Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa

Hanifa, Y, Fielding, K, Chihota, VN, Adonis, L, Charalambous, S, Karstaedt, A, McCarthy, K, Nicol, MP, Ndlovu, NT, Sahid, F, Churchyard, G and Grant, AD. 2016. Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa. [Online]. Figshare. Available from: https://doi.org/10.1371/journal.pone.0156866.

Hanifa, Y, Fielding, K, Chihota, VN, Adonis, L, Charalambous, S, Karstaedt, A, McCarthy, K, Nicol, MP, Ndlovu, NT, Sahid, F, Churchyard, G and Grant, AD. Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa [Internet]. Figshare; 2016. Available from: https://doi.org/10.1371/journal.pone.0156866.

Hanifa, Y, Fielding, K, Chihota, VN, Adonis, L, Charalambous, S, Karstaedt, A, McCarthy, K, Nicol, MP, Ndlovu, NT, Sahid, F, Churchyard, G and Grant, AD (2016). Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa. [Data Collection]. Figshare. https://doi.org/10.1371/journal.pone.0156866.

Description

Background: We assessed the diagnostic accuracy of Determine TB-LAM (LF-LAM) to screen for tuberculosis among ambulatory adults established in HIV care in South Africa. Methods: A systematic sample of adults attending for HIV care, regardless of symptomatology, were enrolled in the XPHACTOR study, which tested a novel algorithm for prioritising investigation with Xpert MTB/RIF. In this substudy, restricted to participants with enrolment CD4<200x106/l, urine was stored at enrolment for later testing with LF-LAM. Sputum was sent for immediate Xpert MTB/RIF if any of: current cough, fever ≥3 weeks, body mass index (BMI)<18.5kg/m2, CD4<100x106/l (or <200x106/l if pre-ART), weight loss ≥10% or strong clinical suspicion were present; otherwise, sputum was stored for Xpert testing at study completion. Participants were reviewed monthly, with reinvestigation if indicated, to 3 months, when sputum and blood were taken for mycobacterial culture. We defined tuberculosis as “confirmed” if Xpert, line probe assay or culture for M. tuberculosis within six months of enrolment were positive, and “clinical” if tuberculosis treatment started without microbiological confirmation. Results: Amongst 424 participants, 61% were female and 57% were taking ART (median duration 22 months); median age, CD4 and BMI were 39 years, 111x106/l, and 23 kg/m2. 56/424 (13%) participants had tuberculosis (40 confirmed, 16 clinical). 24/424 (5.7%) vs. 8/424 (1.9%) were LAM-positive using grade 1 vs. grade 2 cut-off. Using grade 1 cut-off, sensitivity for confirmed TB (all clinical TB excluded) was 12.5% (95% CI 4.2%, 26.8%) and in CD4<100x106/l vs. CD4 ≥100x106/l was 16.7% (95% CI 4.7%, 37.4%) vs. 6.3% (95% CI 0.2%, 30.2%). Specificity was >95% irrespective of diagnostic reference standard, CD4 stratum, or whether grade 1 or grade 2 cut-off was used. Conclusion: Sensitivity of LF-LAM is too low to recommend as part of intensified case finding in ambulatory patients established in HIV care.

Methods

Data capture method	Experiment: Field Intervention
Date (Date published in a 3rd party system)	7 June 2016
Language(s) of written materials	English

People & Groups

Data Creators	Hanifa, Y, Fielding, K, Chihota, VN, Adonis, L, Charalambous, S, Karstaedt, A, McCarthy, K, Nicol, MP, Ndlovu, NT, Sahid, F, Churchyard, G and Grant, AD
LSHTM Faculty/Department	Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology (-2023) Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Participating Institutions	Study consortium

Projects

Funders

Project	Funder	Grant Number	Funder URI
UNSPECIFIED	Bill & Melinda Gates Foundation	OPP103452	UNSPECIFIED

Additional Information

Date Deposited	16 Jun 2016 10:26
Last Modified	07 Oct 2024 09:08
Publisher	Figshare

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Table1_ParticipantCharacteristics_Tab Download

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Description: Baseline characteristics of study participants (Tab-delimited format)

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Table2_DiagnosticAccuracy_Tab Download

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Description: Diagnostic accuracy of LF-LAM among HIV clinic attendees with CD4<200 (tab-delimited format)

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Description: Diagnostic accuracy of LF-LAM among HIV clinic attendees with CD4<200 (MS Excel format)

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Fig1_XPHACTOR_StudyFlow Download

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Description: XPHACTOR study flow and entry point to the LAM substudy

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Fig3_Kaplan-Meier-Curve Download

Filename: Fig3_Kaplan-Meier-Curve.png

Description: Kaplan-Meier curve comparing mortality between LAM positive (dashed line) and LAM negative (solid line) participants using grade 1 cut-off

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Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa

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Methods

People & Groups

Projects

Additional Information

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Data / Code

Table1_ParticipantCharacteristics_Tab Download

Table1_ParticipantCharacteristics_XLS Download

Table2_DiagnosticAccuracy_Tab Download

Table2_DiagnosticAccuracy_XLS Download

Data Visualisation

Fig1_XPHACTOR_StudyFlow Download

Fig2_StudyParticipants_FlowChart Download

Fig3_Kaplan-Meier-Curve Download

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XPHACTOR datasets

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Associated papers in Research Online