June 2, 2021 | Compliance, Legal and Medical Malpractice, Instruments and Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management and Operations
Although the clinical laboratory RT-PCR test is still the “gold standard” when diagnosing COVID-19, the home antigen test provides convenient and rapid test results. But are they accurate?
Less than six months after the US Food and Drug Administration (FDA) issued Ellume the first ever emergency use authorization (EUA) for an over-the-counter SARS-CoV-2 diagnostic test for COVID-19 home antigen testing, consumers The number of tests that can be performed at home has grown enough for popular science to publish reviews of available consumer COVID-19 test kits.
Clinical laboratories and pathologists generally acknowledge that the RT-polymerase chain reaction (RT-PCR) test is still the preferred method for detecting COVID-19 disease. However, according to “Popular Science” reports, rapid home antigen tests that can accurately identify people carrying a large number of viruses are becoming an important tool to combat the spread of coronavirus.
In “We reviewed the popular home COVID-19 test. This is what we learned: There are more and more options for home testing for COVID, everything you need to know,” Popular Science evaluated the ease of use and effectiveness of the following tests :
Many of the latest home tests not only allow users to collect their own swabs or saliva samples, but some can also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home collection kits returned to the clinical laboratory for testing may take 48 hours or more to be shipped and processed.
Mara Aspinall, a professor at Arizona State University’s School of Health Solutions, told Popular Science: “The more we can conduct simple, regular, at-home tests, the less we need it.” It will become a habit, as simple as brushing your teeth,” she added.
However, in “Pathologists Urge to Be Cautious on COVID-19 Test Kits at Home”, MedPage today reported in a virtual media briefing of the American College of Pathologists (CAP) on March 11, pointing out that COVID-19 at home -19 Disadvantages of detection.
Issues cited include insufficient samples and improper handling that may lead to inaccurate results, and uncertainty about whether an antigen test at home will detect COVID-19 variants.
Quest Direct and LabCorp Pixel tests-both are sent to the company laboratory for PCR testing-on the two main statistical indicators of performance sensitivity (positive percentage agreement) and specificity (negative percentage agreement) The highest score. According to “Popular Science” reports, the sensitivity and specificity of these tests are close to 100%.
Popular science has found that these tests are generally easy to use and concluded that they are a useful tool (if not perfect) in the fight against COVID-19.
“If you are not vaccinated and have symptoms, they are a good way to confirm COVID-19 infection without risking going out,” Popular Science said in its article. “If you are not vaccinated and have no symptoms and just want to know if you can safely participate in family dinners or football matches, testing at home is still an imperfect self-screening method. Remember: if the test result is negative , The result may still be wrong. If you don’t wear a mask, you may accidentally be exposed to other people within six feet of others.”
With the popularity of COVID-19 testing at home, clinical laboratories performing RT-PCR testing may wish to pay close attention to the need for rapid antigen testing at home, especially now that some tests are available without a prescription.
Coronavirus (COVID-19) update: FDA authorizes antigen test as the first over-the-counter, completely at-home diagnostic test for COVID-19
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Post time: Jun-25-2021