Guest Essay
Are molecular diagnostics immune from quality problems? Do they need Quality Control? In this new field of testing, methods and manufacturers have been asserting their "difference" from traditional testing practices, while moving slowly on developing any new and different quality practices. Guest author Dr. Clark Rundell explains that "Traditional" QC protocols can be adopted to address gaps in quality assurance for molecular testing. [Reprint from IVD Technology magazine]
A new CLSI guideline has come out with recommendations on the best way to calculate and interpret the stability of IVD reagents. We are pleased to present an essay by James Pierson-Perry, the chairholder of the CLSI subcommittee that developed the guideline, that introduces the concepts and the new recommendations.
Jim Pierson-Perry and Oswald Sonntag discuss the German RiliBÄK rules. These new guidelines set new specifications for quality, both for performance of laboratories in EQA as well as routine operations. New concepts like the %Root Mean Square Deviation are introduced and explained.
Dr. Carmen Ricos and colleagues explain the 2010 additions and updates to the biological variation database.
Jim Pierson-Perry and Oswald Sonntag discuss the German RiliBÄK rules. These new guidelines set new specifications for quality, both for performance of laboratories in EQA as well as routine operations. New concepts like the %Root Mean Square Deviation are introduced and explained.