What are In Vitro Diagnostics?

Among health professionals laboratory tests are called in vitro diagnostic (or IVD) tests because they were traditionally performed in a test tube (in vitro means literally "in glass") and because they are mostly used to help determine (or diagnose) what is wrong with a patient. In vitro is also used in contrast to in vivo, which means "in life" . Unlike many other medical diagnostic procedures which physically effect the patient, in vitro tests are performed on samples and do not come into contact with patients. For this reason in vitro diagnostics are generally considered to have a much smaller risk for patients than other medical devices.

Valuable information about the way the body is functioning and the state of health can be obtained by taking samples (for example blood, tissues or urine) from the body and performing IVDs on these samples in a medical laboratory. The tests performed include microscopic examination of cells and structures, measuring the concentrations of various chemical and biochemical components using automated analysers, counting cells, measuring physical properties and making biological cultures. Most medical laboratory tests are made in connection with an infection, an accident or to follow the treatment that is given.

One of the first steps after a medical examination is often to take a blood sample and to request the medical laboratory to carry out a number of physical and biochemical tests. The results of the tests are used in disease management to assist the doctor (in the hospital or in general practice) in making the best decisions about treatment. Laboratory tests are also widely used in prevention of disease, for example, to screen populations or groups for hidden disease or risk factors and are being used increasingly in health management to check personal health status. The results of these tests are a unique source of objective information about the person's state of health or disease.

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What are the products of the In Vitro Diagnostics industry?

The industry produces analytical instruments and the reagents and accessories which are used to do in vitro diagnostic tests. Reagents are highly specific biological or chemical substances in special solutions that are able to combine with target substances in the samples and give a product that can be measured or seen. The analytical instruments are the various machines and equipment that are used to bring samples and reagents together or to measure other parameters in the samples.

The in vitro diagnostics industry also produces a number of accessory products like software programs to run the instruments, control solutions to check the performance of the systems in addition to supplying information and training for users. Together the reagents, the instruments and the accessories are referred to as in vitro diagnostic "systems".

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What is the Value of Diagnostics?

As new frameworks for patient care emerge, In Vitro Diagnostics hold the key to implementation and the opportunity to provide a cost effective health service to the nation.

In Vitro Diagnostics (IVDs) are the tests that protect our blood supply, monitor the levels of drugs we are given and provide information to assist diagnosis and treatment of our ailments. Government needs to be aware of the full facts concerning the difference diagnostics can make to success of the health service in clinical and financial terms. These tests, generally run in the pathology laboratories of our hospitals, can in some instances be carried out in doctors' surgeries, high street Pharmacists, and some even by patients themselves.

As more money becomes available to provide doctors, nurses, and new hospitals, the role of diagnostics becomes even more critical in providing accurate diagnosis to prevent waste of new, precious resources. Increasing the rate at which Cancer is diagnosed and treated will gain little unless the tests carried out in the laboratory to monitor treatment are properly funded. The management and reduction of the burden of Cardiovascular Disease, so well recognised in the new National Service Framework, requires the appropriate funding of IVDs to realise its goals.

Sickness is expensive to individuals and the health service. Early diagnosis of disease, achieved by testing those most at risk, can identify and allow treatment to begin avoiding later pain and suffering as well as saving healthcare resources. The risks of particular diseases themselves in an individual can also be estimated, and IVDs are again implicated in this important process.

Cardiovascular disease

Diabetes is a condition that is life threatening and consequently expensive when undiagnosed or untreated. One of the complications of this condition which remains undiagnosed in over one million citizens is heart failure. Clearly the use of diagnostics to find the missing million will also impact the incidence of cardiovascular disease. Other factors which influence the likelihood of cardiovascular disease include Cholesterol levels, Homocysteine levels, and genetic markers for predisposition to this condition. Changes in lifestyle, diet, and treatment can reduce these risks, IVDs allow objective measurements to support the individual and his/her medical advisors.

The use of IVDs for rapid differentiation of the causes of acute chest discomfort avoids the costs and distress of inappropriate hospitalisation, or the results of failing to diagnose life-threatening episodes. During intensive care, IVDs continually provide the medical staff with information upon which to treat and support the critically ill patient.

Cancer

Whilst the initiatives to improve the NHS performance in absolute and comparative terms in the area of Cancer management are welcome, the hospital laboratories need to be provided with the diagnostic tools to keep up with the increase in demand the implementation of these initiatives will cause. IVDs are used to monitor treatment, whether it be by testing the levels of biochemical cancer 'markers' in the blood, or by analysing the blood-cells themselves.

IVDs are also used to diagnose cancer, and can do so in the early stages of many tumours. For example, utilising a test for Human Papilloma Virus in conjunction with current cervical smear cytology would significantly improve the performance of the Cervical Cancer screening service, both in its accuracy and in the downstream savings in lives and costs. Another example is the use of blood tests that indicate the presence of prostate cancer, long before physical examination can do so, and before symptoms are reported by the patient.

Central to the successful implementation of the new National Service Frameworks, the role of In Vitro Diagnostics needs to be recognised and adequately funded. So doing will pave the way for the potential benefits of these new initiatives to be fully realised, in both clinical and financial terms.

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