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

222 32 2048 3 7063 document 2048 Fig1_XPHACTOR_StudyFlow.png image/png 5db6108fcdaf1b5c60ebf5dd2e9bdaf14e903574f563b4e7184f6604a263192a SHA256 325268 2016-06-16 10:17:11 https://datacompass.lshtm.ac.uk/id/eprint/222/1/Fig1_XPHACTOR_StudyFlow.png 222 1 1 image/png Image en public cc_by

Fig1_XPHACTOR_StudyFlow.png

data_visualisation indefinite XPHACTOR study flow and entry point to the LAM substudy 2049 2 7065 document 2049 Fig2_StudyParticipants_FlowChart.png image/png 1c91d6c931ae7f3f7ce4446762903929d8ade9492bd73cbd53ed7b7d00f83f45 SHA256 405056 2016-06-16 10:17:14 https://datacompass.lshtm.ac.uk/id/eprint/222/2/Fig2_StudyParticipants_FlowChart.png 222 2 2 image/png Image en public cc_by

Fig2_StudyParticipants_FlowChart.png

data_visualisation indefinite Flow chart of study participants 2050 2 7067 document 2050 Fig3_Kaplan-Meier-Curve.png image/png d56f380bee730705c4df0165bc9b410b690d66f6f472ce0138ba2e463fe29e40 SHA256 36734 2016-06-16 10:17:16 https://datacompass.lshtm.ac.uk/id/eprint/222/3/Fig3_Kaplan-Meier-Curve.png 222 3 3 image/png Image en public cc_by

Fig3_Kaplan-Meier-Curve.png

data_visualisation indefinite Kaplan-Meier curve comparing mortality between LAM positive (dashed line) and LAM negative (solid line) participants using grade 1 cut-off 2051 2 7069 document 2051 Table1_ParticipantCharacteristics_Tab.txt text/plain 024b8fd733889cd762d6888ea6ec5853f0e1b37efc0adf3af1e5dcbcb8eecea2 SHA256 605 2016-06-16 10:17:19 https://datacompass.lshtm.ac.uk/id/eprint/222/4/Table1_ParticipantCharacteristics_Tab.txt 222 4 4 text/plain Dataset en public cc_by

Table1_ParticipantCharacteristics_Tab.txt

data indefinite Baseline characteristics of study participants (Tab-delimited format) 2052 2 7071 document 2052 Table1_ParticipantCharacteristics_XLS.xls application/msword 6b5adc2b033872ff9bc878011eebff1b86b528513697dfded5256cafbd7ce31e SHA256 35328 2016-06-16 10:17:21 https://datacompass.lshtm.ac.uk/id/eprint/222/5/Table1_ParticipantCharacteristics_XLS.xls 222 5 5 application/msword Dataset en public cc_by

Table1_ParticipantCharacteristics_XLS.xls

data indefinite Baseline characteristics of study participants (MS Excel) 2053 2 7073 document 2053 Table2_DiagnosticAccuracy_Tab.txt text/plain 522ff900071d8fd653d3c55a948e1ab2482cad747dbff7d689e727ac03634fc0 SHA256 1458 2016-06-16 10:17:23 https://datacompass.lshtm.ac.uk/id/eprint/222/6/Table2_DiagnosticAccuracy_Tab.txt 222 6 6 text/plain Dataset en public cc_by

Table2_DiagnosticAccuracy_Tab.txt

data indefinite Diagnostic accuracy of LF-LAM among HIV clinic attendees with CD4<200 (tab-delimited format) 2054 2 7075 document 2054 Table2_DiagnosticAccuracy_XLS.xls application/msword dba3845a96120b9986ea69f4a2fcbf8acf2164f880bf420034b2523d6b62235b SHA256 37888 2016-06-16 10:17:25 https://datacompass.lshtm.ac.uk/id/eprint/222/7/Table2_DiagnosticAccuracy_XLS.xls 222 7 7 application/msword Dataset en public cc_by

Table2_DiagnosticAccuracy_XLS.xls

data indefinite Diagnostic accuracy of LF-LAM among HIV clinic attendees with CD4<200 (MS Excel format) 2055 1 7081 document 2055 indexcodes.txt text/plain 102217fadad1563c9cade0e9e505134c515ad9010683268c3600e98499ad4560 SHA256 282 2016-06-16 10:26:34 https://datacompass.lshtm.ac.uk/id/eprint/222/8/indexcodes.txt 222 8 8 text/plain other en public

indexcodes.txt

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2051 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2051 http://eprints.org/relation/isIndexCodesVersionOf https://datacompass.lshtm.ac.uk/id/document/2051 indefinite Generate index codes conversion from Dataset to indexcodes 2056 1 7082 document 2056 indexcodes.txt text/plain b43c0ed0f7836c0d8fcc09df63755f5ab21dc045322d500fc6c26eb25958afc7 SHA256 209 2016-06-16 10:26:34 https://datacompass.lshtm.ac.uk/id/eprint/222/9/indexcodes.txt 222 9 9 text/plain other en public

indexcodes.txt

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2053 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2053 http://eprints.org/relation/isIndexCodesVersionOf https://datacompass.lshtm.ac.uk/id/document/2053 indefinite Generate index codes conversion from Dataset to indexcodes 2057 2 7083 document 2057 lightbox.jpg image/png f29c5b172c047aa01abda0d28a2c64fadfe03d4424eb8c91b5175a41a4968e68 SHA256 85283 2016-06-16 10:27:36 https://datacompass.lshtm.ac.uk/id/eprint/222/10/lightbox.jpg 222 10 10 image/png other en public

