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Blood-based host biomarker diagnostics in active case finding for pulmonary tuberculosis: A diagnostic case-control study.
Moreira, Flora Martinez Figueira; Verma, Renu; Pereira Dos Santos, Paulo Cesar; Leite, Alessandra; da Silva Santos, Andrea; de Araujo, Rafaele Carla Pivetta; da Silva, Bruna Oliveira; de Sá Queiroz, Júlio Henrique Ferreira; Persing, David H; Södersten, Erik; Gnanashanmugam, Devasena; Khatri, Purvesh; Croda, Julio; Andrews, Jason R.
Afiliação
  • Moreira FMF; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • Verma R; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA.
  • Pereira Dos Santos PC; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • Leite A; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • da Silva Santos A; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • de Araujo RCP; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • da Silva BO; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • de Sá Queiroz JHF; Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, MS, Brazil.
  • Persing DH; Cepheid, Sunnyvale, CA, USA.
  • Södersten E; Cepheid AB, Solna, Sweden.
  • Gnanashanmugam D; Cepheid, Sunnyvale, CA, USA.
  • Khatri P; Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford, CA, USA.
  • Croda J; Oswaldo Cruz Foundation, Campo Grande, MS, Brazil.
  • Andrews JR; School of Medicine, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.
EClinicalMedicine ; 33: 100776, 2021 Mar.
Article em En | MEDLINE | ID: mdl-33842866
BACKGROUND: There is a need to identify scalable tuberculosis screening strategies among high burden populations. The WHO has identified a non-sputum-based triage test as a development priority. METHODS: We performed a diagnostic case-control study of point-of-care C-reactive protein (CRP) and Prototype-Xpert-MTB-Host-Response (Xpert-MTB-HR) assays in the context of a mass screening program for tuberculosis in two prisons in Brazil. All incarcerated individuals irrespective of symptoms were screened by sputum Xpert MTB/RIF and sputum culture. Among consecutive, Xpert MTB/RIF or culture-confirmed cases and Xpert MTB/RIF and culture-negative controls, CRP was quantified in serum by a point-of-care assay (iChroma-II) and a 3-gene expression score was quantified from whole blood using the Xpert-MTB-HR cartridge. We evaluated receiver operating characteristic area under the curve (AUC) and assessed specificity at 90% sensitivity and sensitivity at 70% specificity, consistent with WHO target product profile (TPP) benchmarks. FINDINGS: Two hundred controls (no TB) and 100 culture- or Xpert MTB/RIF-positive tuberculosis cases were included. Half of tuberculosis cases and 11% of controls reported any tuberculosis symptoms. AUC for CRP was 0·79 (95% CI: 0·73-0·84) and for Xpert-MTB-HR was 0·84 (95% CI: 0·79-0·89). At 90% sensitivity, Xpert-MTB-HR had significantly higher specificity (53·0%, 95% CI: 45·0-69·0%) than CRP (28·1%, 95% CI: 20·2-41·8%) (p = 0·003), both well below the TPP benchmark of 70%. Among individuals with medium or high sputum Xpert MTB/RIF semi-quantitative load, sensitivity (at 70% specificity) of CRP (90·3%, 95% CI: 74·2-98·0) and Xpert-MTB-HR (96·8%, 95% CI: 83·3-99·9%) was higher. INTERPRETATION: For active case finding in this high tuberculosis-burden setting, CRP and Xpert-MTB-HR did not meet TPP benchmarks for a triage test. However, Xpert-MTB-HR was highly sensitive in detecting individuals with medium or high sputum bacillary burden. FUNDING: National Institutes of Health (R01 AI130058 and R01 AI149620) and Brazilian National Council for Scientific and Technological Development (CNPq-404182/2019-4).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Screening_studies Idioma: En Revista: EClinicalMedicine Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Screening_studies Idioma: En Revista: EClinicalMedicine Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido