Schools may soon be able to test their staff and students for COVID-19 and get results in a matter of minutes as the first antigen rapid test gets distributed mid-September to governors in every state.
The Trump administration’s recent purchase of 150 million Abbott Laboratories’ rapid tests will be sent to governors to “support opening of K-12 schools, daycare, and critical infrastructure,” Assistant Health Secretary Admiral Brett Giroir told reporters in a call on Sept. 1. It will be up to each governor or the local public health officials to decide how the tests will be used.
The rapid test requires only a simple nasal swab, costs less, at only $5, than the other emergency use authorization (EUA) COVID-19 tests, and gives results in 15 minutes, with one line denoting a negative result and two lines a positive, similar to a home pregnancy test.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Dr. Jeff Shuren, director of the FDA’s (Food and Drug Administration) Center for Devices and Radiological Health, said in a press release. “This means people will know if they have the virus in almost real-time.”
The administration will also continue to focus on keeping high-risk groups safe during the pandemic as more areas open up. “So, we’re focusing on nursing homes, elderly, and minorities because they are the most likely to be hospitalized and die,” Giroir said. “I think it’s very clear that the vulnerable need to be shielded and they need to be our first priority.”
The tests will be delivered to over 20,000 assisted living facilities, 14,000 nursing homes, and historically black colleges and universities (HBCU).
Abbott’s plans to produce 48 million rapid tests every month beginning in October will transform the landscape of testing in the United States allowing the possibility of opening the country safely, when used in conjunction with PCR tests, before a vaccine is available. PCR tests are mainly used to diagnose infection and report daily cases.
“Rapid tests are urgently needed to help clear individuals as schools and the economy reopens,” Dr. William W. Li told The Epoch Times in an email. Li, an internationally renowned physician, scientist, and author of New York Times bestseller “Eat to Beat Disease: The New Science of How Your Body Can Heal Itself,” says that its paramount to perform more testing in the fight against COVID-19.
The United States has conducted more than 83 million tests in the past seven months. “New cases are down 38 percent, hospitalizations down 37 percent, and ICU patients down 49 percent since their peaks in late July,” Giroir said.
As with other COVID-19 tests, Abbott’s antigen test has its limitation. Its low sensitivity or the “ability to determine the patient cases correctly” is a concern to experts, as the test is more likely to give a false negative. Antigen tests are generally less sensitive than PCR tests as they require a higher viral load to be able to detect a fragment of the virus’s RNA.
False negative results may still require some patients to receive a PCR test for confirmation. But according to the FDA, false positives may also occur, making it important and necessary to also know the patient’s symptoms, medical history, and exposure to “determine infection status” along with using the rapid antigen test to determine the correct treatment protocol.
While positive tests “indicate the presence of viral antigens,” it doesn’t “rule out bacterial infection or co-infection with other viruses,” the FDA said in an informational packet about the Abbott test. “The agent detected may not be the definite cause of disease,” on the test.
But Dr. Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, told Fox News that he believes the Abbott test can still be a “very useful tool” to stay ahead of the curve.
At-home Test Availability
Regardless of its wide production and distribution, the rapid test requires a prescription and is only for people who healthcare practitioners “suspect” of having COVID-19 “within seven days of symptom onset” according to the FDA. It is currently not available for at-home use, but the federal agency is trying to change that.
In a press release about over-the-counter and at-home diagnostic tests, the FDA updated its template in July to encourage medical developers to manufacture and submit EUA requests for “COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab” and would not require a prescription.
“These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening,” FDA Commissioner Stephen M. Hahn, MD said.
‘Cycle Threshold’ Key Information Missing in Test Result Interpretation
Since the pandemic began, PCR tests have been the gold standard diagnostic test for the CCP (Chinese Communist Party) virus that causes COVID-19, informing physicians only if a patient is infected or not, based on the cycle threshold (CT) value.
The CT is the number of cycles it takes the test machine to find the virus’s genetic material. Unlike an antigen test, a PCR test is a molecular test that looks for the genome of a virus.
Its high specificity and sensitivity allow the test machine to pick up the smallest virus particle (from either a live or a dead virus) and amplify it millions of times. This process can then produce false positives even when a patient has already recovered, according to a study where patients tested positive again after being discharged with a negative test.
“The lower the number of cycles, the more virus is present,” Li said. “The higher the number of cycles needed to pick up signs of the virus, the less is present.”
There is no standard cutoff number for all of the PCR tests currently used, although the CT value ranges from 35-40, but “a sample is usually judged positive for COVID-19 based on a Ct value of 35” in a review of COVID-19 diagnostic tests and their interpretation.
With the possibility that the CT value may predict how contagious a patient is and can help in guiding policy decisions as well as patient management according to experts, it is not included in the decision making of policymakers or medical professionals.
In a narrative review of 18 studies, the authors said that the “lower cycle threshold values may be associated with worse course of illness and outcomes and threshold values may be useful in predicting the clinical course and prognosis of patients.”
Researchers in a preliminary study of 183 COVID-19 positive samples published in the European Journal of Clinical Microbiology & Infectious Disease found that “patients with Ct above 33–34 using our RT-PCR system are not contagious” and recommended their discharge “from hospital care or strict confinement for non-hospitalized patients.”
Li says that it is still too early to tell the role of CT in predicting patient prognosis. “Presently it is not known if cycle threshold (ct) is predictive of how a patient will do, so there is no way yet to use the ct number to guide school and economy reopening,” Li said.