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Meta-Analysis
. 2021 Mar 23;3(3):CD013694.
doi: 10.1002/14651858.CD013694.pub2.

Xpert MTB/RIF and Xpert Ultra assays for screening for pulmonary tuberculosis and rifampicin resistance in adults, irrespective of signs or symptoms

Adrienne E Shapiro  1 , Jennifer M Ross  1 , Mandy Yao  2 , Ian Schiller  2 , Mikashmi Kohli  3 , Nandini Dendukuri  2 , Karen R Steingart  4 , David J Horne  5
Affiliations
Meta-Analysis

Xpert MTB/RIF and Xpert Ultra assays for screening for pulmonary tuberculosis and rifampicin resistance in adults, irrespective of signs or symptoms

Adrienne E Shapiro et al. Cochrane Database Syst Rev. .

Abstract

Background: Tuberculosis is a leading cause of infectious disease-related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one-third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection.

Objectives: To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high-risk groups and in the general population. Screening "irrespective of signs or symptoms" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough). To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high-risk groups and in the general population.

Search methods: We searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies.

Selection criteria: Cross-sectional and cohort studies in which adults (15 years and older) in high-risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture-based drug susceptibility testing and line probe assays.

Data collection and analysis: Two review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS-2. We used a bivariate random-effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high-risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high-risk groups combined.

Main results: We included a total of 21 studies: 18 studies (13,114 participants) evaluated Xpert MTB/RIF as a screening test for pulmonary tuberculosis and one study (571 participants) evaluated both Xpert MTB/RIF and Xpert Ultra. Three studies (159 participants) evaluated Xpert MTB/RIF for rifampicin resistance. Fifteen studies (75%) were conducted in high tuberculosis burden and 16 (80%) in high TB/HIV-burden countries. We judged most studies to have low risk of bias in all four QUADAS-2 domains and low concern for applicability. Xpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis In people living with HIV (12 studies), Xpert MTB/RIF pooled sensitivity and specificity (95% CrI) were 61.8% (53.6 to 69.9) (602 participants; moderate-certainty evidence) and 98.8% (98.0 to 99.4) (4173 participants; high-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 40 would be Xpert MTB/RIF-positive; of these, 9 (22%) would not have tuberculosis (false-positives); and 960 would be Xpert MTB/RIF-negative; of these, 19 (2%) would have tuberculosis (false-negatives). In people living with HIV (1 study), Xpert Ultra sensitivity and specificity (95% CI) were 69% (57 to 80) (68 participants; very low-certainty evidence) and 98% (97 to 99) (503 participants; moderate-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 53 would be Xpert Ultra-positive; of these, 19 (36%) would not have tuberculosis (false-positives); and 947 would be Xpert Ultra-negative; of these, 16 (2%) would have tuberculosis (false-negatives). In non-hospitalized people in high-risk groups (5 studies), Xpert MTB/RIF pooled sensitivity and specificity were 69.4% (47.7 to 86.2) (337 participants, low-certainty evidence) and 98.8% (97.2 to 99.5) (8619 participants, moderate-certainty evidence). Of 1000 people where 10 have tuberculosis on culture, 19 would be Xpert MTB/RIF-positive; of these, 12 (63%) would not have tuberculosis (false-positives); and 981 would be Xpert MTB/RIF-negative; of these, 3 (0%) would have tuberculosis (false-negatives). We did not identify any studies using Xpert MTB/RIF or Xpert Ultra for screening in the general population. Xpert MTB/RIF as a screening test for rifampicin resistance Xpert MTB/RIF sensitivity was 81% and 100% (2 studies, 20 participants; very low-certainty evidence), and specificity was 94% to 100%, (3 studies, 139 participants; moderate-certainty evidence).

Authors' conclusions: Of the high-risks groups evaluated, Xpert MTB/RIF applied as a screening test was accurate for tuberculosis in high tuberculosis burden settings. Sensitivity and specificity were similar in people living with HIV and non-hospitalized people in high-risk groups. In people living with HIV, Xpert Ultra sensitivity was slightly higher than that of Xpert MTB/RIF and specificity similar. As there was only one study of Xpert Ultra in this analysis, results should be interpreted with caution. There were no studies that evaluated the tests in people with diabetes mellitus and other groups considered at high-risk for tuberculosis, or in the general population.

