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Review
. 2021 Nov 25;58(5):2100167.
doi: 10.1183/13993003.00167-2021. Print 2021 Nov.

Tests for tuberculosis infection: landscape analysis

Yohhei Hamada  1 , Daniela Maria Cirillo  2 , Alberto Matteelli  3 , Adam Penn-Nicholson  4 , Molebogeng X Rangaka  5   6   7 , Morten Ruhwald  4   7
Affiliations
Free article
Review

Tests for tuberculosis infection: landscape analysis

Yohhei Hamada et al. Eur Respir J. .
Free article

Abstract

Background: Only the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs), QuantiFERON-TB Gold In-Tube and T-SPOT.TB, are currently endorsed by the World Health Organization as tests for tuberculosis (TB) infection. While IGRAs are more specific than the TST, they require sophisticated laboratory infrastructure and are costly to perform. However, both types of tests have limited performance to predict development of active TB. Tests with improved predictive performance and operational characteristics are needed.

Methods: We reviewed the current landscape of tests for TB infection identified through a web-based survey targeting diagnostic manufacturers globally.

Results: We identified 20 tests for TB infection: 15 in vitro tests and five skin tests. 13 of the in vitro tests are whole-blood IGRAs and 14 use early secreted antigenic target 6 (ESAT-6) and culture filtrate protein 10 (CFP-10), with or without additional antigens. 10 of the tests are based on assays other than an ELISA, such as a fluorescent lateral flow assay that requires less manual operation and shorter assay time and hence is more suitable for decentralisation compared with the existing IGRAs. Four of the five skin tests use ESAT-6 and CFP-10 proteins, while the remaining test uses a new antigen that is specific to Mycobacterium tuberculosis complex.

Conclusions: New tests have the potential to improve accuracy, operational characteristics and end-user access to tests for TB infection. However, published data in various populations and settings are limited for most new tests. Evaluation of these new tests in a standardised design would facilitate their endorsement and programmatic scale-up.

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Conflict of interest statement

Conflict of interest: Y. Hamada has nothing to disclose. Conflict of interest: D.M. Cirillo reports grants from bioMérieux. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: A. Penn-Nicholson reports grants and nonfinancial support from multiple partners, outside the submitted work: FIND has several clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review. FIND has not allocated any financial value to know-how or access to equipment gained through these projects. In addition, A. Penn-Nicholson is an inventor on a patent for prediction of tuberculosis disease risk (WO2017081618A9); rights have been assigned to the University of Cape Town and Seattle Biomed. Conflict of interest: M.X. Rangaka has nothing to disclose. Conflict of interest: M. Ruhwald is an inventor on patents disclosing the use of specific skin tests and IP-10 for the diagnosis of tuberculosis infection (WO2017084671, WO2008028489, WO2012076020 and WO2011137902); all rights have been assigned to Copenhagen University Hospitals and Statens Serum Institut.

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