What Is IVD?

In-Vitro Diagnostic (IVD) tests are a subset of medical devices.

In-vitro diagnostic tests are used for in-vitro examination of specimens derived from the human body to provide information for screening, diagnosis, or treatment monitoring purposes.

An IVD test may include reagents provided either in kit format or separately, as well as calibrators, and controls.

In vitro testing may be performed on a variety of instruments ranging from small, hand held tests to complex laboratory instruments.

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.