A medical self-test serves to detect certain diseases or conditions at home. The tests can be performed on various body materials such as urine, blood and saliva. Self-tests are available at pharmacy, drugstore or online. Species
Some well-known self-tests include: CE mark
Self-tests that may be sold in the Netherlands must be marked with a CE mark. This sign must be followed by a number. This number indicates the so-called Notified Body that evaluated the test. A mandatory part of such an application is a leakage investigation. In this study it must be shown that the self-test is suitable for being performed by laymen or individuals.
Self-tests are classified in different classes in the assessment for the CE attribute. This is stipulated in European legislation (List 2A, 2B or 3 indicates which requirements a test must meet). The higher the classification, the more stringent are the requirements for the test, package leaflet and packaging. Control
Through the sale of unauthorized tests (including HIV, hepatitis, Mexican flu), self-tests have been less well received by the medical world for a few years. With the advent of newer testing and sharper surveillance (including the IGZ), this image changes. Current tests are allowed for home use and meet specific requirements such as specificity and sensitivity.
When purchasing a self-test, it is also advisable to pay attention to the supplier (ISO-certified) of the test. A self-test offered by a drugstore or pharmacy is always provided with the correct CE mark.
The most sensitive and specific self-tests include the pregnancy test, the ovulation test and the menopause test. The reliability of such hormonal tests is almost 100%, as both sensitivity and specificity are often greater than 99%.
Recent studies make SOA tests (chlamydia, syphilis and gonorrhea) highly advised. These tests have not been shown to be sensitive and reliable.
Self-tests with sufficient accuracy will play an increasing role in self-active monitoring of health in the coming years, provided that they are properly regulated. Now often with immunochromatographic speed tests, more and more self-testing based on nanotechnology in the future.
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