To assure the quality of service in laboratory medicine, it is necessary to
implement a quality system which comprises the entire testing process. The
use of quality reagents is an important aspect of the process. Despite the
fact that it is the responsibility of the laboratory to ensure the quality
of the analytical system (including reagents) and since it is impossible t
o evaluate all commercial diagnostic kits, the laboratory often depends on
statements issued by the manufacturer to select the most appropriate diagno
stics for a particular laboratory.
In this study we report the results of the analysis of information provided
in 887 package inserts enclosed in the more widely used commercial diagnos
tic kits, following the Standard for the labelling of clinical laboratory m
aterials of the European Committee for Clinical Laboratory Standards (ECCLS
). Only a third of these were in agreement with the guidelines of ECCLS Sta
ndard, reporting complete and correct information. We believe that it is ne
cessary to implement a constructive cooperation between manufacturers of di
agnostic materials and clinical laboratories to produce a more uniform appr
oach to improvements in laboratory quality assurance.