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Performance of the 2007 WHO Algorithm to Diagnose Smear-Negative Pulmonary Tuberculosis in a HIV Prevalent Setting

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  • Helena Huerga
  • Francis Varaine
  • Eric Okwaro
  • Mathieu Bastard
  • Elisa Ardizzoni
  • Joseph Sitienei
  • Jeremiah Chakaya
  • Maryline Bonnet

Abstract

Background: The 2007 WHO algorithm for diagnosis of smear-negative pulmonary tuberculosis (PTB) including Mycobacterium tuberculosis (MTB) culture was evaluated in a HIV prevalent area of Kenya. Methods: PTB smear-negative adult suspects were included in a prospective diagnostic study (2009–2011). In addition, program data (2008–2009) were retrospectively analysed. At the first consultation, clinical examination, chest X-ray, and sputum culture (Thin-Layer-Agar and Lowenstein-Jensen) were performed. Patients not started on TB treatment were clinically re-assessed after antibiotic course. The algorithm performance was calculated using culture as reference standard. Results: 380 patients were included prospectively and 406 analyzed retrospectively. Culture was positive for MTB in 17.5% (61/348) and 21.8% (72/330) of cases. Sensitivity of the clinical-radiological algorithm was 55.0% and 31.9% in the prospective study and the program data analysis, respectively. Specificity, positive and negative predictive values were 72.9%, 29.7% and 88.6% in the prospective study and 79.8%, 30.7% and 80.8% in the program data analysis. Performing culture increased the number of confirmed TB patients started on treatment by 43.3% in the prospective study and by 44.4% in the program data analysis. Median time to treatment of confirmed TB patients was 6 days in the prospective study and 27 days in the retrospective study. Inter-reader agreement for X-ray interpretation between the study clinician and a radiologist was low (Kappa coefficient = 0.11, 95%CI: 0.09–0.12). In a multivariate logistic analysis, past TB history, number of symptoms and signs at the clinical exam were independently associated with risk of overtreatment. Conclusion: The clinical-radiological algorithm is suboptimal to diagnose smear-negative PTB. Culture increases significantly the proportion of confirmed TB cases started on treatment. Better access to rapid MTB culture and development of new diagnostic tests is necessary.

Suggested Citation

  • Helena Huerga & Francis Varaine & Eric Okwaro & Mathieu Bastard & Elisa Ardizzoni & Joseph Sitienei & Jeremiah Chakaya & Maryline Bonnet, 2012. "Performance of the 2007 WHO Algorithm to Diagnose Smear-Negative Pulmonary Tuberculosis in a HIV Prevalent Setting," PLOS ONE, Public Library of Science, vol. 7(12), pages 1-9, December.
  • Handle: RePEc:plo:pone00:0051336
    DOI: 10.1371/journal.pone.0051336
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    1. J Lucian Davis & William Worodria & Harriet Kisembo & John Z Metcalfe & Adithya Cattamanchi & Michael Kawooya & Rachel Kyeyune & Saskia den Boon & Krista Powell & Richard Okello & Samuel Yoo & Laurenc, 2010. "Clinical and Radiographic Factors Do Not Accurately Diagnose Smear-Negative Tuberculosis in HIV-infected Inpatients in Uganda: A Cross-Sectional Study," PLOS ONE, Public Library of Science, vol. 5(3), pages 1-8, March.
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    1. Nadia Yakhelef & Martine Audibert & Francis Varaine & Jeremiah Chakaya & Joseph Sitienei & Helena Huerga & Marilyne Bonnet, 2013. "Is introducing rapid culture in the diagnostic algorithm of smear-negative tuberculosis cost-effective?," Working Papers halshs-00866530, HAL.

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    1. Nadia Yakhelef & Martine Audibert & Francis Varaine & Jeremiah Chakaya & Joseph Sitienei & Helena Huerga & Marilyne Bonnet, 2013. "Is introducing rapid culture in the diagnostic algorithm of smear-negative tuberculosis cost-effective?," Working Papers halshs-00866530, HAL.

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