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Conflict of interest statement

AES received funding from USAID, administered by the World Health Organization Global TB Programme, Switzerland. She has received salary compensation from the University of Washington, where she is an Acting Assistant Professor in Global Health and Medicine/Infectious Diseases. A portion of her salary derives from NIH grants and from grants from the Bill & Melinda Gates Foundation.

JMR received funding from USAID, administered by the World Health Organization Global TB Programme, Switzerland. JMR has grants/grants pending to her host institution from US National Institutes of Health, KNCV TB Foundation, and The Global Fund to Fight AIDS, TB, and Malaria, The Firland Foundation.

MY has no known conflicts of interest to declare.

IS has no known conflicts of interest to declare.

MK has received funding from USAID, administered by the World Health Organization Global TB Programme, Switzerland for related systematic reviews.

ND has no known conflicts of interest to declare.

KRS has received financial support from Cochrane Infectious Diseases, UK, McGill University, Canada, and USAID, USA, administered by the World Health Organization (WHO) Global TB Programme, Switzerland, for the preparation of systematic reviews and educational materials, consultancy fees from Foundation for Innovative New Diagnostics (FIND), Switzerland (for the preparation of systematic reviews and GRADE tables), honoraria, and travel support to attend WHO guideline meetings.

DJH has received funding from USAID, administered by the World Health Organization Global TB Programme, Switzerland for related systematic reviews.

Figures

1
1
There are two complementary approaches to detection of active tuberculosis. The first is the patient‐initiated pathway, also known as passive case finding. The second is the provider‐initiated screening pathway (WHO Systematic screening 2015), which represents the analytic framework for this review. In the latter pathway, the index test would be applied as the only test, to adults, irrespective of signs and symptoms of tuberculosis, in high‐risk groups and in primary health facilities or community settings.
2
2
Study flow diagram, PRISMA. *One publication, Reeve 2019, contributed two distinct studies, which were classified as Reeve 2019a and Reeve 2019b.
3
3
Risk of bias and applicability concerns graph for Xpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis: review authors' judgements about each domain presented as percentages across included studies.
4
4
Risk of bias and applicability concerns summary for Xpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis: review authors' judgements about each domain for each included study.
5
5
Risk of bias and applicability concerns graph for Xpert MTB/RIF as a screening test for rifampicin resistance: review authors' judgements about each domain presented as percentages across included studies.
6
6
Risk of bias and applicability concerns summary for Xpert MTB/RIF as a screening test for rifampicin resistance: review authors' judgements about each domain for each included study.
7
7
Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in people living with HIV by percentage of tuberculosis symptoms. The individual studies are ordered by decreasing percentage of participants with tuberculosis symptoms. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. TP: true‐positive; FP: false‐positive; FN: false‐negative; TN: true‐negative.
8
8
Summary plots of the accuracy of Xpert MTB/RIF as a screening test for pulmonary tuberculosis in (A) people living with HIV and (B) non‐hospitalized people in high‐risk groups. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity. The solid lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the ROC space where data have been observed.
9
9
Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in household contacts, people in prison, miners, and people admitted to hospital, irrespective of tuberculosis symptoms. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. TP: true‐positive; FP: false‐positive; FN: false‐negative; TN: true‐negative.
10
10
Forest plots of Xpert MTB/RIF sensitivity and specificity for rifampicin resistance, in people irrespective of tuberculosis symptoms. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. TP: true‐positive; FP: false‐positive; FN: false‐negative; TN: true‐negative.
1
1. Test
Xpert MTB/RIF, HIV positive, irrespective of TB symptoms
2
2. Test
Xpert Ultra, HIV, irrespective of TB symptoms
3
3. Test
Xpert MTB/RIF, household contacts, irrespective of TB symptoms
4
4. Test
Xpert MTB/RIF, prisoners, irrespective of TB symptoms
5
5. Test
Xpert MTB/RIF, miners, irrespective of TB symptoms
6
6. Test
Xpert MTB/RIF, admitted patients, irrespective of TB symptoms
7
7. Test
Xpert MTB/RIF, all high‐risk groups
8
8. Test
Xpert MTB/RIF for rifampicin resistance
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Ntinginya 2012 {published data only}
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O'Grady 2012 {published data only}
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Reeve 2019a {published and unpublished data}
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Reeve 2019b {published and unpublished data}
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Santos 2020 {published and unpublished data}
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Tahseen 2018 {published data only}
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Yoon 2017 {published data only}
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References to studies excluded from this review

