Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in HIV-positive adults

Cochrane Database of Systematic Reviews

Volumn 2016, Issue 5, 2016, Pages

  Shah, Maunank ^a   Hanrahan, Colleen ^b   Wang, Zhuo Yu ^c   Dendukuri, Nandini ^c   Lawn, Stephen D ^d   Denkinger, Claudia M ^e   Steingart, Karen R ^f  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c MCGILL UNIVERSITY   (Canada)

^d LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^e FIND ^*  (Switzerland)

^f LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

LIPOARABINOMANNAN; BIOLOGICAL MARKER; LIPOPOLYSACCHARIDE;

ADULT; BAYES THEOREM; CD4 LYMPHOCYTE COUNT; DIAGNOSTIC ACCURACY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; LATERAL FLOW URINE LIPOARABINOMANNAN ASSAY; META ANALYSIS (TOPIC); MYCOBACTERIUM TUBERCULOSIS TEST KIT; NUCLEIC ACID AMPLIFICATION; OUTPATIENT; POINT OF CARE TESTING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SENSITIVITY ANALYSIS; SENSITIVITY AND SPECIFICITY; SPUTUM CYTODIAGNOSIS; SYSTEMATIC REVIEW; TUBERCULOSIS; TUBERCULOSIS RAPID TEST; COMPLICATION; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; META ANALYSIS; POINT OF CARE SYSTEM; TUBERCULOSIS, PULMONARY; URINE;

ADULT; BIOMARKERS; CD4 LYMPHOCYTE COUNT; HIV SEROPOSITIVITY; HUMANS; LIPOPOLYSACCHARIDES; POINT-OF-CARE SYSTEMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SENSITIVITY AND SPECIFICITY; TUBERCULOSIS; TUBERCULOSIS, PULMONARY;

EID: 84966356361     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD011420.pub2     Document Type: Review

References (115)

1. Andrews B, Muchemwa L, Lakhi S, Bwalya M, Mabula C, Chipii G, Heimburger DC, Bernard GR. Validation of a clinical prediction score and performance of urine lipoarabinomannan test for detecting tuberculosis bacteremia in HIV-positive patients with severe sepsis. American Thoracic Society. 2014:A2559.
2. Balcha TT, Winqvist N, Sturegård E, Skogmar S, Reepalu A, Jemal ZH, et al. Detection of lipoarabinomannan in urine for identification of active tuberculosis among HIV-positive adults in Ethiopian health centres. Tropical Medicine & International Health 2014;19(6):734-42.
3. Bjerrum S, Kenu E, Lartey M, Newman MJ, Addo KK, Andersen AB, et al. Diagnostic accuracy of the rapid urine lipoarabinomannan test for pulmonary tuberculosis among HIV-infected adults in Ghana- findings from the DETECT HIV-TB study. BMC Infectious Diseases 2015;15:407.
4. Drain PK, Losina E, Coleman SM, Giddy J, Ross D, Katz JN, et al. Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed HIV-infected adults: a prospective, clinic-based study. BMC Infectious Diseases 2014;14:110.
5. Drain PK, Losina E, Coleman SM, Giddy J, Ross D, Katz JN, et al. Value of urine lipoarabinomannan grade and second test for optimising clinic-based screening for HIV-associated pulmonary tuberculosis. Journal of Acquired Immune Deficiency Syndromes 2015;68(3):274-80.
6. Drain P, Grobler A, Gounder L, Sahid F, Wilson D, Bassett I, et al. Rapid urine lipoarabinomannan testing after two months of tuberculosis treatment independently predicts mortality in a resource-limited setting. 44th World Conference on Lung Health of the International Union Against Tuberculosis and Lung Disease. Paris, 2013; Vol. 17 (Suppl 2):S264.
7. LaCourse SM, Cranmer LM, Matemo D, Richardson B, Kinuthia J, John-Stewart G, et al. Active tuberculosis case finding in HIV-infected pregnant women in Kenya reveals poor performance of symptom screening and rapid diagnostic tests. Journal of Acquired Immune Deficiency Syndromes 2016;71(2):219-27.
8. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Diagnostic accuracy of a low-cost, urine antigen, point-of-care screening assay for HIV-associated pulmonary tuberculosis before antiretroviral therapy: a descriptive study. Lancet Infectious Diseases 2012;12(3):201-9.
