Studies have shown that many commercially available QC materials do not fulfill this basic function, presumably as the materials were far from being patient-like, or commutable (Miller et al, 2011, Clinical Chemistry).
To ensure the best commutability, most of SERO’s products contain more than 95 % genuine human serum with no stabilizers or preservatives added. A strict selection of raw materials based on our high level of expertise and highly controlled manufacturing processes ensures the high quality of SERO products.
ISO 15189 “Medical laboratories – Requirements for quality and competence” clearly states its recommendations with regards to the composition of quality control materials: “The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
Certain analytes such as bilirubin, PTH, C-peptide and various enzymes are biologically unstable in bodily fluids. Minor deviations in the preanalytical phase or in the performance of instruments or reagents may influence the measurement of such unstable analytes. In order to maintain control of the whole analytical process it is important to use a control with the same properties as patient samples.
Patient samples are complex biochemical mixtures with many metabolites and other substances with a potential of interfering with analytical methods. A specially tailored and often heavily buffered solution spiked with pure substances will perform much better than patient samples with most instruments. But can you rely on such materials for your quality assurance? Only a true control will show the real performance of your analytical system allowing you to stay in control.