The test kit was developed by a laboratory at Rutgers University, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. The
The agency has been criticized in recent weeks for allowing a myriad of companies to offer diagnostic and antibody tests without submitting timely data for review, in accordance with its licensing policy. emergency due to the pandemic. Tests have varied considerably in terms of accuracy, and access to diagnostic tests has been dispersed, with test shortages and the materials needed to process them, constraining state-to-state capacity.
To date, 8.1 million people in the United States have been tested for coronavirus. But public health experts like Dr. Anthony Fauci, the country’s leading infectious disease expert, said tests should double by the end of May.
Last week, the F.D.A. Ordered dozens of companies licensed to market antibody tests, which some states and public health experts say will help indicate the depth of infection in communities and quantify who has recovered and possibly developed some immunity, to submit data proving their accuracy within 10 days, or he warned that the products could be withdrawn from the market.
The F.D.A. said Rutgers had submitted data showing that the patient’s own saliva samples, under the observation of a health care provider, were as accurate as the deep nasal swabs that the health care professional had taken gathered from them. The agency also said that pin collection kits should be limited to people with symptoms of Covid-19.
“A patient can open the kit, spit in the tube, put the cap back on and send it back to our lab,” said Dr. Andrew Brooks, Director of Operations and Director of Technology Development at RUCDR. “We bring the test to the patient, instead of the patient to the test. “
The F.D.A. said he still prefers tests based on deep nasal samples, which involve a healthcare professional inserting a long swab through the nose and into the back of the throat. But even these have had problems. In mid-April, for example, an anonymous team of health providers reported to the F.D.A. that the new Abbott ID Now test did not detect coronaviruses in six patients who were known to have Covid-19.
Rutgers has 75,000 saliva test kits ready to ship and can process 20,000 tests daily, within 48 hours. Dr. Brooks said he expected other labs across the country to adopt it for their own use.
He said the Centers for Medicare and Medicaid have approved fees of $ 100 per test, but prices will vary. A company, Vault Health, now offers telehealth meetings in which a health professional supervises the sputum test by video. Vault charges $ 150 per test.
The spindle tests are part of an emergency response to a pandemic by the F.D.A. to help developers of new coronavirus tests get to market quickly. Last month, the agency authorized the The first type of home kit for the virus in the United States, a kit sold by LabCorp that allows people to swab their noses and send samples for testing to company labs across the country.
Now, at a time when some states say they are still facing a test shortage, home pin collection kits have the potential to expand the audience for virus testing. By keeping people with symptoms at home, rather than asking them to go to medical centers for a test, pin kits could reduce the risk of spreading the infection to health workers.
They can also appeal to people who feel more comfortable spitting in a container than inserting swabs into their noses to collect virus samples.
“This combines the ease of saliva collection with home collection,” says Dr. Stephen Hahn, F.D.A. The commissioner said in an interview on Friday.
Some public health experts have warned, however, that home sampling kits can also have drawbacks. One is that it may take longer to get test results when using home kits that need to be sent to labs. Because the infection can take several days to develop, they said, the lag could lead some people to a false negative result for the coronavirus. Doctors, they said, should inform patients of the limits.
The agency also noted that the Rutgers laboratory was the only entity authorized to market home coronavirus self-sampling kits for saliva. In March, the F.D.A. cracked down on several healthcare start-ups that rushed to market unauthorized home kits that involved consumers collecting their own spit or throat swabs for testing.
“This is not a general authorization,” said the F.D.A. said of the Rutgers pin kits, “for the home collection of patient samples using other collection methods, saliva collection devices or tests, or for entirely home tests. “
The decisions of the F.D.A. more than 100 emergency use authorizations have come under heavy criticism from Democratic lawmakers. Earlier this week, Senator Elizabeth Warren, of Massachusetts, and Senator Patty Murray, of Washington, the two Democrats, sent a letter to Dr. Hahn requesting information on how the agency is monitoring the use, safety and efficacy of Covid-19 treatments. and diagnostic tests allowed in an emergency due to the pandemic.
Legislators have expressed particular concern over monitoring by the F.D.A. adverse events caused by hydroxychloroquine, a treatment repeatedly promoted by President Trump.
Senators noted evidence of the cardiac fatal side effects of the drug and its lack of evidence as a treatment for Covid-19. “There is also information that the F.D.A. has lowered its quality control standards so that the administration can accept Bayer Pharmaceutical’s donation of millions of hydroxychloroquine tablets for distribution, “they said.
The senators also told the F.D.A. to ensure that he followed all reports of adverse events with remdesivir, which has received emergency use authorization to treat hospital patients with Covid-19.