Every day, the Pasadena, California-based company ships eight freighters carrying coronavirus tests to the UK.
The top executive of the Innova Medical Group hopes to use rapid tests to slow down infections closer to home. In the worst phase of the pandemic this winter, hospitals in Los Angeles County were full of patients, and the number of deaths hit a record high.
However, Innova has not been authorized by the U.S. Food and Drug Administration to sell these test products in the United States. Instead, jets equipped with tests were flown overseas to serve the “Moon” where British Prime Minister Boris Johnson conducted a large-scale test.
Daniel Elliott, President and CEO of Innova Medical Group, said: “I am a little frustrated.” “I think we have done all the work that may be done, the work that needs to be done, and the work that is required to be tested through the approval process. ”
More research is underway to prove the accuracy of the Innova test, which costs less than $5 and can deliver results within 30 minutes. Elliott said that researchers at Harvard University, University of California, San Francisco and Colby College have evaluated the test, and other private research groups are conducting trials on people with or without COVID-19 symptoms.
Experts say that the United States can rapidly expand the limited supply of test products in the United States and increase the speed by authorizing rapid paper antigen testing (such as Innova diagnosis). Advocates say these tests are cheaper and easier to manufacture, and can be used two to three times a week to detect when someone is infectious and may spread the virus to others.
Disadvantages: Compared with the laboratory test, the accuracy of the rapid test is poor, and the laboratory test takes longer to complete, and the cost is 100 US dollars or more.
Since last spring, the administration of President Joe Biden has supported both methods – investing in fast, inexpensive antigen testing and laboratory-based polymerase chain reaction or PCR testing.
Earlier this month, government officials announced that six unidentified suppliers would deliver 61 million quick tests by the end of the summer. The Ministry of Defense has also reached a $230 million agreement with Australia-based Ellume to open a factory in the United States to conduct 19 million antigen tests per month, of which 8.5 million will be provided to the federal government.
The Biden administration announced a $1.6 billion plan on Wednesday to strengthen testing in schools and other locations, provide necessary supplies, and invest in genome sequencing to identify coronavirus variants.
About half of the money will be used to support the domestic production of important test supplies, such as plastic pen nibs and containers. Laboratories cannot consistently ensure safety – when samples are sent to well-equipped laboratories, supply chain gaps can delay results. Biden’s package plan also includes spending money on the raw materials needed for rapid antigen testing.
Government officials say that this expenditure is sufficient to meet the needs of the pilot project to meet immediate needs. COVID-19 response coordinator Jeffrey Zients said Congress needs to pass Biden’s rescue plan to ensure funding is doubled to improve testing capabilities and reduce costs.
School districts in Seattle, Nashville, Tennessee, and Maine are already using rapid tests to detect the virus among teachers, students, and parents. The purpose of the quick test is to alleviate the worries of reopening the school.
Carole Johnson, the testing coordinator of the Biden administration’s COVID-19 response team, said: “We need a range of options here.” “This includes options that are easy to use, simple and affordable.”
Advocates say that if federal regulators authorize companies that are now able to conduct a large number of tests, then the United States can do more tests.
Dr. Michael Mina, an epidemiologist at Harvard University, has been conducting such tests. He said that rapid testing is “one of the best and most powerful tools in America” for the fight against COVID-19.
Mina said: “We have to wait until summer to test people…this is ridiculous.”
Under extensive screening combined with strict quarantine measures, the European country Slovakia reduced the infection rate by nearly 60% within a week.
The UK has embarked on a more ambitious large-scale screening program. It launched a pilot program to evaluate the Innova test in Liverpool, but has expanded the program to the whole country. The UK has launched a more aggressive screening program, ordering more than $1 billion worth of tests.
Innova’s tests are already in use in 20 countries, and the company is ramping up production to meet demand. Elliott said that most of the company’s tests are conducted at a factory in China, but Innova has opened a factory in Brea, California, and will soon open a 350,000 in Rancho Santa Margarita, California. Square foot factory.
