Consent to COVID-19 Antigen Testing
This page provides information for the consent to testing for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. It is essential for individuals to give consent for testing prior to the procedure and testing is only available to patients who have been asymptomatic of COVID-19 for at least 14 days.
The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This test is strictly intended for professional use.
This page explains the testing procedure, as well as the risks, benefits and limitations of testing in order to help you decide whether to proceed with the test. You are requested to please read the following carefully and to seek advice from your doctor if you have any questions about whether or not the test is suitable for you.
You may also contact London Dental Centre if you have any questions. It is imperative to answer any questions you may have about the test before proceeding. If you agree to have the testing done, you should agree to this consent form.
Please note that testing is optional and a personal choice. We will only carry out testing with informed consent, including additional verbal consent before performing the test procedure. Additionally, consent is implied by booking and paying for a test online for clinic testing or mobile testing.
COVID-19 Antigen Test
The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx via nasopharyngeal swab.
The tests used are CE Marked and manufactured in the UK. This test is for healthcare professional use only.
Conducting the test
Capacity
The healthcare professional administering your test will first assess your capacity to consent to test. If the healthcare professional feels you have the ability to give your consent, your decision will be accepted. If the healthcare professional feels you cannot currently give consent, they reserve the right to decline to test.
Specimen Collection
A sterile swab will be inserted into the patient's nostril/s, swabbing the surface of the nasopharynx. It will then be withdrawn from the nasal cavity ready for testing. The specimen collected will be labelled with your Name and Date of Birth to identify your sample.
The sample will be mixed with an extraction buffer for testing by a trained operator in line with clinical protocol. A final report will be generated with your test results {positive/negative) which will be provided to you via email or text. We do not provide any (medical) interpretation of the test results, and we recommend that you follow up with your regular healthcare provider.
If your test result was indeterminate (control test failure), you will be notified of this and the test may be repeated.
Results
The antigen test provides 3 possible outcomes:
Positive: SARS-CoV-2 Rapid Antigen Detected - clinical correlation with a PCR test is recommended
Negative: SARS-CoV-2 Rapid Antigen Not Detected
Invalid: test result is invalid + needs to be repeated
The benefit of having a SARS-CoV-2 Antigen Test
The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx) . At these locations viral load peaks within the first week after symptom onset, and then declines.
A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
Besides laboratory PCR testing, antigen assays can be used for rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS‑CoV‑2 present in the human nasopharynx. This test is intended to detect antigen from the SARS‑CoV‑2 virus in individuals suspected of COVID‑19. This product is strictly intended for professional use in laboratory and Point of Care environments. Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.
The SARS-CoV-2 Rapid Antigen Test enables fast decision making e.g. whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.
The SARS-CoV-2 Rapid Antigen Test allows for decentralised testing at the point of care and helps to expand the range and quantity of direct virus testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition to that, the SARS-CoV-2 Rapid Antigen Test is an instrument free test, allowing testing in rural/ low-infrastructure areas.
What is COVID-19?
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face.
The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow).
At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments. WHO will continue to provide updated information as soon as clinical findings become available.
When an organism’s immune system encounters a foreign molecule (such as a virus) for the first time, specialised cells in the body recognises the virus as harmful and mount an immune response. This immune response results in the production of antibodies, also known as immunoglobulin. Immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be created. The presence of IgM is an indicator of a recent/present infection. IgG is a more specialised antibody that specifically binds to the virus. The presence of IgG is an indicator of later-stage infection. Antibodies produced in this way are generally specific for the foreign molecule that they are produced in response to infection with COVID-19 elicits an immune response that results in the production of antibodies to the COVID-19 virus. Our test detects these antibodies.
Symptoms of COVID-19:
COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.
Most common symptoms: fever, dry cough, tiredness.
Less common symptoms: aches and pains, sore throat, diarrhoea, conjunctivitis, headache, loss of taste or smell, rash on skin, or discolouration of fingers or toes.
Serious symptoms: difficulty breathing or shortness of breath, chest pain or pressure, loss of speech or movement.
Seek immediate medical attention if you have serious symptoms. Always call before visiting your doctor or health facility.
People with mild symptoms who are otherwise healthy should manage their symptoms at home.
On average it takes 5–6 days from when someone is infected with the virus for symptoms to show, however it can take up to 14 days.