IVD & Molecular Diagnostics Glossary

Enzymatic (e.g. dUTP/UNG) and physical measures that stop amplified DNA from contaminating later runs. Labs with high daily volumes usually require dUTP/UNG chemistry in purchased assays; confirm this when comparing kits from different manufacturers.

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.

A PCR format that partitions each sample into thousands of sub-reactions and calls each partition positive or negative, giving absolute quantification without a standard curve. Useful for low-level targets, copy-number work, and reference material characterization; throughput and per-test cost differ from qPCR.

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.

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.

Placeholder definition before migration.

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.

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.

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.

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.

The lowest concentration of an analyte that can be quantified with acceptable accuracy and precision under stated conditions — distinct from, and higher than, the limit of detection.

A purification method in which nucleic acids bind to paramagnetic beads and are collected with a magnet through wash steps. It automates well, which is why most high-throughput extraction platforms are bead-based; compare deck footprint and sample capacity when shortlisting systems.

Amplification of several targets in a single reaction using multiple primer pairs, each distinguishable by fluorescent channel or melting profile. Multiplexing raises information per sample but makes channel allocation, dye compatibility, and competition between targets key selection criteria.

A reaction that contains all reagents except sample nucleic acid. Amplification in the NTC signals contamination of reagents or the environment, so NTC behavior is one of the first run-validity checks in any qPCR run log.

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.

The sample-preparation stage that lyses cells or virions and purifies DNA/RNA before amplification. Extraction quality (yield, purity, inhibitors removed) often limits assay performance more than the PCR itself, and it defines required instruments and hands-on time in a workflow.

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.

An enzymatic pre-treatment in nucleic-acid extraction that degrades proteins and nucleases, releasing nucleic acids from clinical material before binding, wash, and elution steps.

A PCR method that measures amplification as it happens using fluorescent reporters, so target quantity is estimated from the amplification curve rather than by post-run handling. qPCR is the workhorse format for viral load, pathogen detection, and GMO or food testing workflows.

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.

A two-step setup in which RNA is first copied into complementary DNA by a reverse transcriptase and then amplified by PCR. Used for RNA viruses such as influenza, RSV, SARS-CoV-2, and HCV. In procurement documents, confirm whether "RT-PCR" refers to real-time (quantitative) or endpoint (qualitative) reading.

A purification method that binds nucleic acids to a silica membrane in a spin column through centrifugation or vacuum. It is a common manual and mid-throughput format with well-understood consumable logistics, but is less automation-friendly than magnetic bead approaches.

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.