학술논문

A Prospective Evaluation of Xpert MTB/RIF Ultra for Childhood Pulmonary Tuberculosis in Uganda
Document Type
article
Source
Journal of the Pediatric Infectious Diseases Society. 10(5)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Clinical Research
Tuberculosis
Sexually Transmitted Infections
Emerging Infectious Diseases
Rare Diseases
Pediatric
Lung
Infectious Diseases
HIV/AIDS
Biodefense
4.2 Evaluation of markers and technologies
Infection
Good Health and Well Being
Child
Child
Preschool
Humans
Male
Mycobacterium tuberculosis
Prospective Studies
Sensitivity and Specificity
Sputum
Tuberculosis
Pulmonary
Uganda
child
diagnosis
tuberculosis
Xpert MTB/RIF Ultra
Medical microbiology
Paediatrics
Language
Abstract
BackgroundXpert MTB/RIF Ultra (Xpert Ultra) has improved the sensitivity to detect pulmonary tuberculosis (TB) in adults. However, there have been limited prospective evaluations of its diagnostic accuracy in children.MethodsWe enrolled children undergoing assessment for pulmonary TB in Kampala, Uganda, over a 12-month period. Children received a complete TB evaluation and were classified as Confirmed, Unconfirmed, or Unlikely TB. We calculated the sensitivity and specificity of Xpert Ultra among children with Confirmed vs Unlikely TB. We also determined the diagnostic accuracy with clinical, microbiological, and extended microbiological reference standards (MRSs).ResultsOf the 213 children included, 23 (10.8%) had Confirmed TB, 88 (41.3%) had Unconfirmed TB, and 102 (47.9%) had Unlikely TB. The median age was 3.9 years, 13% were HIV-positive, and 61.5% were underweight. Xpert Ultra sensitivity was 69.6% (95% confidence interval [CI]: 47.1-86.8) among children with Confirmed TB and decreased to 23.4% (95% CI: 15.9-32.4) with the clinical reference standard. Specificity was 100% (95% CI: 96.4-100) among children with Unlikely TB and decreased to 94.7% (95% CI: 90.5-97.4) with a MRS. Sensitivity was 52.9% (95% CI: 35.1-70.2) and specificity 95.5% (95% CI: 91.4-98.1) with the extended MRS. Of the 26 positive Xpert Ultra results, 6 (23.1%) were "Trace-positive," with most (5/6) occurring in children with Unconfirmed TB.ConclusionsXpert Ultra is a useful tool for diagnosing pulmonary TB in children, but there remains a need for more sensitive tests to detect culture-negative TB.