Glossary Term
Notified Body
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.
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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
Any of various amplification and detection strategies applied to detection of virus contamination in donor blood. Specifically designed to detect recently infected individuals during the latency period before seroconversion.
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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.
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Laboratory procedure in which single stranded nucleic acids are allowed to interact so that complexes, or hybrids, are formed by molecules with sufficiently similar, complementary sequences. By this means the degree of sequence identity can be assessed and specific sequences detected. (From Biology-online)
Glossary Term
Nucleotide Excision Repair (NER) mends DNA regions that contain chemical adducts, such as UV-induced thymine dimers or carcinogenic adducts, which distort the DNA helix and interfere with replication and transcription. NER is targeted to actively transcribed regions of the genome. During NER in eukaryotes, shape irregularities are detected by protein complexes that slide along the DNA molecule and induce cuts on each side of a lesion several nucleotides away. Removal of the damaged 25-30 nucleotide fragment is followed by repair synthesis and ligation.
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The ratio of the odds of an event occurring in one group to the odds of it occurring in another group, or to a sample-based estimate of that ratio.
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The concentration of osmoles of solute per kilogram of solvent present in a sample.
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An observation in a data set that is numerically distant from the rest of the data.
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A measure of the probability that a result happened by chance. The lower the p-value, the more likely it is that the result was caused by phenomenon of interest.
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A method used to test whether the mean difference between pairs of measurements in a related group are significant.
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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.
Glossary Term
A measure of the correlation of two variables X and Y measured on the same object or organism, that is, a measure of the tendency of the variables to increase or decrease together. It is defined as the sum of the products of the standard scores of the two measures divided by the degrees of freedom.