Applications of Quality Assurance for Tc 99m MAG3 & DMSA in Department of Nuclear Medicine

Abstract

This prospective study was aimed to assess inter- and intra-operator variability during routine quality control (QC) procedure for technetium-99m (99mTc-MAG3 and DMSA) instant kit formulation. A total of 10 QC analyses with thin layer chromatography (TLC) for 20 separate MAG3 reconstitutions were performed. The percentage of free and hydrolysed 99mTc as well as binding efficiency, were calculated according to standard TLC. Each QC analysis was done using silica gel (SG), silica acrylic (SA), Whatman 1 (W1) and Whatman 3 (W3) TLC strips separately at 1h, following labeling MAG3 instant kit with 99mTc-pertechnetate. To assess the radiochemical stability of 99mTc-MAG3, the same analysis was performed after kit reconstitution. Visual confirmation for QC with scintigraphy was also performed. At both time points, each repeated all the procedure twice for each of the TLC paper types to analyze the intra-operator reliability. Crombach’s Test was used for the reliability analysis. High inter-operator correlation ratios (range: 0.821-0.920) per each TLC strip were found where the highest concordance rate was 0.921 for SA. Each TLC strip showed adequate kit reconstitution with acceptable free and hydrolysed 99mTc percentages in all analyses, along with high binding efficiency values of 94.3 ± 2.9 and 92.5 ± 1.9 at respectively. Intra-observers reliability showed almost equal high concordance rates (range: 0.888-0.961) for all types of strips. In conclusion, all kinds of ITLC/TLC strips were reliable to assess stability of the radiopharmaceutical at 1 and 4 h while analysis with the SA strip had the highest concordance rate. Inter- and intra-operator QC was also reliable.