9. Lawn SD, Kerkhoff A, Burton R, Schutz C, van Wyk G, Vogt M, et al. Massive diagnostic yield of HIV-associated tuberculosis using rapid urine assays in South Africa. Conference on Retroviruses and Opportunistic Infections (CROI). Boston (MA), 2014.
10. Nakiyingi L, Moodley VM, Manabe YC, Nicol MP, Holshouser M, Armstrong DT, et al. Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. Journal of Acquired Immune Deficiency Syndromes 2014;66(3):270-9.
11. Peter JG, Theron G, van Zyl-Smit R, Haripersad A, Mottay L, Kraus S, et al. Diagnostic accuracy of a urine lipoarabinomannan strip-test for TB detection in HIV-infected hospitalised patients. European Respiratory Journal 2012;40(5):1211-20.
12. Peter J, Theron G, Chanda D, Clowes P, Rachow A, Lesosky M, et al. Test characteristics and potential impact of the urine LAM lateral flow assay in HIV-infected outpatients under investigation for TB and able to self-expectorate sputum for diagnostic testing. BMC Infectious Diseases 2015;15:262.
13. Achkar JM, Lawn SD, Moosa MY, Wright CA, Kasprowicz VO. Adjunctive tests for diagnosis of tuberculosis: serology, ELISPOT for site-specific lymphocytes, urinary lipoarabinomannan, string test, and fine needle aspiration. Journal of Infectious Diseases 2011;204(Suppl 4):S1130-41.
14. Agha MA, El-Helbawy RH, El-Helbawy NG, El-Sheak NM. Utility of quantitative analysis of urine lipoarabinomannan in the diagnosis of tuberculosis. Egyptian Journal of Chest Diseases and Tuberculosis 2013;62(3):401-7.
15. Amoudy HA, Al-Asmer ABH, Abul AT, Mustafa AS. Evaluation of complex and defined antigens of Mycobacterium tuberculosis in an IgG-specific ELISA for the diagnosis of tuberculosis. Medical Principles and Practice 1997;6(2):103-9.
16. Boehme C, Molokova E, Minja F, Geis S, Loscher T, Maboko L, et al. Detection of mycobacterial lipoarabinomannan with an antigen-capture ELISA in unprocessed urine of Tanzanian patients with suspected tuberculosis. Transactions of the Royal Society of Tropical Medicine and Hygiene 2005;99(12):893-900.
17. Boyles TH. The pros and cons of urinary lipoarabinomannan testing. AIDS 2012;26(17):2263-4; author reply 2264-5.
18. Chan ED, Reves R, Belisle JT, Brennan PJ, Hahn WE. Diagnosis of tuberculosis by a visually detectable immunoassay for lipoarabinomannan. American Journal of Respiratory and Critical Care Medicine 2000;161(5):1713-9.
19. Cho S-N, Lee J-H, Lee H-Y, Won H-J, Chong Y, Chang J, et al. Detection of Mycobacterium tuberculosis antigens in sputum for the diagnosis of pulmonary tuberculosis. Journal of the Korean Society for Microbiology 1997;32(3):285-91.
20. Conesa-Botella A, Loembé MM, Manabe YC, Worodria W, Mazakpwe D, Luzinda K, et al. Urinary lipoarabinomannan as predictor for the tuberculosis immune reconstitution inflammatory syndrome. Journal of Acquired Immune Deficiency Syndromes 2011;58(5):463-8.
21. Daley P, Michael JS, Hmar P, Latha A, Chordia P, Mathai D, et al. Blinded evaluation of commercial urinary lipoarabinomannan for active tuberculosis: a pilot study. International Journal of Tuberculosis and Lung Disease 2009;13(8):989-95.
22. Deng S, Yuan T, Xia J, Huang H, Cheng X, Chen M. Clinical utility of a combination of lipoarabinomannan, 38-kDa, and 16-kDa antigens as a diagnosis tool for tuberculosis. Diagnostic Microbiology and Infectious Disease 2011;71(1):46-50.
23. Dheda K, Van-Zyl Smit RN, Sechi LA, Badri M, Meldau R, Symons G, et al. Clinical diagnostic utility of IP-10 and LAM antigen levels for the diagnosis of tuberculous pleural effusions in a high burden setting. PLoS One 2009;4(3):e4689.
