INVESTIGADORES
MARELLI Belkis Ester
congresos y reuniones científicas
Título:
Development and validation of analytical techniques unde good laboratory practices for high complexity preclinical trials.
Autor/es:
SANTIAGO, G.; CABAÑA E.R.; GÁLVEZ, V.; MARELLI B.E.; HEIN, G.J.; ORTEGA, H.H.
Lugar:
Mar del Plata
Reunión:
Congreso; LXIII Reunión Anual de la Sociedad Argentina de Investigación Clínica (SAIC).; 2018
Institución organizadora:
SAIC
Resumen:
Performing toxicological tests on small laboratory animals(rats and mice) means that there are few quantities of biological samples,which limits the possibility of carrying out commercial methods. Therefore, weaimed to develop and validate analytical micro-methods to determine relevant biomarkersfor clinical diagnosis with less than 50 µL of serum sampled from mice, rats andrabbits, in accordance with the principles of Good Laboratory Practices. Serumconcentrations of glucose (Glc), triglycerides (Tg), cholesterol (Col), totalprotein (TP), albumin (Alb) and urea (U) were determined using an ultra-fastUV/Vis spectrometer SPECTROstar Nano (BMG LABTECH GmbH, Germany) and commercialkits designed for human and higher sample volumes. The figures of merit were: limitof detection of 4.71 mg/dL for Glc, 2.72 mg/dL for Tg, 2.72 mg/dL for Col, 0.13g/dL for TP, 0.05 g/dL for Alb, and1.25 mg/dL for U ; limit of quantification 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 3.77 mg/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/dLfor Alb and 7-140 mg/dL for U. All thetechniques were in accordance with international regulations (FDA and EMA) inrelation to the intra and inter-precision test, accuracy, inter-laboratoriescomparison, dilutional linearity and stability at ? 20 °C and ? 80 °C for 60days. These validated 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.
