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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.
Glossary Term
The proportion of all the observations that have been classified correctly by the diagnostic procedures in given population, or using some diagnostic test, or by some medical institution or professional.
Glossary Term
The probability that a test will produce a true negative result when used on non-effected subjects as compared to a reference or "gold standard". The specificity of a test can be determined by calculating: number of true negative results divided by the sum of true negative results plus number of false positive results.
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 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
Any physical object that is useful for prevention, diagnosis, monitoring, or treatment of disease or other conditions.
Glossary Term
An organisation designated by an EU member state to assess the conformity of products — including in vitro diagnostics — against applicable regulations before CE marking can be affixed.
Glossary Term
The global analysis of cellular proteins. Proteomics uses a combination of sophisticated techniques including two-dimensional (2D) gel electrophoresis, image analysis, mass spectrometry, amino acid sequencing, and bio-informatics to resolve comprehensively, to quantify, and to characterize proteins. The application of proteomics provides major opportunities to elucidate disease mechanisms and to identify new diagnostic markers and therapeutic targets.
Glossary Term
A part of a thing, or of several things, taken to demonstrate or to determine the character of the whole, e.g. a substance, or portion of material obtained for use in testing, examination, or study; particularly, a preparation of tissue or bodily fluid taken for examination or diagnosis.
Glossary Term
A WHO assessment that confirms a diagnostic meets quality, safety, and performance requirements for procurement by UN agencies and many national programs. WHO PQ status is frequently a tender eligibility criterion for public-health deployment in low- and middle-income countries.
