Glossary Term
Dynamic Range
The largest difference between, or ratio of, an instrument's or method's highest and lowest value in a set, such as pixel (voxel) values in an image.
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Glossary Term
The largest difference between, or ratio of, an instrument's or method's highest and lowest value in a set, such as pixel (voxel) values in an image.
Glossary Term
A WHO procedure that time-limits the listing of diagnostics (and other health products) for use in public-health emergencies when full prequalification is not yet available.
Glossary Term
A 50-150bp DNA sequence that increases the rate of transcription of coding sequences. It may be located at various distances and in either orientation upstream from, downstream from or within a structural gene. When bound by a specific transcription factor it increases the levels of expression of the gene, but is not sufficient alone to cause expression. Distinguished from a promoter, that is alone sufficient to cause expression of the gene when bound.
Glossary Term
Changes in the regulation of the expression of gene activity without alteration of genetic structure.
Glossary Term
The sequences of a gene that are present in the final, mature, spliced messenger RNA molecule from that gene.
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A US pathway in which a device maker demonstrates substantial equivalence to a legally marketed predicate. For IVD test kits, 510(k) clearance documents intended use and analytical/clinical support; it is distinct from CLIA waiver, which concerns point-of-care operation settings.
Glossary Term
The chemical preservation of a substance to maintain structural and/or molecular features of that substance as they exist in the living entity.
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Fluorescence is a luminescence (i.e., optical phenomenon) in cold bodies, in which a molecule absorbs a high-energy photon, and re-emits it as a lower-energy (longer-wavelength) photon. The energy difference between the absorbed and emitted photons ends up as molecular vibrations (heat).
Glossary Term
A mutation occurring within the protein-coding region of a gene which results in a shift in the reading frame of the encoded protein. Frameshift mutations often result in the premature truncation of a gene product.
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Tissue that is not frozen or embedded in preservatives
Glossary Term
Any DNA sequence rearrangement that results in the gain of one or more copies of a DNA segment that contains at least one gene.
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A deletion that results in the loss of a DNA segment encompassing an entire gene sequence.