{"title":"痰液质量的影响和 Xpert® MTB/ RIF 检测法在埃塞俄比亚亚的斯亚贝巴当天诊断策略中检测涂片阴性肺结核中的作用。","authors":"Waganeh Sinshaw, Abebaw Kebede, Adane Bitew, Mengistu Tadesse, Zemedu Mehamed, Ayinalem Alemu, Bazezew Yenew, Misikir Amare, Biniyam Dagne, Getu Diriba, Ephrem Tesfaye, Dinka F Gamtesa, Yeshiwork Abebaw, Helina Molallign Mollalign, Getachew Seid, Muluwork Getahun","doi":"10.4102/ajlm.v11i1.1671","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There is limited information on the performance of the Xpert<sup>®</sup> MTB/RIF test for diagnosis of smear-negative pulmonary tuberculosis (SNPT) and rifampicin resistance (RR) in the same-day diagnosis approach. The effects of sputum quality and other factors affecting the Xpert performance are also under-investigated.</p><p><strong>Objective: </strong>This study aimed to determine the performance of the Xpert<sup>®</sup> MTB/RIF test for detection of SNPT and RR in the same-day diagnosis strategy and the effect of sputum quality and other factors on its performance.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from August 2017 to January 2018 across 16 health facilities in Addis Ababa, Ethiopia. Two spot sputum samples were collected from 418 presumptive SNPT patients, tested with Xpert® MTB/RIF, then compared to tuberculosis culture. Additionally, culture isolates were tested for RR by BACTEC MGIT™ 960 drug susceptibility testing (DST) and MTBDRplus version 2.</p><p><strong>Results: </strong>The Xpert<sup>®</sup> MTB/RIF test detected 24 (5.7%) SNPT cases, with a sensitivity of 92.3% (75.9% - 97.9%) and specificity of 99.2% (97.8% - 99.7%) compared with tuberculosis culture. Xpert<sup>®</sup> MTB/RIF also detected three (11.58%) RR strains with 100.0% concordance with BACTEC MGIT™ 960 DST and MTBDRplus results. Three blood-stained SNPT samples were positive by Xpert (30.0%), which was 6.9 times higher compared to salivary sputum (odds ratio: 6.9, 95% confidence interval: 1.36-34.96, <i>p</i> = 0.020).</p><p><strong>Conclusion: </strong>The performance of the Xpert<sup>®</sup> MTB/RIF to detect SNPT and RR in same-day diagnosis is high. However, SNPT positivity varies among sputum qualities, and good sample collection is necessary for better test performance.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9453192/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of sputum quality and role of Xpert<sup>®</sup> MTB/ RIF assay for detection of smear-negative pulmonary tuberculosis in same-day diagnosis strategy in Addis Ababa, Ethiopia.\",\"authors\":\"Waganeh Sinshaw, Abebaw Kebede, Adane Bitew, Mengistu Tadesse, Zemedu Mehamed, Ayinalem Alemu, Bazezew Yenew, Misikir Amare, Biniyam Dagne, Getu Diriba, Ephrem Tesfaye, Dinka F Gamtesa, Yeshiwork Abebaw, Helina Molallign Mollalign, Getachew Seid, Muluwork Getahun\",\"doi\":\"10.4102/ajlm.v11i1.1671\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There is limited information on the performance of the Xpert<sup>®</sup> MTB/RIF test for diagnosis of smear-negative pulmonary tuberculosis (SNPT) and rifampicin resistance (RR) in the same-day diagnosis approach. The effects of sputum quality and other factors affecting the Xpert performance are also under-investigated.</p><p><strong>Objective: </strong>This study aimed to determine the performance of the Xpert<sup>®</sup> MTB/RIF test for detection of SNPT and RR in the same-day diagnosis strategy and the effect of sputum quality and other factors on its performance.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from August 2017 to January 2018 across 16 health facilities in Addis Ababa, Ethiopia. Two spot sputum samples were collected from 418 presumptive SNPT patients, tested with Xpert® MTB/RIF, then compared to tuberculosis culture. Additionally, culture isolates were tested for RR by BACTEC MGIT™ 960 drug susceptibility testing (DST) and MTBDRplus version 2.