(Dislaimer: The following concerns an old version of the FreeStyle Libre) Last month a representative of Abbott gave a FreeStyle Libre glucometer for a tryout. The Freestyle Libre consists of a small patch with a microneedle and a readout unit. The microneedle patch has to be applied with a special device and lasts for up to 14 days. Therefore frequent, often painful drawing of capillary blood from the fingertip can be avoided. This concept proved so popular, that the FreeStyle Libre was sold out in Germany shortly after introduction. Some health insurances reimburse this device for type I diabetic patients, even though this is not mandatory in Germany.
Objectives: Hemoglobin A1c (HbA1c) is employed for diagnosis and therapy monitoring of diabetes mellitus. The effect of a change of reagent lot on the measured values of a commercial immunoturbidimetric HbA1c assay (A1C3) was investigated. Design and Methods: Comparison measurements of A1C3 and an automated affinity chromatography method (VIIT) were performed in 15 samples for the initial and in 20 samples for the subsequent A1C3 lot. The results of 27 and 19 measurements of a normal and of 28 and 20 of a pathological control (before and after the switch of the A1C3 reagent lot, respectively) were evaluated. Finally, the results of 6463 patient samples that had been measured with the initial and 434 that had been measured with the subsequent A1C3 lot were investigated.
The association Institut für Qualitätsmanagement in Medizinischen Laboratorien (INQUAM) promotes the principle of excellence and supports medical laboratories on their way to the first step of the quality management system of the European Foundation for Quality Management “Committed to Excellence” with an adapted matrix for self-evaluation of medical laboratories.
Point-of-care testing (POCT) enables health care personnel to perform laboratory medicine tests near the patient. The underlying technology and the range of test parameters available are evolving rapidly. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis. The idea of conventional and POCT laboratory services presiding within a hospital seems contradictory; yet, they are, in fact, complementary: together POCT and central laboratory are important for the optimal functioning of diagnostic processes. They complement each other, provided that a dedicated POCT coordination integrates the quality assurance of POCT into the overall quality management system of the central laboratory.