Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults

Lydia Nakiyingi; Vineshree Mischka Moodley; Yukari C. Manabe; Mark P. Nicol; Molly Holshouser; Derek T. Armstrong; Widaad Zemanay; Welile Sikhondze; Olive Mbabazi; Bareng A.S. Nonyane; Maunank Shah; Moses L. Joloba; David Alland; Jerrold J. Ellner; Susan E. Dorman

doi:10.1097/QAI.0000000000000151

Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults

Lydia Nakiyingi, Vineshree Mischka Moodley, Yukari C. Manabe, Mark P. Nicol, Molly Holshouser, Derek T. Armstrong, Widaad Zemanay, Welile Sikhondze, Olive Mbabazi, Bareng A.S. Nonyane, Maunank Shah, Moses L. Joloba, David Alland, Jerrold J. Ellner, Susan E. Dorman

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

59 Citations (Scopus)

Abstract

Objective: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (TB LAM) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design: Prospective diagnostic accuracy study. Setting: Hospital and outpatient settings in Uganda and South Africa. Participants: HIV-infected adults with tuberculosis symptoms and/or signs. Methods: Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and 2 respiratory specimens for smear microscopy and mycobacterial culture. Main Outcome Measures: For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results: A total of 1013 participants were enrolled. Among culturepositive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4 ≤100 cells per cubic millimeter. The test was specific in 559/573 (97.6%) patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4 ≤100. CD4 ≤50 [adjusted odds ratio (AOR), 6.2; P

Original language	English
Pages (from-to)	270-279
Number of pages	10
Journal	Journal of Acquired Immune Deficiency Syndromes
Volume	66
Issue number	3
DOIs	https://doi.org/10.1097/QAI.0000000000000151
Publication status	Published - 1 Jul 2014
Externally published	Yes

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Nakiyingi, L., Moodley, V. M., Manabe, Y. C., Nicol, M. P., Holshouser, M., Armstrong, D. T., Zemanay, W., Sikhondze, W., Mbabazi, O., Nonyane, B. A. S., Shah, M., Joloba, M. L., Alland, D., Ellner, J. J., & Dorman, S. E. (2014). Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. Journal of Acquired Immune Deficiency Syndromes, 66(3), 270-279. https://doi.org/10.1097/QAI.0000000000000151

Nakiyingi, Lydia ; Moodley, Vineshree Mischka ; Manabe, Yukari C. ; Nicol, Mark P. ; Holshouser, Molly ; Armstrong, Derek T. ; Zemanay, Widaad ; Sikhondze, Welile ; Mbabazi, Olive ; Nonyane, Bareng A.S. ; Shah, Maunank ; Joloba, Moses L. ; Alland, David ; Ellner, Jerrold J. ; Dorman, Susan E. / Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. In: Journal of Acquired Immune Deficiency Syndromes. 2014 ; Vol. 66, No. 3. pp. 270-279.

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title = "Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults",

abstract = "Objective: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (TB LAM) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design: Prospective diagnostic accuracy study. Setting: Hospital and outpatient settings in Uganda and South Africa. Participants: HIV-infected adults with tuberculosis symptoms and/or signs. Methods: Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and 2 respiratory specimens for smear microscopy and mycobacterial culture. Main Outcome Measures: For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results: A total of 1013 participants were enrolled. Among culturepositive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4 ≤100 cells per cubic millimeter. The test was specific in 559/573 (97.6%) patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4 ≤100. CD4 ≤50 [adjusted odds ratio (AOR), 6.2; P",

keywords = "Diagnosis, HIV, Opportunistic infections, Sensitivity and specificity, Tuberculosis",

author = "Lydia Nakiyingi and Moodley, {Vineshree Mischka} and Manabe, {Yukari C.} and Nicol, {Mark P.} and Molly Holshouser and Armstrong, {Derek T.} and Widaad Zemanay and Welile Sikhondze and Olive Mbabazi and Nonyane, {Bareng A.S.} and Maunank Shah and Joloba, {Moses L.} and David Alland and Ellner, {Jerrold J.} and Dorman, {Susan E.}",

year = "2014",

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doi = "10.1097/QAI.0000000000000151",

language = "English",

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Nakiyingi, L, Moodley, VM, Manabe, YC, Nicol, MP, Holshouser, M, Armstrong, DT, Zemanay, W, Sikhondze, W, Mbabazi, O, Nonyane, BAS, Shah, M, Joloba, ML, Alland, D, Ellner, JJ & Dorman, SE 2014, 'Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults', Journal of Acquired Immune Deficiency Syndromes, vol. 66, no. 3, pp. 270-279. https://doi.org/10.1097/QAI.0000000000000151

Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. / Nakiyingi, Lydia; Moodley, Vineshree Mischka; Manabe, Yukari C.; Nicol, Mark P.; Holshouser, Molly; Armstrong, Derek T.; Zemanay, Widaad; Sikhondze, Welile; Mbabazi, Olive; Nonyane, Bareng A.S.; Shah, Maunank; Joloba, Moses L.; Alland, David; Ellner, Jerrold J.; Dorman, Susan E.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 66, No. 3, 01.07.2014, p. 270-279.

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

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T1 - Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults

AU - Nakiyingi, Lydia

AU - Moodley, Vineshree Mischka

AU - Manabe, Yukari C.

AU - Nicol, Mark P.

AU - Holshouser, Molly

AU - Armstrong, Derek T.

AU - Zemanay, Widaad

AU - Sikhondze, Welile

AU - Mbabazi, Olive

AU - Nonyane, Bareng A.S.

AU - Shah, Maunank

AU - Joloba, Moses L.

AU - Alland, David

AU - Ellner, Jerrold J.

AU - Dorman, Susan E.

PY - 2014/7/1

Y1 - 2014/7/1

N2 - Objective: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (TB LAM) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design: Prospective diagnostic accuracy study. Setting: Hospital and outpatient settings in Uganda and South Africa. Participants: HIV-infected adults with tuberculosis symptoms and/or signs. Methods: Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and 2 respiratory specimens for smear microscopy and mycobacterial culture. Main Outcome Measures: For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results: A total of 1013 participants were enrolled. Among culturepositive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4 ≤100 cells per cubic millimeter. The test was specific in 559/573 (97.6%) patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4 ≤100. CD4 ≤50 [adjusted odds ratio (AOR), 6.2; P

AB - Objective: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (TB LAM) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design: Prospective diagnostic accuracy study. Setting: Hospital and outpatient settings in Uganda and South Africa. Participants: HIV-infected adults with tuberculosis symptoms and/or signs. Methods: Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and 2 respiratory specimens for smear microscopy and mycobacterial culture. Main Outcome Measures: For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results: A total of 1013 participants were enrolled. Among culturepositive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4 ≤100 cells per cubic millimeter. The test was specific in 559/573 (97.6%) patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4 ≤100. CD4 ≤50 [adjusted odds ratio (AOR), 6.2; P

KW - Diagnosis

KW - HIV

KW - Opportunistic infections

KW - Sensitivity and specificity

KW - Tuberculosis

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DO - 10.1097/QAI.0000000000000151

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JO - Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology

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SN - 1525-4135

IS - 3

ER -

Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults

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