Concerns remain after 60,000 Sofia rapid coronavirus tests administered

"It is feared that the considerations in choosing the device were not purely scientific" • false positives can lead to incorrect treatment and even risking exposure to actual coronavirus patients

Rapid Sofia coronavirus test device in action (Credit: Sofia Israel)
Concerns remain about the accuracy of the rapid Sofia coronavirus test, as the company behind the test reported a 96.7% success rate, while a lab workers association reported that the success rate was only about 84%.
The FDA-approved test that can return results in about 15 minutes has been used about 60,000 times in the country since Israel began using it a few weeks ago.
Earlier this month, Prime Minister Benjamin Netanyahu and Deputy Health Minister Yoav Kish announced that 300 Sofia systems were being deployed around Israel.
According to the Sofia Israel Company, the test has a 96.7% "sensitivity" rate, meaning the true positive result rate, and a 100% "specificity" rate, meaning the true negative rate.
Even before the coronavirus pandemic, the Sofia device was used by the US Centers for Disease Control and Prevention (CDC) to monitor and test for other viruses, including the flu.
"Rarely, there can be mistakes in the field in conducting the test protocol, and accordingly, the Sofia Israel team is refreshing the guidelines and is doing the same in hospitals and in nursing homes after clarifying the circumstances of the cases of the people who were mistakenly diagnosed as positive," said Sofia Israel in a press release on Sunday.
The company stressed that there is no debating that the standard coronavirus tests are more accurate, but added that the tests take much longer.
"Sofia is not intended to replace laboratory tests, but to help provide a quick response in places where the Health Ministry and the HMOs will need it to effectively cut off the chain of infection, which will help in a controlled exit from the second closure, returning to routine and preventing a third closure," the company said.
Sofia Israel stressed as well that the protocols for the testing device are "consistent with the position of the Israel Association of Biochemists, Microbiologists and Laboratory Workers. As a result the rapid tests are carried out with full protection, with everyone staying in the room required to wear full protective equipment."
DESPITE THE statements by the Sofia Israel Company, professionals are still concerned about the accuracy rate of and reliance on the device.
Esther Admon, chairwoman of the Israel Association of Biochemists, Microbiologists and Laboratory Workers, stressed that contrary to the claim by Sofia Israel, the manufacturer's guidelines and Health Ministry's procedures for the device were not in line with the position of the association.
"Even before introducing the device for use in Israel, we warned about the problems," Admon said on Sunday, stressing that despite the success rate reported by Sofia Israel, the association's data showed that the tests actually only had about an 84% success rate.
"The meaning [of this] is difficult," explained Admon. "There are cases of patients who are defined as coronavirus-positive, when they are in fact coronavirus-negative (false positive) – that is, people who come for examination due to coronary heart disease-like symptoms, and are not coronavirus patients (they may have a common cold, or flu or another disease), but the test on the Sofia device mistakenly states that they are positive for the coronavirus, whereas if they were tested in a standard PCR test, they would get a negative result."
Admon warned that the false positives lead to a "chain of serious errors," including incorrect medical treatment and even risking exposing non-infected patients to actual coronavirus patients in coronavirus wards.
"We are very concerned about the marketing and commercial effort to distribute the Sofia device everywhere, even to HMO clinics and private clinics, without guaranteeing, among other things, the vigilance, professionalism and skill of test performers," said Admon, stressing that "any small deviation" in the operation of the device could lead to incorrect results.
"When paramedics and other professionals, who are not skilled lab workers, perform tests that are so sensitive and complex - it is a game in human life," warned Admon, adding that the risk for mistakes will only increase as the flu season begins.
The association recommends that Sofia tests be conducted in a separate room or inside a fume hood, due to the sensitivity of the tests. Those in the room and especially those conducting the tests should be in full protective gear.
Despite a statement by Sofia Israel explaining that the devices are interfaced with the health system's computer systems, the association claimed that this is not the case.
The association stressed that there are other systems for rapid coronavirus testing that are more reliable and easier to operate than the Sofia system, but did not specify which systems it was referring to.
"It is feared that the considerations in choosing the device were not purely scientific," said Admon.