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RAPID ANTIGEN TESTS

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How should I feel about a rapid antigen test?

Rapid antigen tests have been marketed for a full year. Their levels of sensitivity and accuracy have reached a very competent level, although they are not yet comparable to the gold standard of testing, the PCR test. It is important to know that a rapid antigen test only detects the virus if the amount of the virus in your body is very high: usually four or five days after developing symptoms. Individuals may, however, be infectious before they have developed any symptoms, as well as several weeks after they have developed symptoms, and the antigen test is not capable of detecting this.

 

Can I use the rapid antigen test to test myself at home?

Currently only rapid antigen tests which have been designed for professional use are available on the Estonian market. This means that such tests are designed to be used by healthcare professionals or under a healthcare professional’s supervision. It is not prohibited for non-professional users to use such tests when testing themselves, but it should be kept in mind the fact that these tests are, in this case, not being used for their intended purpose. The potential mistakes which may be made during the course of conducting or interpreting the test reduce the reliability of that test, and an untrained user is more likely to obtain a false positive or a false negative result.

One compliant antigen test which is designed for self-testing arrived on the European Union market at the beginning of April. Several further compliant antigen tests which are designed for self-testing are also known to be almost ready to hit the market. Therefore we would advise regular users (ie. those users who are not healthcare professionals) to prefer tests which are equipped with the ‘for self-testing’ label, as well as containing the four-digit code of the respective body to be notified sitting alongside the CE marking. Such tests have passed a proper compliance assessment procedure, while also being subject to manufacturer liability, and the user instructions for such tests are suitable for non-professional users.

 

Which rapid antigen tests should I use?  

Non-professional users should prefer those antigen tests which have been designed for domestic use (meaning self-testing rather than professional testing). Such tests may not immediately be available, but Estonian distributors are expected to do everything in their power to make them available. Healthcare providers are advised to choose those rapid antigen tests which have been verified in European Union member states as being able to provide reliable results. This guarantees the reliability of the test within the limits which have been specified by the manufacturer.

The Health Security Committee has drawn up the following list of tests which meet the minimum requirements and are in use in at least three EU member states (as of 17 February 2021):

  • Abbott Rapid Diagnostics, Panbio™ COVID-19 Ag Rapid Test
  • AMEDA Labordiagnostik GmbH, AMP Rapid Test SARS-CoV-2 Ag
  • Becton Dickinson, BD Veritor System for the Rapid Detection of SARS-CoV-2
  • Beijing Lepu Medical Technology, SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold immunochromatography)
  • BIOSYNEX SWISS SA, BIOSYNEX COVID-19 Ag BSS
  • CerTest Biotect SL, CerTest SARS-CoV-2 CARD TEST
  • Hangzhou Clongene Biotech, Clungene COVID-19 Antigen Rapid Test Kit
  • Healgen Scientific Limited, Coronavirus Ag Rapid Test Cassette (Swab)
  • LumiraDX UK Ltd, LumiraDx SARS-CoV-2 Ag Test
  • Nal von minden GmbH, NADAL COVID -19 Ag Test
  • Quidel Corporation, Sofia 2 SARS Antigen FIA
  • SD BIOSENSOR Inc, Roche, STANDARD F COVID-19 Ag FIA
  • SD BIOSENSOR Inc, Roche, STANDARD Q COVID-19 Ag Test
  • Siemens Healthineers, CLINITEST Rapid COVID-19 Antigen Test
  • Xiamen Boson Biotech Co, Rapid SARS-CoV-2 Antigen Test card
  • Zhejiang Orient Gene Biotech Co Ltd, Coronavirus Ag Rapid Test Cassette (Swab)

The functionality of any other tests has not been proven or guaranteed at the same level.

 

What should I do if I decide to use a rapid antigen test?

Before taking the test, carefully read the packaging leaflet. Firstly ensure that you have collected the sample properly, exactly as described in the user instructions. The collection of a nonlaryngeal sample is an uncomfortable procedure which very often causes tear flow. It is more comfortable to collect the sample from the sidewalls of the nose, but proper contact with the mucosa on the sidewalls is very important in this case. If you fail to collect the sample properly, you will not receive a reliable test result.

Collect the sample in a room which is not used for having means, which is properly ventilated, and where surfaces can be cleaned and disinfected. Make sure that no individuals who are not involved in the process are present in the room, as the collection of the sample is a potentially infectious process. Before using the test, clean your hands and any surfaces which you are going to use. Make sure that you also clean those surfaces after completing the test, as well as your hands.

 

What if I test positive?

A positive test result means that it is very likely that you are infectious, and you should immediately stay home and call your family physician or the family physician advisory line (1220 or +372 634 6630 also for calls from abroad). Unless decided otherwise by the physician, the rapid antigen test result should be confirmed by a PCR test for your positive test result to be registered in the Health Information System. In this case, you will be officially entitled to a certificate for sick leave, and you will also be exempted in the future from the obligation to self-isolate, as you will already have had the disease. You must also let your close contacts know that they are required to self-isolate at home.

 

What if I test negative?

If you are sure that the sample was collected properly, you have no symptoms which are characteristic of COVID-19, and you are not aware of having come into close contact with individuals who have been infected with COVID-19, you may carry on with your normal life. You should still take all precautions to prevent getting infected, including wearing a face mask, taking care of hand hygiene, and observing social distancing rules. Avoiding private parties, various gatherings, and crowded places is also important.

If you have been in contact with an individual who has been infected with COVID-19 or in the event that you yourself develop any of the symptoms of COVID-19 (such as a headache, tiredness, fever, or cough), your test results may produce a false negative, and you are strongly urged to contact your family physician or to call the family physician advisory line (1220 or +372 634 6630 also for calls from abroad) to book a PCR test.

If you suspect that you may have been infected, it could be the case that the amount of the virus in your body is not yet sufficient for the antigen test to detect it. You should monitor your health condition and repeat the test in a few days’ time if necessary.

 

When is it reasonable to use a rapid antigen test?

Before visiting at-risk individuals (prior to a doctor’s appointment, or before visiting a care home). Please keep in mind the necessity of continuing to observe proper social distancing rules and the use of personal protective equipment, even if you have tested negative. In some cases it is reasonable to take the test before going to work, or to use the test for the early detection of the infection in a work collective. Close contacts should also take the test to see whether they have been infected (before going to a grocery shop or a pharmacy, for instance).

If you have been infected or are a close contact, a negative rapid antigen test result may never be used to decide whether you can end your isolation period prematurely Individuals remain infectious even after the rapid antigen test can no longer detect any infection. The rapid antigen test provides the best result if you regularly repeat the test with an interval of a few days, and under the same conditions. Repeated negative results from rapid tests which have been taken in identical conditions, or a lack of symptoms or any close contacts, and responsible social distancing along with the use of personal protective equipment make it possible to reduce the risk of infection, as well as the risk of infecting others.

 

How can a SARS-CoV-2 rapid antigen test be taken?
(Estonian)

How can a SARS-CoV-2 rapid antigen test be taken?
(Russian)