RESEARCH ARTICLE
The Diagnostic Accuracy of Urine Lipoarabinomannan Test for Tuberculosis Screening in a South African Correctional Facility Yasmeen Hanifa1*, Lilanganee Telisinghe1,2, Katherine L. Fielding3, Justin L. Malden1,2, Gavin J. Churchyard1,2,3, Alison D. Grant3, Salome Charalambous1,4 1 Aurum Institute, Johannesburg, South Africa, 2 CAPRISA, University of KwaZulu-Natal, Durban, South Africa, 3 London School of Hygiene & Tropical Medicine, London, United Kingdom, 4 School of Public Health, University of Witwatersrand, Johannesburg, South Africa * [email protected]
OPEN ACCESS Citation: Hanifa Y, Telisinghe L, Fielding KL, Malden JL, Churchyard GJ, Grant AD, et al. (2015) The Diagnostic Accuracy of Urine Lipoarabinomannan Test for Tuberculosis Screening in a South African Correctional Facility. PLoS ONE 10(5): e0127956. doi:10.1371/journal.pone.0127956 Academic Editor: Delia Goletti, National Institute for Infectious Diseases (L. Spallanzani), ITALY Received: September 8, 2014 Accepted: April 21, 2015 Published: May 26, 2015 Copyright: © 2015 Hanifa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: Data are available at http://dx.doi.org/10.6084/m9.figshare.1399199. Funding: Participants in this study were enrolled in treatment programmes supported by the U.S. President’s Emergency Plan for AIDS Relief and by Cooperative Agreement Number PS024055 from the Department of Health and Human Services/Centers for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Global AIDS Program (GAP). The content of this manuscript are solely the responsibility of the authors and do not necessarily
Abstract Background We evaluated the diagnostic accuracy of the urine lipoarabinomannan (LAM) antigen detection assay (Clearview TB-ELISA) to screen for tuberculosis in a South African correctional facility.
Methods Between September 2009 and October 2010, male offenders were screened for tuberculosis (symptoms, chest radiograph, two spot sputum specimens for microscopy and culture), and urine tested for LAM. Sensitivity, specificity and predictive values of LAM were calculated using definite and probable tuberculosis combined as our gold standard.
Findings 33/871 (3.8%) participants (26% HIV-positive) had tuberculosis. Amongst HIV-positive vs. HIV-negative offenders the sensitivity and specificity of LAM was 7.1% vs. 0% and 98.5% vs. 99.8% respectively.
Conclusion Urine LAM ELISA has inadequate sensitivity for TB screening in this population.
Introduction Incarcerated populations worldwide suffer disproportionately high risk of both tuberculosis (TB) [1] and HIV infection,[2] a potent risk factor for TB. In response to the burden of
PLOS ONE | DOI:10.1371/journal.pone.0127956 May 26, 2015
1/5
Urine LAM Test for TB in a Correctional Facility
represent the official views of CDC. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist.
tuberculosis and HIV in its correctional facilities, South Africa recently published national guidelines recommending symptom-based TB screening for all inmates bi-annually, on entry, exit or transfer, and self-presentation, with GeneXpert MTB/RIF as the initial diagnostic test for those requiring further evaluation.[3] Tests for lipoarabinomannan (LAM), a cell wall lipopolysaccharide specific to mycobacteria that is detectable in urine, are a potentially attractive screening tool for correctional facilities, given the potential for rapid TB diagnosis, the low infection risk posed and ease of sample collection. Evaluations of a commercially available urine LAM ELISA (Clearview TB-ELISA; Alere, USA) have demonstrated sensitivity of 21–38% for culture-proven TB in HIV-positive individuals, [4, 5] which increases to 67% in those with CD4 cell counts
The Diagnostic Accuracy of Urine Lipoarabinomannan Test for Tuberculosis Screening in a South African Correctional Facility Yasmeen Hanifa1*, Lilanganee Telisinghe1,2, Katherine L. Fielding3, Justin L. Malden1,2, Gavin J. Churchyard1,2,3, Alison D. Grant3, Salome Charalambous1,4 1 Aurum Institute, Johannesburg, South Africa, 2 CAPRISA, University of KwaZulu-Natal, Durban, South Africa, 3 London School of Hygiene & Tropical Medicine, London, United Kingdom, 4 School of Public Health, University of Witwatersrand, Johannesburg, South Africa * [email protected]
OPEN ACCESS Citation: Hanifa Y, Telisinghe L, Fielding KL, Malden JL, Churchyard GJ, Grant AD, et al. (2015) The Diagnostic Accuracy of Urine Lipoarabinomannan Test for Tuberculosis Screening in a South African Correctional Facility. PLoS ONE 10(5): e0127956. doi:10.1371/journal.pone.0127956 Academic Editor: Delia Goletti, National Institute for Infectious Diseases (L. Spallanzani), ITALY Received: September 8, 2014 Accepted: April 21, 2015 Published: May 26, 2015 Copyright: © 2015 Hanifa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: Data are available at http://dx.doi.org/10.6084/m9.figshare.1399199. Funding: Participants in this study were enrolled in treatment programmes supported by the U.S. President’s Emergency Plan for AIDS Relief and by Cooperative Agreement Number PS024055 from the Department of Health and Human Services/Centers for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Global AIDS Program (GAP). The content of this manuscript are solely the responsibility of the authors and do not necessarily
Abstract Background We evaluated the diagnostic accuracy of the urine lipoarabinomannan (LAM) antigen detection assay (Clearview TB-ELISA) to screen for tuberculosis in a South African correctional facility.
Methods Between September 2009 and October 2010, male offenders were screened for tuberculosis (symptoms, chest radiograph, two spot sputum specimens for microscopy and culture), and urine tested for LAM. Sensitivity, specificity and predictive values of LAM were calculated using definite and probable tuberculosis combined as our gold standard.
Findings 33/871 (3.8%) participants (26% HIV-positive) had tuberculosis. Amongst HIV-positive vs. HIV-negative offenders the sensitivity and specificity of LAM was 7.1% vs. 0% and 98.5% vs. 99.8% respectively.
Conclusion Urine LAM ELISA has inadequate sensitivity for TB screening in this population.
Introduction Incarcerated populations worldwide suffer disproportionately high risk of both tuberculosis (TB) [1] and HIV infection,[2] a potent risk factor for TB. In response to the burden of
PLOS ONE | DOI:10.1371/journal.pone.0127956 May 26, 2015
1/5
Urine LAM Test for TB in a Correctional Facility
represent the official views of CDC. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist.
tuberculosis and HIV in its correctional facilities, South Africa recently published national guidelines recommending symptom-based TB screening for all inmates bi-annually, on entry, exit or transfer, and self-presentation, with GeneXpert MTB/RIF as the initial diagnostic test for those requiring further evaluation.[3] Tests for lipoarabinomannan (LAM), a cell wall lipopolysaccharide specific to mycobacteria that is detectable in urine, are a potentially attractive screening tool for correctional facilities, given the potential for rapid TB diagnosis, the low infection risk posed and ease of sample collection. Evaluations of a commercially available urine LAM ELISA (Clearview TB-ELISA; Alere, USA) have demonstrated sensitivity of 21–38% for culture-proven TB in HIV-positive individuals, [4, 5] which increases to 67% in those with CD4 cell counts
