan Leyong, Ke Zunqiong, Ma Jun, Liu Le, Li Yan

机构信息

Department of Clinical Laboratory, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, P.R. China.

Department of Pharmacy, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei Province, P.R. China.

出版信息

Ann Clin Lab Sci. 2015 Fall;45(6):631-8.

PMID:26663792

Abstract

BACKGROUND

Fluorescence In Situ Hybridization (FISH) assay has been a rapid, accurate and affordable method for detection of Mycobacterium tuberculosis complex (MTBC) in clinical isolates and lymph nodes of clinical samples. However, no performance data exist from sputum samples. The aim of this study was to develop the FISH assay for the simultaneous detection of MTBC in clinical isolates and sputum samples.

DESIGN

We identified the optimum conditions for the detection of MTBC by FISH in culture isolates. Then this approach was applied to detect 542 sputum samples from PTB suspects.

RESULTS

Among 542 cases, 45 (8.3%) had sputum samples that were positive for TB by BACTEC Mycobacteria Growth Indicator Tube 960 TB culture and the FISH technique. The sensitivity of the FISH assay was 97.1% for smear-positive samples and 36.4% for smear-negative samples compared with culture results, and according to clinical data, the sensitivity, specificity, and positive and negative predictive values of the FISH assay were 76.4%, 99.6%, 95.6%, and 97.6%, respectively, compared to 81.8%, 100%, 100%, and 98%, respectively, for culture and 63.6%, 98.6%, 83.3%, and 96%, respectively, for smears. Moreover, the estimated cost of FISH was only $3-$5 per test.

CONCLUSION

The FISH assay is accurate and affordable method for the detection of MTBC and may be an alternative to fluorescent smear as an effective method for detecting MTBC.

摘要

背景

荧光原位杂交（FISH）检测法是一种快速、准确且经济实惠的方法，用于检测临床分离株和临床样本淋巴结中的结核分枝杆菌复合群（MTBC）。然而，尚无痰标本的性能数据。本研究的目的是开发用于同时检测临床分离株和痰标本中MTBC的FISH检测法。

设计

我们确定了通过FISH检测培养分离株中MTBC的最佳条件。然后将该方法应用于检测542例疑似肺结核患者的痰标本。

结果

在542例病例中，45例（8.3%）的痰标本通过BACTEC 960结核分枝杆菌生长指示管培养和FISH技术检测为结核阳性。与培养结果相比，FISH检测法对涂片阳性标本的灵敏度为97.1%，对涂片阴性标本的灵敏度为36.4%。根据临床数据，FISH检测法的灵敏度、特异性、阳性预测值和阴性预测值分别为76.4%、99.6%、95.6%和97.6%，而培养法分别为81.8%、100%、100%和98%，涂片法分别为63.6%、98.6%、83.3%和96%。此外，FISH检测的估计成本仅为每次检测3至5美元。