Glossary Term
A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called retrospective study.
Performance Metrics
Glossary Term
A manufacturer declaration that an in vitro diagnostic complies with applicable EU legislation (the IVDR since May 2022). CE-IVD indicates regulatory conformance, not a statement of clinical superiority; buyers still review performance claims and intended use.
Regulatory Definitions
Glossary Term
A process where a rotating machine exposes a specimen to centrifugal force. This process can be used to remove moisture from a specimen, to subject an organism to increased gravitational forces, or to separate the components of heterogeneous mixtures based on density differences.
Extraction Methodology
Glossary Term
The nonstaining primary constriction of a chromosome which is the point of attachment of the spindle fiber; provides the mechanism of chromosome movement during cell division; the centromere divides the chromosome into two arms, and its position is constant for a specific chromosome: near one end (acrocentric), near the center (metacentric), or between (submetacentric).
Pcr Terms
Glossary Term
The process by which a person demonstrates specific knowledge, skills, or abilities in the view of a certifying body. Similarly, the process by which a product or process can achieve certification indicating its suitability for a specific purpose.
Performance Metrics
Glossary Term
Chi-square test is a statistical test for testing the null hypothesis that the distribution of a discrete random variable coincides with a given distribution. It is one of the most popular goodness-of-fit tests.
Performance Metrics
Glossary Term
The genetic material of the nucleus, consisting of deoxyribonucleoprotein, which occurs in two forms during the phase between mitotic divisions: 1) as heterochromatin, seen as condensed, readily stainable clumps; 2) as euchromatin, dispersed lightly staining or nonstaining material. During mitotic division the chromatin condenses into chromosomes.
Pcr Terms
Glossary Term
A structure found in cells that is comprised of a strand of linearized double-stranded DNA plus proteins that package the DNA in a condensed coil form and regulate chromosomal function.
Pcr Terms
Glossary Term
Neoplasm-derived DNA fragments found in the bloodstream or other bodily fluids that have been released from cells.
Pcr Terms
Glossary Term
The ratio of standard deviation to mean, expressed as a percentage or fraction.
Performance Metrics
Glossary Term
A range of values for a parameter that may contain the parameter and the degree of confidence that it is in fact there.
Performance Metrics
Glossary Term
A sequence pattern derived from the alignment of multiple sequences that represents the nucleotide or amino acid most likely to occur at each position in a sequence.
Pcr Terms
