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Free Content Evaluation of FASTPlaqueTB™ to diagnose smear-negative tuberculosis in a peripheral clinic in Kenya

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OBJECTIVE: To evaluate the performance and feasibility of FASTPlaqueTB™ in smear-negative tuberculosis (TB) suspects in a peripheral clinic after laboratory upgrading.

DESIGN: Patients with cough ≥2 weeks, two sputum smear-negative results, no response to 1 week of amoxicillin and abnormal chest X-ray were defined as smear-negative suspects. One sputum sample was collected, decontaminated and divided into two: half was tested with FASTPlaqueTB in the clinic laboratory and the other half was cultured on Löwenstein-Jensen medium in the Kenyan Medical Research Institute. Test sensitivity and specificity were evaluated in all patients and in human immunodeficiency virus (HIV) infected patients. Feasibility was assessed by the contamination rate and the resources required to upgrade the laboratory.

RESULTS: Of 208 patients included in the study, 56.2% were HIV-infected. Of 203 FASTPlaqueTB tests, 95 (46.8%) were contaminated, which interfered with result interpretation and led to the interruption of the study. Sensitivity and specificity were respectively 31.2% (95%CI 12.1–58.5) and 94.9% (95%CI 86.8–98.4) in all patients and 33.3% (95%CI 9.9–65.1) and 93.9% (95%CI 83.1–98.7) in HIV-infected patients. Upgrading the laboratory cost €20 000.

CONCLUSION: FASTPlaqueTB did not perform satisfactorily in this setting. If contamination can be reduced, in addition to laboratory upgrading, its introduction in peripheral clinics would require further assessment in smear-negative and HIV co-infected patients and test adaptation for friendlier use.
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Keywords: developing countries; diagnosis; phage-based test; smear microscopy; tuberculosis

Document Type: Regular Paper

Affiliations: 1: Epicentre, Paris, France 2: Médecins Sans Frontières, Paris, France 3: Centre for Respiratory Diseases Research, Kenya Medical Research Institute, Nairobi, Kenya

Publication date: September 1, 2009

More about this publication?
  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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