在尼泊尔东部资源有限的实验室环境中，对疑似肺结核患者的呼吸道标本实施GeneXpert MTB/RIF检测法的项目影响。

Programmatic Impact of Implementing GeneXpert MTB/ RIF Assay for the Detection of in Respiratory Specimens from Pulmonary Tuberculosis Suspected Patients in Resource Limited Laboratory Settings of Eastern Nepal.

作者信息

Shrestha Prakash, Khanal Hemanta, Dahal Prasanna, Dongol Pranita

机构信息

Department of microbiology, Sunsari Technical College, Dharan-4, Sunsari, Nepal.

Central Campus of Technology, Tribhuvan University, Hattisar, Dharan, Sunsari, Nepal.

出版信息

Open Microbiol J. 2018 Feb 28;12:9-17. doi: 10.2174/1874285801812010009. eCollection 2018.

DOI:10.2174/1874285801812010009

PMID:29541267

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5842389/

Abstract

BACKGROUND

In Nepal, introduction of GeneXpert MTB/RIF assay (Xpert assay) as an initial confirmation test for tuberculosis (TB) has been considered to have impact as a significant decrease in number of clinically diagnosed pulmonary tuberculosis (PTB) cases than previous years. This study aims to find out the distribution profile of suspected tuberculosis cases according to patients age, gender, treatment history and HIV status as well as to evaluate the utility of the Xpert assay over conventional acid-fast bacilli (AFB) staining method for the proper diagnosis of in respiratory specimens from the tuberculosis (TB) suspected patient samples.

METHODS

The prospective cross-sectional analytical study was conducted in National Anti-Tuberculosis Center (NATA) center- Biratnagar and Primary Healthcare Center (PHC) - Manglabare, Morang District, of eastern Nepal from January 2014 to August 2014. Laboratory investigation was done by conventional AFB staining followed by Xpert assay.

RESULTS

A total of 1549 sputum samples were initially analyzed. AFB staining resulted in 1441 AFB smear negative samples and 88 AFB smear positive samples, whereas 20 samples were directly processed for Xpert assay. The male: female smear positive ratio was 2.8:1 and was higher among age groups (21-40) years. Tuberculosis among HIV patients was found 22.22%. Xpert assay demonstrates that out of 1441 smear negative AFB cases, 258 were found to have TB positive, whereas out of 88 smears positive AFB cases 12 were found to have TB negative. The sensitivity of the Xpert assay in patients classified as AFB smear positive was found 85.4% and the specificity in smear negative patients was 81%.

CONCLUSION

The study concluded that implementation of Gene Xpert MTB/RIF assay is a helpful tool for early and rapid detection of tuberculosis with greater sensitivity and specificity over traditional AFB staining techniques.

摘要

背景

在尼泊尔，采用GeneXpert MTB/RIF检测法（Xpert检测法）作为结核病（TB）的初始确诊检测方法，被认为具有重要意义，因为临床诊断的肺结核（PTB）病例数比前几年大幅减少。本研究旨在根据患者年龄、性别、治疗史和艾滋病毒感染状况，找出疑似结核病病例的分布情况，并评估Xpert检测法相对于传统抗酸杆菌（AFB）染色法在正确诊断疑似结核病患者呼吸道标本中的实用性。

方法

2014年1月至2014年8月，在尼泊尔东部莫朗区比拉特纳格尔的国家抗结核中心（NATA）和芒格拉巴尔的初级卫生保健中心（PHC）进行了前瞻性横断面分析研究。实验室检测先采用传统AFB染色，然后进行Xpert检测。

结果

共对1549份痰标本进行了初步分析。AFB染色结果显示，1441份AFB涂片阴性标本和88份AFB涂片阳性标本，另有20份标本直接进行Xpert检测。涂片阳性的男女比例为2.8:1，在（21 - 40）岁年龄组中更高。艾滋病毒患者中的结核病患病率为22.22%。Xpert检测法显示，在1441份AFB涂片阴性病例中，有258份被检测出结核病呈阳性，而在88份AFB涂片阳性病例中，有12份被检测出结核病呈阴性。Xpert检测法在AFB涂片阳性患者中的敏感性为85.4%，在涂片阴性患者中的特异性为81%。