Kenneth Goossens

The Empower project – a new way of assessing and monitoring test comparability and stability

Abstract Background: Manufacturers and laboratories might benefit from using a modern integrated tool for quality management/assurance. The tool should not be confounded by commutability issues and focus on the intrinsic analytical quality and comparability of assays as performed in routine laboratories. In addition, it should enable monitoring of long-term stability of performance, with the possibility to quasi “real-time” remedial action. Therefore, we developed the “Empower” project. Methods: The project comprises four pillars: (i) master comparisons with panels of frozen single-donation samples, (ii) monitoring of patient percentiles and (iii) internal quality control data, and (iv) conceptual and statistical education about analytical quality. In the pillars described here (i and ii), state-of-the-art as well as biologically derived specifications are used. Results: In the 2014 master comparisons survey, 125 laboratories forming 8 peer groups participated. It showed not only good intrinsic analytical quality of assays but also assay biases/non-comparability. Although laboratory performance was mostly satisfactory, sometimes huge between-laboratory differences were observed. In patient percentile monitoring, currently, 100 laboratories participate with 182 devices. Particularly, laboratories with a high daily throughput and low patient population variation show a stable moving median in time with good between-instrument concordance. Shifts/drifts due to lot changes are sometimes revealed. There is evidence that outpatient medians mirror the calibration set-points shown in the master comparisons. Conclusions: The Empower project gives manufacturers and laboratories a realistic view on assay quality/comparability as well as stability of performance and/or the reasons for increased variation. Therefore, it is a modern tool for quality management/assurance toward improved patient care.

Trueness and comparability assessment of widely used assays for 5 common enzymes and 3 electrolytes.

Differences in laboratory results can be caused by test principle and design, instrumentation, calibrationmaterial, and commutability. External quality assessment (EQA) has earned a well-deserved position in uncovering such differences [1]. However, apart from a few dedicated EQA schemes with the emphasis on the use of commutable samples, e.g., the one conducted in The Netherlands, common designs can only give limited information on the existence of biases due to the use of processed materials not necessarily behaving like patient samples [2]. We emphasized these limitations in recent studies on the standardization status of diagnostic assays for several common clinical chemistry analytes by the use of fresh-frozen, single-donation samples [3,4]. Here, we report on the continuation of this work. This time, we focused on key enzymes commonly requested for laboratory evaluation of liverand bone disease,myocardial and pulmonary infarction (alkaline phosphatase, ALP; alanine aminotransferase, ALT; aspartate aminotransferase, AST; lactate dehydrogenase, LDH; gamma-glutamyl transferase, GGT) and commonly measured electrolytes (potassium, sodium and chloride). We organized, again, a survey with 20 fresh frozen, single donation sera, carefully selected to cover a reasonable concentration range from a pool of ca. 500 possible donors. In total, 125 laboratories participated with the following systems: Abbott/Architect (n = 21 laboratories), Beckman/AU (n = 19), Beckman/DxC (n = 11), Ortho/Vitros (n = 19), Roche/Cobas (n = 26), Roche/Modular (n = 9), Siemens/Advia (n = 12), and Siemens/Vista (n = 8). As described in detail in the report on our previous study, serum was again produced and aliquoted from individual blood collections according to the best available protocol to warrant commutability, i.e., the CLSI C37-A one [3,5]. The aliquots were transported on dry ice to the participating laboratories, which were requested to verify the condition of the samples upon receipt and to store them immediately at −20 °C prior to analysis, which had to be done within max. 4 weeks. Targets were assigned with reference measurement procedure values (determined according to the IFCC recommendations at 37 °C) for ALT [range covered: 10.4–52.4 U/L], AST [15.5–39.8 U/L], GGT [15.6–

Using "big data" to describe the effect of seasonal variation in thyroid-stimulating hormone.

aCurrent affiliation: Thienpont & Stöckl Wissenschaftliches Consulting GbR, 86643 Rennertshofen (OT Bertoldsheim), Germany. *Corresponding author: Linda M. Thienpont, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium, Phone: +49 8434 94 365 22, E-mail: linda.thienpont@ugent.be Linde A.C. De Grande and Kenneth Goossens: Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium Katleen Van Uytfanghe: Ref4U, Laboratory of Toxicology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium Ian Halsall: The Pathology Partnership, Cambridge University Hospitals, Cambridge, UK Jaeduk Yoshimura Noh: Ito Hospital, Tokyo, Japan Koen Hens: Algemeen Medisch Laboratorium (AML), Antwerpen, Belgium Letter to the Editor

On-line flagging monitoring - a new quality management tool for the analytical phase.

*Corresponding author: Linda M. Thienpont, Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium, Phone: +32 9 2648104, Fax: +32 9 2648198, E-mail: linda.thienpont@ugent.be Kenneth Goossens: Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium Thomas Brinkmann: Labor Lademannbogen MVZ GmbH, Hamburg, Germany Letter to the Editor