What Is IVD?

What Is In-Vitro Diagnostics (IVD)?

In-Vitro Diagnostic (IVD) tests represent a critical subset of medical devices designed to examine specimens derived from the human body outside the living organism. These diagnostic tests provide essential information for medical screening, accurate diagnosis, and effective treatment monitoring purposes.

Modern IVD test systems typically include reagents provided in kit format or separately, along with precision calibrators and quality controls to ensure reliable results. In vitro testing can be performed on diverse instruments, ranging from portable hand-held devices to sophisticated laboratory analytical systems.

Point-of-care testing (POCT), also called near-patient testing or bedside testing, is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care

Chemistry analyzers are medical laboratory devices used to calculate the concentration of certain substances within samples of serum, plasma, urine and/or other body fluids. Substances analyzed through these instruments include certain metabolites, electrolytes, proteins, and/or drugs.

Hematology analyzers are used to count and identify blood cells at high speed and accuracy.

Plate readers, also known as microplate readers or microplate photometers, are instruments which are used to detect biological, chemical or physical events of samples in microtiter plates. 

A coagulation analyzer can be used to measure a coagulation pathway speed, as well as thrombolin and thromboplastin levels in as low as a few minutes.

The electrolyte analyser is a device for measuring the electrolytes in the human body. They are primarily used in the quantitative measurement of sodium, potassium, and chloride in whole blood, serum, or plasma.

Blood gas analyzers are used to measure combinations of pH, blood gas (i.e. pCO2 and pO2), electrolytes, and metabolites parameters from whole blood samples.