Adams 2015 {published data only}
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Adejumo 2018 {published data only}
    1. Adejumo OA, Olusola-Faleye B, Adepoju V, Bowale A, Adesola S, Falana A, et al. Prevalence of rifampicin resistant tuberculosis and associated factors among presumptive tuberculosis patients in a secondary referral hospital in Lagos Nigeria. African Health Sciences 2018;18(3):472-8. - PMC - PubMed
Adetunji 2019 {published data only}
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Agizew 2017 {published data only}
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Aia 2016 {published data only}
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Antonenka 2013 {published data only}
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Ardizzoni 2015 {published data only}
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Ardizzoni 2020 {published data only}
    1. Ardizzoni E, Orikiriza P, Ssuuna C, Nyehangane D, Gumsboga M, Taremwa IM. Evaluation of OMNigene sputum and ethanol reagent for preservation of sputum prior to Xpert and culture testing in Uganda. Journal of Clinical Microbiology 2020;58(1):e00810-19. - PMC - PubMed
Assefa 2019 {published data only}
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Auld 2016a {published data only}
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Auld 2016b {published data only}
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Auld 2020 {published data only}
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Awan 2018 {published data only}
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Ayala 2016 {published data only}
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Bablishvili 2015 {published data only}
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Bacells 2016 {published data only}
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Balcha 2014a {published data only}
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Balcha 2015 {published data only}
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Basir 2019 {published data only}
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Bassett 2019 {published data only}
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Benjamin 2019 {published data only}
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Bhardwaj 2019 {published data only}
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Bjerrum 2015 {published data only}
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Blakemore 2011 {published data only}
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Boum 2016 {published data only}
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Byashalira 2019 {published data only}
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Calligaro 2017 {published data only}
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Carmone 2017 {published data only}
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Cavanaugh 2016 {published data only}
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Celik 2015 {published data only}
    1. Celik C, Gozel MG, Bakici MZ, Berk S, Ozsahin SL, Gulturk E. Applicability of Xpert MTB/RIF assay for routine diagnosis of tuberculosis: a four-year single-center experience. Turkish Journal of Medical Sciences 2015;45(6):1329-34. - PubMed
Charoensook 2018 {published data only}
    1. Charoensook P, Upala P, Anuwatnonthakate A, Ruanjai T, Apidechkul T. Pulmonary tuberculosis screening and quality of life among migrant workers, Northern Thailand. Journal of Infection in Developing Countries 2018;12(12):1052-61. - PubMed
Chry 2020 {published data only}
    1. Chry M, Smelyanskaya M, Ky M, Codlin AJ, Cazabon D, Eang MT, et al. Can the high sensitivity of Xpert MTB/RIF Ultra be harnessed to save cartridge costs? results from a pooled sputum evaluation in Cambodia. Tropical Medicine and Infectious Disease 2020;5(1):27. - PMC - PubMed
Chumpa 2020 {published data only}