24. Dheda K, Davids V, Lenders L, Roberts T, Meldau R, Ling D, et al. Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples. PLoS One 2010;5(3):e9848.
25. Elsawy A, Redwan EM. Urine lipoarabinomannan as initial markers for active pulmonary tuberculosis. Australian Journal of Basic and Applied Sciences 2012;6(3):751-5.
26. Gounder CR, Kufa T, Wada NI, Mngomezulu V, Charalambous S, Hanifa Y, et al. Diagnostic accuracy of a urine lipoarabinomannan enzyme-linked immunosorbent assay for screening ambulatory HIV-infected persons for tuberculosis. Journal of Acquired Immune Deficiency Syndromes 2011;58(2):219-23.
27. Hamasur B, Bruchfeld J, Haile M, Pawlowski A, Bjorvatn B, Källenius G, et al. Rapid diagnosis of tuberculosis by detection of mycobacterial lipoarabinomannan in urine. Journal of Microbiological Methods 2001;45(1):41-52.
28. Hanrahan CF, Van Rie A. Urine antigen test for diagnosis of HIV-associated tuberculosis. The Lancet Infectious Diseases 2012;12(11):826.
29. Kashino SS, Pollock N, Napolitano DR, Rodrigues V Jr, Campos-Neto A. Identification and characterization of Mycobacterium tuberculosis antigens in urine of patients with active pulmonary tuberculosis: an innovative and alternative approach of antigen discovery of useful microbial molecules. Clinical and Experimental Immunology 2008;153(1):56-62.
30. Kerkhoff AD, Wood R, Vogt M, Lawn SD. Predictive value of anaemia for tuberculosis in HIV-infected patients in sub-Saharan Africa: an indication for routine microbiological investigation using new rapid assays. Journal of Acquired Immune Deficiency Syndromes 2014;66(1):33-40.
31. Kerkhoff AD, Wood R, Vogt M, Lawn SD. Prognostic value of a quantitative analysis of lipoarabinomannan in urine from patients with HIV-associated tuberculosis. PLoS One 2014;9(7):e103285.
32. Koulchin VA, Boehme C, Molokova E, Turecheck C, Hoelscher M, Perkins M, et al. Evaluation of the detection of urinary lipoarabinomannan as a tool for diagnosis of mycobacterial infections. Abstracts of the General Meeting of the American Society for Microbiology 2007;107:174-5.
33. Kroidl I, Clowes P, Mwakyelu J, Maboko L, Kiangi A, Rachow A, et al. Reasons for false-positive lipoarabinomannan ELISA results in a Tanzanian population. Scandinavian Journal of Infectious Diseases 2014;46(2):144-8.
34. Lawn SD, Edwards DJ, Kranzer K, Vogt M, Bekker LG, Wood R. Urine lipoarabinomannan assay for tuberculosis screening before antiretroviral therapy diagnostic yield and association with immune reconstitution disease. AIDS 2009;23(14):1875-80.
35. Lawn SD. Point-of-care detection of lipoarabinomannan (LAM) in urine for diagnosis of HIV-associated tuberculosis: a state of the art review. BMC Infectious Diseases 2012;12:103.
36. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. AIDS 2012;26(13):1635-43.
37. Lawn SD, Wood R. Point-of-care urine antigen screening tests for tuberculosis and cryptococcosis: potential for mortality reduction in antiretroviral treatment programs in Africa. Clinical Infectious Diseases 2012;54(5):739-40.
38. Lawn SD, Kerkhoff AD, Vogt M, Wood R. HIV-associated tuberculosis: relationship between disease severity and the sensitivity of new sputum-based and urine-based diagnostic assays. BMC Medicine 2013;11:231.
39. Lawn SD, Kerkhoff AD, Burton R, Meintjes G. Underestimation of the incremental diagnostic yield of HIV-associated tuberculosis in studies of the Determine TB-LAM Ag urine assay. AIDS 2014;28(12):1846-8.
40. Manabe YC, Nonyane BA, Nakiyingi L, Mbabazi O, Lubega G, Shah M, et al. Point-of-care lateral flow assays for tuberculosis and cryptococcal antigenuria predict death in HIV infected adults in Uganda. PLoS One 2014;9(7):e101459.
