It’s been six months since the first case of coronavirus was diagnosed in the U.S., but the country is still plagued by severe delays in testing, and many patients wait a week or more to receive their results.
Quest Diagnostics, the largest laboratory company in the US, warned this week that “there was no way” the industry could expand molecular nasal swab testing capabilities in time for fall, when it is expected to increase. Lawsuit as Millions of Americans Get Common Colds and Flu
Why do test delays matter?
If a patient receives a positive result after seven days, they will probably have passed the point where the disease is most contagious. If they have come into contact with others during that time, they may have already been infected.
“These tests are essentially of little or no value if they fall back within that type of time frame,” said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.
Delayed testing results also make it difficult for contact trackers to find and isolate people who are at risk, and it means public health officials are battling the pandemic with outdated data.
What is causing the delays?
An increase in demand in the southern and western states where the disease is rapidly spreading has overwhelmed the laboratory industry, which is dominated by two large companies, Quest and LabCorp.
The surge in demand comes when other states that have managed to cut infection rates, like New York and New Jersey, are encouraging everyone to get tested, even if they don’t have symptoms.
“We’ve had plenty of time to do this right,” Scott Gottlieb, the former commissioner for the US Food and Drug Administration, told CBS News earlier this week. He said LabCorp and Quest were “trying to prioritize” testing in states like Texas and Florida, which have seen an explosion of new cases.
“Not only are they lagging behind in those regions, but they are now withdrawing evidence from other regions and seeing delays there,” he added.
Approximately 5.5 million Americans are being evaluated each week, but LabCorp and Quest can only process 265,000 tests per day. They have plans to expand their combined capacity to 300,000 by the end of this month, but that’s still far less than necessary to cut wait times in a matter of days.
Why can’t laboratory companies expand more quickly?
Quest warns that it is struggling to buy supplies. At one site in California, completed test swabs are stored in an ice chest on a trailer © Bloomberg
Laboratory companies say there are two factors that prevent them from adding additional capacity. First, they struggle to ensure the supply of reagents, the chemicals that are mixed with samples of nasal mucus to determine whether a patient is positive or negative for the coronavirus.
“We could do more testing today if we had more reagents,” said James Davis, executive vice president of Quest.
Second, the labs are struggling to buy enough test machines from companies like Roche, ThermoFisher, and Hologic, which are dealing with a jump in demand not just from the US but also from populated countries like India and Brazil.
“We are not likely to see a doubling of… Capacity over the next three months based largely on supply base constraints for the laboratory industry,” added Mr. Davis.
Will more funding help?
The White House is hampering Democrats’ attempts to include more funds for testing and tracking © Getty Images
Democrats on Capitol Hill passed legislation in May that included $ 75 billion in additional funding for testing and contact tracing, and even some Republicans in the Senate have endorsed the idea of additional funding. But the White House has resisted including more money to test and track in negotiations over a new stimulus package.
Even if there was more money, it’s not clear that spending it on expanding nasal molecular testing capabilities would work. Private labs charge $ 100 per test and make big profits from the job. They insist they would do more tests if it weren’t for the problems to secure their suppliers’ reagents and machines.
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However, additional funding could be used to develop alternatives to nasal swab testing using an 80s-era technology known as polymerase chain reaction (PCR).
Quest’s Mr. Davis said: “What the government can do the most is encourage innovation, making sure that the smartest people in the [Massachusetts Institute of Technology] and Cornell and Harvard are getting what they want and need, just as they have in the vaccine industry. “
Could the Defense Production Law increase capacity?
DPA has already been invoked to stimulate the production of simple components, such as nasal swabs, and could also help expand the supply of chemical reagents.
However, executives in the laboratory industry doubt that it can be used to increase the supply of the sophisticated machines produced by Roche and others.
What are the alternative tests?
Antigen tests, which can quickly detect protein fragments found in or within a nasal swab virus, are much faster and can be manufactured to scale © AFP via Getty Images
The FDA has granted emergency use authorization for two “antigen” tests that can quickly detect protein fragments found in the virus or inside a nasal swab. These are much faster than PCR tests and could be manufactured to scale to evaluate millions of people.
However, they are not very sensitive, which means that they can produce many false negatives. If everyone with a negative result wanted to confirm their status using a PCR test, they could end up putting more pressure on the system.
However, Dr. Jonathan Quick, head of pandemic response at the Rockefeller Foundation, insists that antigen testing is part of the solution. “The fast, frequent heartbeat is slow and responsive for epidemic control,” he said.
The FDA has also said it will allow Quest to conduct “pooled tests” in an attempt to speed up processing times. The method allows the laboratory to analyze samples from four patients in the same “well” at the same time.
If the pooled sample is negative, all patients without the virus are informed. If the result is positive, laboratory technicians must examine each sample individually.
