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For professional use. The package does not contain the lancets for the necessary capillary blood sampling (to be purchased separately).
Features and Benefits
It is a test with capillary blood technology (taken via lancing device by a nurse) to determine the presence of IgM and IgG class antibodies developed in reaction to SARS-COV-2 which is responsible for the Covid-19 infection
Qualitative serological tests are used to detect the antibodies that any individual produces in response to an infection (or vaccination). In this case it is a question of searching for antibodies that act against the main proteins of the Sars-Cov-2 virus which is responsible for the Covid-19 infection.
They are antibodies. When a virus is contracted, after a "window period", the body begins to develop IgM antibodies (active phase) and to follow IgG antibodies. With the passage of time the IgG rise while the IgM descends, with times and kinetics currently under study.
The utility is the rapid screening and monitoring of antibody response on a large scale. In the fight against COVID-19 in order not to congest laboratories and to allow swabs to be carried out by those who fall into certain categories of urgency, the Ministry of Health believes that serological tests are very important for research and epidemiological evaluation of viral circulation.
The test we use has obtained CE certification and is produced by an ISO 9001/2015 and ISO 13485/2016 certified company.
The test result must be reported by a physician or licensed professional healthcare personnel.
In the event of a COVID 19 infection, the body needs a few days to produce its antibody response (window phase). Therefore, if the test were to be performed shortly after infection, it may not detect antibodies precisely because they have yet to be produced by the body. In this case we speak of a false negative. If you are not sure whether to perform the test after the "window phase", the most prudent solution is to schedule a close re-test.
For now the only validated test for diagnosis is the throat swab RT-PCR. Therefore, even if the sensitivity of 90% and the specificity of 96% of this test are very high, the possibility of false positives remains and therefore any possible positive result must be subsequently confirmed by the throat swab.