Chat with us, powered by LiveChat

COVID-19 Antibody Testing

schedule an appointment today

FAQ’s Regarding Antibody Testing Offered at The Hormone Zone – Updated 4.25.20

Alert: If you have suspected active symptoms of COVID-19, such as a cough or fever, do not come to The Hormone Zone medical center for testing. Instead, go to your primary care facility or to a local hospital or urgent care clinic that is working directly with active COVID-19 patients. We offer antibody testing to discover past infections of COVID-19 only. Additionally, in order for the antibody testing to be accurate, you need to have been without symptoms for at least 10 days.

All patients coming to our medical center will be screened for temperature at the door.

Why do you offer antibody testing at The Hormone Zone?

We believe that antibody testing can help provide needed data and accurate perspective in the fight against COVID-19.

Antibodies from a patient’s blood has the potential to help healthcare professionals identify people who have been exposed to COVID-19 and may have developed an immune response and those who could donate a part of their blood, called convalescent plasma, which may provide treatment for COVID-19 patients.

The more people with antibodies will help provide immunity to the entire community. Also, having an accurate understanding helps determine precise death rates. We now understand that the death rates are much lower than previously estimated, and much of this understanding comes from antibody testing.

Antibody testing also helps local, state, and federal officials make decisions towards opening up our economy again.

What type of antibody tests do you offer at The Hormone Zone?

We offer:

  1. An office-use finger-stick Rapid Antibody Test that takes 10 minutes to receive results.
  2. serum based lab test from Sonora Quest that takes one to four days to receive results.

FAQ’s Regarding the CoronaChek™ Rapid Antibody Test

What is the Rapid Antibody Test?

This is a specific device that detects antibodies produced from someone who has been exposed or infected by COVID-19. This type of test uses a simple finger stick amount of blood, placed on the cassette device, all performed conveniently in the office taking only 10 minutes to receive results. This helps to confirm if you had a past infection from COVID-19.

Where do you get your Rapid Antibody Test from?

We use a Rapid Antibody Test called CoronaChek™ that is sourced directly from a San Diego based lab company called CLIAwaived. CoronaChek™ has been distributed to several healthcare organizations in southern California already. From there, we source the tests from ARCpoint Labs in Scottsdale, Arizona.

How accurate is the Rapid Antibody Test?

In medical diagnosis, test sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).

For the IgG antibody that helps to determine a past infection of COVID-19, CoronaChek™ has a 94.4% sensitivity and a 100% specificity. There are many other rapid antibody tests currently on the market that do not have this verified accuracy.

To review the package insert for the CoronaChek™ test click HERE.

To review the validation testing for the CoronaChek™ test click HERE.

According to ARCpoint labs in Scottsdale, Arizona, this specific test is running approximately 7-8% more accurate than the lab-based blood draw antibodies tests so far.

Disclaimer: This test is still under review by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

What specific technology is used in the Rapid Antibody Test versus the lab-based tests?

According to ARCpoint Labs, the lab-based tests use a different ELISA technology that has limited history with the virus to be perfected yet. The Rapid Antibody Test kit uses a different technology called “membrane immunoassay” that is produced based on comparison to actual antibodies from COVID-19 patients.

The RT-PCR active detection tests in use for direct diagnosis of an active infection are less accurate than many of the antibody tests. The RT-PCR test looks for 2 genetic markers for the virus. Many scientists are suggesting it should look for around 6 markers.

What was the Stanford University Study from California that looked at antibodies in LA County? What did they discover?

“The first large-scale community test of 3,300 people in Santa Clara County found that 2.5 to 4.2% of those tested were positive for antibodies — a number suggesting a far higher past infection rate than the official count.” SOURCE: https://abcnews.go.com/Health/antibody-research-coronavirus-widespread/story?id=70206121

It is important to note that the Stanford University research study used a Rapid Antibody Test similar to the one The Hormone Zone offers.

Research like this is starting to present the likelihood that many people have had contact with COVID-19, and either never were symptomatic but developed protective antibodies or had some type of symptoms and also recovered and developed protective antibodies. These numbers will begin to lower hospitalization and death rates that we are currently seeing. We believe that rapid antibody testing can help provide needed data and accurate perspective in the fight against COVID-19.

What are the percentages of positive results using this specific Rapid Antibody test?

In the ARCpoint System across the nation, they are seeing 3-4% positives. Results vary by location and type of patients tested, such as healthcare workers who are at higher risk for exposure. In most cases, the general population positives are running a fraction of 1%, and this is mostly people who had some respiratory symptoms this past winter.

As of Thursday April 23, 2020, ARCpoint Scottsdale reveals:

  • In the Phoenix Arizona metro area, testing is revealing positive rates of approximately 1%. 
  • Tucson is running a higher positive rate than we are here, mostly because they test a group of hospital workers actively treating COVID-19 patients. That hospital group is running 30-40% positives. 
  • New Orleans is running even higher (they suspect because of Mardi Gras).