lightbox.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/islightboxThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 indefinite Thumbnails conversion from Image to thumbnail_lightbox 2058 2 7084 document 2058 preview.jpg image/png a724a099f32a00577dc95b17a8629cbe5a4e9bc2c4b1cb656d43195e059e8f18 SHA256 42630 2016-06-16 10:27:37 https://datacompass.lshtm.ac.uk/id/eprint/222/11/preview.jpg 222 11 11 image/png other en public

preview.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/ispreviewThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 indefinite Thumbnails conversion from Image to thumbnail_preview 2059 2 7085 document 2059 medium.jpg image/png 1e3c97438340a7ecba27187d87c00b6629f8501ce0c4eafc7f230f343bfb4e28 SHA256 16763 2016-06-16 10:27:37 https://datacompass.lshtm.ac.uk/id/eprint/222/12/medium.jpg 222 12 12 image/png other en public

medium.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/ismediumThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 indefinite Thumbnails conversion from Image to thumbnail_medium 2060 2 7086 document 2060 small.jpg image/png 4cba439f3d1f136fa8cb6cfafe22dee47fcf1d35fc2406b52c237a8bf00c661f SHA256 3199 2016-06-16 10:27:37 https://datacompass.lshtm.ac.uk/id/eprint/222/13/small.jpg 222 13 13 image/png other en public

small.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 http://eprints.org/relation/issmallThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2050 indefinite Thumbnails conversion from Image to thumbnail_small 2061 2 7087 document 2061 lightbox.jpg image/png 301fc0866501f84ef605223678b256a49e1ebc5944cf1b9b607821ef862a52eb SHA256 61584 2016-06-16 10:27:39 https://datacompass.lshtm.ac.uk/id/eprint/222/14/lightbox.jpg 222 14 14 image/png other en public

lightbox.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/islightboxThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 indefinite Thumbnails conversion from Image to thumbnail_lightbox 2062 2 7088 document 2062 preview.jpg image/png 33be5712e52164b89f4d1d748615344b9dec2630b26071bc1dffe3d09f3d3c64 SHA256 30875 2016-06-16 10:27:41 https://datacompass.lshtm.ac.uk/id/eprint/222/15/preview.jpg 222 15 15 image/png other en public

preview.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/ispreviewThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 indefinite Thumbnails conversion from Image to thumbnail_preview 2063 2 7089 document 2063 medium.jpg image/png c80f561fef32ccf2133c03a57ab7568106345e3d5c654640e6c022da34ad604a SHA256 11199 2016-06-16 10:27:41 https://datacompass.lshtm.ac.uk/id/eprint/222/16/medium.jpg 222 16 16 image/png other en public

medium.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/ismediumThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 indefinite Thumbnails conversion from Image to thumbnail_medium 2064 2 7090 document 2064 small.jpg image/png ea374edb7878683ef0cd7e824b48460fc35407bb38a7ebc9ffdb4f804f6b2071 SHA256 2551 2016-06-16 10:27:42 https://datacompass.lshtm.ac.uk/id/eprint/222/17/small.jpg 222 17 17 image/png other en public

small.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 http://eprints.org/relation/issmallThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2049 indefinite Thumbnails conversion from Image to thumbnail_small 2065 2 7091 document 2065 lightbox.jpg image/png 8ba6506ea5571c13c6caa457699e0ca01ebbaf8cbeda1d276f7d0144cc449ec1 SHA256 66122 2016-06-16 10:27:44 https://datacompass.lshtm.ac.uk/id/eprint/222/18/lightbox.jpg 222 18 18 image/png other en public

lightbox.jpg

preview.jpg

medium.jpg

small.jpg

http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/2048 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/2048 http://eprints.org/relation/issmallThumbnailVersionOf https://datacompass.lshtm.ac.uk/id/document/2048 indefinite Thumbnails conversion from Image to thumbnail_small archive 3 disk0/00/00/02/22 2016-06-16 10:26:11 2024-10-07 09:08:16 2016-06-16 10:26:11 data_collection show 1 Hanifa Yasmeen TRUE 3882e45254c93d8b35981d46f7986775 Fielding Katherine 0000-0002-6524-3754 TRUE 0aa3885fd6201076535210a253a38f98 Chihota Violet N. FALSE Adonis Lungiswa FALSE Charalambous Salome FALSE Karstaedt Alan FALSE McCarthy Kerrigan FALSE Nicol Mark P. FALSE Ndlovu Nontobeko T. FALSE Sahid Faieza FALSE Churchyard Gavin TRUE 285da50b2e6269d09abfbeb49da9092d Grant Alison D. 0000-0002-2437-5195 TRUE b0df4f9b5b9ba10639ecece0cb30bd4f Study consortium Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa EPID ITCR Tuberculosis HIV diagnosis and management Tuberculosis diagnosis and management Mycobacterium tuberculosis Sputum Urine Antiretroviral therapy Weight loss 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. 2016-06-07 published Figshare 10.1371/journal.pone.0156866 Dataset Study consortium Experiment.FieldIntervention http://purl.org/dc/terms/isPartOf /id/eprint/790 public Bill & Melinda Gates Foundation Dataset Quantitative OPP103452 en Figshare digital collection https://figshare.com/collections/Diagnostic_Accuracy_of_Lateral_Flow_Urine_LAM_Assay_for_TB_Screening_of_Adults_with_Advanced_Immunosuppression_Attending_Routine_HIV_Care_in_South_Africa/3268076 data Diagnostic Accuracy of Lateral Flow Urine LAM Assay for TB Screening of Adults with Advanced Immunosuppression Attending Routine HIV Care in South Africa. http://researchonline.lshtm.ac.uk/id/eprint/2550805 Bill & Melinda Gates Foundation OPP103452 2016-06-07