Innova can now manufacture 15 million test kits per day. The company plans to expand its packaging to 50 million sets a day in the summer.
Elliott said: “Sounds a lot, but it is not the case.” People need to test three times a week to effectively break the chain of transmission. There are 7 billion people in the world. ”
The Biden government has purchased more than 60 million tests, which will not be able to support large-scale screening programs in the long term, especially if schools and companies test people two to three times a week.
Some Democrats called for more active promotion of mass screening through rapid tests. U.S. sales representatives Kim Schrier, Bill Foster, and Suzan DelBene urged Acting FDA Commissioner Janet Woodcock to conduct an independent evaluation of the rapid test to “pave the way for extensive, inexpensive home testing.”
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The FDA has provided emergency authorization for dozens of tests using different technologies, which are used in laboratories, medical institutions for immediate medical services, and home testing.
The $30 Ellume test is the only test that can be used at home without a prescription, does not require a laboratory, and can provide results within 15 minutes. Abbott’s BinaxNow home test requires a recommendation from a telemedicine provider. Other home tests require people to send saliva or nasal swab samples to an external laboratory.
Innova has submitted data to the FDA twice, but has not yet been approved. The company officials said that as the clinical trial progresses, it will submit more data in the next few weeks.
In July, the FDA issued a document requiring home testing to correctly identify the virus that causes COVID-19 at least 90% of the time. However, a senior FDA official responsible for overseeing testing told USA Today that the agency will consider testing with a lower sensitivity-measuring the frequency with which the test correctly identifies the virus.
Jeffrey Shuren, director of the FDA’s Center for Equipment and Radiological Health, said the agency has approved several point-of-care antigen tests and expects that more companies will seek authorization for home testing.
Shuren told USA Today: “From the beginning, this is our position, and we are working hard to promote access to effective tests.” “Especially accurate and reliable tests make the American people feel confident about it.”
Dr. Patrick Godbey, Dean of the American College of Pathologists, said: “Each type of examination has its purpose, but it needs to be used correctly.”
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Godbey says that the rapid antigen test works well when used on a person within five to seven days of the onset of symptoms. However, when used to screen asymptomatic people, antigen testing is likely to miss infection.
Cheaper tests may be easier to obtain, but he worried that the missed cases could be used as a widespread screening tool. If they test negative results incorrectly, it may give people a false sense of security.
Goldby, laboratory director of the Southeast Georgia Regional Medical Center in Brunswick, Georgia, said: “You have to balance the cost of (testing) with the cost of missing an active person and allowing that person to interact with others.” “This is a real concern. It boils down to the sensitivity of the test.”
A team from the University of Oxford and the government’s Porton Down laboratory have conducted extensive research on Innova’s rapid test in the UK.
In a non-peer-reviewed study of rapid testing evaluated by Innova and other manufacturers, the research team concluded that testing is an “attractive option for large-scale testing.” But the researchers say that quick tests should be used frequently to assess accuracy and potential benefits.
The study evaluated 8,951 Innova tests performed on clinical patients, medical staff, military personnel, and school children. The study found that Innova’s test correctly identified 78.8% of the cases in the 198 sample group compared to the laboratory-based PCR test. However, for samples with higher virus levels, the sensitivity of the detection method is increased to more than 90%. The study cited “increasing evidence” that people with higher viral loads are more infectious.
Other experts said that the United States should shift its detection strategy to a strategy that emphasizes screening through rapid testing to identify outbreaks more quickly.
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In a comment published on Wednesday by The Lancet, Mina and researchers at the University of Liverpool and Oxford stated that recent studies have misunderstood the sensitivity of rapid antigen testing.
They believe that when people are unlikely to spread the virus to others, laboratory-based PCR tests can detect fragments of the virus. As a result, after testing positive in the laboratory, people stay in isolation longer than they need.
Mina said that how regulators in the United States and other countries interpret data from the UK’s rapid test program has “great global importance.”
Mina said: “We know that the American people want these tests.” “There is no reason to think that this test is illegal. That’s crazy.”
Post time: Mar-15-2021