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

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dc.contributor.authorLawn, Stephen D
dc.contributor.authorKerkhoff, Andrew D
dc.contributor.authorBurton, Rosie
dc.contributor.authorSchutz, Charlotte
dc.contributor.authorBoulle, Andrew
dc.contributor.authorVogt, Monica
dc.contributor.authorGupta-Wright, Ankur
dc.contributor.authorNicol, Mark P
dc.contributor.authorMeintjes, Graeme
dc.date.accessioned2021-10-08T06:54:43Z
dc.date.available2021-10-08T06:54:43Z
dc.date.issued2017
dc.description.abstractAbstract Background We previously reported that one-third of HIV-positive adults requiring medical admission to a South African district hospital had laboratory-confirmed tuberculosis (TB) and that almost two-thirds of cases could be rapidly diagnosed using Xpert MTB/RIF-testing of concentrated urine samples obtained on the first day of admission. Implementation of urine-based, routine, point-of-care TB screening is an attractive intervention that might be facilitated by use of a simple, low-cost diagnostic tool, such as the Determine TB-LAM lateral-flow rapid test for HIV-associated TB. Methods Sputum, urine and blood samples were systematically obtained from unselected HIV-positive adults within 24 hours of admission to a South African township hospital. Additional clinical samples were obtained during hospitalization as clinically indicated. TB was defined by the detection of Mycobacterium tuberculosis in any sample using Xpert MTB/RIF or liquid culture. The diagnostic yield, accuracy and prognostic value of urine-lipoarabinomannan (LAM) testing were determined, but urine-LAM results did not inform treatment decisions. Results Consecutive HIV-positive adult acute medical admissions not already receiving TB treatment (n = 427) were enrolled regardless of clinical presentation or symptoms. TB was diagnosed in 139 patients (TB prevalence 32.6%; median CD4 count 80 cells/μL). In the first 24 hours of admission, sputum (spot and/or induced) samples were obtained from 37.0% of patients and urine samples from 99.5% of patients (P < 0.001). The diagnostic yields from these specimens were 19.4% (n = 27/139) for sputum-microscopy, 26.6% (n = 37/139) for sputum-Xpert, 38.1% (n = 53/139) for urine-LAM and 52.5% (n = 73/139) for sputum-Xpert/urine-LAM combined (P < 0.01). Corresponding yields among patients with CD4 counts <100 cells/μL were 18.9%, 24.3%, 55.4% and 63.5%, respectively (P < 0.01). The diagnostic yield of urine-LAM was unrelated to respiratory symptoms, and LAM assay specificity (using a grade-2 cut-off) was 98.9% (274/277; 95% confidence interval [CI] 96.9–99.8). Among TB cases, positive urine-LAM status was strongly associated with mortality at 90 days (adjusted hazard ratio 4.20; 95% CI 1.50–11.75). Conclusions Routine testing for TB in newly admitted HIV-positive adults using Determine TB-LAM to test urine provides major incremental diagnostic yield with very high specificity when used in combination with sputum testing and has important utility among those without respiratory TB symptoms and/or unable to produce sputum. The assay also rapidly identifies individuals with a poor prognosis.
