LOMINA Covid-19
Antibody self-test
First European COVID-19 antibody IVD test approved for home use in IVD self-testing.
Purpose
Antibody self-test to detect antibodies after a corona infection or to determine your antibody status after corona vaccinations.
The Lomina COVID-19 Antibody Test Kit is an IVD test for self-testing of IgG and IgM antibodies in the blood.
Sampling independently from home (without visiting a doctor or pharmacist)
The self-test is not suitable as the primary tool for early detection of COVID-19. This requires PCR methods, antigen assays and the like.
What does the Lomina COVID-19 Antibody Test Kit contain?
• 2 x test cassette
• 2 x automatic lancet (short needle for blood collection)
• 2 x lancet for blood collection
• 1 x disinfectant wipe
• 1 x instruction manual
test principle
This antibody self-test works according to the principle of immunochromatography with colloidal gold. The test kit contains :
1.) An antigen labeled with colloidal gold and a complex of control antibodies.
2.) Nitrocellulose membranes with two test strips (M and G line) and one quality control strip (C line).
To deliver the required amount of sample to the hole on the test strip, the sample flows across the nitrocellulose membrane in the test strip due to capillary action. If the test sample contains SARS-CoV IgM/IgG antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen and the antibody complex will release IgM monoclonal antibody or IgG monoclonal antibody on the nitrocellulose membrane as purple-red M or G lines and thus represents whether the samples are positive for IgM or IgG antibodies and thus prove a COVID-19 infection, or provides indications of past infections and active presence of antibodies in the body.
Interpretation of the test result
1. Negative result
If the QCC (Quality Control – C) control line is visible and the M and G lines are not, the sample is negative as no antibodies were detected. However, continue health monitoring. A retest 24 hours later is recommended. Do not forget that the amount of antibodies produced in case of disease is individual, and usually the production of antibodies is manifested by increased temperature. Danger! The test detects the presence of antibodies, but its accuracy depends on the amount of antibodies, which is unique to each person. Even if the test is negative, continue to monitor your health. If fever and flu-like symptoms persist, repeat the test in 24-48 hours. If you have breathing or other serious problems, or your condition persists, always consult your doctor. If you have symptoms and have been in an infected environment or have been in contact with an infected person, always consult your doctor about your condition and procedure.
2. Positive test result
2.1 If the control C line appears together with the M line, an IgM antibody has been detected and the sample is positive.
2.2 If the control C line appears together with the G line, an IgG antibody has been detected and the sample is positive.
2.3 If the control C line occurs together with the G and M line, both IgG and IgM antibodies have been detected and the sample is positive. In all three cases, remain calm and read the instructions on the next page.
3. Invalid test result
If no C line appears, the test is invalid and must be repeated! This can be due to time delays in testing, reagent contamination, test interference from temperature, improper volume of fluids, etc.
Excluded from the right of return
Packaging unit: 5/2/1 tests/kit
Precautions
for in vitro diagnostic use only
The product does not serve as a primary tool for early detection of COVID19! For these purposes it is necessary to use PCR methods, antigen assays and the like.
do not use after the expiry date
please read all the information in this leaflet before performing the test
the detection kit should be kept in a sealed pouch before use
all specimens should be classified as potentially hazardous and treated as if they were an infectious agent
the used detection kit should be disposed of in accordance with federal, state, and local government regulations.
Below you will find further links to documents of the "LOMINO" antibody self-test
specificity
IgG 96.79% IgM 98.54%
Specificity describes how rarely a test misclassifies people as infected. This is about the statistically false-positive results. Again, the closer the value is to 100 percent, the better.
Source: Federal Institute for Drugs and Medical Devices
*Status: 12.11.2020
sensitivity
IgG 97.27% IgM 88.46%
Sensitivity describes how well a test actually recognizes infected people and how many infected people slip through the cracks. In statistics, one speaks of false-negative results. The closer the value is to 100 percent, the more reliably the test detects all infected people.
Source: Federal Institute for Drugs and Medical Devices
*Status: 12.11.2020
LOMINA COVID-19 antibody self-test test procedure
Current scientific information can be found at
Important NOTE
FPFP International excludes any direct or indirect liability for improper use or interpretation of the antibody test. When ordering the product, you will receive a letter from us by e-mail in which you declare that you exclude any liability when purchasing the test.
Please note that as with any other diagnostic test commonly found on the market, the results must be compared to other clinical information that is also available to any physician.