Coronaviruses are types of viruses. They are lots of different kinds and some cause disease. A new coronavirus – SARs-CoV-2 – was discovered in 2019 and this has caused a pandemic of respiratory illness, known as Covid-19. Covid-19 can be severe and has caused millions of deaths around the world. It has also created lasting health problems for people who have survived the illness.

There are many symptoms associated with Covid-19. The most common symptoms are a new continuous cough, a high temperature, and loss of, or change in, your sense of taste or smell. Other symptoms include shortness of breath, fatigue, muscle and body aches, congestion or a running nose, nausea or vomiting, diarrhoea, or a sore throat. Even people with no symptoms or very mild symptoms can transmit the virus to others.

The SARS-CoV-2 lateral flow antigen rapid tests are tests that look for specific molecules (antigens) found on the surface of the virus that causes Covid-19. When you take the test, you put the swab on the inside of your nose and then put it into a small pot of liquid. Then you put a few drops of the liquid onto the testing strip. When the test is positive two lines will appear and when the test is negative just one line will appear.

FlowFlex tests are manufactured by a large global healthcare diagnostics company called Acon Labs. This company is based in the US, with manufacturing facilities in US, Mexico, and China. The factories have been inspected and approved by the FDSA (US Food & Drug Administration).

The MHRA is the regulatory or competent body in the UK. They do not approve tests but allow manufacturers to put a CE mark on the product. They also created a target profile looking at criteria that the tests should meet and FlowFlex tests meet the target profile.

All medical and healthcare devices go through a testing and certification procedure prior to being sold in the UK. The FlowFlex tests are CE marked and have been through this process. These lateral flow tests are approved for home use in the UK.

If you have a positive result, this means the SARS-CoV-2 nucleocapsid antigen has been detected. This antigen is generally found in upper respiratory samples during acute infection. Clinical correlation must be established with patient history and other diagnostic information to understand infection status. A positive result does not rule out co-infection with another virus or bacterial infection. A negative test result does not rule out a SARS-CoV-2 infection and should not be used as the only basis for treatment or patient management. This should be looked at alongside the patient’s recent exposure, history, or presence of clinical symptoms that might indicate a Covid-19 infection

The known limitations of the SARS-CoV-2 Antigen Rapid Test are:

  • A positive test result does not distinguish between SARS-CoV and SARS-CoV-2.
  • A negative test result is not planned to rule out other viral or bacterial infections.
  • A positive test result does not rule out co-infections with other pathogens.
  • The SARS-CoV-2 Antigen Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2 antigens in nasal swab specimens only. The intensity of the test line does not necessarily correlate to the SARS-CoV-2 viral titer in the specimen.
  • A negative result, from a patient with symptom onset beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for clinical management.
  • Specimens should be tested as quickly as possible after specimen collection and at most within the hour following collection.
  • The use of viral transport media may result in deduced test sensitivity.
  • A false-negative test may result if the level of antigen in a sample is less than the detection limit of the test or if the sample was collected incorrectly.
  • Test results should be correlated with other clinical data available to the physician.
  • If the differentiation of specific SARS viruses and strains is needed, additional testing is required.