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Clinical Trial

Line Probe Assay Evaluation Study

NCT: NCT02984579 · COMPLETED

NCT IDNCT02984579
StatusCOMPLETED
SponsorFoundation for Innovative New Diagnostics, Switzerland (OTHER)
First posted
Last updated

Brief Summary

This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples. The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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