Fearing false positives, hospitals scrap Sofia COVID-19 testing kits

"This goes against the most basic of medicals tenets – do no harm," said one of the hospital directors.

Rapid Sofia coronavirus test device in action (photo credit: SOFIA ISRAEL)
Rapid Sofia coronavirus test device in action
(photo credit: SOFIA ISRAEL)
Clalit hospitals will stop using the Sofia rapid coronavirus testing kits, suspecting tens of false positives, N12 reported Thursday night.
What this means for those who tested positive but didn't actually have COVID-19, is that they ended up in the various hospitals' coronavirus wards, exposed to actual patients.
So far, the Meir Medical Center, Kfar Saba has completely terminated their use of the testing kits, with Soroka-University Medical Center, Beersheba close behind. Schneider Children’s Medical Center for Israel, Petah Tikva and Carmel Medical Center, Haifa have both not yet even begun using them.
"The thought that tens of Israelis mistakenly tested positive and sent to coronavirus wards in hospitals, effectively ensuring their ultimate exposure and infection – that thought is chilling and horrifying," said a director of one of the hospitals that is working to discontinue their use of the kits.
Sofia's pioneering technology is what sets it apart: test results in 15 minutes. The kits have been approved by the FDA and the Health Ministry.
"This goes against the most basic of medicals tenets –  do no harm," the hospital director added. 
"Sofia is an important technological development that was already approved by the FDA and the Health Ministry," stated Sofia Israel.
"Globally, the reaction to the intelligent software that provides results instantaneously has been overall positive. Only in Israel are there forces that are having a hard time incorporating new technologies," the company noted. 
Israel received a shipment of 70 new Sofia testing kits earlier this month, as part of a plan for Israel to secure 300 of them from the San Diego-based company Quidel.
Sofia Israel has a logistical center in Modi'in Ilit, where the shipment was sent to be distributed to various institutions throughout the country, including medical clinics and health funds.

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Added the hospital director, "I cannot begin to understand how, even with data confirming that the tests produce false positives, these kits are the what's ensuring Eilat's green status."
On Wednesday, November 18, Sheba Medical Center, Tel Hashomer, announced that they have medical teams receiving training in operating the Sofia rapid testing machines.
The machines were to be set up at stations along the road to Eilat, to rapidly test individuals before they enter the city.
Already in October, when the kits were brought to Israel, health professionals expressed their concerns over the accuracy of the tests.
While Sofia reported a 96.7% success rate, a lab workers association had it at about 84%.
"Hospitals that aren't interested in the technology are welcome to pass it on to old age homes. They need it," concluded Sofia Israel.