Journal article
Diagnostic performance of tuberculosis-specific IgG antibody profiles in patients with presumptive tuberculosis from two continents.
- Abstract:
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Background
Developing rapid diagnostic tests for tuberculosis (TB) is a global priority. A whole proteome screen identified M. tuberculosis antigens associated with serological responses in TB patients. We used WHO target product profile criteria for a detection test and a triage test to evaluate these antigens in a field-based assay and a reference bead-based assay.
Methods
Consecutive patients presenting to microscopy centers and district hospitals in Peru and to outpatient clinics at a TB reference center in Vietnam, were recruited. We tested blood samples from 755 HIV-uninfected adults with presumptive pulmonary TB to measure IgG antibody responses to 57 M. tuberculosis antigens using a field-based multiplexed serological assay and a 132-antigen reference assay. We evaluated single antigen performance, and models of all possible three-antigen combinations and multi-antigen combinations.
Results
Three-antigen and multi-antigen models performed similarly, and were superior to single antigens. With specificity set at 90% for a detection test, the best sensitivity of a three-antigen model was 35% (95% CI 31-40). With sensitivity set at 85% for a triage test, the specificity of the best three-antigen model was 34% (95% CI 29-40). The reference assay also did not meet study targets. Antigen performance differed significantly between the study sites for 7/22 of the best-performing antigens.
Conclusions
Although M. tuberculosis antigens were recognized by the IgG response during TB, no single antigen or multi-antigen set performance approached WHO target product profile criteria for clinical utility among HIV-uninfected adults with presumed TB in high-volume, urban settings in TB endemic countries.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 5.0MB, Terms of use)
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- Publisher copy:
- 10.1093/cid/cix023
Authors
- Publisher:
- Oxford University Press
- Journal:
- Clinical Infectious Diseases More from this journal
- Volume:
- 64
- Publication date:
- 2017-01-01
- Acceptance date:
- 2017-01-12
- DOI:
- ISSN:
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1537-6591 and 1058-4838
- Language:
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English
- Keywords:
- Pubs id:
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pubs:685240
- UUID:
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uuid:6992da69-416a-4555-8fe1-659a6706f9f7
- Local pid:
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pubs:685240
- Source identifiers:
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685240
- Deposit date:
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2017-05-24
Terms of use
- Copyright holder:
- Basu Roy et al
- Copyright date:
- 2017
- Notes:
- © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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