    1. Chumpa N, Kawkitinarong K, Rotcheewaphan S, Sawatpanich A, Petsong S, Tumwasorn S, et al. Evaluation of AnyplexTM II MTB/MDR kit's performance to rapidly detect isoniazid and rifampicin resistant Mycobacterium tuberculosis from various clinical specimens. Molecular Biology Reports 2020;47(4):2501-8. - PubMed
Deshmukh 2020 {published data only}
    1. Deshmukh S, Atre S, Chavan A, Raskar S, Sawant T, Mave V, et al. Assessment of the Xpert assay among adult pulmonary tuberculosis suspects with and without diabetes mellitus. International Union against Tuberculosis and Lung Disease 2020;24(1):113-7. - PubMed
Ekeke 2020 {published data only}
    1. Ekeke N, Aniwada E, Chukwu J, Nwafor C, Meka A, Chukwuka A, et al. Screening diabetes mellitus patients for tuberculosis in Southern Nigeria: a pilot study. Advances in Respiratory Medicine 2020;88(1):6-12. - PubMed
Farra 2017 {published data only}
    1. Farra A, Manirakiza A, Yambiyo BM, Zandanga G, Lokoti B, Berlioz-Arthaud A, et al. Surveillance of rifampicin resistance with GeneXpert MTB/RIF in the National Reference Laboratory for tuberculosis at the Institut Pasteur in Bangui, 2015-2017. Open Forum Infectious Diseases 2019;6(3):ofz075. - PMC - PubMed
Floridia 2017 {published data only}
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Gautam 2019 {published data only}
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Gelalcha 2017 {published data only}
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Gizachew 2017 {published data only}
    1. Gizachew Beza M, Hunegnaw E, Tiruneh M. Prevalence and associated factors of tuberculosis in prisons settings of East Gojjam Zone, Northwest Ethiopia. International Journal of Bacteriology 2017;2017:3826980. - PMC - PubMed
Gupta‐Wright 2018 {published data only}
    1. Gupta-Wright A, Corbett EL, Oosterhout JJ, Wilson D, Grint D, Alufandika-Moyo M, et al. Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial. Lancet 2018;392(10144):292-301. - PMC - PubMed
Gursoy 2016 {published data only}
    1. Gursoy NC, Yakupogullari Y, Tekerekoglu MS, Otlu B. [Evaluation of the diagnostic performance of Xpert MTB/RIF test for the detection of Mycobacterium tuberculosis and rifampin resistance in clinical samples]. Mikrobiyoloji Bulteni 2016;50(2):196-204. - PubMed
Habeenzu 2017 {published data only}
    1. Habeenzu C, Nakajima C, Solo E, Bwalya P, Kajino K, Miller M, et al. Evaluation of in-house loop-mediated isothermal amplification for tuberculosis diagnosis compared with Xpert MTB/RIF. Journal of Infection in Developing Countries 2017;11(6):440-4. - PubMed
Habte 2016 {published data only}
    1. Habte D, Melese M, Hiruy N, Gashu Z, Jerene D, Moges F, et al. The additional yield of GeneXpert MTB/RIF test in the diagnosis of pulmonary tuberculosis among household contacts of smear positive TB cases. International Journal of Infectious Diseases 2016;49:179-84. - PubMed
Hanifa 2016 {published data only}
    1. Hanifa Y, Fielding KL, Chihota VN, Adonis L, Charalambous S, Karstaedt A, et al. Diagnostic accuracy of lateral flow urine LAM assay for TB screening of adults with advanced immunosuppression attending routine HIV care in South Africa. PLOS One 2016;11(6):e0156866. - PMC - PubMed
Head 2019 {published data only}
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Hiruy 2018 {published data only}
    1. Hiruy N, Melese M, Habte D, Jerene D, Gashu Z, Alem G, et al. Comparison of the yield of tuberculosis among contacts of multidrug-resistant and drug-sensitive tuberculosis patients in Ethiopia using GeneXpert as a primary diagnostic test. International Journal of Infectious Diseases 2018;71:4-8. - PubMed
Ho 2016 {published data only}
    1. Ho J, Nguyen PT, Nguyen TA, Tran KH, Van Nguyen S, Nguyen NV, et al. Reassessment of the positive predictive value and specificity of Xpert MTB/RIF: a diagnostic accuracy study in the context of community-wide screening for tuberculosis. Lancet Infectious Diseases 2016;16(9):1045-51. - PubMed
Hosseinipour 2016 {published data only}
