LOMINA Samotest pro detekci a hodnotu protilátek z krve na SARS-CoV-2/COVID19 IgM/IgG - 1ks

Interpretation of LOMINA test results for detection of antibodies to SARS-CoV-2/COVID19

1. Negative antibody test result:
If the QCC (Quality Control - C) control strip is visible and the M and G lines do not become coloured, the sample is negative as no antibodies have been detected.
This test is not intended for early detection of COVID-19 disease, so if you have symptoms of COVID-19 disease or suspect COVID-19 and have been in an infected environment or have been in contact with an infected person, always consult your physician about your condition and the procedure.
2. Positive antibody test result:
2.1 If the control strip "C" appears together with the strip "IgM", the IgM antibody has been detected and the sample is positive. IgM antibodies are indicative of an acute immune system response after an immediate encounter with the virus, but can also be triggered by a vaccine.
2.2 If the control strip "C" appears together with the strip "IgG", the IgG antibody has been detected and the sample is positive. Depending on the rate of IgG band display, it is possible to tentatively determine the antibody value after infection or vaccination. The presence of IgG antibodies in the body is desirable to increase protection against COVID-19
2.3 If the control strip "C" appears together with both the "IgG" and "IgM" strips, both IgG and IgM antibodies have been detected and the sample is positive for both types of antibodies.
3. Invalid result:
If the control strip "C" does not appear, the test is invalid in any case and you must repeat it! This can be caused by long delays in testing, contamination of the reagent, temperature degradation of the test, etc.

Positive test result

In case of a positive test result, you have antibodies to COVID-19 in your body.
After vaccination against COVID-19, the level of antibodies and their approximate amount can be measured after 14 days. The level of antibodies can be detected even after COVID-19 disease.
The level of IgG antibodies is directly related to the speed of display of the IgG strip on the test cartridge. The faster the IgG band is visible, the higher the antibody level.

IgG bar appears:

• Within 1 minute after the test, then the antibody level is >640 titer
• After 1 - 2 minutes >320 titer
• After 2 - 3 minutes >160 titer
• After 3 - 10 minutes >80 titer
• Within 10 minutes after imaging, antibody titres are considered high (strong antibodies)
• The generally accepted safe level of antibodies providing protection to the organism is about >10 titre

Titer = a unit that expresses the quantity of a substance. Usually indicates the lowest dilution of the substance at which the reaction is still taking place, i.e. at which the concentration of antibodies can destroy the active virus. The higher the antibody titre, the higher the level of antibodies and protection you have. If you have had a COVID-19 infection or vaccination and the test still shows no antibodies within 45 minutes (repeatedly), then you most likely do not have antibodies. In that case, it is advisable to address the situation and inform your doctor. If an IgM band is displayed during testing, it may be an initial immune reaction related to the body's response to the virus and the vaccination. However, should you develop this streak, it may be an acute infection and it is advisable to inform your doctor and have a PCR or antigen test.

Specificity / Sensitivity

IgG - 96.79 % (CI 95%: 94,46 % - 98,33 %) / 97,27 %; (CI 95%: 95,86 % - 98,30 %).
IgM - 98.54 % (CI 95%: 97.14 %-99.37 %) / 88.46 % (CI 95%: 84,18 % - 94,92 %).
100% response to the COVID-19 complex IgG antibody series

Notice

1. Serological rapid tests can only be used as auxiliary screening tools.
2. The accuracy and detectable rate cannot reach 100% due to individual antibody production in specific patients.
3. If positive IgM antibodies without IgG are detected, it is advisable to retest as soon as possible by direct virus detection methods such as PCR, antigen, etc. The presence of IgM may indicate active or end-stage disease. IgG antibodies, on the other hand, are indicative of the disease and are present in the body for many months after infection or vaccination.
4. The principle of the test is based on the detection of antibodies, not on the detection of the virus itself! The body produces antibodies almost immediately after infection and also after vaccination, but detectable levels are usually present at the same time as the patient's temperature rises. Because the rate of IgM and IgG production varies between individuals, a patient can be infected even if the test is negative. If you observe flu/coronavirus-like symptoms, do not use this test as a tool to detect COVID-19 disease. In the meantime, maintain a quarantine to be on the safe side. If you are unsure, always consult a medical professional about your condition.

Package contents:
Test strip in plastic cassette
Plastic dropper (1 drop 20 - 25 ul) (Use only the dropper provided with the test kit to ensure the correct amount of solution is used)
Reagent tube (predominant component PBS - Phosphate-Buffered Saline)
Lancet for single blood sample collection
Disinfectant swabs/pads (alcohol-based disinfectant)
Manual