4.
DIAGNOSTIC PRODUCTS...
__________________________________________________________________
//
______________________________________
 | A. What are medical laboratory tests? |
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 tests 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.
| B. What happens to the sample in the medical laboratory? |
TopAnyone who has visited a medical laboratory will know that it is a "high tech" world, with automated machines testing hundreds of samples a day. Many hundreds of sample components can be measured, but usually between two and ten are measured for each sample. Some tests (for example biological cultures) take time, but others can be carried out rapidly if there is an emergency.
The results are sent to the doctor in the form of a laboratory report for each sample that gives the results in comparison with normal values. In many cases the doctor will discuss the results with and request additional information from specialists in the medical laboratory.
| C. What are In Vitro Diagnostics? |
TopAmong 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.
| D. What products are available for self testing? |
TopMost laboratory tests are used in the management of disease. Although there are a number of tests that could be performed as part of health management, for example testing blood cholesterol or lipoprotein levels as predictor of heart disease, usually healthy people do not ask for such tests. Factors which play a part are the inconvenience of going to a medical laboratory or to the doctor's surgery to have a test performed and waiting for the result.
Laboratory tests can be developed in formats that are suitable for public use and give rapid results. When such self-tests are available (for example pregnancy tests) they are generally well accepted and widely used. In general the Public understand that tests can be performed incorrectly, can require additional testing before the result is certain and that the doctor may need to be consulted. Even tests requiring blood sampling (for example, blood glucose tests for diabetics) can be developed into user-friendly formats.
Unfortunately, there is little acceptance for self testing among health authorities and many health professionals. There are a number of possible reasons for this. For example, there is a fear that such tests will increase the demand for health care and therefore its cost. Health authorities in many European countries prohibit HIV selftests, because they can be performed privately. They are convinced that a test indicating infection with the virus (perhaps a false result) could result in suicide, unless medical counselling is given.
| E. 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".
| F. What are these products used for? |
TopIn vitro diagnostic products and systems are used in medical practice for a variety of applications. As the name implies they are mainly used to determine (or diagnose) what is wrong with a patient. In addition, they have many other uses in the management of disease. For example, to make sure that the treatment given is having the right effect, to ensure a proper match in blood transfusion and organ transplantation, to control that the levels of medicine given are providing the right amount in the circulation. They are used to detect infection and the presence of micro-organisms (bacteria, viruses and fungal diseases). They are used to screen populations at risk for hidden diseases that do not give symptoms.
Similar products can also be used in health management. Pregnancy tests fall into this category. However, there are many other tests that could be used more widely to check individual health status. Many of these are discussed in the press and for example in women's journals (often it is the women of the family who are most health conscious).
Many similar or identical products are also used for applications other than the management of individual health and disease.
For example similar tests are used for the detection of viruses in pooled blood for plasma protein production in the medicinal industry, as a part of the production process. The tests are used in veterinary medicine, for pet animals, for farm animals. They are used widely in forensic medicine
Non medical applications include environmental control (for example the control of water quality), for detection of contamination of food and raw materials (for example for traces of penicillin in milk), for detection of micro-organisms in the production of food and medicine
| G. What about genetic testing? |
There is nothing new about genetic testing itself, but the technologies now available will allow a more reliable estimation of the risks of disease that individuals have because of their genetic make up. The ethical debate centers on whether we should use the tests and under what circumstances.
There are numerous examples of use of genetic information that is accepted and supported widely.
Insurance companies have always had an interest in the family history and other simple indicators (for example weight in relation to height and blood pressure) in order to estimate the risk of invalidity or premature death that a new applicant for insurance may have.
It is common in Southern Europe for families to be tested for sickle cell anemia as part of genetic counselling before marriage
EDMA has developed a position paper on the ethical aspects of genetic testing.