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Huang 2018 {published data only}
    1. Huang H, Zhang Y, Li S, Wang J, Chen J, Pan Z, et al. Rifampicin resistance and multidrug-resistant tuberculosis detection using Xpert MTB/RIF in Wuhan, China: a retrospective study. Microbial Drug Resistance 2018;24(5):675-9. - PubMed
Huerga 2020 {published data only}
    1. Huerga H, Cossa L, Manhiça I, Bastard M, Telnov A, Molfino L, et al. Systematic, point-of-care urine lipoarabinomannan (Alere TB-LAM) assay for diagnosing tuberculosis in severely immunocompromised HIV-Positive ambulatory patients. American Journal of Tropical Medicine and Hygiene 2020;102(3):562-6. - PMC - PubMed
Huh 2019 {published data only}
    1. Huh HJ, Song DJ, Ki CS, Lee NY. Is cross-reactivity with nontuberculous mycobacteria a systematic problem in the Xpert MTB/RIF assay? Tuberculosis and Respiratory Diseases 2019;82(1):88-9. - PMC - PubMed
Kamenska 2019 {published data only}
    1. Kamenska N, Nabirova D, Davtyan K, Davtyan H, Zachariah R, Aslanyan G. Strategies for active detection of tuberculosis in Ukraine: Comparative effectiveness amongst key populations (2014-2018). Journal of Infection in Developing Countries 2019;13(7.1):89s-94s. - PubMed
Kerkhoff 2014 {published data only}
    1. Kerkhoff AD, Wood R, Vogt M, Lawn SD. Prognostic value of a quantitative analysis of lipoarabinomannan in urine from patients with HIV-associated tuberculosis. PLOS One 2014;9(7):e103285. - PMC - PubMed
Kurbaniyazova 2017 {published data only}
    1. Kurbaniyazova G, Joncevska M, Kalon S, Kalmambetova G, Mohr T, Toktogonova A, et al. Results of Xpert MTB/RIF implementation in Kyrgyzstan. International Journal of Tuberculosis and Lung Disease 2017;21(3):333-7. - PubMed
Kuyinu 2018 {published data only}
    1. Kuyinu YA, Odugbemi BA, Salisu-Olatunji SO, Adepoju FO, Odusanya OO. Characteristics of Mycobacterium tuberculosis positive patients screened for drug-resistant tuberculosis at a tertiary health facility in Lagos, Nigeria. Journal of the National Medical Association 2018;110(1):88-91. - PubMed
LaCourse 2014 {published data only}
    1. LaCourse SM, Chester FM, Preidis G, McCrary LM, Arscott-Mills T, Maliwichi M, et al. Use of Xpert for the diagnosis of pulmonary tuberculosis in severely malnourished hospitalized Malawian children. Pediatric Infectious Disease Journal 2014;33(11):1200-2. - PMC - PubMed
LaCourse 2018 {published data only}
    1. LaCourse SM, Pavlinac PB, Cranmer LM, Njuguna IN, Mugo C, Gatimu J, et al. Stool Xpert MTB/RIF and urine lipoarabinomannan for the diagnosis of tuberculosis in hospitalized HIV-infected children. AIDS 2018;32(1):69-78. - PMC - PubMed
Lawn 2012a {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clinical Infectious Diseases 2012;54(8):1071-9. - PMC - PubMed
Lawn 2012b {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. AIDS 2012;26(13):1635-43. - PubMed
Lawn 2013 {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. HIV-associated tuberculosis: relationship between disease severity and the sensitivity of new sputum-based and urine-based diagnostic assays. BMC Medicine 2013;11:231. - PMC - PubMed
Lawn 2015 {published data only}
    1. Lawn SD, Kerkhoff AD, Burton R, Schutz C, Wyk G, Vogt M, et al. Rapid microbiological screening for tuberculosis in HIV-positive patients on the first day of acute hospital admission by systematic testing of urine samples using Xpert MTB/RIF: a prospective cohort in South Africa. BMC Medicine 2015;13:192. - PMC - PubMed
Lawn 2017 {published data only}
    1. Lawn SD, Kerkhoff AD, Burton R, Schutz C, Boulle A, Vogt M, et al. Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort. BMC Medicine 2017;15(1):67. - PMC - PubMed
Lebina 2016 {published data only}
    1. Lebina L, Fuller N, Osoba T, Scott L, Motlhaoleng K, Rakgokong M, et al. The Use of Xpert MTB/Rif for active case finding among TB contacts in North West Province, South Africa. Tuberculosis Research and Treatment 2016;2016:4282313. - PMC - PubMed