</p><p><strong>Results: </strong>The Xpert<sup>®</sup> MTB/RIF test detected 24 (5.7%) SNPT cases, with a sensitivity of 92.3% (75.9% - 97.9%) and specificity of 99.2% (97.8% - 99.7%) compared with tuberculosis culture. Xpert<sup>®</sup> MTB/RIF also detected three (11.58%) RR strains with 100.0% concordance with BACTEC MGIT™ 960 DST and MTBDRplus results. Three blood-stained SNPT samples were positive by Xpert (30.0%), which was 6.9 times higher compared to salivary sputum (odds ratio: 6.9, 95% confidence interval: 1.36-34.96, <i>p</i> = 0.020).</p><p><strong>Conclusion: </strong>The performance of the Xpert<sup>®</sup> MTB/RIF to detect SNPT and RR in same-day diagnosis is high. However, SNPT positivity varies among sputum qualities, and good sample collection is necessary for better test performance.</p>\",\"PeriodicalId\":45412,\"journal\":{\"name\":\"African Journal of Laboratory Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2022-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9453192/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"African Journal of Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4102/ajlm.v11i1.1671\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"African Journal of Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4102/ajlm.v11i1.1671","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Effect of sputum quality and role of Xpert® MTB/ RIF assay for detection of smear-negative pulmonary tuberculosis in same-day diagnosis strategy in Addis Ababa, Ethiopia.
Background: There is limited information on the performance of the Xpert® MTB/RIF test for diagnosis of smear-negative pulmonary tuberculosis (SNPT) and rifampicin resistance (RR) in the same-day diagnosis approach. The effects of sputum quality and other factors affecting the Xpert performance are also under-investigated.
Objective: This study aimed to determine the performance of the Xpert® MTB/RIF test for detection of SNPT and RR in the same-day diagnosis strategy and the effect of sputum quality and other factors on its performance.
Methods: A cross-sectional study was conducted from August 2017 to January 2018 across 16 health facilities in Addis Ababa, Ethiopia. Two spot sputum samples were collected from 418 presumptive SNPT patients, tested with Xpert® MTB/RIF, then compared to tuberculosis culture. Additionally, culture isolates were tested for RR by BACTEC MGIT™ 960 drug susceptibility testing (DST) and MTBDRplus version 2.
Results: The Xpert® MTB/RIF test detected 24 (5.7%) SNPT cases, with a sensitivity of 92.3% (75.9% - 97.9%) and specificity of 99.2% (97.8% - 99.7%) compared with tuberculosis culture. Xpert® MTB/RIF also detected three (11.58%) RR strains with 100.0% concordance with BACTEC MGIT™ 960 DST and MTBDRplus results. Three blood-stained SNPT samples were positive by Xpert (30.0%), which was 6.9 times higher compared to salivary sputum (odds ratio: 6.9, 95% confidence interval: 1.36-34.96, p = 0.020).
Conclusion: The performance of the Xpert® MTB/RIF to detect SNPT and RR in same-day diagnosis is high. However, SNPT positivity varies among sputum qualities, and good sample collection is necessary for better test performance.
期刊介绍：
The African Journal of Laboratory Medicine, the official journal of ASLM, focuses on the role of the laboratory and its professionals in the clinical and public healthcare sectors,and is specifically based on an African frame of reference. Emphasis is on all aspects that promote and contribute to the laboratory medicine practices of Africa. This includes, amongst others: laboratories, biomedical scientists and clinicians, medical community, public health officials and policy makers, laboratory systems and policies (translation of laboratory knowledge, practices and technologies in clinical care), interfaces of laboratory with medical science, laboratory-based epidemiology, laboratory investigations, evidence-based effectiveness in real world (actual) settings.
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