7. The implementation of semi-automated FISH analysis of Acute Myeloid Leukemia - A pilot study

      The increasing demand for FISH testing and the desire for laboratories to provide the best patient care in a timely manner, as well as a shortage of qualified staff, have made automated analysis systems a growing trend. We compared the FISH analysis of our current manual method to the semi-automated method by Applied Spectral Imaging (ASI). Manual analysis was conducted by two technologists each analyzing 100 cells. The ASI GenASIs system – the semi-automated method – was utilized to perform the initial analysis and then one technologist verified the classification of the cells. The panel used in the comparison includes FISH probes for t(15;17), RARA BAP, and t(9;22) with ASS. Ten patients’ specimens, both positive and negative, were analyzed by both methods. Accuracy and precision studies were also performed. The results of both the manual and semi-automated analyses were all comparable for t(15;17), RARA BAP, and t(9;22) with ASS. The time documented for the manual analysis averaged 15 minutes per probe for each technologist, totaling 1½ hours to complete the entire panel. The average time to complete the analysis of the panel using the GenASIs analysis software averaged 30 minutes. The accuracy was determined by comparing the signal quality and semi-automated analysis of four scans with the original manual analysis on one positive and one negative case. The precision study was completed by comparing the signal quality and semi-automated analysis of the four scans. There were no major differences seen between the two methods. We found that the ASI GenASIs semi-automated system provided an accurate and timely approach with high quality image captured to perform FISH studies on cells from suspension cultures. Validation of more probes on cultured cells and on FFPE tissue slides is currently ongoing in our laboratory.
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