The analytic specificity was measured by running clinical specimens with potentially cross-reacting pathogens such as Penicillium, Sporothrix, Blastonzyces, Coccidioides, Histoplasma, and Candida as well as interferents such as rheumatoid factor, bilirubin, and lipoprotein.
The analytic specificity of the LFA also remained high, with very few instances of cross-reaction.
However, I observed an error in the equations given for analytic sensitivity (p 30) and analytic specificity (p 31) in the article.
Similarly, the correct equation for analytic specificity is [True-negatives/ (True-negatives + False-positives)] X 100% NOT [True-negatives/(True-positives + False-positives)] X 100%, as stated in the article.
When Hamlet is a new scientist and Elizabeth I an anatomist, anatomy has become so metaphorical as to lose its analytic specificity
Given that this assay is a qualitative genotyping test intended, in this example, to be used specifically for carrier testing in adults of reproductive age in a particular clinical laboratory, relevant performance characteristics are accuracy, precision (reproducibility in a qualitative assay), analytic sensitivity (including limit of detection), and analytic specificity (including interfering substances).
12) Analytic specificity is the ability of the assay to detect only the target analyte, or, in molecular genetic testing, the ability of the assay to distinguish the target sequence, mutation, or variant from the other sequences or the rest of the genome in the specimen.
These include accuracy, precision, reportable range, reference range (normal range), analytic sensitivity (LOD and limit of quantification [LOQ]), and analytic specificity (including interfering substances), as well as any other parameter that may be considered important.
To assess the analytic specificity of the test, 22 leukemia samples were run that were known to be BCR-ABL1 fusion transcript negative (by chromosome analysis and/ or fluorescence in situ hybridization).
CLIA requires that laboratories performing LDTs, and modified FDA-cleared/approved tests, "establish" the same 4 performance characteristics that are required for FDA-cleared/approved tests, as well as determine analytic sensitivity, analytic specificity, and any additional performance characteristics that may be important to establish (eg, specimen stability, linearity).
For this reason, the meaning and relevance of some performance characteristics, such as reportable range, reference range, and analytic specificity for molecular diagnostic tests, is still being discussed and refined.
Likewise, analytic specificity
has been defined by the American College of Medical Genetics as the proportion of biologic samples that have a negative test result or no identified mutation (being tested for) and that are correctly classified as negative (www.