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Peer reviewedOpen accessTuberculosis

Diagnostic and prognostic accuracy of the Mycobacterium tuberculosis host response 3-gene cartridge among tuberculosis household contacts in Mozambique, Tanzania, and Zimbabwe: a prospective, longitudinal, diagnostic and prognostic accuracy cohort study

The Lancet Infectious Diseases·

Leyla Larsson, Ioana Diana Olaru, Anna-Lisa Behnke, Edson T Marambire, Martha Chipinduro, Claire J Calderwood, Denise Banze, Alfred Mfinanga, Celina Nhamuave, Harieth L Mwambola, Kathrin Held, Rishi K Gupta, Lillian T Minja, Celso Khosa, Norbert Heinrich, Katharina Kranzer, Tejaswi Appalarowthu, Candido Azize, Tsitsi Bandason, Denise Floripes Banze, Anna-Lisa Behnke, Claire J. Calderwood, Martha Chipinduro, Hazel Dockrell, Nyanda Elias Ntinginya, Christof Geldmacher, Norbert Heinrich, Kathrin Held, Gunilla Källenius, Fungai Kavenga, Celso Khosa, Abisai Kisinda, Katharina Kranzer, Leyla Larsson, Carla Madeira, Beauty Makamure, Forget Makoga, Edson T. Marambire, Alfred Mfinanga, Lilian Tina Minja, Bariki Mtafya, Mishelle Mugava, Kuda Mutasa, Junior Mutsvangwa, Harrieth Mwambola, Sidonia Nhacubangane, Celina Nhamuave, Lilian Njovu, Willyhelmina Olomi, Doreen Pamba, Ursula Panzner, Andrea Rachow, Jorge Ribeiro, Friedrich Rieß, Sandra Rukobo, Issa Sabi, Anna Shepherd, Alice Shoo, Emanuel Sichone, Nadia Sitoe, Lwithio Sudi, Christopher Sundling, Nelson Tembe, Peter Towo, Deepika Zende, Lindsay Zurba

DOI
10.1016/s1473-3099(26)00114-3
PMID
42026013
PMCID
OpenAlex
W7155006547
Study type
Cohort study
Publisher
Elsevier BV
Article type
journal-article
Integrity
current

Why this research matters now

The MTB-HR assay did not meet WHO target product profile criteria for screening or prognostic use, but its positive predictive value exceeded that of currently used tests. The authors suggest the assay may still have a role in tuberculosis screening and prevention strategies for household contacts, a priority population where existing tests perform poorly.

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Structured evidence summary

Research question

The study evaluated whether a host-response assay (MTB-HR) could accurately diagnose tuberculosis in household contacts at the time of screening and predict who would develop incident tuberculosis in the following months.

Study design

This was a prospective, longitudinal cohort study with diagnostic and prognostic accuracy endpoints. Household contacts underwent MTB-HR testing and comprehensive tuberculosis screening every six months for up to 24 months, with diagnoses established by an endpoint review committee.

Population and setting

The study enrolled 2079 household contacts aged 10 years and older living with a person diagnosed with tuberculosis in Mozambique, Tanzania, and Zimbabwe. Contacts who had taken antimycobacterial antibiotics within the past four weeks were excluded.

Main findings

For diagnostic use, the MTB-HR assay achieved an AUROC of 0.86 among 41 household contacts with tuberculosis. For prognostic use, the assay showed declining performance over time: AUROC 0.80 for predicting tuberculosis 1-6 months ahead, 0.64 for 6-12 months, and 0.71 for 1-12 months. At the optimized cutoff for 6-month prediction, the positive predictive value was 7.5%.

Public-health relevance

The MTB-HR assay did not meet WHO target product profile criteria for screening or prognostic use, but its positive predictive value exceeded that of currently used tests. The authors suggest the assay may still have a role in tuberculosis screening and prevention strategies for household contacts, a priority population where existing tests perform poorly.

Important limitations

The abstract does not explicitly state study limitations. This summary is limited to the supplied single-article abstract and metadata; the original paper is required for decision-grade interpretation of methodological constraints, generalizability, and potential biases.

GIDS interpretation

The classifier links indicate this article was discovered through queries related to tuberculosis diagnostics and treatment in Mozambique, Tanzania, and Zimbabwe. This contextualization reflects the article's topical and geographic scope and does not imply association with a live surveillance signal or outbreak.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 12 auditable classifier relationships to diseases, places, topics, and study design.

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