Article
Head-to-head evaluation of a commercial real-time PCR assay targeting plasmodial species causing human malaria against a composite reference standard.
Research record from Eur J Microbiol Immunol (Bp), 2026-07-01. PMID 42384441.
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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.
Tests
Molecular detection of M. tuberculosis complex, with or without rifampicin resistance markers.
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.
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.
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.
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.
Glossary Term
A study in which the participants are assigned by chance to separate groups to evaluate treatments. The study also includes a control group, which is undergoing the same rigors of the study with placebo treatment or standard treatment. The trial can also be controlled by the addition of a test group to ensure there are no factors present to skew the results and by the inclusion of peer-review analysis by appropriate government officials. 2005
Tests
A red cell distribution width (RDW) test measures how much the volume and size of your red blood cells (erythrocytes) varies.
Glossary Term
A measure of the range of values in a set of numbers. Standard deviation is a statistic used as a measure of the dispersion or variation in a distribution, equal to the square root of the arithmetic mean of the squares of the deviations from the arithmetic mean.
Glossary Term
The standard deviations of the sample in a frequency distribution, obtained by dividing the standard deviation by the square root of the total number of cases in the frequency distribution.