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The analytic specificity of the HPV 16 and 18 assays was 100 and 97%, respectively.
Enzymatic digestion with an ATP-dependent DNase improved the analytic specificity to a greater than 1 10,000 ratio of cccDNA RC DNA (relaxed circular DNA).
The performance characteristics that must be established are precision, accuracy, reportable range, reference interval, analytic sensitivity, and analytic specificity, as well as evaluation of any other characteristics required for test performance (e.g., specimen stability, reagent stability, alternate extraction methods, and multiple instruments).
It is a determinant of analytic sensitivity, analytic specificity, cost, and choice of sequencing instrument.
This experience has confirmed the results reported herein – namely that analytic specificity remains adequate for clinical use despite such sensitivity.
This notion includes the capacity that the test will be positive if the genetic variant is present (analytic sensitivity), and negative if it is absent (analytic specificity) [ 21].
Similar(53)
The blocking ELISA is based on monoclonal antibodies for capture and blocking to ensure a defined analytic sensitivity and specificity and, assumingly, an increased diagnostic specificity.
Analytic sensitivity and specificity plateaued at approximately 40-fold (sensitivity 99.84 % and 99.85 %, and specificity 99.74 % and 99.85 %, for genotypes and variant calls, respectively).
Possibly more remarkable was 99.4 % analytic sensitivity and specificity with 20X genome sequence and the same methods.
In silico modeling suggests that analytic sensitivity and specificity for nucleotide variants would remain >95 % with such read lengths.
Specimens should be masked and the assays should include panels of specimens to estimate analytic sensitivity and specificity.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com