Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis.

Autor:	Hamada Y; Institute for Global Health, University College London, London, United Kingdom., Gupta RK; Institute for Global Health, University College London, London, United Kingdom., Quartagno M; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom., Izzard A; Institute for Global Health, University College London, London, United Kingdom., Acuna-Villaorduna C; Section of Infectious Diseases, Boston University Medical Center, Boston, MA, USA., Altet N; Unitat de Tuberculosis, Hospital Universitari Vall d'Hebron-Drassanes, Barcelona, Spain.; Unitat de TDO de la Tuberculosis 'Servicios Clínicos', Barcelona, Spain., Diel R; Institute for Epidemiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany., Dominguez J; Institut d'Investigació Germans Trias i Pujol, CIBER Enfermedades Respiratorias, Instituto de Salud Carlos III, Universitat Autònoma de Barcelona, Barcelona, Spain., Floyd S; Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom., Gupta A; Johns Hopkins University School of Medicine, Baltimore, MD, USA., Huerga H; Epicentre, Paris, France., Jones-López EC; Division of Infectious Diseases, Department of Medicine, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA., Kinikar A; Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospital, Pune, Maharashtra, India., Lange C; Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany.; German Center for Infection Research (DZIF), Clinical Tuberculosis Unit, Borstel, Germany.; Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany.; Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.; Tuberculosis Network European Trials Group (TBnet), Borstel, Germany., van Leth F; Tuberculosis Network European Trials Group (TBnet), Borstel, Germany.; Department of Health Sciences, VU University, Amsterdam, the Netherlands.; Amsterdam Public Health research institute, Amsterdam, the Netherlands., Liu Q; Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China., Lu W; Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China., Lu P; Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China., Rueda IL; Institut d'Investigació Germans Trias i Pujol, CIBER Enfermedades Respiratorias, Instituto de Salud Carlos III, Universitat Autònoma de Barcelona, Barcelona, Spain., Martinez L; Department of Epidemiology, School of Public Health, Boston University, Boston, MA, USA., Mbandi SK; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, South Africa, Western Cape, South Africa., Muñoz L; Department of Clinical Sciences, University of Barcelona, Barcelona, Spain., Padilla ES; Epicentre, Paris, France., Paradkar M; Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, Maharashtra, India.; Johns Hopkins India, Pune, Maharashtra, India., Scriba T; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, South Africa, Western Cape, South Africa., Sester M; Tuberculosis Network European Trials Group (TBnet), Borstel, Germany.; Department of Transplant and Infection Immunology, Saarland University, Homburg, Germany., Shanaube K; Zambart, Lusaka, Zambia., Sharma SK; Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.; Department of Molecular Medicine, Jamia Hamdard Institute of Molecular Medicine, Hamdard University, Delhi, India.; Departments of General Medicine & Pulmonary Medicine, JNMC, Datta Meghe Institute of Medical Sciences, Maharashtra, India., Sloot R; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa., Sotgiu G; Tuberculosis Network European Trials Group (TBnet), Borstel, Germany.; Clinical Epidemiology and Medical Statistics Unit, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy., Thiruvengadam K; National Institute for Research in Tuberculosis, Indian Council of Medical Research, Chennai, Tamil Nadu, India., Vashishtha R; Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India., Abubakar I; Institute for Global Health, University College London, London, United Kingdom., Rangaka MX; Institute for Global Health, University College London, London, United Kingdom.; School of Public Health, and Clinical Infectious Disease Research Institute-Africa, University of Cape Town, Cape Town, South Africa.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2023 Jan 05; Vol. 56, pp. 101815. Date of Electronic Publication: 2023 Jan 05 (Print Publication: 2023).
