Top quality research on quality control

I have received the “Ivar Trautschold award for the promotion of young scientists” from the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) for my work on quality control. As I pointed out in my award speech, quality control in laboratory medicine should be patient-oriented. Instead of determining laboratory artifacts, it should reduce real risk for patients. Furthermore, quality control methods should be able to distinguish precisely between normal and out-of-control situations. A specific method should attribute errors to root causes to facilitate their quick correction. Lastly, quality control methods need to be easily integrable into laboratory daily routine.

AR-V7 in Peripheral Whole Blood of Patients with Castration-resistant Prostate Cancer: Association with Treatment-specific Outcome Under Abiraterone and Enzalutamide

Background Androgen receptor splice variant 7 (AR-V7) expression in circulating tumor cells (CTCs) was demonstrated to predict poor treatment response in metastatic castrationresistant prostate cancer (mCRPC) patients treated with abiraterone or enzalutamide. Objective To develop a practical and robust liquid profiling approach for direct quantification of AR-V7 in peripheral whole blood without the need of CTC capturing and to determine its potential to predict treatment response in mCRPC patients. Design, setting, and participants Whole blood samples from a prospective biorepository of 85 mCRPC patients before treatment initiation with abiraterone (n=56) or enzalutamide (n=29) were analyzed with droplet digital PCR. Outcome measurement and statistical analyses The association of AR-V7 status with prostate-specific antigen (PSA) response defined by PSA decline ≥50% as well as PSA-progression-free survival (PSA-PFS), clinical PFS, and overall survival (OS) was assessed.

New Book on POCT out in Germany

The book “POCT - Patientennahe Labordiagnostik” (Point-of-Care Testing) has finally been released by Springer Heidelberg. (Disclaimer: I contributed to some chapters.) It is already the third edition of this book in Germany but it will be the first to be translated and released worldwide. The book is divided into chapters covering analytical methods, clinical applications, legal and organizational framework conditions, areas of applications, quality control and further development trends. This wide range of topics certainly distinguishes this work. POCT is now beeing employed in diverse fields such as development assistance or sports medicine. It might be surprising that this laboratory medicine book dedicates so much space to quality and organizational issues.

Bright and dark sides of Abbott's FreeStyle Libre

(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.

Clinically relevant lot-to-lot reagent difference in a commercial immunoturbidimetric assay for glycated hemoglobin A1c

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.