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First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Recercat. Dipósit de la Recerca de Catalunya, instname, PLoS ONE, PLoS ONE, Vol 12, Iss 11, p e0188550 (2017), Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, CONICET Digital (CONICET), Consejo Nacional de Investigaciones Científicas y Técnicas, instacron:CONICET
- Publication Year :
- 2017
- Publisher :
- Public Library of Science (PLoS), 2017.
-
Abstract
- 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. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. 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. Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina Fil: Parrado, Rudy. Universidad Mayor de San Simon; Bolivia Fil: Sulleiro, Elena. Universitat Autònoma de Barcelona; España Fil: De La Barra, Anabelle. Universidad Mayor de San Simon; Bolivia Fil: Rodríguez, Marcelo. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina Fil: Villarroel, Sandro. Universidad Mayor de San Simon; Bolivia Fil: Irazu, Lucía. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina Fil: Alonso Vega, Cristina. Drugs for Neglected Diseases initiative; Suiza Fil: Alves, Fabiana. Drugs for Neglected Diseases initiative; Suiza Fil: Curto, Maria de Los Angeles. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina Fil: García, Lineth. Universidad Mayor de San Simon; Bolivia Fil: Ortiz, Lourdes. Universidad Autonoma Juan Misael Saracho; Bolivia Fil: Torrico, Faustino. Fundacion CEADES; Bolivia Fil: Gascón, Joaquim. Universidad de Barcelona; España Fil: Flevaud, Laurence. Medecins Sans Frontières Operational Center Barcelona-Athens; España Fil: Molina, Israel. Universitat Autònoma de Barcelona; España Fil: Ribeiro, Isabela. Drugs for Neglected Diseases initiative; Suiza Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
- Subjects :
- 0301 basic medicine
Chagas disease
Posaconazole
Molecular biology
lcsh:Medicine
Artificial Gene Amplification and Extension
Satellite DNA
Ravuconazole
Polymerase Chain Reaction
Biochemistry
Geographical locations
purl.org/becyt/ford/1 [https]
0302 clinical medicine
Malaltia de Chagas
Medicine and Health Sciences
lcsh:Science
Protozoans
Trypanosoma Cruzi
Multidisciplinary
External quality assurance
Eukaryota
Trypanocidal Agents
Clinical Laboratory Sciences
3. Good health
Nucleic acids
Clinical Laboratories
Nitroimidazoles
Benznidazole
CIENCIAS NATURALES Y EXACTAS
Research Article
medicine.drug
Trypanosoma
Bolivia
medicine.medical_specialty
Drug Research and Development
Forms of DNA
Otras Ciencias Biológicas
Concordance
030231 tropical medicine
030106 microbiology
Real-Time Polymerase Chain Reaction
Research and Analysis Methods
Ciencias Biológicas
03 medical and health sciences
Diagnostic Medicine
Internal medicine
parasitic diseases
Parasitic Diseases
Genetics
medicine
Humans
Chagas Disease
Clinical Trials
purl.org/becyt/ford/1.6 [https]
Molecular Biology Techniques
Molecular Biology
Monitoring, Physiologic
Biologia molecular
Pharmacology
proficiency testing
business.industry
lcsh:R
Organisms
Biology and Life Sciences
DNA
Triazoles
South America
Molecular diagnostics
medicine.disease
Parasitic Protozoans
Clinical trial
Chagas' disease
Immunology
lcsh:Q
Real-Time PCR
Clinical Medicine
People and places
business
Quality assurance
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, Recercat. Dipósit de la Recerca de Catalunya, instname, PLoS ONE, PLoS ONE, Vol 12, Iss 11, p e0188550 (2017), Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, CONICET Digital (CONICET), Consejo Nacional de Investigaciones Científicas y Técnicas, instacron:CONICET
- Accession number :
- edsair.doi.dedup.....b0171b8dc7c0e90f7dd1123f62bc824b