Israel set to launch antibody testing this week

“The FDA-approved serological tests will allow thousands of tests a day in Israel."

 TEST TUBE with coronavirus label is seen at the end of January.  (photo credit: REUTERS)
TEST TUBE with coronavirus label is seen at the end of January.
(photo credit: REUTERS)
Israel will begin serological testing as early as this week to determine if a patient has been exposed to the SARS-CoV-2 virus and, if so, if the patient has developed antibodies against it, according to Gamidor Diagnostics.
The country will use Roche’s Elecsys Anti-SARS-CoV-2 test, which received US Food and Drug Administration (FDA) emergency use administration on Sunday. Gamidor Diagnostics is the exclusive representative of Roche in Israel. The country will be one of the first to implement the test in the world.
“The FDA-approved serological tests will allow thousands of tests a day in Israel, as they are being tested on systems already in place in various laboratories in Israel,” said Gamidor vice president Dr. Koby Millard.
Israel has around 100 of Roche’s “cobas e analyzers” on which the test is processed. 
Until now, Israel has been solely conducting molecular tests for the detection of novel coronavirus, which determines if the virus is active in a patient’s system. These tests have been found to have a 30% false negative rate. 
Serological tests identify immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. The body quickly produces IgM antibodies for the initial fight against infection. IgG antibodies remain longer in the body, suggesting possible immunity.
Gamidor originally thought the tests would only be available in the country by mid-May.
Roche has already started shipping the new test to leading laboratories globally and said it will ramp up production capacity to high double-digit millions per month to serve healthcare systems that accept FDA approval and the CE mark, the certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area. 
The test has a specificity greater than 99.8% and 100% sensitivity, according to a release. 
“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker, Roche Diagnostics CEO. 


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