in vitro Diagnostics Glossary

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

IVD GLOSSARY IN VITRO DIAGNOSTICS (IVD) TERMS AND DEFINITIONS

Welcome to the IVD Glossary, an essential resource designed to provide clarity and understanding for in vitro diagnostics (IVD) innovators, manufacturers, and healthcare providers alike.

VERSION: 1.0 DATE: 30 AUG 2024 C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

INTRODUCTION

WHY ARE IVD TERMS AND DEFINITIONS IMPORTANT? In the dynamic field of clinical diagnostics, precise terminology is not merely a matter of communication; it forms the bedrock of safety, compliance, and innovation.

THE PURPOSE OF THE IVD GLOSSARY This glossary aims to demystify the intricate language surrounding in vitro diagnostics, offering concise definitions and explanations of key terms that span the entire development and management lifecycle, from conceptualisation and design to manufacturing, regulation, and clinical management.

Whether you are navigating the complexities of regulatory requirements, ensuring quality standards in manufacturing, or seeking to enhance patient outcomes through innovative technology, this glossary serves as your trusted companion.

With contributions from experts in the field and regularly updated to reflect the latest advancements and regulatory changes, the IVD Glossary is your reliable gateway to mastering the language of clinical diagnostics. It can be used in conjunction with the MedDev Central Medical Device Glossary. We invite you to explore, learn, and leverage this resource to advance your knowledge and expertise in the dynamic world of medical devices.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

USER GUIDE

HOW TO USE THIS RESOURCE Search and Navigation: Start by familiarising yourself with the structure of the glossary. This glossary is organised alphabetically, making it easy to locate specific terms. Related terms are cross-referenced for ease of navigation.

Definitions and Explanations: Each term in the glossary is accompanied by a general definition and, in some cases, additional explanations or context. These definitions aim to provide a basic understanding of the term. Formal definitions for some terms vary between jurisdictions and settings.

Contextual Use: Understand how each term is used within the context of medical devices. Some terms may have specific meanings or implications in different phases of device development (e.g., design, manufacturing, clinical trials) or regulatory processes (e.g., FDA requirements, CE marking).

Cross-Referencing: Use cross-references provided within the glossary to explore related terms. This can deepen your understanding of interconnected concepts and how they relate to each other within the medical device ecosystem.

Regulatory and Compliance Guidance: Pay attention to terms related to regulatory affairs and compliance standards. This glossary includes terms to help you navigate the regulatory landscape more effectively. However, precise definitions do vary by regulatory authority and in standards, so it’s important to reference the formal definitions included in relevant regulations and standards for regulatory submissions and documentation.

Training and Education: Glossaries are valuable tools for training new team members or educating stakeholders about IVD terminology. Incorporate the glossary into training programs to ensure consistency in understanding and communication across your organisation.

Updates and Revisions: IVD technology evolves rapidly, and regulatory and payer requirements can change. Check the glossary periodically for updates and revisions to stay current with the latest terminology and industry practices.

Feedback and Contributions: If you encounter unclear or missing terms from the glossary, provide feedback to MedDev Central. Your input can help improve the glossary for future users.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

TERMS AND DEFINITIONS

The following 8 pages contain a list of key in vitro diagnostics (IVD) terms and definitions arranged alphabetically. They cover terms associated with: •

IVD Innovation (Research, Design and Development, Market Access and Commercialisation)

•

Regulation and Quality

•

Health Technology Assessment (HTA)

•

Clinical Laboratory Management

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

A Analytical Sensitivity: The ability of a test to detect even small amounts of a substance in a sample.

Analytical Specificity: The ability of a test to distinguish between the substance of interest and other substances that might be present in the sample.

Analyser: A specific type of instrument used in clinical laboratories to perform automated analysis of samples. Analysers are designed to carry out a variety of tests, including chemical, immunological, haematological, and molecular diagnostics, providing accurate and reliable results quickly and efficiently. They can process multiple samples simultaneously and are often integrated with software for data management and interpretation.

