Accuracy of an immune diagnostic assay based on RD1 selected epitopes for active tuberculosis in a clinical setting: A pilot study

D. Goletti, S. Carrara, D. Vincenti, C. Saltini, E. Busi Rizzi, V. Schininà, G. Ippolito, M. Amicosante, E. Girardi

Research output: Contribution to journalArticlepeer-review

Abstract

A previous case-control study reported that an in-vitro interferon (IFN)-γ response to early secreted antigenic target (ESAT)-6 selected peptides was associated with active tuberculosis (A-TB). The objective of the present pilot study was to evaluate the diagnostic accuracy of this assay for TB disease in a clinical setting. An IFN-γ ELISPOT assay was performed on samples from patients with suspected A-TB using two peptides selected from ESAT-6 protein and three peptides selected from culture filtrate 10 (CFP-10) proteins. The results were compared with those obtained by two commercially available assays approved for diagnosis of TB infection (T SPOT-TB and QuantiFERON-TB Gold) which use ESAT-6/CFP-10 (RD1) overlapping peptides. Sensitivity to the RD1 selected peptides was 70% (positive for 16 of 23 patients with microbiologically diagnosed A-TB) and specificity was 91% (positive for three of 32 controls). In contrast, the sensitivity and specificity were 91% and 59%, respectively, for T SPOT-TB, and were 83% and 59%, respectively, for QuantiFERON-TB Gold. The RD1 selected peptides assay had the highest diagnostic odds ratio for A-TB. Thus, the results suggest that an assay based on RD1 selected peptides has a higher diagnostic accuracy for A-TB in a clinical setting compared with commercially available assays based on RD1 overlapping peptides.

Original languageEnglish
Pages (from-to)544-550
Number of pages7
JournalClinical Microbiology and Infection
Volume12
Issue number6
DOIs
Publication statusPublished - Jun 2006

Keywords

  • Diagnosis
  • ELISPOT
  • IFN-γ
  • Immunodiagnosis
  • RD1 selected peptides
  • Tuberculosis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Microbiology

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