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Houston lab mass-processes FDA-approved COVID antibody test

4 months 4 weeks 1 day ago Tuesday, April 28 2020 Apr 28, 2020 April 28, 2020 4:38 PM April 28, 2020 in News
By JOHN L. MONE
Associated Press
  
HOUSTON (AP) - A Houston medical diagnostic lab is now capable of testing thousands of blood samples for coronavirus antibodies.
  
SynerGene Laboratories, a facility owned by Principle Health Systems, is offering a COVID-19 test developed by pharmaceuticals giant, Abbott Laboratories. It tests for antibodies for the novel coronavirus and can detect whether a person has been exposed.
  
For most people, the coronavirus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia.
  
What differentiates the test from other antibody screenings is that the Abbott Labs version is approved by the Food and Drug Administration, Principle Health Systems CEO James Dieter said Tuesday.
  
“There are a lot of tests on the market right now that are not, but Abbott did go through the painstaking process of getting FDA approval,” Dieter said.
  
The lab performs daily calibrations on equipment and quality control checks test results for reliability, he said, and the lab could potentially process up to 500,000 coronavirus antibody tests per month.
  
Dozens of blood tests are being marketed in the United States that are not entirely accurate or comparable to one another, according to a report released by researchers at Johns Hopkins University.
  
Even a small rate of false positives can substantially distort the understanding of how many people have been infected. It’s even possible false positives could outnumber real positives.
  
The Food and Drug Administration is overseeing a validation process for ensuring that commercial tests are accurate. So far the agency has authorized only four. Dozens of other tests are being marketed in the U.S. without such authorization.
  
The Abbott Labs test received “Emergency Use Authorization” by the FDA, an expedited approval that can be used during a public health crisis. The company said it plans to ship millions of tests to labs nationwide.
  
Dr. Peter Hotez, an infectious disease expert at the Baylor College of Medicine in Houston, questioned the value of antibody tests at this point in the pandemic. 
  
“Being antibody positive is not really informing you that it’s okay to go back to work, because the vast majority of Americans are not going to be antibody positive, certainly not down in Texas," he said.
  
He said their value increases as time goes by, adding that antibody tests “may become relevant because if you know you’re antibody positive you may or may not need a vaccine.” Researchers around the world are still working on finding a vaccine for COVID-19, the disease caused by the coronavirus.
  
Harris County, which includes Houston, leads the state in confirmed COVID-19 cases reported to health officials with more than 5,800 of the state's 26,000-plus reported, the Texas Department of State Health Services said Tuesday. It also leads in COVID-19-related deaths reported with 98 of the state's 690 fatalities. Dallas County ranked second in both categories with slightly more than 3,100 cases reported with 84 fatalities.
  
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Associated Press Medical Writer Mike Stobbe in New York and AP writer Matthew Perrone in Washington contributed to this report.
(Copyright 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.)

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