FDA Approves COVID-19 Saliva Diagnostic Test / Quest Launches COVID-19 Antibodies Testing

On April 20, 2020, Quest Diagnostics announced that in partnership with Abbott Labs, it will start conducting  serology testing on clients for the COVID-19’s antigen/ antibodies for an out of pocket expense of about $151.00- $170.00.

I’ve personally signed up to be tested by Quest (800-579-3914 ) during the week of 4/28/2020 and I was pre-charged $169.00. Then I was informed that I would be notified as to any outcomes within 3 business days, and that if I signed up for an account, I would be contacted there with the test results.

Quest Diagnostics is a monopoly, schemed with insurers, California ...

Here’s the rest of the story…

During the week of May 4, 2020, I am scheduled to undergo a procedure designed to eliminate a large kidney stone. This intervention had been rescheduled due to elective surgeries being cancelled because of state ordered “shut down” rules implemented because of the Spring 2020 coronavirus COV-19 pandemic.

Thanks to the recommendation by a blogging family member, Xena, I’ve been taking a herb, “Chanka Piedra” (Phyllanthus niruri). I’m hoping that this natural remedy will keep any kidney stones from enlarging. It’s a good thing that I had horded pain medications from past health incidents.

As per Wikipedia, “Phyllanthus niruri” is a widespread tropical plant commonly found in coastal areas, known by the common names gale of the wind, stonebreaker or seed-under-leaf. It is a relative of the spurges, belonging to the genus Phyllanthus of the family Phyllanthaceae. Amazonian tribes historically used Phyllanthus niruri to treat kidney stones and gallstones, naming it Chanca piedra or Quebra-pedra, respectively, Spanish and Portuguese terms for stonebreaker. Phyllanthus niruri is nowadays marketed as a herbal remedy under the name Chanca piedra.”

Tampa General Hospital, OnMed partner for new telemedicine ...
TGH Tampa General Hospital

Normally, I’d expect another schedule adjustment but since I reside in the western part of central Florida that’s governed by a wannabe President Trump, Governor Ron DeSantis, that’s not likely to occur. I’ve been told that I will have to comply with a COVID-19 infection diagnostic test conducted by staff at Tampa General Hospital. This is the test that’s known as the “brain tickler” because the long swab used to collect the required specimen goes all-the-way up past the inside of the nose.

It’s too bad that the Tampa General Hospital’s decision makers aren’t aware of recent clinical trials for a less invasive testing process, being overseen at Rutgers, where saliva can be collected and used to diagnose a patient for the COV-19 bug.

Quest's San Juan Capistrano Lab Earns ISO15189 Accreditation

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Here’s Quest’s press release published on April 20, 2020:

“Quest launched IgG antibody serology testing by blood draw to help patients and healthcare professionals identify who may have been previously exposed to the SARS-CoV-2 virus and may have developed an immune response to the virus.”

As per Quest website:

COVID-19 Antibody Testing

“On April 21, Quest announced that it has begun to perform antibody testing for coronavirus (COVID-19) using blood samples. These services primarily employ a test platform from Abbott that received FDA emergency use authorization on April 26.”

Capacity

Quest has performed and reported results of approximately 75,000 COVID-19 antibody testsWe are now able to perform more than 150,000 antibody tests a day, or about 1 million a week, ahead of our plan (see press release from April 21) to scale to this level of capacity by early May.

Our test capacity outpaces demand and we have not experienced a test backlog to date. We perform antibody testing in more than 20 Quest Diagnostics labs around the country.

Turnaround Times

We are reporting antibody test results within 1-2 days from specimen collection, depending on demand. Turnaround time includes the time to transport a specimen after collecting it at a Quest Diagnostics patient service center or provider site to reporting results.

What is the FDA?

As per April 15, 2020 Business Insider report by Dane Finley, “FDA grants emergency use authorization to Rutgers-developed coronavirus saliva test”

Excerpts:

“In the latest sign the US Food and Drug Administration (FDA) is looking to tackle testing shortages and equip US patients with diagnostic coronavirus tests, the agency granted an emergency use authorization (EUA) for a saliva-based coronavirus test developed by Rutgers University’s RUCDR Infinite Biologics biorepository, according to CNBC.”

“Saliva-based tests could help ramp up wide-scale coronavirus testing in the US, while protecting frontline healthcare staff and overcoming supply shortages. Rutgers’ test is currently available to the RWJBarnabas Health system in hard-hit New Jersey.”

Coronavirus in NJ: Rutgers develops broader, faster saliva test
Coronavirus in NJ: Rutgers develops broader, faster saliva test / MyCentralJersey.com

“But a larger-scale rollout of the test could be on the horizon, considering the university’s RUCDR lab has the capacity to run 10,000 tests per day and the FDA’s recent EUA should enable other labs to adopt this form of testing, per CNBC. An expanded rollout of Rutgers’ test could help ramp up wide-scale coronavirus testing efforts across the US — which still lags behind other countries such as Italy and Germany in coronavirus tests conducted per million people.”

“And the nature of Rutgers’ test — which requires individuals with coronavirus symptoms to spit into a cup — could be significant in overcoming testing barriers such as limited supplies and mitigating the spread of the virus among vulnerable healthcare workers. For example, the test eliminates the need for nose and throat swabs — which NYC hospitals currently  face a shortage of.”

Saliva samples preferable to deep nasal swabs for testing COVID-19 ...
Saliva samples preferable to deep nasal swabs for testing COVID-19 …/Yale News – Yale University

“And while healthcare professionals are required to supervise sample collection, the fact that they’re no longer collecting samples themselves limits their potential exposure to the virus and could help hospitals better allocate dwindling supplies of personal protective equipment.”

We’re also seeing fast-moving health tech startups like MicroGen DX extending into saliva-based coronavirus testing — but murky home use guidelines could stunt consumer adoption. At-home testing firms’ are also wading into saliva-based coronavirus testing, but their efforts have been hampered by FDA regulatory hurdles.”

“Texas-based MicroGen DX launched a saliva-based coronavirus test on March 31st for $99. And while the health tech startup indicated its test does not require FDA approval since an accredited lab processes its results, the at-home nature of the test led the FDA to clarify that no coronavirus tests have been authorized for home use, per STAT.”

One comment

  1. What I would like to see is general testing; i.e., even if you don’t have symptoms, you would be able to take a test. As has been reported, many people without symptoms are still infected and capable of spreading the virus. In fact, one wonders if it isn’t these people who may be the hidden culprits for the continued upward trend of the pandemic.

    Liked by 2 people

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