Accuracy and incremental yield of urine Xpert MTB/RIF Ultra versus Determine TB-LAM for diagnosis of pulmonary tuberculosis

A Andama¹, D Jaganath², R Crowder³, L Asege⁴, M Nakaye⁴, D Katumba⁴, S Mwebe⁴, F Semitala⁵, W Worodria⁶, M Joloba⁷, S Mohanty⁸, A Somoskovi⁹, A Cattamanchi¹⁰

Affiliations

¹ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Infectious Diseases Research Collaboration, Kampala, Uganda. Electronic address: andama.alf@gmail.com.
² University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; University of California, San Francisco, Department of Pediatrics, Division of Pediatric Infectious Diseases, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA.
³ University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA.
⁴ Infectious Diseases Research Collaboration, Kampala, Uganda.
⁵ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Infectious Diseases Research Collaboration, Kampala, Uganda.
⁶ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Mulago National Referral Hospital, Kampala, Uganda.
⁷ Department of Medical Microbiology, Makerere University College of Health Sciences, Kampala, Uganda.
⁸ University of Utah, Department of Metallurgical Engineering, Department of Chemical Engineering, Salt Lake City, USA.
⁹ Global Good Intellectual Ventures Laboratory, Seattle, USA.
¹⁰ University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; Center for Vulnerable Populations, Department of Medicine, University of California, San Francisco, USA; Curry International Tuberculosis Center, University of California, San Francisco, USA.

PMID: 31727376
PMCID: PMC6906254
DOI: 10.1016/j.diagmicrobio.2019.114892

Comparative Study

Accuracy and incremental yield of urine Xpert MTB/RIF Ultra versus Determine TB-LAM for diagnosis of pulmonary tuberculosis

A Andama et al. Diagn Microbiol Infect Dis. 2020 Jan.

. 2020 Jan;96(1):114892.

doi: 10.1016/j.diagmicrobio.2019.114892. Epub 2019 Sep 4.

Authors

A Andama¹, D Jaganath², R Crowder³, L Asege⁴, M Nakaye⁴, D Katumba⁴, S Mwebe⁴, F Semitala⁵, W Worodria⁶, M Joloba⁷, S Mohanty⁸, A Somoskovi⁹, A Cattamanchi¹⁰

Affiliations

¹ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Infectious Diseases Research Collaboration, Kampala, Uganda. Electronic address: andama.alf@gmail.com.
² University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; University of California, San Francisco, Department of Pediatrics, Division of Pediatric Infectious Diseases, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA.
³ University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA.
⁴ Infectious Diseases Research Collaboration, Kampala, Uganda.
⁵ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Infectious Diseases Research Collaboration, Kampala, Uganda.
⁶ Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Mulago National Referral Hospital, Kampala, Uganda.
⁷ Department of Medical Microbiology, Makerere University College of Health Sciences, Kampala, Uganda.
⁸ University of Utah, Department of Metallurgical Engineering, Department of Chemical Engineering, Salt Lake City, USA.
⁹ Global Good Intellectual Ventures Laboratory, Seattle, USA.
¹⁰ University of California, San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, California, USA; Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; Center for Vulnerable Populations, Department of Medicine, University of California, San Francisco, USA; Curry International Tuberculosis Center, University of California, San Francisco, USA.

PMID: 31727376
PMCID: PMC6906254
DOI: 10.1016/j.diagmicrobio.2019.114892

Abstract

The performance of urine Xpert MTB/RIF Ultra (Xpert Ultra) for pulmonary TB diagnosis is unknown. HIV-positive and HIV-negative adults were enrolled at two health facilities in Kampala, Uganda. We compared the accuracy of urine Xpert Ultra and Determine TB-LAM in reference to sputum-based testing (positive Xpert MTB/RIF or culture), and assessed incremental yield. Urine Xpert Ultra had low sensitivity (17.2%, 95% CI 12.3-23.2) but high specificity (98.1%, 95% CI 94.4-99.6). Sensitivity reached 50.0% (95% CI 28.2-71.8) among HIV-positive patients with CD4 <100 cells/μL. Compared to Determine TB-LAM, urine Xpert Ultra was 9.4% (95% CI 3.8-14.9, P = 0.01) more sensitive, and 17.2% (95% CI 4.5-29.8, P = 0.01) more sensitive among HIV-positive patients. However, the incremental sensitivity of urine Xpert Ultra relative to sputum Xpert MTB/RIF was only 1% (95% CI -0.9 to 2.8). Urine Xpert Ultra could be an alternative for patients with advanced HIV infection unable to produce sputum.

Keywords: Diagnostics; Lipoarabinomannan; Tuberculosis; Urine; Xpert ultra.

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Conflict of interest statement

Declarations of Interest: None

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References

1. Atherton RR, Cresswell FV, Ellis J, Kitaka SB, Boulware DR. Xpert MTB/RIF Ultra for tuberculosis testing in children: A mini-review and commentary. Frontiers in pediatrics 2019;7:34. - PMC - PubMed
1. Atherton RR, Cresswell FV, Ellis J, Skipper C, Tadeo KK, Mugumya G, et al. Detection of Mycobacterium tuberculosis in urine by Xpert MTB/RIF Ultra: A useful adjunctive diagnostic tool in HIV-associated tuberculosis. Int J Infect Dis 2018;75:92–4. - PMC - PubMed
1. Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, et al. The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing. MBio 2017;8(4):e00812–17. - PMC - PubMed
1. Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open 2016;6(11):e012799. - PMC - PubMed
1. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis 2018;18(1):76–84. - PMC - PubMed

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Accuracy and incremental yield of urine Xpert MTB/RIF Ultra versus Determine TB-LAM for diagnosis of pulmonary tuberculosis

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Accuracy and incremental yield of urine Xpert MTB/RIF Ultra versus Determine TB-LAM for diagnosis of pulmonary tuberculosis

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Conflict of interest statement

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