Glossary of Terms
Assay. Chemical reactions that allow detection or quantification of substances or biomarkers in samples.
Biomarker. A characteristic that is objectively measured and evaluated as an indicator of normal biologic or pathogenic processes or pharmacological responses to a therapeutic intervention.
Biopsy. Sample of tissue from a living body extracted for diagnostic purposes.
Classification. The division of a disease into medically relevant subtypes, such as aggressive and nonaggressive subclasses of tumours in oncology.
Clinical Trial. A single statistically significant trial for patients with disease. The results of the trial provide performance statistics for the test and are written up and published in a peer reviewed journal.
DNA. Deoxyribonucleic acid. The carrier of genetic information for all complex organisms. DNA consists of four different bases bound to a sugar phosphate backbone: adenine (A), cytosine (C), guanine (G), thymine (T). The genetic information is encoded in the sequence of four bases.
Indication. A valid reason to use a certain test, medication, procedure or surgery.
In vitro. In a test tube.
IVD. In vitro diagnostic.
Molecular classification test. Diagnostic test that, based on the analysis of DNA or RNA allows the more precise classification of a disease in clinically or pathologically relevant subgroups.
Molecular Diagnostics. Diagnostics based on genetic and epigenetic information.
Monitoring. The tracing of potential recurrence or assessment of progression of a disease.
Oncology. The branch of medicine that studies tumours (cancer) and seeks to understand their development, diagnosis, treatment and prevention.
PCR. Polymerase chain reaction. Method to multiply a section of the DNA in a test tube.
Prognosis. Prediction of how a patient’s disease will progress, and the chance of recovery.
Reagents. Chemical substances needed for the performance of an assay.
Relapse. Disease return following treatment to the primary or distant organ.
Recurrence. Disease return following medical intervention (see relapse).
RNA. Ribonucleic acid. Molecule build of similar components as DNA that mainly as an information carrier is involved in the use of genetic information to direct the synthesis of proteins. Compared to DNA, RNA is chemically and biologically considerably less stable.
RT PCR. Real-time PCR. PCR in which the amplification of a DNA segment is continuously measured.
Screening. The systematic and preventative mass screening of an asymptomatic population for early detection of disease.
Sensitivity. The measure of a test’s ability to accurately detect the presence of a disease. For example, a sensitivity of 90% means that out of 100 patients which actually have the disease, on average 90 are correctly diagnosed.
Specificity. The measure for a test’s ability to exclude a disease if it is truly not present. For example, a specificity of 90% means that out of 100 healthy people ten are falsely identified as having the disease.
Surveillance. Tight surveillance of individuals at high risk of developing a disease by using diagnostic procedure.
Test kit. Test reagent kit. A set of reagents, consumables and processing instructions necessary to perform a diagnostic laboratory test.
Test panel. Combination of different biomarkers in a diagnostic test.
Tumour. A mass of excess tissue that results from abnormal cell division.
Urologist. Specialist clinicians for urological diseases and disorders.
Validation. Establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly and meet its predetermined specifications and quality attributes.