Shortages of key ingredients for diagnostic tests risk worsening delays in testing Americans for the coronavirus, exacerbating the crisis by preventing health officials from tracking how many people are infected and where.
The US has lagged behind other countries in diagnostics, with just over 11,000 public and an unknown, but probably lower, number of private tests conducted. The World Health Organization said China had capacity to do 1.7m tests a week, while South Korea has tested more than 200,000 people.
Now a big supplier for the chemicals used to extract the RNA of the virus from samples — the cellular information that would identify whether it is Covid-19 — is having to ration the ingredients, after shipping more than twice the number of testing kits so far this year as it did in 2019.
Qiagen, which manufactures the “buffers” used to single out the RNA in factories in Germany, Spain and the US, said it was ramping up the production particularly in the US, putting on extra shifts, hiring new staff, and putting aside other work.
“Like everyone in the industry, we are addressing supply constraints and allocating shipments to the customers with highest needs,” a spokesperson said. “It is imperative that the industry works together to address the unprecedented demand for testing components across the entire workflow.”
The US Centers for Disease Control and Prevention says that tests from public health laboratories across all states are mainly still in the hundreds a day. After the CDC allowed private labs to do tests, it still took each company several days to verify the accuracy of their diagnostics before they could start testing.
On Thursday, LabCorp said it was able to do several thousand tests a day and was adding new equipment and staff, while Quest Diagnostics said it would have done several thousand in total by the end of the week.
A dearth of diagnostic tests mean public health officials are struggling to understand the extent to which the virus has spread — and therefore which measures they should be taking to stop it. Rapid testing is also important because some of the experimental drugs being deployed against Covid-19 appear to be much more effective if a patient receives them early.
A top health official on Thursday conceded that the US had failed to provide the testing needed during the coronavirus outbreak.
“The system is not really geared to what we need right now,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told Congress.
“That is a failing. Let’s admit it.”
Jeremy Levin, the chair of BIO, the biotech trade association, said the US was paying for a “troubling” lack of testing.
“The first principle of medicine is to be able to diagnose what an individual has,” he said.
Other companies including Danaher’s Integrated DNA Technologies (IDT) and ThermoFisher, which is in the process of acquiring Qiagen for $11.5bn, also make the ingredients for tests. But Qiagen’s were recommended in the WHO and the CDC guidelines. IDT said it had scaled up production to enable testing of over 700,000 individuals using the CDC test. ThermoFisher did not respond to a request for comment.
Tom Frieden, former director of the CDC, said labs have had problems obtaining RNA extraction kits and other laboratory supplies.
“I have seen that some of the facilities are having real supply chain problems with everything,” he said.
Promega, a Wisconsin-based supplier of ingredients for diagnostic tests, has also increased production to seven days a week. But it has not yet had to ration supplies, said Chuck York, vice-president of its manufacturing operations.
“We carry high levels of inventory,” he said. “The demand, by its nature, is very unpredictable.”
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The troubles with supplies for testing come after the CDC initially had problems with the effectiveness of its own test. Robert Redfield, CDC director, said on Wednesday there had been problems with one of the chemical compounds in the CDC’s test, either because of contamination or because the compound simply did not work. He said the CDC was working with IDT, the company that supplied it, to work out exactly what went wrong.
A government official briefed on the testing process said they had to rebuild and reissue the test because they did not verify that it worked on many real samples of the disease that came from patients. “The CDC threw out its first test because it was tested against less than five clinical samples. They validated it using synthetic samples and screwed it up,” the official said.
The CDC did not comment.
Some experts have urged the US to use tests from other countries or organisations, such as South Korea, Germany or the WHO.
Michael Mina, assistant professor of epidemiology at the Harvard School of Public Health, said the CDC should probably have just used the test developed and in use by the WHO. But he said: “Frankly, at this point, we’re in crisis mode and have to move forward and figure out what we need to do to test people.”