埃塞俄比亚阿姆哈拉地区西部公共卫生设施中的结核病实验室诊断质量保证

Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

作者信息

Shiferaw Melashu Balew, Hailu Hiwot Amare, Fola Abebe Alemu, Derebe Mulatu Melese, Kebede Aimro Tadese, Kebede Abayneh Admas, Emiru Manamnot Agegne, Gelaw Zelalem Dessie

机构信息

Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.

Walter and Eliza Hall institute of medical research, Melbourne, Australia.

出版信息

PLoS One. 2015 Sep 16;10(9):e0138488. doi: 10.1371/journal.pone.0138488. eCollection 2015.

DOI:10.1371/journal.pone.0138488

PMID:26376438

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4574440/

Abstract

INTRODUCTION

Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia.

MATERIALS AND METHODS

A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20.

RESULTS

Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results.

CONCLUSION

The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

摘要

引言

在资源有限的国家，可靠的涂片显微镜检查是结核病控制项目直接观察治疗策略（DOTS）的重要组成部分。尽管埃塞俄比亚已建立了外部质量评估，但阿姆哈拉地区的结核病检出率（48%）低于世界卫生组织（WHO）的估计值（70%）。这突出表明需要对涂片显微镜检查的质量进行评估。因此，本研究的目的是评估埃塞俄比亚阿姆哈拉地区西部卫生中心实验室痰涂片显微镜检查的性能质量。

材料与方法

于2013年7月8日至2014年7月7日进行了一项横断面研究。使用结构化问卷从201个公共卫生中心实验室收集数据。根据批量质量保证抽样（LQAS）方法收集玻片，并由经过培训的实验室技术人员进行盲法复查。数据录入EPI info V.7，痰涂片质量指标和抗酸杆菌（AFB）结果通过SPSS 20版进行分析。

结果

在本研究纳入的201个实验室中，47个（23.4%）实验室存在重大错误。41个（20.4%）实验室共有67例假阴性结果，29个（14.4%）实验室共有68例假阳性结果。分别有134个（66.7%）、133个（66.2%）和126个（62.7%）实验室的标本质量、涂片厚度和均匀度较差。显微镜镜片清洁液不可用（比值比[AOR]：2.90；95%置信区间[CI]：1.25 - 6.75；P：0.013）和涂片脏污（AOR：2.65；95% CI：1.14 - 6.18；P：0.024）与假阴性结果相关，而之前未参与外部质量评估（AOR：3.43；95% CI：1.39 - 8.45；P：0.007）与假阳性结果相关。