How the tests work
Testing for COVID-19 can or could be done in the following, three ways:
A sample is collected by the person having the test (self-administered) or by someone else (assisted) in a home or mobile environment such as police stations, care homes or drive-through centres. The sample is taken either through the use of a swab applied to the nose and throat, or by providing saliva. The sample should be placed into special packaging provided and sent to the designated lab for analysis.
This type of sampling kit is currently being rolled out at scale by the government to key workers and those prioritised for testing. Those eligible can access sampling kits through the government’s official channels.
Read more about the testing process.
A sampling kit that has a valid CE mark can be sold to members of the public and used by them privately.
The person having the test could conduct it themselves and read the result at home (similar to a home pregnancy test).
No home testing kits have received a CE mark and there are no testing kits available in the UK for home use. A CE mark is applied by manufacturers to devices which meet the requirements of medical device regulations.
This means it is currently illegal to supply tests for use by members of the public in the UK, though this may change, when CE-marked home testing kits become available. Members of the public should not purchase or use home testing kits. Using the wrong type of testing kit in the wrong setting can lead to inaccurate results, a false sense of protection or recovery and increased pressure on our NHS and social care systems.
It is important to note that home testing should not be confused with the use of a sampling kit at home, as mentioned above.
Laboratory or point-of-care testing
These tests are always done by healthcare professionals. They are not designed to be used by people in their homes as they may give results that need to be interpreted by a trained and qualified healthcare professional.
Some tests are undertaken in a laboratory by specialist staff using specialist equipment. Other tests require less equipment, are easier to use and can be performed by a fully trained and qualified healthcare professional – often in the presence of the person being tested.
Types of COVID-19 tests
Tests for the virus
This type of test looks for the presence of genetic material from the COVID-19 virus within a swab or saliva sample. These tests are commonly referred to as polymerase chain reaction (PCR) tests. A positive test shows that the person being tested has a current, COVID-19 virus infection.
The sampling kits referred to above are for PCR tests.
How it works
The test is performed by a fully trained, healthcare professional in a laboratory, ward or clinic. It involves analysing a sample collected from deep inside the nose or the back of the throat by a swab or the sample might be saliva or other fluid. The test can take from less than an hour to several days to get a result.
Tests for antibodies to the virus
This type of test looks for the presence of antibodies (produced by people with the virus to counteract the virus) against the COVID-19 virus. These antibody tests are also referred to as serology tests and can be conducted in a laboratory or through point-of-care testing.
How it works
The test is intended to determine if someone has previously been infected with COVID-19 and now may have antibodies against the virus. A positive result from this test does not guarantee immunity to COVID-19 infection. It may just indicate a recent infection that may or may not have been COVID-19.
The tests involve taking a blood sample, often a finger prick, which will be analysed for the presence of antibodies associated with COVID-19. These tests should only be performed and interpreted by fully trained, healthcare professionals and not by members of the public.
Some manufacturers are selling products intended to detect COVID-19 antibodies. These typically use a few blood drops applied to a small cassette. These tests should be available to healthcare professionals only.
The limits of testing kits
Even if a test has a CE mark, it may have limitations.
For example, the link between the presence of antibodies and immunity is not proven, and some tests are not specific for COVID-19 antibodies. These two facts mean that a positive test result for antibodies does not necessarily mean that the person being tested is immune to COVID-19.
How testing kits are regulated
The MHRA is the designated competent authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality.
An in vitro diagnostic medical device (IVD) includes tests performed on human samples (for example, blood, tissues, saliva, urine) for a medical purpose. As with all medical devices, manufacturers must place the CE mark on an IVD before it can be placed on the UK market.
CE marks are not issued by the MHRA. They are granted by an independent certification body, called a Notified Body authorised by the MHRA to issue them. These notified bodies are overseen by the MHRA.
The #FakeMeds campaign is a public health campaign which aims to reduce the harm caused by purchasing fake or unlicensed medical products online.
Learn how to spot a fake and purchase medical products safely online.
Any incidents involving medical devices, including testing kits, or suspected fake or unlicensed testing kits, can be reported via the Yellow Card scheme.