1. Inside the lab where technicians are preparing test samples
3. SOUNDBITE (ENGLISH) James Dieter, CEO Principle Health Systems:
"Right now, we're doing COVID antibody test, we're doing IGG serology testing, so this is a test that tells us and the physician if a patient has been exposed to COVID-19."
4. Lab tech dropping COVID-19 related blood samples into centrifuge
5. Various of lab technician putting COVID diagnostic samples into an Abbott Labs screening machine for tests
6. SOUNDBITE (ENGLISH) James Dieter, CEO Principle Health Systems:
"This is actually a test which is not telling if you're sick, this is telling if you had some exposure in the past."
7. Various of tech taking blood draw from patien, machines
8. SOUNDBITE (ENGLISH) James Dieter, CEO Principle Health Systems:
"So these machines have a very high throughput, currently we have the reagents and instruments to do about half a million a month, now the logistics of that would be incredibly difficult but our machinery, our instrumentation has that capacity."
9. Various of tech scanning in lab samples for diagnostics
10. SOUNDBITE (ENGLISH) James Dieter, CEO Principle Health Systems:
"This test that we're running is actually FDA approved there's a lot of tests on the market right now that are not, but Abbott did go through the painstaking process of getting FDA approval."
11. Various in lab, samples
12. SOUNDBITE (ENGLISH) Dr. Peter Hotez, Dean National College of Tropical Medicine, Baylor College of Medicine:
"Being antibody positive is not really informing you whether 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."
13. Centrifuge spins with COVID-19 related blood samples
14. Tech filling vial with blood draw for a patient
15. SOUNDBITE (ENGLISH) Dr. Peter Hotez, Dean National College of Tropical Medicine, Baylor College of Medicine:
"And it may become relevent because you know if you're antibody positive you may not need to be vaccinated, if a vaccine is developed, but right now I don't see antibody testing as a … it's not a priority."
16. Technician prepping more samples and placing into antibody test machine
17. Test machine working on sample
18. Display on test machine
19. SOUNDBITE (ENGLISH) James Dieter, CEO Principle Health Systems:
"I believe that if an individual is positive for antibodies that it gives them some confidence that they can re-enter society, that they do have some type of immune resistance. Now I think that's different for everyone. If someone has co-morbidities, if they have some type of underlying disease, I think they should still be very careful right now, but I believe it will give some confidence to some individuals but again that is up for them and their physician to discuss and make that decision."
Houston – 28 April 2020
20. STILL of COVID-19 related blood sample in vial, the label clearly says "COVID"
A Houston area 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 Labs. It tests for antibodies for the novel coronavirus, which means it can detect whether you have been exposed to it or not.
James Dieter, the CEO of Principle Health Systems, said what differentiates this test from various other antibody screenings is that the Abbott Labs version is approved the Food and Drug Administration.
"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.
Dieter adds his lab performs daily calibrations on equipment and quality control checks test results for reliability. He said that his lab could potentially process up to a half-million coronavirus antibody tests per month.
Dozens of blood tests are being marketed in the United States that are not entirely accurate and are not comparable to each other, according to a report released by researchers at Johns Hopkins University.
Dozens of blood tests are being marketed in the United States that are not entirely accurate and are not comparable to each other, according to a report released this week 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. In a press release, the company says it plans on shipping millions of these tests out to labs in the US.
Infectious disease expert Dr. Peter Hotez of the Baylor College of Medicine questions 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," Dr. Hotez said, "because the vast majority of Americans are not going to be antibody positive, certainly not down in Texas."
Hotez said there value increases as time goes and that perhaps 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 COVID-19 vaccine.
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