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Algorithm for the diagnosis of smear-negative pulmonary tuberculosis in high-incidence resource-constrained settings

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Abstract
OBJECTIVES: Diagnosis of smear-negative pulmonary tuberculosis (SNPT) remains a challenge, particularly in resource-constrained settings. We evaluated a diagnostic algorithm that combines affordable laboratory tools and a clinical prediction rule (CPR). METHODS: We derived, based on published evidence, a diagnostic algorithm for SNPT. Sputum concentration constitutes its first step. In suspects with negative results, SNPT probability is classified with a CPR as low (excluded), high (confirmed) or intermediate. For intermediate patients, sputum Middlebrook 7H9 liquid culture is performed, and they are assessed after 2 weeks. If clinically deteriorated, with still negative liquid culture, bronchoscopy is offered. Otherwise, results of Middlebrook 7H9 culture are awaited. We prospectively evaluated this algorithm against a reference standard of solid and liquid cultures in two reference hospitals in Lima, Peru. RESULTS: 670 SNPT suspects were included from September 2005 to March 2008. The prevalence of SNPT was 27% according to the reference standard. The algorithm's overall accuracy was 0.94 (95% CI 0.91-0.95), its sensitivity was 0.88 (95% CI 0.82-0.92) and its specificity, 0.96 (95% CI 0.94-0.98). Sputum concentration, the CPR, Middlebrook 7H9 sputum culture and bronchoscopic samples defined a diagnosis of SNPT according to the algorithm in 57 (37%), 25 (16%), 63 (41%) and 8(5%) of patients, respectively. 65% of patients were diagnosed within 3 weeks. CONCLUSIONS: The algorithm was accurate for SNPT diagnosis. Sputum concentration, CPR and selective Middlebrook 7H9 culture are essential components.
Keywords
BACILLI, CULTURE, RESISTANCE, ASSAY, PREVALENCE, METAANALYSIS, HIV, SPUTUM, decision-making, MICROSCOPY, ACCURACY, algorithms, pulmonary, tuberculosis, smear-negative, diagnosis

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Chicago
Soto, Alonso, Lely Solari, Juan Agapito, Eduardo Gotuzzo, Roberto Accinelli, Dante Vargas, Vilma Acurio, Francine Matthys, and Patrick Van Der Stuyft. 2013. “Algorithm for the Diagnosis of Smear-negative Pulmonary Tuberculosis in High-incidence Resource-constrained Settings.” Tropical Medicine & International Health 18 (10): 1222–1230.
APA
Soto, Alonso, Solari, L., Agapito, J., Gotuzzo, E., Accinelli, R., Vargas, D., Acurio, V., et al. (2013). Algorithm for the diagnosis of smear-negative pulmonary tuberculosis in high-incidence resource-constrained settings. TROPICAL MEDICINE & INTERNATIONAL HEALTH, 18(10), 1222–1230.
Vancouver
1.
Soto A, Solari L, Agapito J, Gotuzzo E, Accinelli R, Vargas D, et al. Algorithm for the diagnosis of smear-negative pulmonary tuberculosis in high-incidence resource-constrained settings. TROPICAL MEDICINE & INTERNATIONAL HEALTH. 2013;18(10):1222–30.
MLA
Soto, Alonso, Lely Solari, Juan Agapito, et al. “Algorithm for the Diagnosis of Smear-negative Pulmonary Tuberculosis in High-incidence Resource-constrained Settings.” TROPICAL MEDICINE & INTERNATIONAL HEALTH 18.10 (2013): 1222–1230. Print.
@article{4306230,
  abstract     = {OBJECTIVES: Diagnosis of smear-negative pulmonary tuberculosis (SNPT) remains a challenge, particularly in resource-constrained settings. We evaluated a diagnostic algorithm that combines affordable laboratory tools and a clinical prediction rule (CPR).
METHODS: We derived, based on published evidence, a diagnostic algorithm for SNPT. Sputum concentration constitutes its first step. In suspects with negative results, SNPT probability is classified with a CPR as low (excluded), high (confirmed) or intermediate. For intermediate patients, sputum Middlebrook 7H9 liquid culture is performed, and they are assessed after 2 weeks. If clinically deteriorated, with still negative liquid culture, bronchoscopy is offered. Otherwise, results of Middlebrook 7H9 culture are awaited. We prospectively evaluated this algorithm against a reference standard of solid and liquid cultures in two reference hospitals in Lima, Peru.
RESULTS: 670 SNPT suspects were included from September 2005 to March 2008. The prevalence of SNPT was 27% according to the reference standard. The algorithm's overall accuracy was 0.94 (95% CI 0.91-0.95), its sensitivity was 0.88 (95% CI 0.82-0.92) and its specificity, 0.96 (95% CI 0.94-0.98). Sputum concentration, the CPR, Middlebrook 7H9 sputum culture and bronchoscopic samples defined a diagnosis of SNPT according to the algorithm in 57 (37%), 25 (16%), 63 (41%) and 8(5%) of patients, respectively. 65% of patients were diagnosed within 3 weeks.
CONCLUSIONS: The algorithm was accurate for SNPT diagnosis. Sputum concentration, CPR and selective Middlebrook 7H9 culture are essential components.},
  author       = {Soto, Alonso and Solari, Lely and Agapito, Juan and Gotuzzo, Eduardo and Accinelli, Roberto and Vargas, Dante and Acurio, Vilma and Matthys, Francine and Van Der Stuyft, Patrick},
  issn         = {1360-2276},
  journal      = {TROPICAL MEDICINE & INTERNATIONAL HEALTH},
  keywords     = {BACILLI,CULTURE,RESISTANCE,ASSAY,PREVALENCE,METAANALYSIS,HIV,SPUTUM,decision-making,MICROSCOPY,ACCURACY,algorithms,pulmonary,tuberculosis,smear-negative,diagnosis},
  language     = {eng},
  number       = {10},
  pages        = {1222--1230},
  title        = {Algorithm for the diagnosis of smear-negative pulmonary tuberculosis in high-incidence resource-constrained settings},
  url          = {http://dx.doi.org/10.1111/tmi.12172},
  volume       = {18},
  year         = {2013},
}

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