Guest Essay
Dietmar Stockl, colleague, friend, and expert in statistics, starts a series on looking at QC data examples from the real world of the laboratory. Sometimes what happens in reality is different than what's predicted in theory.
Despite years of intensive use and the recent advent of “high sensitivity” assays, fundamental questions about cardiac Troponin methods remain. Is precision of 10% CV required at the upper 99th percentile value of the reference population? Are methods with CV > 20% unacceptable? Is a change of 20% in an individual significant? Callum G Fraser, the internationally respected expert on biological variation, provides a logical technique for the interpretation of serial test results.
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.
Dr. Carmen Ricos and colleagues explain the 2010 additions and updates to the biological variation database.