Evaluation of the tuberculosis culture color plate test for rapid detection of drug susceptible and drug-resistant Mycobacterium tuberculosis in a resource-limited setting, Addis Ababa, Ethiopia

• Published in: PloS one Vol. 14; no. 5; p. e0215679
• Main Authors: Mekonnen, Biruk, Mihret, Adane, Getahun, Muluwork, Hailu, Tsegaye, Sidiki, Sabeen, V. Kelley, Holden, Scordo, Julia M., Hunt, W. Garrett, Pan, Xueliang, Balada-Llasat, Joan-Miquel, Gebreyes, Wondwossen, Evans, Carlton A., Aseffa, Abraham, Torrelles, Jordi B., Wang, Shu-Hua, Abebe, Tamrat
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 28.05.2019; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; Adolescent; Adult; Aged; Aged, 80 and over; AIDS; Antitubercular agents; Antitubercular Agents - pharmacology; Biology and Life Sciences; Biomedical research; Child; Color; Culture; Culture Techniques; Drug resistance; Drug Resistance, Bacterial; Drug therapy; Ethiopia; Female; Health Resources - supply & distribution; Health sciences; HIV; Human immunodeficiency virus; Humans; Immunology; Infections; Infectious diseases; Infrastructure; Isoniazid; Laboratories; Lung diseases; Male; Medical diagnosis; Medicine; Medicine and Health Sciences; Methods; Microbial drug resistance; Microbial Sensitivity Tests - economics; Microbial Sensitivity Tests - methods; Middle Aged; Multidrug resistance; Mycobacterium tuberculosis; Mycobacterium tuberculosis - drug effects; Mycobacterium tuberculosis - growth & development; Parasitology; Patient outcomes; Public health; Pyrazinamide; R&D; Research & development; Rifampin; Sensitivity; Sputum; Technology; Test procedures; Time Factors; Tuberculosis; Young Adult; Ethiopia; Ohio; United States > US; Texas; Addis Ababa Ethiopia
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0215679

Timely diagnosis of tuberculosis (TB) is limited in Ethiopia. We evaluated the performance of a low technology, thin layer agar, Mycobacterium tuberculosis (M.tb) culture color plate (TB-CX) test with concurrent drug susceptibility testing (DST) to isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) directly from sputum specimens. Patients undergoing examination for TB and multidrug-resistant (MDR)-TB were enrolled in Addis Ababa, Ethiopia from March 2016 to February 2017. All subjects received a GeneXpert MTB/RIF PCR test. TB-CX test results were compared to reference Löwenstein-Jensen (LJ) culture for M.tb detection and DST for susceptibility to INH and RIF. Kappa statistic was applied to test agreement between results for TB-CX test and the reference methods, a cut-off Kappa value of 0.75 was considered as high level of agreements. A total of 137 participants were analyzed: 88 (64%) were new TB cases, 49 (36%) were re-treatment cases. The TB-CX test detected M.tb and DST in an average of 13 days compared to 50 days for the conventional DST result. The sensitivity and specificity of the TB-CX test for detecting M.tb were 94% and 98%, respectively (concordance, 96%; kappa 0.91). The sensitivity of the TB-CX test to detect drug resistance to INH, RIF, and MDR-TB was 91%, 100%, and 90% respectively. The specificity of the TB-CX test for detecting INH, RIF, and MDR-TB was 94%, 40%, and 94% respectively. Overall agreement between TB-CX test and LJ DST for detection of MDR-TB was 93%. The TB-CX test showed strong agreement with the GeneXpert test for detecting M.tb (89%, kappa 0.76) but low agreement for the detection of RIF resistance (57%, kappa 0.28). The TB-CX test was found to be a good alternative method for screening of TB and selective drug resistant-TB in a timely and cost-efficient manner.