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  • Performance of host blood transcriptomic signatures for diagnosing and predicting progression to tuberculosis disease in HIV-negative adults and adolescents: a systematic review protocol

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Public health
Protocol
Performance of host blood transcriptomic signatures for diagnosing and predicting progression to tuberculosis disease in HIV-negative adults and adolescents: a systematic review protocol
  1. Humphrey Mulenga1,
  2. Erick Wekesa Bunyasi1,
  3. Stanley Kimbung Mbandi1,
  4. Simon C Mendelsohn1,
  5. Benjamin Kagina2,
  6. Adam Penn-Nicholson1,
  7. Thomas Scriba1,
  8. Mark Hatherill1
  1. 1 South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Department of Pathology, University of Cape Town, Faculty of Health Sciences, Cape Town, Western Cape, South Africa
  2. 2 Vaccines For Africa (VACFA), University of Cape Town, Faculty of Health Sciences, Cape Town, Western Cape, South Africa
  1. Correspondence to Dr Mark Hatherill; mark.hatherill{at}uct.ac.za

Abstract

Introduction One-quarter of the global population, including the majority of adults in tuberculosis (TB) endemic countries, are estimated to be Mycobacterium tuberculosis (MTB) infected. An estimated 10 million new TB cases occurred in 2017. One of the biggest challenges confronting TB control is the lack of accurate diagnosis and prediction of prevalent and incident TB disease, respectively. Several host blood transcriptomic messenger RNA (mRNA) signatures that reflect the host immune response following infection with MTB and progression to TB disease in different study populations have recently been published, but these TB biomarkers have not been systematically described. We will conduct a systematic review of the performance of host blood transcriptional signatures for TB diagnosis and prediction of progression to TB disease.

Methods and analysis This systematic review will involve conducting a comprehensive literature search of cohort, case–control, cross-sectional and randomised-controlled studies of the performance of host blood transcriptomic signatures for TB diagnosis and prediction of progression to TB disease. We will search Medline via PubMed, Scopus, Web of Science and EBSCO libraries, complemented by a search of bibliographies of selected articles for other relevant articles. The literature search will be restricted to studies published in English from 2005 to 2018 and conducted in HIV-uninfected adults and adolescents (≥12 years old). Forest plots and a narrative synthesis of the findings will be provided. The primary outcomes will be sensitivity, specificity, as well as true/false positives and true/false negatives. Heterogeneity resulting from differences in the design, composition and structure of individual signatures will preclude meta-analysis and pooling of results.

Ethics and dissemination Ethics approval is not required for this systematic review protocol. The results of this review will be disseminated through a peer-reviewed journal as well as conference presentations.

PROSPERO registration number CRD42017073817.

  • tuberculosis
  • sensitivity and specificity
  • transcriptomic
  • signature

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-026612

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    Footnotes

    • TS and MH contributed equally.

    • Contributors MH and TS conceived the study. HM wrote the protocol under supervision from MH and TS. HM, EWB, SKM, SCM, BK, AP-N, TS and MH, reviewed, revised and approved the final version of protocol and will be involved in analysis and interpretation of the results.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests TS and AP-N are inventors of blood transcriptomic signatures of risk of TB.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.