Evaluation of a commercial ligase chain reaction assay for the diagnosis of pulmonary and extra-pulmonary tuberculosis

M. Viveiros, S. Pinheiro, Patrícia Raquel Moreira, Teresa Pacheco, Laura Maria Lourenço Brum da Cruz Martins

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Abstract

SETTING: Egas Moniz Hospital, Lisbon, Portugal. 

OBJECTIVE: To evaluate the Ligase Chain Reaction (LCx®) Mycobacterium tuberculosis Assay for the direct detection of M. tuberculosis complex in respiratory specimens after smear observation, and its suitability for non-respiratory clinical specimens. 

DESIGN: Analysis of 156 specimens collected from 123 patients with pulmonary tuberculosis and/or extrapulmonary involvement. 

RESULTS: Among 93 pulmonary secretions and 63 extra-pulmonary samples and after resolution of discrepancies based on clinical and laboratory findings, two pulmonary samples from a patient with a diagnosis of sarcoidosis, four samples of cerebrospinal and one of seminal fluid were considered as false positives. Two tissue biopsy samples, one pericardial effusion and one pulmonary secretion from patients strongly suspected of having tuberculosis were considered as false negatives for the assay, without inhibition of amplification. All specimens yielding M. avium on culture were LCx negative. 

CONCLUSION: The LCx® Mycobacterium tuberculosis Assay was found to be useful for the rapid identification of M. tuberculosis complex in all types of specimens. It revealed a high specificity both in pulmonary and extrapulmonary products, and a sensitivity of 97% for the pulmonary secretions and of 75% for the extra-pulmonary specimens, independently of the bacilloscopy results.

Original languageEnglish
Pages (from-to)508-514
Number of pages7
JournalInternational Journal of Tuberculosis and Lung Disease
VolumeVol. 3
Issue numbern.º 6
Publication statusPublished - Jun 1999

Keywords

  • Direct detection
  • Early diagnosis
  • Ligase chain reaction assay
  • Pulmonary/extra-pulmonary tuberculosis

UN Sustainable Development Goals (SDGs)

  • SDG 3 - Good Health and Well-Being

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