About the COVID-19 rapid antibody test
It is the responsibility of the test provider to ensure that the proper protective equipment is used to protect both the staff and the test subject. Protective clothing, mouth protection, and gloves are not included in the test packages, which implies that this must be provided by the care unit/medical professional that executes the testing. The executing professional medical unit warrants in an agreement with Novir, prior delivery of the material, that they have the routines and material for safe implementation of testing routines.
Because the test result needs to be interpreted and analyzed correctly. More parameters than just the test result need to be included in the analysis and the recommendation going forward. For example, symptoms showed since the start of 2020. In addition, the EUA authorization of the test is only valid if the test is carried out by a healthcare professional.
- SARS-CoV-2 Antibody Tests can be ordered by healthcare providers to test human plasma or serum to detect if there has been an adaptive immune response to COVID-19, indicating recent or prior infection.
- SARS-CoV-2 Antibody Tests should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions. Direct testing for SARS-CoV-2 should be performed if acute infection is suspected.
- SARS-CoV-2 Antibody Tests are authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a.
- This test has been validated and the FDA has been notified. This test has not been approved by the FDA. A negative result does not rule out SARS-CoV-2 infection. This antibody test result should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
No, this test is available under EUA (Emergency Use Authorization). This test has been validated and the FDA has been notified. This test has not been approved by the FDA. Novir is providing serology testing based on tests from various manufacturers. Such tests have either received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) or were released for use under FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administration Staff” that was updated on May 4, 2020. Tests being performed under a EUA have not been FDA cleared or approved and
Novir has completed the independent validation of these tests.
A study conducted together with Akademiska Sjukhuset, Uppsala University Hospital has shown adequate results and this has now been submitted for review. As soon as the study is published, the results will be posted here. What we can already say with certainty is that test accuracy increases if it is performed correctly and at the right time.
A study conducted at Uppsala University, in collaboration with the Academic Hospital in Uppsala, showed that the specificity of the test is 100% for IgM and 99.2% for IgG. The study is published and can be provided here. A further evaluation, with a quantitative so-called “gold standard”, which can determine which of the positive samples from the study actually had detectable IgM and IgG antibodies respectively, shows extremely strong sensitivity with 100% for both IgM and IgG! The results thus look very promising and this test has stuck out in quality in comparison with other similar antibody tests in several studies from different countries. However, it should be pointed out that no tests are 100 percent, nor are Novir’s , and from this, we collect more and more data to have additional evidence on the test’s accuracy. There are also further studies in the Uppsala research team on precisely our tests with larger control panels (more samples) to secure the numbers more and more. However, what we can conclude is that the tests are of a very high standard!
First, a healthcare professional takes a blood test, a stick in the finger. Next, the blood sample is added to a sample container, along with 2 to 3 drops of a buffer solution. The test answers can be read within 15 minutes. It shows if you have IgM and/or IgG or none. For a more detailed description, please see the instructions enclosed with the test.
Novir’s rapid test is a combined IgM-IgG antibody test for COVID-19 used to qualitatively detect the presence of IgG and IgM antibodies by the new human coronavirus using a few drops of either serum, plasma, or whole blood.
About the COVID-19 rapid antibody test
The card on the test contains a control line (C). Regardless of the antibodies that exist in the sample, the C line should go from blue to red to indicate that the sample has been adequately moved through the membrane. If the C line does not change color, it indicates that the test result is invalid. Repeat the test procedure with a new test cartridge.
If you have recently undergone a coronavirus infection, you most likely have achieved an immunity (protection against the virus). However, you should still be careful about your own and others’ sake. According to the public health authority, it is yet uncertain how long you will be immune if you have been infected and built up antibodies to the virus. Based on past experience, the assessment is that the immunity lasts so long that you will not be infected multiple times in the same season. We will update this continuously if new information is published.
Follow the public health authority’s recommendations and consult with your health care provider.
The test needs to be assessed in combination with the symptoms shown. If you get a negative result but feel you have disease symptoms, it may be that you have not yet developed antibodies. Take the test again in 2 days. If you still haven’t developed antibodies and been healthy for 48h, you can go back to work according to current recommendations (Last updated by Public Health Agency of Sweden: 2020-03-12). Please note, your disease symptoms are probably not caused by COVID-19. Updated recommendations may come from the public health authority and should be followed.
The test needs to be assessed in combination with the symptoms shown. If you are still feeling symptoms, you should follow the public health authority’s recommendation to stay home. This is true even if you have mild symptoms. Then you should not go to work or school. Only after you have been symptom-free for 48 hours and have shown a positive result can you go back to work according to current recommendations (Last updated by Public Health Agency of Sweden: 2020-03-12). You are very likely to have developed antibodies to COVID-19 and are less likely to become infected again or infect others. Updated recommendations may come from the public health authority and should be followed.
About the COVID-19 rapid antibody test
The testing needs to be done by health care professionals, meaning people with formal education in health care or medicine. An important reason for this is that the EUA marking of the test is only valid for use by healthcare professionals. Furthermore, the test needs to be used properly and the test result needs to be interpreted and analyzed in combination with other parameters such as type of symptoms and when they were evident.
For large orders, please contact firstname.lastname@example.org. Please specify which order volume you want to order.
The minimum orders are 100 pcs. Of course, we want to be able to help small business owners too. Therefore, you are welcome to contact us even if you need less than 100 tests, so we will try to link your order with other small companies so you can place a joint order.
Typical delivery time is 2-3 weeks but may change depending on order time. The time will. This may change depending on the order quantity and we will work with you to deliver the tests to you as soon as we can.