Diagnostic Accuracy Study of a Novel Blood-Based Assay for Identification of Tuberculosis in People Living with HIV

Author:

Södersten Erik1,Ongarello Stefano2,Mantsoki Anna2,Wyss Romain2,Persing David H.3,Banderby Sara1,Strömqvist Meuzelaar Linda1,Prieto Jacqueline1,Gnanashanmugam Devasena3,Khatri Purvesh45,Schumacher Samuel G.2ORCID,Denkinger Claudia M.26ORCID

Affiliation:

1. Cepheid AB, Solna, Sweden

2. FIND, Geneva, Switzerland

3. Cepheid, Sunnyvale, California, USA

4. Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford, California, USA

5. Department of Medicine, Division of Biomedical Informatics Research, Stanford University School of Medicine, Stanford, California, USA

6. Division of Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany

Abstract

A nonsputum triage test to rule out tuberculosis (TB) disease is a WHO high-priority diagnostic, and a combinatory score based on a 3-gene host signature has shown promise in discriminating TB from other illnesses. We evaluated the accuracy of an early-prototype cartridge assay (“Xpert MTB Host Response” or Xpert-MTB-HR-Prototype) of this 3-gene signature on biobanked blood samples from people living with HIV (PLHIV) against a comprehensive microbiological reference standard (CMRS) and against Xpert MTB/RIF on the first sputum sample alone.

Funder

HHS | National Institutes of Health

U.S. Department of Defense

Bundesministerium für Bildung und Forschung

Ministerie van Buitenlandse Zaken

Dr. Ralph and Marian Falk Medical Research Trust

Bill and Melinda Gates Foundation

Department of Foreign Affairs and Trade, Australian Government

UK Department for International Development

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference15 articles.

1. World Health Organization. 2014. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. World Health Organization, Geneva, Switzerland.

2. World Health Organization. 2016. Chest radiography in tuberculosis detection—summary of current WHO recommendations and guidance on programmatic approaches. World Health Organization, Geneva, Switzerland.

3. Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?

4. Point-of-care C-reactive protein-based tuberculosis screening for people living with HIV: a diagnostic accuracy study

5. Genome-wide expression for diagnosis of pulmonary tuberculosis: a multicohort analysis

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