In Vitro Diagnostics refers to medical tests and examinations conducted on samples such as blood, urine, or tissues, outside the body in a controlled laboratory setting. These tests are crucial for diagnosing diseases, monitoring treatment effectiveness, and guiding patient care.
Any substance or component being measured or analyzed in a diagnostic test. Analytes can include proteins, enzymes, hormones, genetic material, and various metabolites.
A method or procedure used to detect, measure, or analyze an analyte in a biological sample. Assays can vary widely in complexity and are often specific to the target analyte.
Diagnostic testing performed at or near the site of patient care, such as a doctor’s office, clinic, or bedside. POCT enables rapid test results, facilitating immediate clinical decisions.
A type of diagnostic assay that relies on the interaction between antibodies and antigens to detect and measure analytes. Immunoassays are commonly used for detecting hormones, proteins, and specific infectious agents.
A branch of diagnostics that analyzes nucleic acids (DNA or RNA) to diagnose genetic disorders, infectious diseases, and certain types of cancers. Techniques such as PCR (Polymerase Chain Reaction) and sequencing are central to molecular diagnostics.
Chemical substances or components used in diagnostic tests to induce a chemical reaction or interaction with the analyte. Reagents are critical components of diagnostic assays.
Procedures and measures implemented to ensure the accuracy, reliability, and consistency of diagnostic test results. Quality control protocols include regular calibration, proficiency testing, and adherence to regulatory standards.
Parameters used to evaluate the performance of diagnostic tests. Sensitivity measures the ability of a test to correctly identify individuals with the disease, while specificity measures the ability to correctly identify individuals without the disease.
The process by which diagnostic tests and devices receive authorization from regulatory agencies, such as the FDA in the United States or the EMA in Europe, before they can be marketed and used in clinical practice. Approval typically involves rigorous testing to assess safety, efficacy, and performance characteristics.