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 0.8ml minimum were sub-sampled into plastic screw-cap 3ml 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).
