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Copyright © 2018 by the University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina.
1
Clinical Institute of Laboratory Diagnosis,
University Hospital Centre Zagreb,
2
Department of Paediatrics, University of
Zagreb School of Medicine, University
Hospital Centre Zagreb, Croatia
Correspondence:
vkusec@kbc-zagreb.hr
Tel.: + 385 1 236 7 289
Fax.: + 385 1 236 7 395
Received: November 29, 2017
Accepted: June 18, 2018
Key words: Hormone measurement ■
Measurement methods ■ Immunoassay ■
Quality management ■ Six sigma.
Understanding the Basics of Quality Control in the Medical Laboratory – the
Impact on Result Interpretation
Vesna Kušec
1
, Nataša Rojnić Putarek
2
, Nevena Krnić
2
, Anita Špehar Uroić
2
, Katja Dumić
2
Review article
Central Eur J Paed 2018;14(2):224-235
DOI 10.5457/p2005-114.221
Te aim of this paper was to provide information on the limitations of
current analytical methods and the basics in quality control in labora-
tory endocrinology which afect the results and their interpretation.
For the practicing clinical endocrinologist it is important to under-
stand the essentials of the quality of hormone measuring methods and
their limitations. Awareness of the quality of methods will allow cau-
tion and/or ensure the reliability of result interpretation. A measuring
method cannot be performed with equal precision and trueness for
the entire measuring range, and may difer between parameters and
manufacturers. According to the level of medical decision, the medical
laboratory should determine the quality of the method and commu-
nicate that information to the clinician. Te basic approach to qual-
ity control of measurement methods is useful knowledge for doctors
working in a hospital setting or private practice. Te advantages and
limitations are presented of immunoassay-based methods and tandem
mass spectrometry (LC-MS/MS) used for measurement in biochemis-
try laboratory. Conclusion – Hormone measurement is widely avail-
able but the methods may be afected by limitations. Understanding
a method’s limitations and options for improvement enables the prac-
ticing clinician to interpret the test results rationally.
Introduction
Hormone measurement remains an essential
aspect of diagnosis and management in paedi-
atric endocrinology, in conjunction with imag-
ing and molecular diagnostic tests. Laboratory
tests have advanced since the introduction of
commercial radio-immunoassays for hormone
measurement that have ensured the availabil-
ity of laboratory tests at reasonable cost. Both
methodological improvements and modern
technology have been important milestones
in laboratory diagnostics, allowing for the
current state in which results are obtained
in a shorter time and more frequently. Tests
are in general more specifc and precise, costs
are lower and the development of automated
instruments or platforms have helped make
laboratory work less demanding for personnel.
Tus, every hospital biochemistry laboratory
is able to ofer some hormone tests.
Moreover, awareness of good clinical and
laboratory practice and safety is now an im-
portant part of routine health care. In labo-
ratory medicine, measurement methods may
be standardized, through use of certifed ref-
erence materials for assay calibration, or, in
the absence of higher-order reference mate-
rials, external inter-laboratory quality assess-
Medical Laboratory