A quality control program for mutation detection in KIT and PDGFRA in gastrointestinal stromal tumours.

BACKGROUND: Although most gastrointestinal stromal tumours (GIST) carry oncogenic mutations in KIT exons 9, 11, 13 and 17, or in platelet-derived growth factor receptor alpha (PDGFRA) exons 12, 14 and 18, around 10% of GIST are free of these mutations. Genotyping and accurate detection of KIT/PDGFRA mutations in GIST are becoming increasingly useful for clinicians in the management of the disease. METHOD: To evaluate and improve laboratory practice in GIST mutation detection, we developed a mutational screening quality control program. Eleven laboratories were enrolled in this program and 50 DNA samples were analysed, each of them by four different laboratories, giving 200 mutational reports. RESULTS: In total, eight mutations were not detected by at least one laboratory. One false positive result was reported in one sample. Thus, the mean global rate of error with clinical implication based on 200 reports was 4.5%. Concerning specific polymorphisms detection, the rate varied from 0 to 100%, depending on the laboratory. The way mutations were reported was very heterogeneous, and some errors were detected. CONCLUSION: This study demonstrated that such a program was necessary for laboratories to improve the quality of the analysis, because an error rate of 4.5% may have clinical consequences for the patient.

Toward A Reliable Quality Control Test For Microneedle Insertion

Microneedles (MNs) are emerging devices that can be used for the delivery of drugs at specific locations1. Their performance is primarily judged by different features and the penetration through tissue is one of the most important aspects to evaluate. For detailed studies of MN performance different kind of in-vitro, exvivo and in-vivo tests should be performed. The main limitation of some of these tests is that biological tissue is too heterogeneous, unstable and difficult to obtain. In addition the use of biological materials sometimes present legal issues. There are many studies dealing with artificial membranes for drug diffusion2, but studies of artificial membranes for Microneedle mechanical characterization are scarce3. In order to overcome these limitations we have developed tests using synthetic polymeric membranes instead of biological tissue. The selected artificial membrane is homogeneous, stable, and readily available. This material is mainly composed of a roughly equal blend of a hydrocarbon wax and a polyolefin and it is commercially available under the brand name Parafilm®. The insertion of different kind of MN arrays prepared from crosslinked polymers were performed using this membrane and correlated with the insertion of the MN arrays in ex-vivo neonatal porcine skin. The insertion depth of the MNs was evaluated using Optical coherence tomography (OCT). The implementation of MN transdermal patches in the market can be improved by make this product user-friendly and easy to use. Therefore, manual insertion is preferred to other kind of procedures. Consequently, the insertion studies were performed in neonatal porcine skin and the artificial membrane using a manual insertion force applied by human volunteers. The insertion studies using manual forces correlated very well with the same studies performed with a Texture Analyzer equipment. These synthetic membranes seem to mimic closely the mechanical properties of the skin for the insertion of MNs using different methods of insertion. In conclusion, this artificial membrane substrate offers a valid alternative to biological tissue for the testing of MN insertion and can be a good candidate for developing a reliable quality control MN insertion test.

Does Inappropriate Quality Control Demotivate Workers

The construction industry requires quality control and regulation of its contingent,unpredictable environment. However, taking too much control from workers candisempower and demotivate. In the 1970s Deci and Ryan developed selfdeterminationtheory which states that in order to be intrinsically motivated, threecomponents are necessary - competence, autonomy and relatedness. This study aimsto examine the way in which the three ‘nutriments’ for intrinsic motivation may beundermined by heavy-handed quality control. A critical literature review analysesconstruction, psychological and management research regarding the control andmotivation of workers, using self-determination theory as a framework. Initialfindings show that quality management systems do not always work as designed.Workers perceive that unnecessary, wasteful and tedious counter checking of theirwork implies that they are not fully trusted by management to work without oversight.Control of workers and pressure for continual improvement may lead to resistanceand deception. Controlling mechanisms can break the link between performance andsatisfaction, reducing motivation and paradoxically reducing the likelihood of thequality they intend to promote. This study will lead to a greater understanding ofcontrol and motivation, facilitating further research into improvements in theapplication of quality control to maintain employee motivation.