Antibody: A protein produced by the immune system in response to the presence of a foreign substance (antigen). Antibodies can specifically bind to antigens to neutralize or mark them for destruction by other immune cells.

Antigen: Any substance that the immune system can recognize and react against. Antigens are typically proteins or polysaccharides on the surface of pathogens, such as bacteria and viruses, but can also include other substances like toxins or allergens.

Assay: A laboratory procedure measuring the presence, amount, or activity of a specific substance. Also see Test.

Association for Diagnostics & Laboratory Medicine (ADLM): A professional association dedicated to advancing the practice and profession of clinical laboratory science and its application to healthcare, through education, advocacy, and collaboration. Formerly known as the American Association for Clinical Chemistry (AACC).

Arterial Blood Sample: A blood sample taken from an artery, often used to measure blood gases such as oxygen and carbon dioxide levels.

B Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

Biomarker Discovery: The process of identifying new biomarkers, which are biological molecules that indicate a particular disease state or condition.

Biomarker Validation: The process of confirming that a biomarker is a reliable indicator of a disease state or condition, often involving clinical trials and other studies to verify its efficacy and accuracy.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

Blood Gas: A test that measures the levels of oxygen (O2) and carbon dioxide (CO2) in the blood, as well as the pH (acidity or alkalinity). It helps assess lung function and the effectiveness of oxygen therapy.

C Calibration: The process of setting a test to known standards to ensure accuracy and reliability of the results.

Capillary Blood Sample: A small blood sample usually obtained by pricking the skin, typically the fingertip, earlobe, or heel.

Clinical Chemistry: A branch of laboratory medicine that focuses on the analysis of bodily fluids (primarily blood and urine) to diagnose and monitor diseases, involving tests such as glucose, cholesterol, and enzyme levels.

Clinical Laboratory Improvement Amendments (CLIA): Regulations in the United States governing laboratory testing to ensure quality and accuracy.

Clinical Laboratory Professional: A healthcare professional who performs laboratory tests and analyses results to help diagnose, treat, and prevent diseases. This can include roles such as medical laboratory scientists, technologists, and technicians.

Clinical Setting: A healthcare environment where patient care is provided, such as hospitals, clinics, or private practices, where medical professionals diagnose and treat patients.

Coefficient of Variation (CV): A standardized measure of the dispersion of a probability distribution or frequency distribution, calculated as the ratio of the standard deviation to the mean (often expressed as a percentage). It is used to assess the precision of a test.

Coagulation: The process by which blood changes from a liquid to a gel, forming a blood clot. This is a crucial mechanism to stop bleeding and involves the action of blood cells (platelets) and proteins (clotting factors). Coagulation tests are performed to assess how well the blood clotting process is working.

Companion Diagnostic: A diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person.

Consumable: Items that are used up or discarded after a single use or a specific period in the laboratory. They include items such as reagents, test tubes, pipette tips, slides, gloves, and other materials necessary for conducting tests and experiments. Consumables are essential for daily laboratory operations and must be replenished regularly.

Control Sample: A sample that is used to ensure the test is working correctly and to provide a baseline C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

for comparison with patient samples.

Cerebrospinal Fluid Sample (CSF): A sample of the fluid surrounding the brain and spinal cord, typically obtained via lumbar puncture, used for diagnostic testing of neurological conditions.

D Decentralised Testing The process of conducting clinical trials or diagnostic tests outside traditional clinical settings.

Deoxyribonucleic Acid (DNA): A molecule that carries the genetic instructions used in the growth, development, functioning, and reproduction of all known living organisms and many viruses. DNA is composed of two strands that coil around each other to form a double helix, containing nucleotides with bases adenine (A), cytosine (C), guanine (G), and thymine (T).

Diagnostic: Pertaining to the identification of a disease or condition. Diagnostic tests and procedures are used to determine the cause of symptoms or to confirm the presence of a particular disorder.

Dynamic Range: The range over which a test can measure an analyte with acceptable accuracy and precision, extending from the LOQ to the upper limit of quantification.

E F False Positive: A test result indicating that a person has a disease or condition when they do not.

False Negative: A test result indicating that a person does not have a disease or condition when they do.

