We showed 100% analytic specificity
for 10 exons that were within reference range by Sanger sequencing (supplementary table 1).
By using survey data, the MPEP can evaluate parameters such as analytic sensitivity and analytic specificity
for particular HIV-1 tests along with laboratory characteristics such as laboratory type.
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.
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).
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.
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).
The analytic specificity
of the assay was calculated using the following formula: Analytic specificity
= [True negatives/(True positives + False positives)] x 100% = ([15/15] x 100%) = 100%.
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.acmg.net; accessed May 23, 2008).
To confirm the analytic specificity
of the BRAF assay and determine its limit of detection (LOD) relative to the 500 MFI cutoff, serial dilutions of gDNA extracted from c.
When Hamlet is a new scientist and Elizabeth I an anatomist, anatomy has become so metaphorical as to lose its analytic specificity
. But The Body Emblazoned is filled with powerful and arresting readings that take into account not only contemporary fashionable preoccupations with gender, status, and colonial exploration, but the learned traditions of religious iconography and the memento mori and the wider contexts of European poetics and the visual arts.
Laboratory performance was described in terms of analytic sensitivity (i.e., of positive specimens, the proportion that were reactive), analytic specificity
i.e., of negative specimens, the proportion that were nonreactive), and overall analytic performance (i.e., for all specimens tested, the proportion for which test results were correct).
Limited analytic specificity
may be a result of misclassification of microorganism or nucleic acid contained in patient specimens or contaminated reagents.