The City of Los Angeles spent more than $62 million in the first few months of the pandemic buying COVID-19 testing kits that were widely used contrary to the instructions of the Food and Drug Administration, according to invoices obtained by Motherboard via a public records request. And the tests continue to be used off-label in Los Angeles despite FDA warnings.
The Curative tests, which were granted an emergency use authorization by the FDA in April 2020, are polymerase chain reaction (PCR) tests, a widely-accepted and accurate testing method when used properly. But they have to be used in accordance with FDA guidance, which only approved the tests to be used for symptomatic patients under the supervision of a healthcare worker. If they are not, they run an increased risk of false negatives, or patients thinking they do not have COVID-19 when they actually do.
The City of Los Angeles purchased large quantities of the test including for mass test centers like Dodger Stadium. Mayor Eric Garcetti later defended using the Curative tests at these mass testing centers, where it is quite likely many of the patients are asymptomatic, even after the FDA issued a reminder earlier this month of how Curative tests are supposed to be used.
“It’s not like there’s some other tests the FDA says is better or that’s working better on asymptomatic,” Garcetti claimed. “This is something that has saved lives, will continue to save lives. And if we move away from it, I worry we would have a lot fewer people diagnosed and even more spread.”
Health experts say there is not a one-size-fits-all test, but rather a toolkit in which the right test must be chosen based on the situation. But this isn't happening in most cases, including but hardly limited to LA, and there could be serious consequences to false negatives. Curative also conducts COVID testing in Austin, Dallas, Denver, Houston, Miami, San Antonio, San Francisco, and Washington, D.C. per its website.
"A false negative is actually very dangerous from a public health perspective," Jessica Malaty Rivera of the COVID Tracking Project, a volunteer organization dedicated to tracking and understanding COVID-19, told Motherboard. "When you have people unknowingly walk around positive, symptoms or not, that is kind of the worst case scenario for understanding the disease."
Thanks in part to a widespread testing shortage in the early days of the pandemic—when even government agencies were encouraging testing through any available means—Curative became the primary COVID-19 test kit in the Los Angeles area for anyone suspected of being exposed to the virus. By the end of April, Curative accounted for one out of every five tests in all of California, according to the Los Angeles Times, which ran an article on April 28 with the headline, "L.A. is using a streamlined coronavirus test. But it has potential risks and rewards."
Los Angeles placed a big bet on the rewards being bigger than the risks. The day before that article ran, Curative invoiced LA for the cost of 21,000 test kits, or $2,874,375 after taxes, bringing the total bill for Curative tests to that date to more than $12 million (it is not clear why the city told the LA Times it had only paid Curative $5.9 million to date). Two days later, it was invoiced for another $2,669,062.50. Five days after that, on May 4, Curative billed LA for 75,000 test kits for a total of $9,444,375.
Do you know anything about Curative or other coronavirus testing companies? Email Aaron Gordon at firstname.lastname@example.org.
These invoices—and the $62 million total bill through June—are only a fraction of what the City of Los Angeles has spent on Curative tests to date. Motherboard's public records request was filed on December 1 and asked for all Curative invoices to the time of the search. The Mayor's office provided Motherboard with invoices only from March 23 to June 23 and did not respond to repeated inquiries about why there were no invoices after that date. Therefore it is unclear how much the city spent on Curative tests in 2020.
In the meantime, experts were already raising alarm about using the Curative test off-label, as it was being used in LA, particularly at the Dodger Stadium testing site to which Curative was delivering many of its kits. Elodie Ghedin, a molecular virologist at New York University, told the LA Times that "If [the Curative] test comes back negative, don't believe it."
This may have sounded like a jarring statement, but it is essentially the same thing the FDA said in its Emergency Use Authorization Summary: "Negative results for SARS-CoV-2 RNA from oral fluid specimens should be confirmed by testing of another specimen type authorized for use with this test if clinically indicated."
There are several reasons a test could return a false negative, according to Malaty Rivera, but it likely boils down to a bad sample, which can happen with both nasal and oral swabs, especially when the collection is not closely supervised by a professional. An oral swab, the method widely used by Curative, is less likely to get a good sample than a nasal swab.
In later months when the testing shortage abated, people got Curative tests who simply wanted a test for any reason, with many mistaking a negative result with some kind of temporary immunity passport. Neither the City of Los Angeles nor Curative took obvious steps to correct this misconception.
When Motherboard asked Curative about its tests being used off-label, a spokesperson for Curative said all tests must be prescribed by a healthcare professional per the EUA. "It is the ordering physician—who is not a Curative employee, but a public health agency employee or a telemedicine physician—who determines whether or not to prescribe a test," the spokesperson said. The spokesperson further passed responsibility onto that "ordering physician" for informing people that a negative test doesn't necessarily mean you don't have COVID, even though tests are scheduled through Curative's website. The LA Mayor's office didn't respond to multiple requests for comment.
Curative's assertion that its COVID tests are prescribed by a physician doesn't match reality in Los Angeles. The City of Los Angeles's official COVID-19 information page encourages all residents to get a COVID test, in partnership with Curative, "whether or not you are experiencing COVID-19 symptoms." The page doesn't instruct people to consult a physician or health expert before getting a test (unless experiencing severe symptoms, in which case they should call 911). A button with the label "Sign up for a Free Test" takes the user to Curative's website, where a person needs only to fill out a quick online form and select a time slot at a local testing center.
The form asks a series of questions, including a symptoms check, if you have come into contact with someone who tested positive, and if you have been to public places in the last 14 days. Motherboard filled out the form, choosing the options that said we had not been exposed to any COVID risk or had any symptoms for 14 days, and successfully got to the point of scheduling a test. At no time did the Curative form suggest we should consult a healthcare professional or inform us that the Curative test was not designed for patients like us.
Malaty Rivera said this was a red flag, especially when Motherboard selected that we had no symptoms but was able to schedule a test anyways without any disclaimer. "It literally should have been one of those stopgaps where it is like, OK this is not the right test for you."
To be clear, it is good that people have access to COVID tests and can take them relatively conveniently. But the vast majority of people who get tested via Curative are unlikely to learn about its limitations, particularly around false negatives. Like any other health screening, it is important for people to know what the test is and isn't telling you. That isn't happening in Los Angeles.
"I don’t want to demonize Curative here because it’s a good test when it’s used right," Malaty Rivera added. "I think so much of this was like, let’s throw the kitchen sink at the problem and see what helps. And in a situation like this precision was lost. And precision when it comes to undetected positive cases is a huge public health issue."
Update: After this story was published, Curative sent Motherboard a new study it conducted which indicated using the test for asymptomatic patients does not increase the risk of false negatives. The study has not yet been peer reviewed.