INVESTIGADORES
HEIN Gustavo Juan
congresos y reuniones científicas
Título:
Development and validation of analytical techniques under good laboratory practices for high complexity preclinical trials
Autor/es:
SANTIAGO G; GALVEZ V; CABANA E; MARELLI B; HEIN GJ; ORTEGA HH
Lugar:
Mar del Plata
Reunión:
Congreso; LXIII Reunión Científica Anual de la Sociedad Argentina de Investigación Clínica (SAIC); 2018
Institución organizadora:
SAIC
Resumen:
Performing toxicological tests on small laboratoryanimals (rats and mice) means that there are few quantities of biologicalsamples, which limits the possibility of carrying out commercial methods. Therefore,we aimed to develop and validate analytical micro-methods to determine relevantbiomarkers for clinical diagnosis with less than 50 µL of serum sampled frommice, rats and rabbits, in accordance with the principles of Good LaboratoryPractices. Serum concentrations of glucose (Glc), triglycerides (Tg),cholesterol (Col), total protein (TP), albumin (Alb) and urea (U) weredetermined using an ultra-fast UV/Vis spectrometer SPECTROstar Nano (BMGLABTECH GmbH, Germany) and commercial kits designed for human and higher samplevolumes. The figures of merit were: limit of detection of 4.71 mg/dL for Glc, 2.72 mg/dL for Tg, 2.72 mg/dL for Col, 0.13 g/dLfor TP, 0.05 g/dL for Alb, and 1.25 mg/dL for U ; limit ofquantification of 14.29 mg/dL for Glc, 8.25 mg/dL for Tg, 8.25 mg/dL for Col, 0.39 g/dL for TP, 0.16 g/dL for Alb and 3.77mg/dL for U; quantifiable range of 20-500 mg/dL for Glc, 80-1040 mg/dL for Tg, 50-600 mg/dL for Col, 0.98-9.60 g/dL for TP, 1.55-6.20 g/dL for Alband 7-140 mg/dL for U. All the techniques were in accordance with internationalregulations (FDA and EMA) in relation to the intra and inter-precision test,accuracy, inter-laboratories comparison, dilutional linearity and stability at ? 20 °Cand ? 80 °C for 60 days. Thesevalidated analytical techniques will allow monitoring pathophysiologicalchanges in different animal models, designed for the study of damages occurred incertain organs (such as liver, pancreas, kidney and heart), and involving verysmall amounts of samples in agreement to the principle of the 3Rs.