41. Mukundan H, Kumar S, Price DN, Ray SM, Lee YJ, Min S, et al. Rapid detection of Mycobacterium tuberculosis biomarkers in a sandwich immunoassay format using a waveguide-based optical biosensor. Tuberculosis (Edinburgh, Scotland) 2012;92(5):407-16.
42. Mutetwa R, Boehme C, Dimairo M, Bandason T, Munyati SS, Mangwanya D, et al. Diagnostic accuracy of commercial urinary lipoarabinomannan detection in African tuberculosis suspects and patients. International Journal of Tuberculosis and Lung Disease 2009;13(10):1253-9.
43. Patel VB, Bhigjee AI, Paruk HF, Singh R, Meldau R, Connolly C, et al. Utility of a novel lipoarabinomannan assay for the diagnosis of tuberculous meningitis in a resource-poor high-HIV prevalence setting. Cerebrospinal Fluid Research 2009;6:13.
44. Patel VB, Singh R, Connolly C, Kasprowicz V, Zumla A, Ndungu T, et al. Comparison of a clinical prediction rule and a LAM antigen-detection assay for the rapid diagnosis of TBM in a high HIV prevalence setting. PLoS One 2010;5(12):e15664.
45. Peter JG, Haripesad A, Mottay L, Kraus S, Meldau R, Dheda K. The clinical utility of urine lipoarabinomannan and the novel point-of-care lateral flow strip test (Determine TB) for the diagnosis of tuberculosis in hospitalised patients with HIV-related advanced immunosuppression. American Journal of Respiratory and Critical Care Medicine Conference: American Thoracic Society International Conference, ATS 2011;183:A5313.
46. Peter JG, Cashmore TJ, Meldau R, Theron G, van Zyl-Smit R, Dheda K. Diagnostic accuracy of induced sputum LAM ELISA for tuberculosis diagnosis in sputum-scarce patients. International Journal of Tuberculosis and Lung Disease 2012;16(8):1108-12.
47. Peter JG, Theron G, Muchinga TE, Govender U, Dheda K. The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalised patients who are smear-negative or sputum scarce. PLoS One 2012;7(7):e39966.
48. Peter JG, Theron G, Dheda K. Can point-of-care urine LAM strip testing for tuberculosis add value to clinical decision making in hospitalised HIV-infected persons?. PLoS One 2013;8(2):e54875.
49. Reid S, Kancheya N, Kapata N, Kruuner A, Henostroza G, Harris J. Detection of lipoarabinomannan in urine for the diagnosis of tuberculosis in ART clinic enrollees in Lusaka, Zambia. http://www.cidrz.org/past-studies/ (accessed 4 September 2015).
50. Reither K, Saathoff E, Jung J, Minja LT, Kroidl I, Saad E, et al. Low sensitivity of a urine LAM-ELISA in the diagnosis of pulmonary tuberculosis. BMC Infect Diseases 2009;9:141.
51. Sada E, Aguilar D, Torres M, Herrera T. Detection of lipoarabinomannan as a diagnostic test for tuberculosis. Journal of Clinical Microbiology 1992;30(9):2415-8.
52. Savolainen L, Kantele A, Sandboge B, Sirén M, Valleala H, Tuompo R, et al. Modification of Clearview tuberculosis (TB) enzyme-linked immunosorbent assay for TB patients not infected with HIV. Clinical and Vaccine Immunology 2013;20(9):1479-82.
53. Schmidt R, Jacak J, Schirwitz C, Stadler V, Michel G, Marmé N, et al. Single-molecule detection on a protein-array assay platform for the exposure of a tuberculosis antigen. Journal of Proteome Research 2011;10(3):1316-22.
54. Shah M, Variava E, Holmes CB, Coppin A, Golub JE, McCallum J, et al. Diagnostic accuracy of a urine lipoarabinomannan test for tuberculosis in hospitalised patients in a high HIV prevalence setting. Journal of Acquired Immune Deficiency Syndromes 2009;52(2):145-51.
55. Shah M, Martinson NA, Chaisson RE, Martin DJ, Variava E, Dorman SE. Quantitative analysis of a urine-based assay for detection of lipoarabinomannan in patients with tuberculosis. Journal of Clinical Microbiology 2010;48(8):2972-4.
56. Shah M, Dowdy D, Joloba M, Ssengooba W, Manabe YC, Ellner J, et al. Cost-effectiveness of novel algorithms for rapid diagnosis of tuberculosis in HIV-infected individuals in Uganda. AIDS 2013;27(18):2883-92.
