Description: These are medical devices and other accessories that are used
to perform tests on samples that are extracted from the living organisms
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.
IVD Disciplines
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 Receptacle
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.
Indispensible IVD
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.
No comments:
Post a Comment