Description: These are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms
Understanding In-Vitro Diagnostics
In vitro diagnostics: Introduction
The word ‘invitro’ means ‘in glass’ in Latin. In vitro diagnostics are performed outside the living organism in a controlled environment, generally in a test tube. The diagnostic tests can include simple blood cell count to sophisticated DNA technology applications. These tests are generally conducted in pathology laboratories of hospitals, drug development facilities and other research facilities.
In Vitro Diagnostic Device
In Vitro Diagnostic Devices are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms. These samples could be blood, tissue, urine, or other pus cells that are taken from the living organism, generally human beings. A detailed observation of these samples for the content and the quantity or count of different contents helps in identifying a medical condition, or in identifying the severity of the medical condition. These diagnostics devices can also be used to check the effects of medication or other treatments on a medical condition. IVD devices include reagents, calibrators, specimen receptacles, meters, control materials, software, kits and many other related instruments.
There are several IVD disciplines such as clinical chemistry, haemostasis, haematology, molecular diagnostics, immunochemistry, and microbiology. The focus area of each of these disciplines is different although all of them aim at infection detection, diagnosis or prevention of medical conditions as well as drug therapy monitoring. IVD diagnostic techniques are extensively used in research and drug formulation.
Specimen receptacles are the devices that contain and preserve the specimens or samples derived from the human body. These are specifically designed and manufactured with the intention of being put to use for in vitro diagnostic examination.
Common InVitro Tests
Common tests include liver enzymes, blood tests for glucose, levels of electrolytes such as calcium, sodium, and potassium, thyroid tests, blood composition tests, lipid profile, and tests for drugs.
In Vitro Diagnostic Directive (IVDD)
The Directive 98/79/EC by the European Parliament and the Council has brought about In Vitro Diagnostics Directive which specifies regulatory requirements for compliance following which the product can be allowed for CE marking. This is important for manufacturers to gain access to the markets in the European Economic Area (EEA). This is done in order to safeguard patient’s health and safety and to ensure that the product meets the required quality standards and performs as intended.
IVD diagnostics has become an essential and indispensible part of global health care. Rapid technological advancement , increased awareness about healthcare as well as improved drug development techniques have all contributed to make in vitro diagnostics an important part of healthcare industry.