First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease

by Ramírez JC, Parrado R, Sulleiro E, de la Barra A, Rodríguez M, Villarroel S, Irazu L, Alonso-Vega C, Alves F, Curto MA, García L, Ortiz L, Torrico F, Gascón J, Flevaud L, Molina I, Ribeiro I, Schijman AG. PLOS ONE 2017, 12(11): e0188550.

Summary: Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.

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