Lima 2020 {published data only}
    1. Lima F, Santos AS, Oliveira RD, Silva CC, Goncalves CC, Andrews JR, et al. Oral swab testing by Xpert(R) MTB/RIF Ultra for mass tuberculosis screening in prisons. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2020;19:100148. - PMC - PubMed
Luo 2019 {published data only}
    1. Luo J, Luo M, Li J, Yu J, Yang H, Yi X, et al. Rapid direct drug susceptibility testing of Mycobacterium tuberculosis based on culture droplet digital polymerase chain reaction. International Journal of Tuberculosis and Lung Disease 2019;23(2):219-25. - PubMed
Maria 2018 {published data only}
    1. Maria MC, Rosarys MR, Misleidis SA, Grechen GL, Secretario CT, Raul DR. Diagnostic importance of "GeneXpert Mtb-Rif" in patients infected by the human immunodeficiency virus (HIV) [Spanish]. Archivos Venezolanos de Farmacologia y Terapeutica 2018;37(4):355-8.
Marks 2019 {published data only}
    1. Marks GB, Nguyen NV, Nguyen PT, Nguyen TA, Nguyen HB, Tran KH, et al. Community-wide screening for tuberculosis in a high-prevalence setting. New England Journal of Medicine 2019;381(14):1347-57. - PubMed
Marlowe 2011 {published data only}
    1. Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, et al. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Journal of Clinical Microbiology 2011;49(4):1621-3. - PMC - PubMed
Mbatchou 2019 {published data only}
    1. Mbatchou Ngahane B, Gaping Simen S, Halle M, Okalla C, Goupeyou Wandji IA. Prevalence of tuberculosis and its factors among patients on maintenance dialysis in Douala, Cameroon. American Journal of Respiratory and Critical Care Medicine. Conference 2019;201(Meeting abstracts):A5146.
Mbu 2018 {published data only}
    1. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BM, Morgan KL, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: Burden, comparative screening and diagnostic yields, and patient outcomes. PLOS One 2018;13(6):e0199634. - PMC - PubMed
Meng 2017 {published data only}
    1. Meng C, Shen Y, Wang J, Wang S, Chen X, Yu S, et al. A two-step algorithm for rapid diagnosis of active pulmonary tuberculosis in entry applicants using the T-SPOT.TB and Xpert MTB/RIF assays in Shanghai, China. Emerging Microbes & Infections 2017;6(7):e67. - PMC - PubMed
Metcalfe 2015 {published data only}
    1. Metcalfe JZ, Makumbirofa S, Makamure B, Mutetwa R, Penaloza RA, Sandy C, et al. Suboptimal specificity of Xpert MTB/RIF among treatment-experienced patients. European Respiratory Journal 2015;45(5):1504-6. - PMC - PubMed
Metcalfe 2016 {published data only}
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Miller 2011 {published data only}
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Mishra 2020 {published data only}
    1. Mishra H, Reeve BW, Palmer Z, Caldwell J, Dolby T, Naidoo CC. Xpert MTB/RIF Ultra and Xpert MTB/RIF for diagnosis of tuberculosis in an HIV-endemic setting with a high burden of previous tuberculosis: a two-cohort diagnostic accuracy study. Lancet Respiratory Medicine 2020;8(4):368-82. - PubMed
Modi 2016 {published data only}
    1. Modi S, Cavanaugh JS, Shiraishi RW, Alexander HL, McCarthy KD, Burmen B, et al. Performance of clinical screening algorithms for tuberculosis intensified case finding among people living with HIV in Western Kenya. PLOS One 2016;11(12):e0167685. - PMC - PubMed
Morishita 2017 {published data only}
    1. Morishita F, Garfin AM, Lew W, Oh KH, Yadav RP, Reston JC, et al. Bringing state-of-the-art diagnostics to vulnerable populations: the use of a mobile screening unit in active case finding for tuberculosis in Palawan, the Philippines. PLOS One 2017;12(2):e0171310. - PMC - PubMed
Nathavitharana 2017 {published data only}
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Nicol 2018 {published data only}
    1. Nicol MP, Workman L, Prins M, Bateman L, Ghebrekristos Y, Mbhele S, et al. Accuracy of Xpert MTB/RIF Ultra for the diagnosis of pulmonary tuberculosis in children. Pediatric Infectious Disease Journal 2018;37(10):e261-e3. - PubMed