57. Shah M, Ssengooba W, Armstrong D, Nakiyingi L, Holshouser M, Ellner JJ, et al. Comparative performance of urinary lipoarabinomannan assays and Xpert MTB/RIF in HIV-infected individuals. AIDS 2014;28(9):1307-14.
58. Singh L, Grover N. Detection of TB antigen by rapid test kit. Medical Journal Armed Forces India 2011;67(2):196-7.
59. Sun D, Dorman S, Shah M, Manabe YC, Moodley VM, Nicol MP, et al. Cost utility of lateral-flow urine lipoarabinomannan for tuberculosis diagnosis in HIV-infected African adults. International Journal of Tuberculosis and Lung Disease 2013;17(4):552-8.
60. Swaminathan S, Rekha VV. Antigen detection as a point-of-care test for TB: the case of lipoarabinomannan. Future Microbiology 2012;7(5):559-64.
61. Talbot E, Munseri P, Teixeira P, Matee M, Bakari M, Lahey T, et al. Test characteristics of urinary lipoarabinomannan and predictors of mortality among hospitalised HIV-infected tuberculosis suspects in Tanzania. PLoS One 2012;7(3):e32876.
62. Tessema TA, Hamasur B, Bjun G, Svenson S, Bjorvatn B. Diagnostic evaluation of urinary lipoarabinomannan at an Ethiopian tuberculosis centre. Scandinavian Journal of Infectious Diseases 2001;33(4):279-84.
63. Tessema TA, Bjune G, Assefa G, Svenson S, Hamasur B, Bjorvatn B. Clinical and radiological features in relation to urinary excretion of lipoarabinomannan in Ethiopian tuberculosis patients. Scandinavian Journal of Infectious Diseases 2002;34(3):167-71.
64. Tessema TA, Bjune G, Hamasur B, Svenson S, Syre H, Bjorvatn B. Circulating antibodies to lipoarabinomannan in relation to sputum microscopy, clinical features and urinary anti-lipoarabinomannan detection in pulmonary tuberculosis. Scandinavian Journal of Infectious Diseases 2002;34(2):97-103.
65. Tlali M, Fielding K, Charalambous S, Karat A, Hoffmann C, Johnson S, et al. Sensitivity of the TB Determine LAM test compared to sputum culture gold standard TB in ambulant HIV positive participants enrolled in the TB fast track study in South Africa. 4th South African TB Conference. Durban, 2014.
66. Van Rie A, Jong E, Mkhwanazi M, Sanne I. Diagnosing TB in those hardest to diagnose: urine lipoarabinomannan for suspects of disseminated and extrapulmonary TB. Conference on Retroviruses and Opportunistic Infections (CROI). Atlanta (GA), 2013:443.
67. Wood R, Racow K, Bekker LG, Middelkoop K, Vogt M, Kreiswirth BN, et al. Lipoarabinomannan in urine during tuberculosis treatment: association with host and pathogen factors and mycobacteriuria. BMC Infect Diseases 2012;12:47.
68. NCT01990274 . The utility of intensified case finding combined with a package of novel TB diagnostics performed at community-based-clinics in South Africa - a multi-centric prospective cohort study (XACT study). https://clinicaltrials.gov/ct2/show/NCT01990274?term=xact&rank=2 (accessed 04 September 2015).
69. Grant A. Xpert MTB/Rif for people attending HIV care: an interventional cohort study to guide rational implementation (XPHACTOR). http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=10&ved=0ahUKEwj5tLmS-JvMAhUKRCYKHRClA2sQFghBMAk&url=http%3A%2F%2Fwww.auruminstitute.org%2Findex.php%3Foption%3Dcom_k2%26view%3Ditem%26task%3Ddownload%26id%3D36_7c17257dd9dc8861a916a708f6613af8&usg=AFQjCNF7uy6NicdwmPpa-FbGGDfjEmMpvQ (accessed 4 April 2016).
70. TM TB LAM Ag Product Information. http://www.alere.com/ww/en/product-details/determine-tb-lam.html (accessed 16 November 2014).
71. Bartlett JG. Tuberculosis and HIV infection: partners in human tragedy. Journal of Infectious Diseases 2007;196(Suppl 1):S124-5.
