Analytical methods validation is an important regulatory requirement in pharmaceutical analysis. High-Performance Liquid Chromatography (HPLC) is commonly used as an analytical technique in developing and validating assay methods for drug products and drug substances. Method validation provides documented evidence, and a high degree of assurance, that an analytical method employed for a specifi...

CONTEXT Diagnostic laboratory testing for Clostridium difficile infection has undergone considerable and rapid evolution during the last decade. The ideal detection method(s), which should exhibit high analytical and clinical sensitivity and specificity, remains undefined. OBJECTIVE We sought to evaluate the analytical and clinical performance characteristics of three methods for the laborato...

This article explores the relationship between the job characteristics underlying the Goldthorpe model of social class (work monitoring difficulty and human asset specificity) and those underlying theories of technological change (routine and analytical tasks) highlighted as key drivers for growing inequality. Analysis of the 2012 British Skills and Employment Survey demonstrate monitoring diff...

The use of enzymes in analytical chemistry has gained tremendous attention during the last 2-3 decades. The obvious and straightforward reason has to do with the specificity of enzymatic reactions. In other words, by incorporating an enzyme-related step in the analytical cycle, someone can achieve high selectivity by using non-selective detection techniques (e.g. spectrophotometry, fluorescence...

To the editor: The report on assessment of diagnostic properties of rapid influenza H1N1 diagnostic test demonstrated an interesting finding that ‘Rapid tests have high specificity but low sensitivity and thus limited usefulness’. The metaanalysis in this work might have some problems. As different rapid influenza H1N1 diagnostic tests have different basic principles, the use of overall sensiti...

The new BD Max GC real-time PCR assay showed high clinical and analytical sensitivity and specificity. It can be an effective and accurate supplementary test for the BD ProbeTec GC Qx amplified DNA assay, which had suboptimal specificity, and might also be used for initial detection of Neisseria gonorrhoeae.