Nikolayevskyy 2019 {published data only}
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Ou 2019 {published data only}
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Ozkutuk 2014 {published data only}
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Parcell 2017 {published data only}
    1. Parcell BJ, Jarchow-MacDonald AA, Seagar AL, Laurenson IF, Prescott GJ, Lockhart M. Three year evaluation of Xpert MTB/RIF in a low prevalence tuberculosis setting: a Scottish perspective. Journal of Infection 2017;74(5):466-72. - PubMed
Park 2013 {published data only}
    1. Park KS, Kim JY, Lee JW, Hwang YY, Jeon K, Koh WJ, et al. Comparison of the Xpert MTB/RIF and Cobas TaqMan MTB assays for detection of Mycobacterium tuberculosis in respiratory specimens. Journal of Clinical Microbiology 2013;51(10):3225-7. - PMC - PubMed
Pimkina 2015 {published data only}
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Ramamurthy 2016 {published data only}
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Reepalu 2016 {published data only}
    1. Reepalu A, Balcha TT, Skogmar S, Güner N, Sturegård E, Björkman P. Factors associated with early mortality in HIV-positive men and women investigated for tuberculosis at Ethiopian health centers. PLOS One 2016;11(6):e0156602. - PMC - PubMed
Reis 2019 {published data only}
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Sarinoglu 2020 {published data only}
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Semitala 2019 {published data only}
    1. Semitala FC, Cattamanchi A, Andama A, Atuhumuza E, Katende J, Mwebe S, et al. Brief report: yield and efficiency of intensified tuberculosis case-finding algorithms in 2 high-risk HIV subgroups in Uganda. Journal of Acquired Immune Deficiency Syndromes 2019;82(4):416-20. - PMC - PubMed
Shah 2019 {published data only}
    1. Shah I, Bhamre R, Shetty NS. Accuracy of Xpert Mycobacterium tuberculosis/rifampicin assay in diagnosis of pulmonary tuberculosis. Infectious Diseases 2019;51(7):550-3. - PubMed
Sun 2019 {published data only}
    1. Sun DF, Zheng LL, Jin F, Wang MS. Evaluation of the double sputum Xpert tests for the diagnosis of pulmonary tuberculosis. Infectious Diseases 2019;51(7):541-2. - PubMed
Teo 2011 {published data only}
    1. Teo J, Jureen R, Chiang D, Chan D, Lin R. Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF assay and the amplified Mycobacterium tuberculosis direct assay, for detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Journal of Clinical Microbiology 2011;49(10):3659-62. - PMC - PubMed
Trajman 2014 {published data only}
    1. Trajman A, Durovni B, Saraceni V, Cordeiro-Santos M, Cobelens F, den Hof S. High positive predictive value of Xpert in a low rifampicin resistance prevalence setting. European Respiratory Journal 2014;44(6):1711-3. - PubMed
van Kampen 2015 {published data only}
    1. Kampen SC, Tursynbayeva A, Koptleuova A, Murzakhmetova Z, Bigalieva L, Aubakirova M, et al. Effect of introducing Xpert MTB/RIF to test and treat individuals at risk of multidrug-resistant tuberculosis in Kazakhstan: a prospective cohort study. PLOS One 2015;10(7):e0132514. - PMC - PubMed
Van Rie 2011 {published data only}
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Yasemin 2019 {published data only}
    1. Yasemin A, Ahmad S, Afzal S, Ullah A, Sheed A. Evaluation of GeneXpert MTB/RIF assay for detection of pulmonary tuberculosis on sputum samples. Journal of College of Physicians and Surgeons Pakistan 2019;29(1):66-9. - PubMed
Yoon 2019 {published data only}
    1. Yoon C, Semitala FC, Asege L, Katende J, Mwebe S, Andama AO, et al. Yield and efficiency of novel intensified tuberculosis case-finding algorithms for people living with HIV. American Journal of Respiratory and Critical Care Medicine 2019;199(5):643-50. - PMC - PubMed

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