G H Haematology Testing: The study and analysis of blood, blood-forming organs, and blood diseases. Tests in haematology often include complete blood counts (CBC), blood film examination, and coagulation tests to diagnose conditions like anaemia, clotting disorders, and infections.

Histology: The study of the microscopic structure of tissues. Histology involves examining cells and tissues under a microscope to identify abnormalities and diagnose diseases.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

Home Testing: Medical tests that can be performed by individuals in their own homes without the need to visit a healthcare provider.

I Ion: An atom or molecule with a net electric charge due to the loss or gain of one or more electrons.

Ions are essential for many biological processes, including the transmission of nerve impulses and muscle contraction.

Immunoassay: A biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody or antigen.

Instrument: In the context of in vitro diagnostics, an instrument refers to any device or apparatus used to perform diagnostic tests on biological samples. Instruments can range from simple tools like pipettes and microscopes to complex automated machines used for a variety of assays and analyses.

ISO 15189: An international standard that specifies requirements for quality and competence in medical laboratories. It ensures that laboratories meet international criteria for quality management and technical competence.

International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): A global organization dedicated to the advancement of clinical chemistry and laboratory medicine through scientific collaboration, education, and quality standards.

In Vitro Diagnostics (IVD): Tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.

IVD Directive (IVDD): European regulation for the safety and performance of in vitro diagnostic medical devices.

IVD Regulation (IVDR): New regulation in the European Union that updates and replaces the IVDD, aimed at ensuring the safety and performance of IVD medical devices.

J K L Laboratory: A controlled environment where scientific research, experiments, and measurements are conducted. In the context of healthcare, it often refers to a medical lab where tests on clinical specimens are carried out to obtain information about the health of a patient.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

Laboratory Information System (LIS): A software system designed to manage and support laboratory operations. It tracks samples, manages test orders, records results, and ensures the secure exchange of data. LIS facilitates workflow management, improves data accuracy, and supports regulatory compliance in laboratory environments.

Laboratory Information Management System (LIMS)*: A software solution that helps manage samples, associated data, and laboratory workflows to improve efficiency, accuracy, and compliance in laboratory environments.

Lateral Flow Test (LFT): A simple diagnostic tool used to detect the presence or absence of a target analyte in a sample, typically through a rapid, portable test strip that produces results visually, often used for purposes like pregnancy testing or infectious disease screening. Also known as a Lateral Flow Assay (LFA) Limit of Detection (LOD): The lowest amount of an analyte that a test can reliably detect but not necessarily quantify.

Limit of Quantification (LOQ): The lowest amount of an analyte that can be quantitatively detected with suitable precision and accuracy.

M Microarray: A laboratory tool used to detect the expression of thousands of genes at the same time.

Microbiology: The study of microorganisms, such as bacteria, viruses, fungi, and parasites. In the context of diagnostics, microbiology involves identifying and analyzing these microorganisms to diagnose infections and determine appropriate treatment options.

Molecular Diagnostics: Techniques used to analyse biological markers in the genome and proteome by applying molecular biology to medical testing.

Monitoring: The ongoing observation and assessment of a patient’s condition over time. Monitoring involves regularly measuring certain parameters to track the progress of a disease or the effectiveness of treatment.

N Next-Generation Sequencing (NGS): A high-throughput methodology that enables rapid sequencing of the base pairs in DNA or RNA samples.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

O Outpatient Clinic: A healthcare facility where patients receive diagnosis, treatment, and care without being admitted to a hospital. These clinics are designed for patients who do not require overnight stays.

Outreach Clinic: A type of clinic that provides healthcare services to communities that are underserved or geographically isolated.

P Pathology: The study of diseases, including the causes, development, and effects on the body.

Pathology involves examining tissues, organs, bodily fluids, and autopsies to diagnose and understand diseases.

Polymerase Chain Reaction (PCR): A technique used to amplify small segments of DNA or RNA to facilitate their detection and analysis.

Point-of-Care Testing (POCT): Medical testing at or near the site of patient care.

