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Guidance for Studies Evaluating the Accuracy of Sputum-Based Tests to Diagnose Tuberculosis

Schumacher, Samuel G, Wells, William A, Nicol, Mark P, Steingart, Karen, Theron, Grant, Dorman, Susan E, Pai, Madhukar, Churchyard, Gavin, Scott, Lesley, Stevens, Wendy, Nabeta, Pamela, Alland, David, Weyer, Karin, Denkinger, Claudia M and Gilpin, Christopher (2019) 'Guidance for Studies Evaluating the Accuracy of Sputum-Based Tests to Diagnose Tuberculosis'. Journal of Infectious Disease, Vol 220, Issue 3, S99-S107.

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Tests that can replace sputum smear microscopy have been identified as a top priority diagnostic need for tuberculosis by the World Health Organization. High-quality evidence on diagnostic accuracy for tests that may meet this need is an essential requirement to inform decisions about policy and scale-up. However, test accuracy studies are often of low and inconsistent quality and poorly reported, leading to uncertainty about true test performance. Here we provide guidance for the design of diagnostic test accuracy studies of sputum smear-replacement tests. Such studies should have a cross-sectional or cohort design, enrolling either a consecutive series or a random sample of patients who require evaluation for tuberculosis. Adults with respiratory symptoms are the target population. The reference standard should at a minimum be a single, automated, liquid culture, but additional cultures, follow-up, clinical case definition, and specific measures to understand discordant results should also be included. Inclusion of smear microscopy and Xpert MTB/RIF (or MTB/RIF Ultra) as comparators is critical to allow broader comparability and generalizability of results, because disease spectrum can vary between studies and affects relative test performance. Given the complex nature of sputum (the primary specimen type used for pulmonary TB), careful design and reporting of the specimen flow is essential. Test characteristics other than accuracy (such as feasibility, implementation considerations, and data on impact on patient, population and health systems outcomes) are also important aspects.

Item Type: Article
Subjects: QY Clinical Pathology > Diagnostic Tests > QY 120 Sputum
WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
Depositing User: Christianne Esparza
Date Deposited: 16 Oct 2019 14:58
Last Modified: 20 Jan 2020 13:12


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