= Emerging. More than 5 years before clinical availability. (26.55%)
= Expected to be clinically available in 1 to 4 years. (39.66%)
= Clinically available now. (33.79%)
MSACL 2020 US : Geistanger

MSACL 2020 US Abstract

Keynote Presentation

Topic: Data Science

Podium Presentation in Room 3 on Wednesday at 16:15 (Chair: Stephen Master)

MCR and VCA – Two R Packages to Facilitate Your Method Comparison and Precision Studies

Andrea Geistanger (Presenter)
Roche Diagnostics GmbH

Presenter Bio(s): Andrea Geistanger is Head of Systems Data Analytics, at Roche Diagnostics in Germany. Her department of biostatisticians supports system and assay development through the whole life cycle of Roche’s cobas products. Her team is involved in the early development phases, including biomarker search projects with machine learning and multivariate statistics analysis. During product development phases, Andrea’s data analysts support scientists in experimental planning with Design of experiments, as well as in the experiment of validation studies according to regulatory requirements. Furthermore, they develop standardization schemes and calibration concepts for cobas analyzers. Throughout the development phase, software tools are designed and developed as needed. These programs are also made available to a broader community through open software projects.
Andrea Geistanger studied mathematics

Authors: Andrea Geistanger (1), André Schützenmeister (2), Ekaterina Manuilova (3)
(1) Roche Diagnostics GmbH, Munich, Germany, (2) Roche Diagnostics GmbH, Penzberg, Germany, (3) (2) Roche Diagnostics GmbH, Penzberg, Germany


Trueness and precision are the key quality attributes of a diagnostic assay and have to be proven in validation experiments throughout each assay development. CLSI does also acknowledge the importance of these criteria, having two guidelines in place, EP9 for method comparison, and EP5 for precision studies describing the design and the analysis of the corresponding experiments. The statistical methodology for both experiments is quite advanced and cannot be operated in a bread and butter software such as Excel. For method comparison studies a Deming regression is required and in some cases also a robust Passing-Bablok regression is state-of-the-art. Classical linear regression methods are not appropriate here, as measurement errors occur for both measurement methods. For precision studies, an appropriate variance-components design should be used and statistically analyzed accordingly.

The mcr R-package is a free available open source R package, which incorporates all analysis methods for method comparison studies, with special focus on the regression methods as Deming or Passing-Bablok regression.

The VCA package is the pendant for precision experiments, where different measurement designs can be analyzed. It is also freely available as open source R-package. Both R packages have been developed and are maintained by the Roche Diagnostics R&D biostatistics department.

The talk will cover the major aspects of the analysis requirements for method comparison and variance-components studies. In addition, we show the features of both R packages, their calculation capabilities as well as the graphical representation possibilities.

Financial Disclosure

SalaryyesRoche Diagnostics GmbH
Board Memberno
Stockyes Roche Diagnostics GmbH
ExpensesyesRoche Diagnostics GmbH
IP Royaltyno

Planning to mention or discuss specific products or technology of the company(ies) listed above: