Viral TikTok videos showing teenagers hacking rapid COVID-19 tests by inserting sodas and other acidic solutions into the tests’ inlet are causing quite a stir, especially in the UK, where these easy-to-use, at-home tests are currently used for regular screening of students and teachers in secondary schools and colleges. Show
While PCR tests remain the gold standard for SARS-CoV-2 detection, so-called rapid COVID-19 tests employ lateral flow technology instead, and can return a result in 30 minutes or less. In addition to their speed, these rapid tests can also be performed anywhere, increasing the accessibility of testing. However, preliminary research posted to the preprint server medRxiv on July 5 confirms that certain beverages can cause false positives. And because anyone in the UK who obtains a positive rapid test result must immediately self-isolate for up to 10 days, report the result, and follow up with a PCR test—or face a fine—education leaders in the UK are concerned such false positives are being used to get out of school. Geoff Barton, the general secretary of the Association of School and College Leaders in the UK, tells the news outlet i that such hacking is limited to “a very small minority of pupils.” The sudden explosion of rapid test hacking videos has added to existing concerns about their accuracy. “People are saying ‘well, these tests are hopeless,’” explains Alexander Edwards, who researches and develops clinical and microbiological tests at the University of Reading School of Pharmacy in the UK. See “COVID-19 Diagnostics: How Do Saliva Tests Compare to Swabs?”The Scientist spoke with Edwards to understand how sodas can cause false positives and the broader implications of this kind of test hacking—as well as why these tests aren't hopeless.  Courtesy of Alexander Edwards The Scientist: What is a lateral flow test, and how does it work?Alexander Edwards: A lateral flow test is a rapid way of measuring one particular target, which is useful for clinical diagnosis, in a complex mixture. And that mix could be something coming off a swab, or it could be blood, or something like that. The way it works is it binds to that target using antibodies. And if the target is present, the antibodies present in the system allow you to get a visual line, which is your positive line, because the antibodies and the antigen trap the target on that stripe on that little line. TS: How accurate are they?AE: Lateral flow tests can be extremely accurate, and they’re very powerful for detecting particular targets in complex mixtures. The only catch is that they’re only as accurate as how they’re being used. The great benefit of lateral flow tests is they’re portable, they’re cheap, they’re disposable, and they’re easy to use near the patient, but that does come at a slight cost in terms of their analytical performance. . . . The good news is that lateral flow tests can be extremely specific, and what that means is that if you get a positive result, it’s very likely to be a real result. What we mean by that is, we don’t tend to get a huge number of false positives for COVID-19 lateral flow tests.
There is a final challenge about the accuracy of these tests, which is that . . . sometimes the tests are less accurate when they’re used in a different way. And one really good example of that is that if you take a test and use it in a trained supervised environment, you tend to get very reproducible, reliable results—they work the same way every time. But if you then roll it out in a community setting, when perhaps the people using them aren’t as experienced, what you start to see is more false negatives and more false positives, sometimes simply because the people operating the test might make a mistake, the instructions may not be very clear, or even something really silly, like the test has gone out of date, or it’s just broken in some way. TS: Why might something like sodas return a false positive result?AE: The biochemistry of it’s quite interesting, because it seems like there’s something odd there at first sight. You might say, ‘well, you should only be able to get a positive result if there is the virus particle there, because that’s the whole point of the test; it should only be able to detect the virus particle.’ But there are some ways that these tests can go wrong, and one really obvious one is if you put something into the test which isn’t supposed to go in the test, particularly something like a strong acid or an acidic solution. What you can do is you can mangle up, if you like, or mess up the antibodies in the test. And when you do that, you can get unexpected results. What I’ve been able to see—and there’s even some papers that have looked at this experimentally—is that under some circumstances, you can get the appearance of a positive line. The manufacturers would say that this is quite simply because you have these gold particles, which forms the colored element, and if that’s treated with an acidic solution, you may get it clumping together or aggregating. That makes it sticky, and then it sticks where it shouldn’t stick.
To be fair to the manufacturer, they never intended those things to go into the test. So it’s certainly not a weakness or a criticism of the test, because if you follow the instructions that come with a test, and you don’t put soda or a slice of kiwi fruit or whatever it is that people have tried onto the test, and you actually follow the rules and do the test thirty minutes after eating and drinking, if that’s what the instructions say, then you won’t get these unexpected results. TS: Why might false positives, whether intentional or not, be a concern?AE: If you have a testing program where you test people a lot of the time . . . especially if you’re screening people without symptoms, every time you get a false positive, the person involved and also all those people who’ve been in contact with them have to be treated as if they have this very dangerous, highly contagious infectious disease. In many countries, it is a legal requirement to report that result, because the pathogen is considered to be so dangerous. . . . So anytime you get a false positive, especially if it’s a false positive that’s arising from improper use of the test, you’re actually damaging the system, and the system is the public health system that’s there to protect us. This is obviously a bad thing. TS: What can be done to minimize the impact of false positives?AE: The advice is really very simple. . . . Try and follow the instructions that come with the kit as closely as possible. And the reason I say that is because when we have data to trust the test, that data is always generated when using the test according to the manufacturer’s instructions. So it may well be possible that you could change the way you do the test, and it would still work fine, but we don’t know that. That sounds kind of boring, to just follow the instructions. . . . But because it’s a medical test, it’s actually really, really important that you do follow the instructions—otherwise the system tends to break down. Editor's note: This interview was edited for brevity.
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2 antigens in authorized specimen types collected from individuals who are suspected of COVID-19 by their healthcare provider within a certain number of days of symptom onset. The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings and continues to monitor and evaluate these reports and other available information about device safety and performance. The FDA reminds clinical laboratory staff and health care providers about the risk of false positive results with all laboratory tests. Laboratories should expect some false positive results to occur even when very accurate tests are used for screening large populations with a low prevalence of infection. Health care providers and clinical laboratory staff can help ensure accurate reporting of test results by following the authorized instructions for use of a test and key steps in the testing process as recommended by the Centers for Disease Control and Prevention (CDC), including routine follow-up testing (reflex testing) with a molecular assay when appropriate, and by considering the expected occurrence of false positive results when interpreting test results in their patient populations. RecommendationsThe FDA recommends clinical laboratory staff and health care providers who use antigen tests for the rapid detection of SARS-CoV-2:
BackgroundThe FDA issued the first Emergency Use Authorization (EUA) for a COVID-19 antigen test in May 2020. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. A list of the FDA-authorized antigen tests are available on the FDA's In Vitro Diagnostics EUA page. Antigen tests are an important tool in the overall response against COVID-19 and benefit public health. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. The availability of these types of tests may provide the ability to test millions of Americans rapidly. In general, antigen tests are not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions. Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information. Like molecular tests, antigen tests are typically highly specific for the SARS-CoV-2 virus. However, all diagnostic tests may be subject to false positive results, especially in low prevalence settings. Health care providers should always carefully consider diagnostic test results in the context of all available clinical, diagnostic and epidemiological information. Test interference from patient-specific factors, such as the presence of human antibodies (for example, Rheumatoid Factor, or other non-specific antibodies) or highly viscous specimens could also lead to false positive results. FDA ActionsThe FDA continues to work with other agencies, such as the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to safeguard COVID test use in nursing homes and other settings. The FDA is also working with test manufacturers to ensure that their instructions for use are as clear as possible to minimize the occurrence of false results. The FDA will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed of new or additional information. Additional ResourcesReporting Problems to the FDAThe FDA encourages stakeholders to report any adverse events or suspected adverse events experienced with antigen tests for rapid detection of SARS-CoV-2. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Contact InformationIf you have questions about this letter, contact . |
What causes a false positive rapid COVID test
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