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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]
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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.
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Dr. Carmen Ricos and colleagues explain the new additions and updates to the increasingly vital biological variation database. For more than 10 years, Dr. Ricos and her colleagues have diligently updated and revised their database - as well as graciously allowed this database to be presented to all visitors on this website.
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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.
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Dr. Callum Fraser discusses scientific statements that are often made in the trade journals and even the scienfitic journals. Sadly, they are often not true. And it's easy to calculate just how wrong they are.
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