These days, the media is full of news about diagnostic tests. Here’s what you need to shine in every discussion about testing
The emerging market for diagnostics in the UAE is as potentially rich as it is relatively unexplored. While global research in the field of molecular diagnostics and the levels of R&D in product development for diagnosis of genetic disease as well as forensic and paternity testing is of a high standard, local markets are still in their nascent stages though primed for growth through government support and entrepreneurial drive.
From genetic diseases and diagnostic findings that aid in cancer research to forensic and paternity molecular diagnostics, the UAE is exploring an expansive industry that also provides opportunity for players, established and new to make a mark in the sector. As one of the biggest global brands in cutting- edge diagnostic research, Roche has made its mark by bringing the latest research findings in the field to local labs and clinics, standing firm by their corporate creed of doing now what the patient needs next. As an introductory feature into the realm of diagnostics, Roche in collaboration with Gulf News presents a ready reckoner, a veritable laundry list of industry jargon that will help patients, bystanders and those interested in the field of diagnostics to get familiar with the terminology involving diagnostic tests, while coincidentally providing a bird’s eye perspective on what Roche has to offer to local markets.
Antibodies are proteins that help fight infections. An antibody test is a blood-based test used to determine whether a person was exposed to and might have gained immunity against a pathogen (a bacterium, virus, or other microorganism that can cause disease).
An antigen is the part of a pathogen that causes an immune response. An antigen test detects proteins specific to that pathogen (a bacterium, virus, or other microorganism that can cause disease).
CE Marked test
CE marking indicates that a test has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU or in non-EU countries accepting the CE mark.
Clinical (bio-)chemistry is the area of chemistry that is generally concerned with analysis of bodily fluids for diagnostic purposes. These are performed on any kind of body fluid, but mostly on serum or plasma. Serum is the liquid that remains after the blood has clotted. Plasma is the liquid that remains when clotting is prevented with the addition of an anticoagulant.
Clinical sensitivity of a test
Clinical sensitivity indicates the ability of a test to correctly identify patients that have the pathogen, disease or condition (“true positives”).
Clinical specificity of a test
Clinical specificity indicates the ability of a test to correctly identify patients that do not have the pathogen, disease or condition (“true negatives”).
A companion diagnostic is a test that provides information for the safe and effective use of a specific treatment. The test is critical to help healthcare professionals determine whether a particular treatment’s benefits to patients will outweigh any potential serious side effects or risks. Companion diagnostics are most commonly used with targeted treatments for cancer.
Consumables are disposable parts such as tips, plates, sealing foils, cassettes, containers and bottles.
Diagnostics play a critical role in healthcare. They aid in disease prevention, screening, diagnosis, monitoring and treatment.
False-negative test result
A false negative occurs when a test result improperly indicates no presence of a pathogen, disease or condition, when in reality it is present.
False-positive test result
A false positive occurs when a test result improperly indicates the presence of a pathogen, disease or condition, when in reality it is not present.
(Highly) automated instrument
Highly automated systems are very sophisticated pieces of robotics that significantly reduce manual steps in the lab, reducing the risk of errors and enhancing patient safety and process quality.
High throughput instrument
A high throughput instrument in a highly automated machine or combination of machines that allows high volumes of testing over a short period of time.
Immunodiagnostics is a diagnostic methodology that uses antibodies for the identification of pathogens as the primary means of detecting infectious diseases, tumours, drug abuse, diabetes, proteins, therapeutic drugs, and allergens.
Systems are very sophisticated pieces of robotics used to run and automate diagnostics tests. Some instruments are stand-alone while others may form part of a system.
In-vitro diagnostics are tests done on samples such as blood, tissue or urine that have been taken from the human body. They provide objective information used for disease detection, management, and prevention. They influence roughly two-thirds of clinical decision making while accounting for just 2% of healthcare spending.
Molecular diagnostics help identify pathogen, disease or condition by studying molecules, such as proteins, DNA, and RNA, in patient samples.
PCR or polymerase chain reaction
The polymerase chain reaction (PCR) technology allows to amplify small amounts of genetic material (DNA or RNA) and has enabled major leaps in disease diagnosis and monitoring, e.g. for HIV.
Reagents are complex mixtures of biochemicals or chemicals used in in-vitro diagnostic testing. Example: “Lysis buffer” is a reagent used in SARS-CoV-2 testing to break open cells and/or viruses in order to identify their genetic make-up to confirm whether a patient has the virus.
Samples are small quantities of human material — blood, urine or tissue to be analyzed. Auxiliary devices such as swabs are sometimes used to collect those samples.
Serology or serological test
Serology tests are blood-based tests used to identify antibodies and antigens in a patient’s sample.
Test or assay
An assay is used to test for the presence or to determine the concentration of specific components in the human body --proteins, nucleic acid, infectious agents, cancer cells, etc. Assays help address the screening, diagnosis, monitoring, prevention and treatment of disease.
Test kits are packaged sets of reagents that make up a test for customer use.
Tissue diagnostics focus on the analysis of biopsies or other tissue samples from the human body. They are mostly commonly used for cancer detection, evaluation and management.
For more information visit www.roche-middleeast.com