An overestimation of the percentage of malignant cells could lead to false-negative results if the true percentage of malignant cells in the specimen fell below the particular assay's analytic sensitivity
, and could subsequently lead to incorrect selection of therapy.
Data regarding analytic sensitivity
and specificity were obtained from the Food and Drug Administration submission file for the LFA.
This includes maintenance of FNA sample stability during collection and shipment; analytic sensitivity
, as demonstrated by the test's tolerance of low RNA quantities and small amounts of malignant material in patient samples; and analytical specificity, as the test performed well even when samples were highly diluted by blood and other genetic material.
The 6 parameters were (a) the mean number of reads mapped to ExQC DNA, (b) the mean number of sample reads normalized to the mean number of reads of ExQC DNA, (c) the correlation coefficient of the expected vs observed values of ExQC DNA heteroplasmy, (d) the ratio of the SD of the mean number of reads to the mean number of reads mapped to sample DNA, (e) the analytic specificity, and (f) the analytic sensitivity
of a run determined from the reads mapped to mtDNA.
The analytic sensitivity
of the reaction was tested by diluting the toxin in Hepes reaction buffer to 100, 10, 1, 0.
Earlier this year, we began development of these kits for the WAVE MCE, a faster, lower cost system which has exhibited equivalent analytic sensitivity
to the WAVE and better analytic sensitivity
than competitive technologies typically used for this testing.
Advances in immunoassay technologies and the international adoption of traceable troponin calibration standards have resulted in development of troponin assays with unprecedented analytic sensitivity
However, I observed an error in the equations given for analytic sensitivity
(p 30) and analytic specificity (p 31) in the article.
The enhanced analytic sensitivity
of COLD-PCR allows clinicians to use smaller amounts of sample for their genetic analysis and less intrusive sample collection methods such as a blood draw for serum or plasma preparation, urine, fine needle aspirates or bronchial lavage as well as studying mutated DNA in tumors directly.
In the presence of ischemia, cTn above the 99th percentile has become the cornerstone for the definition of acute myocardial infarction (MI) in nonST-elevation MI (1, 2), leading manufacturers of in vitro diagnostic tests to improve low-end analytic sensitivity
This technology is designed to significantly increase analytic sensitivity
compared to first generation sDNA assays.
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).