News
07-March-2008 - LGC launches reference materials for
testosterone research
LGC introduces frozen human serum certified for testosterone
measurement to ensure the highest levels of traceability and
accuracy
LGC, in its capacity as the UK’s designated National Measurement Institute for chemical
and biochemical measurements, has worked closely with the
University Hospital of Wales (UHW) to produce two new higher order
certified reference materials (CRMs) for testosterone in frozen
human serum. These materials are intended for method validation and
for monitoring the performance of methods commonly used in medical
laboratories. The new materials meet the stringent technical
guidelines of the European Reference Materials (ERM) status.
The determination of testosterone in human serum is carried out in
medical laboratories to assess a range of conditions. For example,
testosterone is measured in males to evaluate impotence or
infertility, and in females to help evaluate male body
characteristics and irregular menstrual periods. Testosterone
measurements are also used to check for abnormal levels in
sportsmen and sportswomen. To be confident in the quality of the
results of analysis of such samples, it is important to validate
and monitor procedures using CRMs close in matrix and composition
to the test samples.
The materials were prepared from a single native female human serum
pool. Half of the serum pool was used to produce a material with a
level of testosterone within the normal female range; testosterone
in methanol was added to the other half to produce a material with
a level of testosterone within the normal male range. They
were sterile filtered, and aliquots of 0.8 mL minimum were
sub-sampled into plastic screw-cap 3 mL vials. The matrix of these
materials is novel - until now only lyophilised serum materials
certified for testosterone have been available. The
development of the materials was carried out under the National
Measurement System’s ChemBio programme.
The materials were certified by LGC using isotope dilution mass
spectrometry and the data were corroborated by measurements carried
out by UHW, by data from the Wales External Quality Assessment
Scheme (WEQAS) and by the National Institute of Standards and
Technology (NIST) in the USA. The data were accepted as complying
with the principles laid down in the Technical Guidelines of the
ERM co-operation agreement between
LGC, BAM and IRMM.
The materials have also been accepted for inclusion by the Joint
Committee for Traceability in Laboratory Medicine (JCTLM) on its
database of higher order reference materials. This is a database of
reference materials that have been reviewed for their compliance
with the European Union’s IVD Directive (IVDD) requirement for
higher order materials. The new materials from LGC Standards will enable laboratories to
comply with the IVDD’s regulatory requirements to use higher order
reference materials.
These materials are available for sale from LGC Standards as ERM
DA345a (normal male level) and ERM DA346a (normal female level).
For product information, email: uksales@lgcstandards.com
Notes to Editors