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.
Performance Metrics
Glossary Term
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.
Pcr Terms
Tests
An index of the variation in the size of the red cells and can be used to detect subtle degress of anisocytosis. It is computed directly from the RBC histogram and is calculated as a standard statictical value, the coefficient of variation of the red cell volume ditribution (ratio of standard deviation and mean copuscular volume).
For professionals
Article
Research record from J Microbiol Methods, 2026-09-26. PMID 42800479.
Article
Research record from Eur J Microbiol Immunol (Bp), 2026-07-01. PMID 42384441.
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.
Regulatory Definitions
Tests
Molecular detection of M. tuberculosis complex, with or without rifampicin resistance markers.
For professionals
Glossary Term
A family of probability density functions whose mean, median and mode are identical. The function generates a symmetrical curve, whose position and shape is determined by its location and scale parameters, the mean and standard deviation respectively. The standard normal distribution has a location parameter of 0 and a scale parameter of 1.
Performance Metrics
Glossary Term
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.
Performance Metrics
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.
Performance Metrics
Platform Page
IVD technical documents published by standards bodies, regulators and manufacturers, each linked and quoted from the publisher’s own page.
Glossary Term
Programs of regular assessment of medical and nursing activities to evaluate the quality of medical care including all actions taken to ensure that standards and procedures are adhered to and that delivered products or services meet performance requirements.
Performance Metrics