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Glossary Term
A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis.
Glossary Term
EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.
Glossary Term
The relative frequency of occurrence of something.
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.
Glossary Term
The act of hindering or obstructing or impeding.
Glossary Term
A non-target amplification built into a reaction to prove the assay chemistry worked even when the sample is negative. It helps distinguish a true negative from inhibition or setup failure, which matters when interpreting single-target assays on difficult matrices.
Glossary Term
The difference between the 3rd and 1st quartiles is called the interquartile range and it is used as a measure of variability (dispersion).
Glossary Term
Non-coding, intervening sequences of DNA that are transcribed, but are removed from within the primary gene transcript and rapidly degraded during maturation of messenger RNA.
Glossary Term
The act of turning inside out, upside down, or end-for-end.
Glossary Term
The weighted concentration of ions in solutions.
Glossary Term
The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.
Glossary Term
An isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic.
