Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis (MTB) and drug resistance has become a high priority. The Xpert® MTB/RIF Assay does not provide information on INH-resistance and the LPA is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. Several novel assays have been recently developed/CE-marked offering high sample throughput and higher sensitivity for detection of MTB, RIF- and INH-resistance in centralized laboratories. However, published data on their performance and operational characteristics is extremely limited. This is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised TB assay solutions will be assessed at the intended setting of use with culture, phenotypic DST and sequencing as reference standard. Potential trial participants will be identified at participating TB clinics or hospitals (enrolment sites). Sputum samples will be collected and transported to the associated TB reference laboratories (testing sites). In order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary TB undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden TB countries. Additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the FIND specimen bank will be used.
Study Type
OBSERVATIONAL
Enrollment
1,050
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
Forschungszentrum Borstel. Leibniz Lungenzentrum (Borstel)
Borstel, Germany
Indian Council of Medical Research (ICMR) Regional Medical Research Centre
Bhubaneswar, India
National Institute for Research in Tuberculosis
Chennai, India
Institute of Phthisiopneumology "Ch. Draganiuc" (PPI NRL), Moldova
Chisinau, Moldova
Division of Wits Health Consortium (DMMH)
Johannesburg, South Africa
Diagnostic accuracy for MTB detection
clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.
Time frame: four to six months
Diagnostic accuracy for RIF/INH detection
clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing.
Time frame: four to six months
Operational characteristics:
description of operator experience with the assays through daily observed usage and user appraisal questionnaires.
Time frame: four to six months
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