Inter-laboratory difference among eleven clinical laboratories in the Okayama City area.

The aim of the present study was to find the cause of inter-laboratory differences in laboratory test data and to examine whether control assessment helps to reduce inter-laboratory differences. Blood and serum samples of one healthy subject and one subject with liver cirrhosis were analyzed by 11 laboratories in the Okayama City area. No differences were found in the assay units of 26 tests surveyed. However, considerable differences were observed in test data, reference interval, and clinical level (CL), though most laboratories pointed out that the test data for the normal subject was within the reference intervals and those for the patient with liver cirrhosis showed abnormalities in tests for liver function. The difference in reference intervals was serious in the tests of direct bilirubin (D-Bil), thymol turbidity test (TTT), alkaline phosphatase (ALP), gamma-glutamyltranspeptidase (GGTP) and choline sterase. Marked differences in CLs were found in the tests of D-Bil, TTT, ALP, GGTP, creatine phosphokinase, amylase, heavy density lipoprotein cholesterol and white blood cell count. However, three hepatologists independently suggested that such inter-laboratory differences would not seriously affect a clinical decision on the disease status of the cirrhotic patient. Most tests that showed a trend error in a recent quality control survey appeared to have the same trend in the present study. These results indicate that inter-laboratory differences occur at various levels and control assessment are helpful in establishing, and therefore reducing, the level of inter-laboratory differences.