Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay

Shubhada Shenai; Danielle Amisano; Katharina Ronacher; Magdalena Kriel; Padmapriya P. Banada; Taeksun Song; Myungsun Lee; Joon Sung Joh; Jill Winter; Rich Thayer; Laura E. Via; Soyeon Kim; Clifton E. Barry; Gerhard Walzl; David Alland

doi:10.1128/JCM.01743-13

Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay

Shubhada Shenai, Danielle Amisano, Katharina Ronacher, Magdalena Kriel, Padmapriya P. Banada, Taeksun Song, Myungsun Lee, Joon Sung Joh, Jill Winter, Rich Thayer, Laura E. Via, Soyeon Kim, Clifton E. Barry, Gerhard Walzl, David Alland

Rutgers, The State University

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

The utility of the GeneXpert MTB/RIF (Xpert) assay for detection of Mycobacterium tuberculosis in sputum samples has been extensively studied. However, the performance of the Xpert assay as applied to other readily accessible body fluids such as exhaled breath condensate (EBC), saliva, urine, and blood has not been established. We used the Xpert assay to test EBC, saliva, urine, and blood samples from HIV-negative, smear- and culture-positive pulmonary tuberculosis (TB) patients for the presence of M. tuberculosis. To compare the ability of the assay to perform bacterial load measurements on sputum samples with versus without sample processing, the assay was also performed on paired direct and processed sputum samples from each patient. The Xpert assay detected M. tuberculosis in none of the 26 EBC samples (sensitivity, 0.0%; 95% confidence interval [95% CI], 0.0%, 12.9%), 10 of the 26 saliva samples (sensitivity, 38.5%; 95% CI, 22.4%, 57.5%), 1 of 26 urine samples (sensitivity, 3.8%; 95% CI, 0.7%, 18.9%), and 2 of 24 blood samples (sensitivity, 8.3%; 95% CI, 2.3%, 25.8%). For bacterial load measurements in the different types of sputum samples, the cycle thresholds of the two M. tuberculosis-positive sputum types were well correlated (Spearman correlation of 0.834). This study demonstrates that the Xpert assay should not be routinely used to detect M. tuberculosis in EBC, saliva, urine, or blood samples from HIV-negative patients suspected of having pulmonary tuberculosis. As a test of bacterial load, the assay produced similar results when used to test direct versus processed sputum samples. Sputum remains the optimal sample type for diagnosing pulmonary tuberculosis in HIV-negative patients with the Xpert assay.

Original language	American English
Pages (from-to)	4161-4166
Number of pages	6
Journal	Journal of clinical microbiology
Volume	51
Issue number	12
DOIs	https://doi.org/10.1128/JCM.01743-13
State	Published - Dec 2013

ASJC Scopus subject areas

Microbiology (medical)

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10.1128/JCM.01743-13

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Shenai, S., Amisano, D., Ronacher, K., Kriel, M., Banada, P. P., Song, T., Lee, M., Joh, J. S., Winter, J., Thayer, R., Via, L. E., Kim, S., Barry, C. E., Walzl, G., & Alland, D. (2013). Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay. Journal of clinical microbiology, 51(12), 4161-4166. https://doi.org/10.1128/JCM.01743-13

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title = "Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay",

abstract = "The utility of the GeneXpert MTB/RIF (Xpert) assay for detection of Mycobacterium tuberculosis in sputum samples has been extensively studied. However, the performance of the Xpert assay as applied to other readily accessible body fluids such as exhaled breath condensate (EBC), saliva, urine, and blood has not been established. We used the Xpert assay to test EBC, saliva, urine, and blood samples from HIV-negative, smear- and culture-positive pulmonary tuberculosis (TB) patients for the presence of M. tuberculosis. To compare the ability of the assay to perform bacterial load measurements on sputum samples with versus without sample processing, the assay was also performed on paired direct and processed sputum samples from each patient. The Xpert assay detected M. tuberculosis in none of the 26 EBC samples (sensitivity, 0.0%; 95% confidence interval [95% CI], 0.0%, 12.9%), 10 of the 26 saliva samples (sensitivity, 38.5%; 95% CI, 22.4%, 57.5%), 1 of 26 urine samples (sensitivity, 3.8%; 95% CI, 0.7%, 18.9%), and 2 of 24 blood samples (sensitivity, 8.3%; 95% CI, 2.3%, 25.8%). For bacterial load measurements in the different types of sputum samples, the cycle thresholds of the two M. tuberculosis-positive sputum types were well correlated (Spearman correlation of 0.834). This study demonstrates that the Xpert assay should not be routinely used to detect M. tuberculosis in EBC, saliva, urine, or blood samples from HIV-negative patients suspected of having pulmonary tuberculosis. As a test of bacterial load, the assay produced similar results when used to test direct versus processed sputum samples. Sputum remains the optimal sample type for diagnosing pulmonary tuberculosis in HIV-negative patients with the Xpert assay.",

author = "Shubhada Shenai and Danielle Amisano and Katharina Ronacher and Magdalena Kriel and Banada, {Padmapriya P.} and Taeksun Song and Myungsun Lee and Joh, {Joon Sung} and Jill Winter and Rich Thayer and Via, {Laura E.} and Soyeon Kim and Barry, {Clifton E.} and Gerhard Walzl and David Alland",

year = "2013",

month = dec,

doi = "10.1128/JCM.01743-13",

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Shenai, S, Amisano, D, Ronacher, K, Kriel, M, Banada, PP, Song, T, Lee, M, Joh, JS, Winter, J, Thayer, R, Via, LE, Kim, S, Barry, CE, Walzl, G & Alland, D 2013, 'Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay', Journal of clinical microbiology, vol. 51, no. 12, pp. 4161-4166. https://doi.org/10.1128/JCM.01743-13

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T1 - Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay

AU - Shenai, Shubhada

AU - Amisano, Danielle

AU - Ronacher, Katharina

AU - Kriel, Magdalena

AU - Banada, Padmapriya P.

AU - Song, Taeksun

AU - Lee, Myungsun

AU - Joh, Joon Sung

AU - Winter, Jill

AU - Thayer, Rich

AU - Via, Laura E.

AU - Kim, Soyeon

AU - Barry, Clifton E.

AU - Walzl, Gerhard

AU - Alland, David

PY - 2013/12

Y1 - 2013/12

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Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the geneXpert MTB/RIF assay

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