Validation of the Coulter LH 750 in a hospital reference laboratory.

Validation of the Coulter LH 750 was carried out in our central hospital laboratory, which processes 1500 hemograms per day for patients admitted into the 4 hospitals of our hospital complex and their corresponding outpatient departments. It is the reference laboratory for the provincial health care area. The analytical quality and the practical use of the instrument were studied, and we obtained within- and between-run imprecision estimates with reference controls of between 0.24% and 2.56% and inaccuracies of between -1.32% and 3.07% for basic hemogram parameters. Similar results were obtained with specimens from patients, with imprecision estimates between 0.56% and 2.56%. Linearity estimates were between 0.3 x 10(9)/L and 380 x 10(9)/L for leukocytes and between 3 x 10(9)/L and 1900 x 10(9)/L for platelets. The instrument evaluation was completed with a study of interference by bilirubin, lipemia, hemolysis, platelet clumps, and heparin and an examination of other variables, including carryover, detection limits, and the correlation of results with those of the Coulter Gen-S. A special evaluation was made of the new erythroblast count feature; with reference controls, imprecision estimates for this count were 10% to 12%, and with patient specimens imprecision averaged 10.39% up to 4 erythroblasts per 100 leukocytes. We also studied the correlation of LH 750 results and interferences with those of the manual reference method. Finally, National Committee for Clinical Laboratory Standards protocols were used to test for suspect and confirmation flags in leukocyte differential counts for 258 specimens representative of our routine. The practicability of the analyzer was studied in terms of technical difficulty, speed, and cost; also evaluated were new software elements for validation by source clinic and pathology and for reference values based on age. In conclusion, we analyzed the impact and improvements that may be expected in our laboratory (a user of Technicon and Coulter instruments) from introducing the new LH 750 analyzer into our routine.