Post-analytical: The phase in IVD that includes all activities following the analysis of a sample, such as result interpretation, reporting, storage of results, and data management.

Pre-analytical: The phase in in vitro diagnostics (IVD) that encompasses all processes before the actual analysis of a sample, including sample collection, handling, transport, storage, and preparation.

Precision: The degree to which repeated measurements under unchanged conditions show the same results. It reflects the reproducibility of the test results.

Predictive: Relating to the likelihood of developing a particular condition in the future. Predictive tests can identify individuals at higher risk of developing a disease, often based on genetic or molecular markers.

Prognostic: Relating to the prediction of the future course and outcome of a disease. Prognostic factors help determine the likely progression and outcome of a condition, as well as inform treatment decisions.

Protein: Large, complex molecules made up of amino acids and play many critical roles in the body.

They are required for the structure, function, and regulation of the body’s tissues and organs.

Q Quality Control (QC): Procedures implemented in the lab to ensure that the test results meet specified C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

quality standards.

R Reagent: A substance or mixture used in chemical analysis or other reactions, such as those found in diagnostic tests.

Reference Range: The normal range of values for a given test based on a healthy population, used as a comparison to determine if results are abnormal.

S Saliva Sample: A sample of saliva collected from the mouth, used for various diagnostic tests, including genetic and hormone analysis.

Sample: A portion of material, such as blood, urine, or tissue, taken from a patient for testing or analysis to provide information about their health.

Sample Processing: The steps required to prepare a sample for testing. This includes sample collection, labelling, transportation, preparation (such as centrifugation or aliquoting), and ensuring the sample is in the correct form and condition for the desired tests.

Sample Type: The specific kind of sample collected for analysis, such as blood, urine, saliva, or tissue, which can affect the type of tests that can be performed and the accuracy of the results.

Scientific Validity: The extent to which the results of a test or study accurately reflect or measure the concept or phenomenon being studied. In diagnostics, scientific validity refers to the ability of a test to correctly identify or measure a health condition, based on sound scientific evidence and methodology.

Screening: The process of testing individuals who do not yet have symptoms of a disease to detect the condition at an early stage. Screening aims to identify diseases early when they are more likely to be treatable.

Sensitivity: The ability of a diagnostic test to correctly identify individuals with a disease.

Serology: The scientific study of serum and other bodily fluids, often referring to diagnostic identification of antibodies in the serum.

Small Molecule: Low molecular weight organic compounds that can regulate biological processes.

These molecules are often used as drugs because they can easily enter cells due to their small size.

C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

Society of Laboratory Professionals and Technicians Association (SLPTA): An organisation that represents and supports laboratory professionals and technicians, promoting standards, education, and advocacy for the profession.

Specificity: The ability of a diagnostic test to correctly identify individuals without a disease.

Specimen: A sample taken from the body (e.g., blood, urine, tissue) that is used for laboratory testing to help diagnose disease, monitor health, or evaluate treatment.

Sputum Sample: A sample of mucus and other matter brought up from the lungs and respiratory tract by coughing, used for diagnosing respiratory diseases.

T Total Laboratory Automation (TLA): The integration and automation of laboratory processes, from sample receipt to result reporting. TLA systems automate pre-analytical, analytical, and post-analytical stages to increase efficiency, reduce errors, and improve turnaround times in clinical laboratories.

U Urinalysis: A test that evaluates urine to detect and manage a wide range of disorders, such as urinary tract infections, kidney disease, and diabetes. Urinalysis involves checking the appearance, concentration, and content of urine, which can include tests for protein, glucose, ketones, haemoglobin, and other substances.

Urine Sample: A sample of urine collected for the purpose of diagnostic testing or analysis.

V Venous Blood Sample: A blood sample drawn from a vein, usually in the arm, using a needle and syringe or a vacuum tube system.

W X Y Z C LIMEBURNERS BAY INTERNATIONAL AG

IN VITRO DIAGNOSTICS (IVD) GLOSSARY

meddev-central

@meddev.central

contact@meddevcentral.com

C LIMEBURNERS BAY INTERNATIONAL AG

@meddev.central