10 The US drug and device regulator, the Food and Drug Administration, has not approved the Innova test and in June 2021 issued a safety communication warning the public not to use the test based on concerns that its performance had not been adequately established. 9 In the UK the Innova test is approved by the Medicines and Healthcare products Regulatory Agency to identify covid-19 in people who do not have symptoms and is the only test widely used.
For covid-19, these devices are detecting a SARS-CoV-2 antigen, consequently sometimes they are termed “rapid antigen tests.” A large number of SARS-CoV-2 antigen LFD tests are available internationally. Their use is well established for home pregnancy testing. Lateral flow devices can detect the presence of a target substance in a liquid, typically in a single use disposable device.
#Lateral flow test how to#
This practice pointer considers how to interpret and communicate results from LFD tests based on our current understanding of the tests’ performance. 8 People taking a test receive advice on what their result means and what they should do however, the widespread use of these tests means doctors may increasingly be asked about them (for example, when patients with a recent result present to services). In the week ending 19 May, 4.9 million registered tests were undertaken in England. 1 5 6 7 Despite concerns about accuracy, LFD tests continue to be widely used. The risks and benefits of using LFDs for widespread testing of asymptomatic people are the subject of ongoing uncertainty and debate. Lateral flow devices (LFDs) are being used to test asymptomatic people for covid-19 as part of the approach in the UK and elsewhere to control the spread of the disease and to enable society to reopen.
If covid-19 is clinically suspected, a PCR test is recommended, even if the patient has received a negative result from a recent LFD test If a symptomatic patient informs you that they have had a negative covid-19 test, check what type of test was done LFD testing is not recommended when the person has symptoms of covid-19, as a negative LFD is not sufficient to rule out covid-19 However, if your clinical opinion is that covid-19 is likely, then a positive test is likely to be reliable When the disease incidence is low, a positive result should be validated by a polymerase chain reaction (PCR) test. The positive predictive value of a positive lateral flow device (LFD) test depends on the underlying likelihood of disease
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