Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda

被引:3
作者
Sessolo, Abdulwahab [1 ]
Musisi, Emmanuel [1 ,2 ,3 ]
Kaswabuli, Sylvia [1 ]
Zawedde, Josephine [1 ]
Byanyima, Patrick [1 ]
Sabiiti, Wilber [3 ]
Walimbwa, Stanley [4 ]
Ola, Joseph [4 ]
Sanyu, Ingvar [1 ]
Lalitha, Rejani [5 ]
Kamya, Moses [1 ]
Davis, Lucian [6 ,7 ]
Worodria, William [1 ]
Huang, Laurence [1 ,8 ,9 ]
机构
[1] Infect Dis Res Collaborat, Kampala, Uganda
[2] Makerere Univ, Dept Biochem & Sports Sci, Kampala, Uganda
[3] Univ St Andrews, Sch Med, Div Infect & Global Hlth, St Andrews, Scotland
[4] China Uganda Friendship Hosp Naguru, Kampala, Uganda
[5] Makerere Univ Coll Hlth Sci, Dept Internal Med, Kampala, Uganda
[6] Yale Sch Publ Hlth, Dept Epidemiol Microbial Dis, New Haven, CT USA
[7] Yale Sch Med, Pulm Crit Care & Sleep Med, New Haven, CT USA
[8] Univ Calif San Francisco, Div Pulm & Crit Care Med, San Francisco, CA USA
[9] Univ Calif San Francisco, Div HIV Infect Dis & Global Med, San Francisco, CA USA
来源
PLOS ONE | 2023年 / 18卷 / 04期
关键词
CHILDHOOD PULMONARY TUBERCULOSIS; RAPID DIAGNOSIS; CHILDREN; PERFORMANCE; SPECIMENS; SAMPLES; AFRICA;
D O I
10.1371/journal.pone.0284041
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
BackgroundStool is a potential sample for diagnosing Mycobacterium tuberculosis (Mtb) in patients with difficulty in expectorating. However, high mycobacterial culture contamination rates and Xpert MTB/RIF Ultra test error rates on stool samples have limited its use. OMNIgene SPUTUM (OM-S) is a sample transport reagent with characteristics of sputum decontamination while maintaining viable Mtb. We evaluated the impact of OM-S on Mtb diagnostic yield from stool using smear microscopy, Xpert MTB/RIF Ultra, and culture among presumptive TB patients. MethodsPaired stool and expectorated sputum samples were collected from consecutive Ugandan adults undergoing diagnostic evaluation for pulmonary TB between June 2018 and June 2019. Stool was divided into 2 portions: one was homogenized in OM-S (OM-S stool) and the other in PBS (PBS stool) as control. Both sputum and processed stool were tested for Mtb using concentrated smear fluorescence microscopy (CFM), Xpert MTB/RIF Ultra (Xpert) and Mycobacteria Growth Indicator Tube (MGIT) culture. Sensitivity, specificity, and predictive values for each test were calculated against sputum MGIT culture as the reference standard. ResultsOf the 200 participants, 120 (60%) were male, 73 (37%) were HIV positive (median CD4 120 cells/uL (IQR 43-297)) and 128 (64%) had confirmed pulmonary TB by sputum MGIT culture. Seven (4%) OM-S stool Xpert samples reported errors while 47 (25%) and 103 (61%) were contaminated on OM-S stool MGIT and PBS stool MGIT, respectively. OM-S stool MGIT was able to accurately diagnose 56 of the contaminated PBS stool MGIT samples compared to only 5 of the contaminated OM-S stool MGIT samples diagnosed by PBS stool MGIT.Sensitivity (95% Confidence Interval, CI) 89% (83-94) for OM-S stool Xpert was higher compared to that of OM-S stool MGIT 60% (51-69) and PBS stool MGIT 42% (32-52). Specificity (95%CI) 91% (82-97) was also higher for OM-S stool Xpert compared to OM-S stool MGIT 64% (51-75) and PBS stool MGIT 26% (16-38). ConclusionStool processed with OM-S showed potential to improve Mtb diagnostic yield and reduce rates of indeterminate results when tested on Xpert and MGIT culture. The method may thus be of value in Mtb detection among patients with difficulty to expectorate.
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