The aim of the present study was to find the cause of inter-laboratory
differences in laboratory test data and to examine whether control as
sessment helps to reduce inter-laboratory differences. Blood and serum
samples of one healthy subject and one subject with liver cirrhosis w
ere analyzed by 11 laboratories in the Okayama City area. No differenc
es were found in the assay units of 26 tests surveyed. However, consid
erable differences were observed in test data, reference interval, and
clinical level (CL), though most laboratories pointed out that the te
st data for the normal subject was within the reference intervals and
those for the patient with liver cirrhosis showed abnormalities in tes
ts for liver function. The difference in reference intervals was serio
us 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 he
patologists independently suggested that such inter-laboratory differe
nces would not seriously affect a clinical decision on the disease sta
tus 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 differenc
es occur at various levels and control assessment are helpful in estab
lishing, and therefore reducing, the level of inter-laboratory differe
nces.