Glossary Term
A statistical method of partitioning a sample of data into subsets such that the analysis is initially performed on a single subset, while the other subsets are retained for subsequent use in confirming and validating the initial analysis.
Performance Metrics
Glossary Term
The act of validating; finding or testing the truth of something.
Regulatory Definitions
Glossary Term
Validation evidence that an assay detects the range of variants, genotypes, or serotypes it claims to cover. For evolving targets such as influenza or SARS-CoV-2, inclusivity statements carry a validation date and should be checked against circulating variant lists at procurement time.
Performance Metrics
Glossary Term
How close amplification is to ideal doubling each cycle, reported as a percentage or derived from the standard curve slope. Efficiency near 90–110% with a linear standard curve supports quantification claims; it is a standard checklist item when auditing assay validation dossiers.
Performance Metrics
Glossary Term
A statistical technique which helps in making inference whether three or more samples might come from populations having the same mean; specifically, whether the differences among the samples might be caused by chance variation.
Performance Metrics
Glossary Term
Variation in the number of copies of a particular sequence within the genetic material of an individual. Large-scale copy number polymorphisms are common and widely distributed in the human genome.
Pcr Terms
Glossary Term
Genetic Variation consists of deviation(s) in the nucleotide sequence of the genetic material of an individual from that typical of the group to which the individual belongs, or deviation(s) in the nucleotide sequence of the genetic material of offspring from that of its parents.
Pcr Terms
Glossary Term
Any mutation that appears in the gametes and which will therefore be transmitted to the progeny with some frequency.
Pcr Terms
Glossary Term
A genetic variation where gain, loss, or exchange of DNA results in monoallelic loss of function mutations in a diploid cell. In the context of tumor suppressor genes, where a single copy is sufficient for functionality, loss of function for the second allele is associated with tumorigenesis.
Pcr Terms
Glossary Term
A statistical method to test if observations are significant or due to chance. It proposes that no statistical significance exists in a set of given observations and attempts to show that no variation exists between variables or that a single variable is no different than its mean. It is presumed to be true until statistical evidence nullifies it for an alternative hypothesis.
Performance Metrics
Glossary Term
The difference between the lowest and highest numerical values; the limits or scale of variation.
Performance Metrics
Glossary Term
Complementary precision measures: repeatability is variation under the same conditions (same operator, equipment, short interval); reproducibility is variation across conditions — different days, operators, lots, or laboratories.
Performance Metrics