dc.identifier.apacitationLawn, S. D., Kerkhoff, A. D., Burton, R., Schutz, C., Boulle, A., Vogt, M., ... Meintjes, G. (2017). 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. <i>BMC Medicine</i>, 15(1), 174 - 177. http://hdl.handle.net/11427/34321en_ZA
dc.identifier.chicagocitationLawn, Stephen D, Andrew D Kerkhoff, Rosie Burton, Charlotte Schutz, Andrew Boulle, Monica Vogt, Ankur Gupta-Wright, Mark P Nicol, and Graeme Meintjes "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." <i>BMC Medicine</i> 15, 1. (2017): 174 - 177. http://hdl.handle.net/11427/34321en_ZA
dc.identifier.citationLawn, S.D., Kerkhoff, A.D., Burton, R., Schutz, C., Boulle, A., Vogt, M., Gupta-Wright, A. & Nicol, M.P. et al. 2017. 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. <i>BMC Medicine.</i> 15(1):174 - 177. http://hdl.handle.net/11427/34321en_ZA
dc.identifier.issn1741-7015
dc.identifier.ris TY - Journal Article AU - Lawn, Stephen D AU - Kerkhoff, Andrew D AU - Burton, Rosie AU - Schutz, Charlotte AU - Boulle, Andrew AU - Vogt, Monica AU - Gupta-Wright, Ankur AU - Nicol, Mark P AU - Meintjes, Graeme AB - Abstract Background We previously reported that one-third of HIV-positive adults requiring medical admission to a South African district hospital had laboratory-confirmed tuberculosis (TB) and that almost two-thirds of cases could be rapidly diagnosed using Xpert MTB/RIF-testing of concentrated urine samples obtained on the first day of admission. Implementation of urine-based, routine, point-of-care TB screening is an attractive intervention that might be facilitated by use of a simple, low-cost diagnostic tool, such as the Determine TB-LAM lateral-flow rapid test for HIV-associated TB. Methods Sputum, urine and blood samples were systematically obtained from unselected HIV-positive adults within 24 hours of admission to a South African township hospital. Additional clinical samples were obtained during hospitalization as clinically indicated. TB was defined by the detection of Mycobacterium tuberculosis in any sample using Xpert MTB/RIF or liquid culture. The diagnostic yield, accuracy and prognostic value of urine-lipoarabinomannan (LAM) testing were determined, but urine-LAM results did not inform treatment decisions. Results Consecutive HIV-positive adult acute medical admissions not already receiving TB treatment (n = 427) were enrolled regardless of clinical presentation or symptoms. TB was diagnosed in 139 patients (TB prevalence 32.6%; median CD4 count 80 cells/μL). In the first 24 hours of admission, sputum (spot and/or induced) samples were obtained from 37.0% of patients and urine samples from 99.5% of patients (P < 0.001). The diagnostic yields from these specimens were 19.4% (n = 27/139) for sputum-microscopy, 26.6% (n = 37/139) for sputum-Xpert, 38.1% (n = 53/139) for urine-LAM and 52.5% (n = 73/139) for sputum-Xpert/urine-LAM combined (P < 0.01). Corresponding yields among patients with CD4 counts <100 cells/μL were 18.9%, 24.3%, 55.4% and 63.5%, respectively (P < 0.01). The diagnostic yield of urine-LAM was unrelated to respiratory symptoms, and LAM assay specificity (using a grade-2 cut-off) was 98.9% (274/277; 95% confidence interval [CI] 96.9–99.8). Among TB cases, positive urine-LAM status was strongly associated with mortality at 90 days (adjusted hazard ratio 4.20; 95% CI 1.50–11.75). Conclusions Routine testing for TB in newly admitted HIV-positive adults using Determine TB-LAM to test urine provides major incremental diagnostic yield with very high specificity when used in combination with sputum testing and has important utility among those without respiratory TB symptoms and/or unable to produce sputum. The assay also rapidly identifies individuals with a poor prognosis. DA - 2017 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Medicine LK - https://open.uct.ac.za PY - 2017 SM - 1741-7015 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/34321 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34321
dc.identifier.vancouvercitationLawn 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):174 - 177. http://hdl.handle.net/11427/34321.en_ZA
dc.language.isoeng
dc.publisher.departmentDepartment of Medicine
dc.publisher.facultyFaculty of Health Sciences
dc.sourceBMC Medicine
dc.source.journalissue1
dc.source.journalvolume15
dc.source.pagination174 - 177
dc.source.urihttps://dx.doi.org/10.1186/s12916-017-0822-8
dc.subject.otherAfrica
dc.subject.otherDetermine TB-LAM
dc.subject.otherDiagnosis
dc.subject.otherHIV
dc.subject.otherHospital
dc.subject.otherLAM
dc.subject.otherLipoarabinomannan
dc.subject.otherScreening
dc.subject.otherTuberculosis
dc.subject.otherUrine
dc.subject.otherXpert
dc.subject.otherAdult
dc.subject.otherDiagnostic Tests, Routine
dc.subject.otherFemale
dc.subject.otherHIV Infections
dc.subject.otherHumans
dc.subject.otherLipopolysaccharides
dc.subject.otherMale
dc.subject.otherPoint-of-Care Testing
dc.subject.otherPredictive Value of Tests
dc.subject.otherPrevalence
dc.subject.otherPrognosis
dc.subject.otherProspective Studies
dc.subject.otherSensitivity and Specificity
dc.subject.otherSouth Africa
dc.subject.otherTuberculosis
dc.titleDiagnostic 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
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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