Is the Rapid Antibody test FDA Approved?

No. But this is a complicated answer that has created an incredible amount of confusion and misinformation.

The FDA is open to reviewing antibody testing, but the process is appropriately comprehensive and typically takes many months. In the interim, laboratories can offer antibody tests under the pandemic emergency rules specified by the FDA. One such FDA rule is the EUA or Emergency Use Approval.

The FDA has permitted 100 devices to be registered in early to mid-March. On April 17, 2020, the FDA stated they have no objection to the use of properly validated tests.

To review the FDA REGISTRATION of the CoronaChek™ rapid antibody test:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=653219&lpcd=QKO

As stated in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019, during the COVID-19 public health emergency, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

SOURCE: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency

The FDA has been working on granting approval for the lab-based tests first. However, the FDA finished accuracy validation of the CoronaChek™  test recently. On Thursday April 23, 2020 the FDA received the last of the information they requested for cross-reactivity validation. A letter from John Hopkins Medicine accompanied the last information submittal, as John Hopkins has separately validated the CoronaChek™ device. It is expected the CoronaChek™ antibody test device to be approved as a “CLIA Waived device” very soon, which is an approval a step higher than EUA approval.

In respect to the CoronaChek™ rapid antibody test that is used at The Hormone Zone, we have a relationship with ARCpoint Labs, and they have examined and screened many rapid antibody tests and found this particular test to be the most accurate and reliable.

ARCpoint Labs in Scottsdale, Arizona has assured us about the accuracy and validity of their tests: “We have done over 10,000 of these in our system around the country in the last few days [from April 22 to April 24]. Approximately 60% of the tests we have done were for doctors who reviewed the specifications for our test. None of them has had any issue with them. We have also tested several elected officials – local, state (including members of the governor’s staff) and federal (Representatives and Senators from both parties) at our location. All of them asked us to continue testing with the devices we have.”

How much does the Rapid Antibody test cost?

The test is only $160. We are very busy at The Hormone Zone medical center serving the community, but have no wait times for this test, making it safe, convenient, and simple. Patients are in and out of our office in 15 minutes or less. ARCpoint has a wait list of over 5000 patients and has been actively referring patients to The Hormone Zone medical center to assist.

Can the Rapid Antibody test be covered by insurance?

This is a cash-based test.

FAQ’s Regarding the Lab-Based Blood Test by Sonora Quest

As of Friday April 24th, 2020, Sonora Quest is offering a serum lab-based antibody test for COVID-19.

Is this serum based antibody test FDA approved?

Just as the rapid antibody test described above, no, this test is not FDA approved.

Please see the detailed explanation above regarding FDA approval and EUA status.

Where does Sonora Quest get their test from?

Sonora Quest is utilizing technologies developed by EuroIMMUN to perform antibody testing for COVID-19.

How accurate is the lab-based test from Sonora Quest?

In medical diagnosis, test sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).

As stated in literature provided by EUROIMMUN, analytical specificity of the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG antibody test is 98.5-99%. Due to the low homology of the SARS-CoV-2 S1 protein to the human coronavirus family (HCoV-229E, HCoV-NL63, HCoV-HKU1 or HCoV-OC43), cross-reactions to most of the human pathogenic representatives of this virus family are virtually excluded.

Can I have this test done at The Hormone Zone?

Yes. We operate as a draw station for Sonora Quest and are able to draw your blood on behalf of Sonora Quest and then your blood is processed by them directly allowing your insurance to cover the test.

Does insurance cover this serum based antibody test?

Through Sonora Quest, the COVID-19 antibody test is priced at $65. Based on the regulations and expected coverage for testing, Sonora Quest is not billing patients for this testing when ordered by a physician. A physician ordered COVID-19 test would likely be covered by insurance if the order meets the insurer’s medical coverage guidelines, resulting in zero out-of-pocket expense. You would be responsible to pay the $65 in the unlikely event your insurance provider does not cover the cost.

How much is the draw fee for this test?

Due to the high demand of this test, the draw fee for this specific test is only $75. The Hormone Zone is convenient and easy and does not have significant wait times as compared to the limited Sonora Quest draw stations. The Hormone Zone is responsibly open and read to serve our community.

How long will it take for the test results to come back from the lab-based antibody test?

It takes one to four days for results, or perhaps longer due to the expected high demand.

Should I have both tests performed?

No single medical blood test is perfect. We believe there are advantages and disadvantages to both types of tests that we offer. The most accurate way to ensure a true positive or true negative would be to have both tests performed at the same time.

If only one test of the two shows a positive, you should consider to repeat the positive test again to confirm.

 

DISCLAIMER: To date, there are no known FDA approved treatments for COVID-19 (aka SARS-CoV, aka coronavirus). This website and all digital communications are intended to provide educational information only. Please consult with a medical professional if you have any symptoms related to COVID-19 or believe you have been exposed to the virus.

[/vc_column_inner][/vc_row_inner]