Health ministry Approved: Import permit for rapid test kit for the detection of corona virus

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by Ifi Reporter Category:Health Dec 18, 2020

The Ministry of Health has issued an import permit for the rapid test kit for the detection of the corona virus by the global medical technology giant Ketone Dickinson (BD) for immediate use in Israel. The test, dubbed Veritor, was approved by the regulatory authorities in the United States and Europe several months ago.
The kit works on the basis of identifying proteins from the envelope of the virus (antigens), and allows a result to be obtained within about 15 minutes. It is simple to operate, and will be approved for use in laboratories. In the future, home operation may be possible without the need for medical staff.

Prof. Gili Regev, director of the Infection Prevention and Control Unit at Sheba Tel Hashomer Hospital, explained that the kit has a sensitivity and specificity that can be estimated at about 90%. "This kit is very reliable, for both symptomatic and asymptomatic people, and provided it is in the first week of infection, during which there is a viral load and the person is most contagious," she said.
Prof. Regev described that when the viral load is low, the sensitivity of the test drops to 80%, but because this test can be done often - once someone starts infecting their environment, it can be known quickly. "The test can be done very quickly and thus open up the economy. The vaccines are here and we have light at the end of the tunnel, but we have another three difficult months to go through until they start affecting the general population and we must minimize damage," she stressed.
In the world the test is widely used - the Government of Canada has already purchased seven million tests; Dutch government - 9.2 million tests; As well as millions more tests in the United States and other Western countries.
The rapid tests currently in use in Israel are "Sofia" tests, but their use is very partial, after it was discovered that in asymptomatic patients the sensitivity of the test drops below 60%. A month ago, the head of public health services, Dr. Sharon Elrai-Price, sent a letter to hospitals and health funds demanding that they not treat patients who came out positive in the speed tests as verified, but perform another PCR test - the standard corona test.
Following the new requirement, most hospitals and some HMOs have stopped using tests on the Sofia device to avoid duplication in the work of medical staff. Today, the "Sofia" device is used at the entrance to the green tourist islands, but only for the locals who work outside the islands. Vacationers and those wishing to enter are required to bring with them the results of a standard PCR test.
The rapid entry into force of the tests could have an impact on the controlled opening of the economy. This is while the third wave of morbidity is beginning to gain momentum, and for several days now the threshold set by the Corona Cabinet for closing the trade - 2,500 new patients a day. This coming Sunday, the cabinet is expected to convene and set new restrictions, but perhaps this time, with the help of the quick inspections, it will be possible to keep parts of the economy open instead of another general closure, and perhaps even allow events in green cities.
A spokeswoman for Sofia said in a response that the Ministry of Health has purchased about 300 Sofia devices for immediate antigen testing from FDA approvers, which in stark contrast to the article operate very successfully and fully in nursing homes, the Home Front Command, the Prison Service and the Green Tourism Islands in Eilat and the Dead Sea. As of today, about 37,000 Israelis have been examined there. " At this stage, Sofia prefers to ignore data from the Ministry of Health. Which the public should take into account and take seriously.

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