DOI:	10.1016/j.eclinm.2022.101815
Abstrakt:	Background: Evidence on the comparative performance of purified protein derivative tuberculin skin tests (TST) and interferon-gamma release assays (IGRA) for predicting incident active tuberculosis (TB) remains conflicting. We conducted an individual participant data meta-analysis to directly compare the predictive performance for incident TB disease between TST and IGRA to inform policy. Methods: We searched Medline and Embase from 1 January 2002 to 4 September 2020, and studies that were included in previous systematic reviews. We included prospective longitudinal studies in which participants received both TST and IGRA and estimated performance as hazard ratios (HR) for the development of all diagnoses of TB in participants with dichotomised positive test results compared to negative results, using different thresholds of positivity for TST. Secondary analyses included an evaluation of the impact of background TB incidence. We also estimated the sensitivity and specificity for predicting TB. We explored heterogeneity through pre-defined sub-group analyses (e.g. country-level TB incidence). Publication bias was assessed using funnel plots and Egger's test. This review is registered with PROSPERO, CRD42020205667. Findings: We obtained data from 13 studies out of 40 that were considered eligible (N = 32,034 participants: 36% from countries with TB incidence rate ≥100 per 100,000 population). All reported data on TST and QuantiFERON Gold in-Tube (QFT-GIT). The point estimate for the TST was highest with higher cut-offs for positivity and particularly when stratified by bacillus Calmette-Guérin vaccine (BCG) status (15 mm if BCG vaccinated and 5 mm if not [TST 5/15 mm ]) at 2.88 (95% CI 1.69-4.90). The pooled HR for QFT-GIT was higher than for TST at 4.15 (95% CI 1.97-8.75). The difference was large in countries with TB incidence rate <100 per 100,000 population (HR 10.38, 95% CI 4.17-25.87 for QFT-GIT VS. HR 5.36, 95% CI 3.82-7.51 for TST 5/15 mm ) but much of this difference was driven by a single study (HR 5.13, 95% CI 3.58-7.35 for TST 5/15 mm VS. 7.18, 95% CI 4.48-11.51 for QFT-GIT, when excluding the study, in which all 19 TB cases had positive QFT-GIT results). The comparative performance was similar in the higher burden countries (HR 1.61, 95% CI 1.23-2.10 for QFT-GIT VS. HR 1.72, 95% CI 0.98-3.01 for TST 5/15 mm ). The predictive performance of both tests was higher in countries with TB incidence rate <100 per 100,000 population. In the lower TB incidence countries, the specificity of TST (76% for TST 5/15 mm ) and QFT-GIT (74%) for predicting active TB approached the minimum World Health Organization target (≥75%), but the sensitivity was below the target of ≥75% (63% for TST 5/15 mm and 65% for QFT-GIT). The absolute differences in positive and negative predictive values between TST 15 mm and QFT-GIT were small (positive predictive values 2.74% VS. 2.46%; negative predictive values 99.42% VS. 99.52% in low-incidence countries). Egger's test did not show evidence of publication bias (0.74 for TST 15 mm and p = 0.68 for QFT-GIT). Interpretation: IGRA appears to have higher predictive performance than the TST in low TB incidence countries, but the difference was driven by a single study. Any advantage in clinical performance may be small, given the numerically similar positive and negative predictive values. Both IGRA and TST had lower performance in countries with high TB incidence. Test choice should be contextual and made considering operational and likely clinical impact of test results. Funding: YH, IA, and MXR were supported by the National Institute for Health and Care Research (NIHR), United Kingdom (RP-PG-0217-20009). MQ was supported by the Medical Research Council [MC_UU_00004/07]. Competing Interests: YH and MXR report donation of QIAreach, an IGRA, by QIAGEN for a LTBI infection survey. YH, MXR, and IA report donations of Cy-TB, a TB-specific skin test for detection of LTBI, by the Serum Institute of India for a study on the feasibility and patient-important outcomes. They had no role in the submitted work. RD declared the receipt of payment for lectures from Qiagen and Oxford Immunotec. JD declared honoraria for lectures from Oxford Immunotec. AG declared receipt of research grants from the US National Institute of Health (NIH) and membership in NIH Council and IndoUS Science Technology Forum. CL provided consultation service to INSMED and received speakers honoraria from INSMED, GILEAD, JANSSEN and is a member of the Data Safety Board of trials from Medicines sans Frontiers, all outside of the submitted work. ILR has a patent (PCT/EP2019/064885), in vitro method for the diagnosis or detection of non-tuberculous mycobacteria. MS reports receipt of test kits free of charge from Qiagen and Oxford Immunotec. MS also reports receipt of research grants from Biotest and Astellas, consulting fees and honoraria from Biotest, Moderna, Qiagen, and Takeda, support for travel from Biotest, and participation on advisory board for Biotest and Moderna, all outside of this work. GS reports receipt of consulting fees from Pfizer, Diasorin, and INSMED. All other authors declare no competing interests. (© 2022 The Author(s).)
Databáze:	MEDLINE
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