The federal government also continues to distribute thousands of the rapid coronavirus tests made by Abbott Laboratories each week throughout the country, spending what adds up to hundreds of millions of dollars on them, all while questions about the test’s accuracy have mounted and some states are urging precautions for health care providers using them.
Abbott’s point-of-care “ID NOW COVID-19” test, which was promoted by Trump at the White House, produces results in minutes rather than hours and is portable enough to be used in mobile testing sites and rural regions that lack easy access to labs.
A spokesperson for HHS did not respond to a question about the details of that requirement but said in a statement that HHS, including the FDA, is closely monitoring the efficacy of the ID NOW tests and working with Abbott on follow-up studies.
“We do believe Abbott positive tests are accurate and that the Abbott test remains critically important and accurate when used as directed especially for remote areas and during outbreak investigations. At this time we are not recommending to end the use of Abbott test devices or tests,” the HHS spokesperson said.
An Abbott spokesperson said the test is delivering reliable results, that the company has delivered 4.3 million ID NOW tests to all states and that the rate of false negative complaints is 0.015%.
Ten state health agencies told CNN they specifically recommend or require that individuals who test negative on the Abbott rapid device be retested, and most recommended using a different, slower, more reliable method for diagnosing Covid-19, known as lab-based “polymerase chain reaction” or PCR tests.
Vermont’s commissioner of health, Dr. Mark Levine, decided not to give the Abbott rapid devices received from the federal government to hospitals in the state due to the FDA’s update on possible accuracy concerns, according to a spokesperson for the state’s Health Department.
A Wisconsin Department of Health Services spokesperson told CNN that the ID NOW tests are used in different locations in the state but that “We have urged caution when using these instruments.”
Other states have found the Abbott tests useful. A spokesperson for the Rhode Island Department of Health, Joseph Wendelken, said the Abbott rapid test has been “enormously beneficial” and has enabled the state to quickly identify thousands of positive cases and get those individuals and their recent contacts into quarantine.
But Wendelken also said the Rhode Island COVID-19 Testing and Validation Task Force reviewed studies on the ID NOW and recommended phasing out the state’s use of it.
He described the test as “a little less sensitive than other tests,” and said, “For that reason, we decided strategically to be less reliant on Abbott ID Now tests as other, more sensitive tests came onto the market.”
Dr. Mark Pandori, director of the Nevada State Public Health Laboratory, which receives ID NOW tests from HHS and disperses them in the state, said that while there has been some concern over the test’s quality, other data show the test performs well.
He said the test must be performed exactly as the manufacturer has instructed, and although such point-of-care tests typically do not perform as well as lab-based tests, he said they serve a purpose.
“The convenience and power of being able to run the test so conveniently is considered against the slightly lower performance factors,” Pandori said.
The authors of the study acknowledged it has limitations, including its small sample size, but said the Abbott test was “unacceptable” for use with their patients.
Abbott has argued that study was “flawed” due to two different sample collection techniques, no tiebreaker test for discrepancies and a population that included patients with low viral levels who were tested more than two weeks after they first developed symptoms. A spokesperson for NYU Langone Health said they stand by the study’s findings.
Scott Becker, the CEO of the Association of Public Health Laboratories, which represents state and local public labs, said he is waiting for additional guidance from the FDA on the ID NOW to better understand the test’s performance.
Becker said that in light of the emergency of coronavirus, he thinks HHS did the responsible thing by procuring a point-of-care diagnostic for states that had been authorized by the FDA, but he said emerging data must be considered in future decision-making.
“Until we get the results of new information from FDA and Abbott, I think there will be this dichotomy,” Becker said, referring to differing assessments and approaches to using the test. “Right now, we need all the tools that we can get our hands on, but they have to be tools that work.”
Source : CNN