Target Health Blog

FDA Authorizes First In-Home Test for Coronavirus

April 27, 2020

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Quiz
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This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19).
Graphic credit: by CDC/ Alissa Eckert, MS; Dan Higgins, MAM - This media comes from the Centers for Disease Control and Prevention's Public Health Image Library (PHIL), with identification number #23312. Note: Public Domain,
Commons.Wikimedia.org

COVID-19 testing can identify the 1) _____ virus and includes methods that detect the presence of virus itself (RT-PCR and isothermal nucleic acid amplification) and those that detect 2) _____ produced in response to infection. Detection of antibodies (serology) can be used both for diagnosis and population surveillance. Antibody tests show how many people have had the disease, including those whose symptoms were minor or who were asymptomatic. An accurate mortality rate of the disease and the level of herd immunity in the population can be determined from the results of this test. However, the duration and effectiveness of this immune response are still unclear.

Due to limited testing, as of March 2020 no countries had reliable data on the prevalence of the virus in their population. As of 21 April, the countries that published their testing data have on average performed a number of tests equal to only 1.2% of their population, and no country has tested samples equal to more than 12.8% of its population. There are variations in how much testing has been done across countries. This variability is also likely to be affecting reported case fatality rates, which have probably been overestimated in some countries, due to sampling bias, and underestimated in other countries.

The in-home test, sold by LabCorp, called Pixel, will be available for consumers in most states. On Tuesday 21 April, the 3) _____ granted emergency clearance to this first in-home test for the coronavirus. The FDA said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor's office, hospital or other testing site. According to FDA, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home. For the test, subjects will 4) _____ their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company.

LabCorp said that it would first make the tests available to health care workers and emergency workers who may have been exposed to the virus or have symptoms, and that it would be making the self-collection kits available to consumers “in the coming 5) _____.“ The company also noted that because the tests are done by consumers in their own home, it should cut down on the demand for masks and other protective equipment that is usually needed to collect testing specimens. The company said the test will cost 6) _____. Consumers will have to pay out of pocket for the test, and ask their insurer for reimbursement. Interestingly, the federal government has repeatedly said that diagnostic tests for the coronavirus will be covered so that consumers would not have to foot the bill.

Since governors across the country say their states are facing a shortage of tests, and companies like 7) _____ and Walmart are setting up drive-through testing centers in parking lots, the arrival of kits that let people collect their own nasal specimens at home has the potential to open up testing to a wider audience. Thus, home-swabbing tests could increase convenience for consumers, and reduce the need for people to go to medical offices where there could be exposure to the infection.

The public needs to be cautioned, however, that the 8) _____ swabs can be less accurate for testing than the gold standard specimen collection for the coronavirus, which involves inserting a long-nasal swab up through the nose into the back of the throat. One small peer-reviewed study from 9) _____, reported last week that coronavirus tests using nasal swabs had a higher false negative rate than the longer swabs.

As the 10) _____ spreads in the United States, several companies rushed unauthorized home kits to the market, even though the FDA had said it had not evaluated whether they worked properly, so caveat emptor or buyer beware as the Romans told us 2,000 years ago.

ANSWERS: 1) SARS-CoV-2; 2) antibodies; 3) FDA; 4) swab; 5) weeks; 6) $119; 7) CVS; 8) nasal; 9) France; 10) virus

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