72. Batz HG, Cooke GS, Reid SD. Towards lab-free tuberculosis diagnosis. August 2011. http://www.msfaccess.org/sites/default/files/MSF_assets/TB/Docs/TB_Report_TowardsLabFreeTBDX_2011_ENG.pdf. London: Imperial College, (accessed 16 November 2014).
73. Cain KP, McCarthy KD, Heilig CM, Monkongdee P, Tasaneeyapan T, Kanara N, et al. An algorithm for tuberculosis screening and diagnosis in people with HIV. New England Journal of Medicine 2010;362(8):707-16.
74. Chu H, Chen S, Louis TA. Random effects models in a meta-analysis of the accuracy of two diagnostic tests without a gold standard. Journal of the American Statistical Association 2009;104(486):512-23.
75. Dowdy D. A review of cost-effectiveness analyses of LF-LAM for TB diagnosis among people living with HIV [personal communication]. Email to: M Shah. 4 September 2015.
76. Drain PK, Gounder L, Grobler A, Sahid F, Bassett IV, Moosa MY. Urine lipoarabinomannan to monitor antituberculosis therapy response and predict mortality in an HIV-endemic region: a prospective cohort study. BMJ Open 2015;5(4):e006833.
77. Getahun H, Harrington M, O'Brien R, Nunn P. Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet 2007;369(9578):2042-9.
78. Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clinical Infectious Diseases 2010;50(Suppl 3):S201-7.
79. Getahun H, Kittikraisak W, Heilig CM, Corbett EL, Ayles H, Cain KP, et al. Development of a standardized screening rule for tuberculosis in people living with HIV in resource-constrained settings: individual participant data meta-analysis of observational studies. PLoS Medicine 2011;8(1):e1000391.
80. McMaster University (developed by Evidence Prime, Inc.). GRADEpro GDT: GRADEpro Guideline Development Tool. McMaster University (developed by Evidence Prime, Inc.), 2015.
81. Gupta RK, Lucas SB, Fielding KL, Lawn SD. Prevalence of tuberculosis in post-mortem studies of HIV-infected adults and children in resource-limited settings: a systematic review and meta-analysis. AIDS 2015;29(15):1987-2002.
82. Havlir DV, Getahun H, Sanne I, Nunn P. Opportunities and challenges for HIV care in overlapping HIV and TB epidemics. Journal of the American Medical Association 2008;300(4):423-30.
83. Kwan CK, Ernst JD. HIV and tuberculosis: a deadly human syndemic. Clinical Microbiology Reviews 2011;24(2):351-76.
84. Lawn SD, Dheda K, Kerkhoff AD, Peter JG, Dorman S, Boehme CC, et al. Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies. BMC Infectious Diseases 2013;13:407.
85. Lawn SD, Kerkhoff AD, Nicol PM, Meintjes G. Underestimation of the true specificity of the urine lipoarabinomannan (LAM) point-of-care diagnostic assay for HIV-associated tuberculosis. Journal of Acquired Immune Deficiency Syndromes 2015;69(4):e144-6.
86. Lunn DJ, Thomas A, Best N, Spiegelhalter D. WinBUGS - a Bayesian modelling framework: concepts, structure, and extensibility. Statistics and Computing 2000;10:325-37.
87. Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Chapter 10: Analysing and Presenting Results. In: Deeks JJ, Bossuyt PM, Gatsonis C (editors), Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration, 2010. Available from http://srdta.cochrane.org/.
88. Minion J, Leung E, Talbot E, Dheda K, Pai M, Menzies D. Diagnosing tuberculosis with urine lipoarabinomannan: systematic review and meta-analysis. European Respiratory Journal 2011;38(6):1398-405.
89. Novielli N, Sutton AJ, Cooper NJ. Meta-analysis of the accuracy of two diagnostic tests used in combination: application to the ddimer test and the wells score for the diagnosis of deep vein thrombosis. Value Health 2013;16(4):619-28.
90. Pai NP, Pai M. Point-of-care diagnostics for HIV and tuberculosis: landscape, pipeline, and unmet needs. Discovery Medicine 2012;13(68):35-45.
91. Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. Journal of Infectious Diseases 2007;196(Suppl 1):S15-27.
92. Peter J, Green C, Hoelscher M, Mwaba P, Zumla A, Dheda K. Urine for the diagnosis of tuberculosis: current approaches, clinical applicability, and new developments. Current Opinion of Pulmonary Medicine 2010;16(3):262-70.
