Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools. This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
The study is designed as a prospective study for the evaluation of diagnostic tests. Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture. In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status. In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation. The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.
Study Type
OBSERVATIONAL
Enrollment
300
Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
Lusaka, Zambia
RECRUITINGProportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
Time frame: baseline
Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
Time frame: baseline
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