COVID-19 Rapid Antibody Test


1. How accurate is this test and how much does it matter? 

Our antibody test is the latest version available to the market and is more accurate than the tests released earlier in the year. 


2. Is the test CE approved for testing by healthcare professionals? 

The CE mark is for point of care vitro finger prick capillary use by a Health Care Professional. The test can only be performed and evaluated by a Health Care Professional such as a pharmacist and cannot be sold directly to the public to self-test. 


3. What is the test actually testing for? 

The COVID-19 rapid antibody test is a finger prick test which identifies if the body has developed an antibody response to a COVID-19 infection. 


4. Does the test tell you if you have an active COVID-19 infection? 

No. The test is not a viral test to identify if you currently have COVID-19. The test is a highly sensitive and a very reliable marker of past infection. 


5. Is the test specific to COVID-19 or will antibodies to other Coronavirus show a positive result? 

The test is highly specific for COVID-19. Evaluation found it had a 99.3% Specificity which means that less than 7 in 1000 positive tests might be false positives due to other reasons such as other coronaviruses. 


6. What is the difference between IgM and IgG (these are the antibodies that might be picked up on the test)? 

IgM antibodies are the body’s initial immune response that help the body fight off infection. IgG antibodies are the body’s secondary immune response that remain in the blood to fight off infection. By leaving the test procedure to be completed after 21 days of symptoms, the more accurate IgG can be used to identify a patient’s antibody response. 


7. How accurate is the test’s IgG response? 

No test can be 100% accurate however, the test is highly accurate. The manufacturer quotes the following accuracy data: IgG Specificity 98.3% IgG Sensitivity @ 21 days+ 99.9%* Specificity = The % of people who will test correctly negative for COVID-19 antibodies Sensitivity = The % of people who will test correctly positive for COVID-19 antibodies


8. What is the incidence of false results? 

At 21 days post symptoms, the test is >99.9%* accurate at detecting IgG antibodies and has 99.3% specificity in producing a correct negative test result. 


9. If the test gives a positive result does this mean I have had COVID-19 before and can I catch it again? 

There is currently no evidence that the presence of antibodies protects you from being infected by the virus again or possibly passing on the infection again. All patients being tested should be told that the presence of antibodies does not infer immunity and to continue following Government guidelines in maintaining vigilance, practicing social distancing and isolating when appropriate. 


10. What is the benefit of having the test? 

For now, it is for no other reason than a confirmation that you have had/not had COVID-19. Feedback is that people simply want peace of mind that they have had COVID-19 and recovered. A positive test does not mean that you will have immunity, or any improved resistance should you catch the virus again. However, it does confirm that you have most likely been through a coronavirus infection and built up antibodies for COVID-19. In the future, a mixture of test methods may be used to provide details for a Health Passport that is currently being developed by a number of stakeholders in Public Health. 


11. If antibodies don’t mean I am immune, why have the test? 

It is up to the individual if they want to be tested. Some people may want to do the test to find out if it was coronavirus that they had previously contracted when they may have experienced symptoms. Knowing you have had the virus before may give peace of mind that your body managed to successfully fight off the virus. 


12. If a patient is positive for IgM antibodies does that mean the patient is infectious? 

Presence of IgM antibodies can be detected for some time after the infection has been fought off. IgM is usually only detected once the patient has built up enough antibodies and this is usually in the post-infectious stage. We request patients to be tested at least 21 days after the onset of symptoms and at least 28 days after contact with a symptomatic individual, in order to ensure that they are no longer infectious. Although a test result detecting IgM ONLY, can potentially be a marker of the patient fighting the virus and may be infectious if they are 21 days post infection, this is very unlikely. If IgM only is presented, we would question the patient on when they first felt ill, their symptoms and when they stopped. The Government advises a 14-day quarantine for coronavirus. However, the individual should continue isolation if they are still presenting the following symptoms: 

• a high temperature or feeling hot and shivery 

• any type of cough 

• shortness of breath 

• change to or loss of smell or taste