COVID-19 IgG/IgM RAPID TEST
COVID-19 IgG/IgM RAPID TEST is a rapid assay for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum or plasma specimens. It is intended to be used by healthcare professionals as a first approach in the diagnosis of COVID-19 - CE cerified for professional in vitro diagnostic use only.
COVID-19 IgG/IgM RAPID TEST is a qualitative membrane based lateral flow immunochromatographic assay for the detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) against SARS-CoV-2 in whole blood, serum or plasma specimens. Immunoglobulins, or antibodies, are proteins produced by specific immune cells in response to bacteria, viruses, microorganisms and other substances recognized by the body as foreign antigens. There are five classes of immunoglobulins, of which IgM are generally produced as the bodys first response to a new infection, providing short-term protection. The concentration of these antibodies increases for a few weeks and then decreases at the end of the infection. IgG, on the other hand, account for about 70 80% of immunoglobulins in the blood and they are generally produced later than the IgM. IgG levels usually tend to increase for a few weeks and then stabilise. The body is able to remember the different IgG levels, which can then be reproduced at each exposure to the same antigen.
WHY THE NEED FOR A COVID-19 SEROLOGICAL TEST?
The use of a serological test allows to identify individuals possibly exposed to the virus and to take initial precautionary isolation measures in order to reduce further spread of the virus itself. In infected individuals the incubation period can vary between 1 and 14 days, with a prevalence of 3 to 7 days, after which the first symptoms begin to appear. Sethuraman et al. show the trend over time in the detection of diagnostic tests for SARS-CoV-2. In case of nasopharyngeal swab, the detection increases after the onset of the first symptoms, reaching a peak of detection in the first week after the onset of symptoms and then decreases steadily. IgM and IgG antibodies to SARS-CoV-2 appear in the blood of infected individuals from a few days up to 2 weeks after these symptoms and, while IgM levels decrease after the end of the infection, IgG levels remain high and detectable. For this reason, these tests are useful for:
a) help the diagnosis of late symptomatic cases, as a support for molecular testing (nasopharyngeal swabs followed by PCR tests)
b) screen asymptomatic individuals who may have recently been exposed to the virus
c) assist in seroprevalence investigations to define population exposure levels.
HOW TO USE IT
1) Take a sample of whole blood after pricking the finger with the sterile lancet, taking care not to squeeze the pipette bulb. Alternatively, a laboratory micropipette can be used.
2) Deposit the blood sample into the sample well of the cassette.
3) Add 2 drops of diluent. Wait 10 minutes and read the results.