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

• Published in: African journal of laboratory medicine 2022, Vol.11 (1), p.1-7
• Main Authors: Sinshaw, Waganeh, Kebede, Abebaw, Bitew, Adane, Tadesse, Mengistu, Mehamed, Zemedu, Alemu, Ayinalem, Yenew, Bazezew, Amare, Misikir, Dagne, Biniyam, Diriba, Getu, Tesfaye, Ephrem, Gamtesa, Dinka F., Abebaw, Yeshiwork, Mollalign, Helina Molallign, Seid, Getachew, Getahun, Muluwork
• Format: Article
• Language: English
• Subjects: Data entry; diagnostic performance; Drug resistance; Laboratories; Medical Laboratory Technology; Microscopy; Mortality; Mutation; Original Research; Patients; Preventive maintenance; Public health; Quality standards; Questionnaires; smear-negative pulmonary tuberculosis; Sociodemographics; Software; sputum quality; Tuberculosis; tuberculosis culture; Xpert® MTB/RIF test
• ISSN: 2225-2002; 2225-2010; 2225-2010
• DOI: 10.4102/ajlm.v11i1.1671

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.