93. Peter JG, Theron G, van Zyl-Smit R, Haripersad A, Mottay L, Kraus S, et al. Diagnostic accuracy of a urine lipoarabinomannan strip-test for TB detection in HIV-infected hospitalised patients. European Respiratory Journal 2012;40(5):1211-20.
94. Peter JG, Zijenah LS, Chanda D, Clowes P, Lesosky M, Gina P, et al. Effect on mortality of point-of-care, urine-based lipoarabinomannan testing to guide tuberculosis treatment initiation in HIV-positive hospital inpatients: a pragmatic, parallel-group, multicountry, open-label, randomised controlled trial. Lancet 2016;387(10024):1187-97.
95. R Development Core Team. R: A language and environment for statistical computing. Version 3.2.1. Vienna: R Foundation for Statistical Computing, 2015.
96. Reitsma JB, Glas AS, Rutjes AW, Scholten RJ, Bossuyt PM, Zwinderman AH. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. Journal of Clinical Epidemiology 2005;58(10):982-90.
97. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
98. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008;336(7653):1106-11.
99. Schünemann H, Brozek J, Guyatt G, Oxman A, editors. The GRADE Working Group. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html (accessed 12 April 2016).
100. Siddiqi K, Lambert ML, Walley J. Clinical diagnosis of smear-negative pulmonary tuberculosis in low-income countries: the current evidence. Lancet Infectious Diseases 2003;3(5):288-96.
101. StataCorp . Stata Statistical Software. Version 13. Texas: StataCorp LP, 2011.
102. Steingart KR, Henry M, Ng V, Hopewell PC, Ramsay A, Cunningham J, et al. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infectious Diseases 2006;6(9):570-81.
103. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. [DOI: 10.1002/14651858.CD009593.pub3]
104. TB CARE I. International Standards for Tuberculosis Care, Edition 3. TB Care 1, The Hague. http://www.who.int/tb/publications/ISTC_3rdEd.pdf?ua=1 (accessed 16 Nov 2014):1-87.
105. Trikalinos TA, Hoaglin DC, Schmid CH. An empirical comparison of univariate and multivariate meta-analyses for categorical outcomes. Statistics in Medicine 2014;33(9):1441-59.
106. Vacek PM. The effect of conditional dependence on the evaluation of diagnostic tests. Biometrics 1985;41(4):959-68.
107. Weyer K, Carai S, Nunn P. Viewpoint TB diagnostics: what does the world really need?. Journal of Infectious Diseases 2011;204(Suppl 4):S1196-202.
108. Whalen C, Horsburgh CR, Hom D, Lahart C, Simberkoff M, Ellner J. Accelerated course of human immunodeficiency virus infection after tuberculosis. American Journal of Respiratory and Critical Care Medicine 1995;151(1):129-35.
109. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine 2011;155(8):529-36.
110. World Health Organization. Global tuberculosis report 2015. WHO/HTM/TB/2015.22. Global tuberculosis report 2015. WHO/HTM/TB/2015.22. Geneva: World Health Organization, 2015.
111. World Health Organization. The use of lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis and screening of active tuberculosis in people living with HIV. Policy guidance. WHO/HTM/TB/2015.25. Geneva: World Health Organization, 2015.
112. World Health Organization. Systematic screening for active tuberculosis: principles and recommendations. WHO/HTM/TB/2013.04. Systematic screening for active tuberculosis: principles and recommendations. WHO/HTM/TB/2013.04. Geneva: World Health Organization, 2013.
113. World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system for the diagnosis of pulmonary and extrapulmonary TB in adults and children: policy update. WHO/HTM/TB/2013.16. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system for the diagnosis of pulmonary and extrapulmonary TB in adults and children: policy update. WHO/HTM/TB/2013.16. Geneva: World Health Organization, 2013.
114. World Bank. World Bank List of Economies. http://data.worldbank.org/country. Washington (District of Columbia): World Bank, (accessed 10 February 2014).
115. Shah M, Hanrahan C, Wang ZY, Steingart KR, Lawn SD, Denkinger C, et al. Urine lateral flow lipoarabinomannan assay for diagnosing active tuberculosis in adults living with HIV. Cochrane Database of Systematic Reviews 2014, Issue 12. [DOI: 10.1002/14651858.CD011420]