The Current State of COVID-19 Antibody Testing blog featured image from 8.6.20. Title over several images of COVID-19-related items. Oswald's Pharmacy logo in bottom right corner.

The Current State of COVID-19 Antibody Testing

Posted on: August 6th, 2020 by Oswald's Pharmacy Team

We have been offering COVID-19 antibody testing on-site for almost a month now. Over that time, we have gotten many questions, as well as learned more ourselves, regarding the testing itself. Who should get tested? Do I need to get tested? How accurate are the results? Is paying for an Antibody test worth it?

The answers to these questions are not always simple. COVID-19 research is constantly shifting as more is learned about the virus. I want to go over some of the most common questions and answers. A lot of the answers will require some personal input—how you feel about your current wellbeing (and that of your family and friends).

What Does a COVID-19 Antibody Test Actually Do?

COVID-19 antibody tests are used to potentially identify people who have developed antibodies to SARS-CoV-2 (the virus that causes COVID-19). Antibody tests are not meant to tell someone if they currently have the virus—only that they have been exposed to it in the past 3-6 months. (University of Minnesota)

Tests for levels of antibodies are currently being evaluated by the FDA. These tests will tell people the numbers of antibodies in their bloodstream. How the number of antibodies correlates to the body fighting COVID-19 is still being researched. (FDA Policy Prioritization)

Why Should I Get a COVID-19 Antibody Test?

Getting a COVID-19 antibody test is not required by any law, but there are individual benefits to consider.

  • Letting a person know they did not have COVID-19 recently. This is important as it reinforces the need to follow social distancing guidelines and use effective PPE (personal protective equipment).
  • Letting a person know they had COVID-19 recently. This is a more personal answer—you may want to inform anyone you have had regular contact with who is in an at-risk group for COVID-19. You may also want to look at potential ramifications at work and any other social situations where COVID-19 transmission could be a problem.
  • Letting a person know if they have antibodies in general. Research is currently being done on convalescent plasma treatments for COVID-19. These treatments use plasma from people with antibodies to develop antibodies that can be transferred to others. Research into convalescent plasma treatments is still in the early stages, but antibodies may be used to help accelerate the search for an efficient treatment for COVID-19.

(US Government Clinical Trials)

You should go into a COVID-19 antibody test with a specific goal in mind. Do you want to know that you had COVID? That you didn’t have COVID? Do you want to make sure you weren’t unknowingly exposed (asymptomatic—you had COVID with no symptoms) or have exposed others to COVID? Asking yourself why you need a COVID-19 antibody test is the first question you should ask yourself.

(The Guardian “Should I Get a COVID-19 Antibody Test”)

Regardless of your test results, you still need to practice social distancing guidelines and use PPE. This is for the safety of you and everyone around you. Research into whether people who have had COVID-19 can get it again is still ongoing. PPE and social distancing are still the most effective way to prevent the spread and keep everyone healthy.

(BBC)

Does COVID-19 Antibody Testing Work? Is it Accurate?

The short answer is yes. The longer answer is yes, but it’s not perfect. COVID-19 is a new virus and scientists haven’t had much time to look at it. Current COVID-19 antibody tests authorized by the FDA are done so under an Emergency Use Authorization (EUA). A EUA grants temporary authorization status to tests that have passed current FDA standards. For all intents and purposes, however, the current FDA-authorized tests are accurate.

Testing ranges from an overall accuracy of 95%-99.5% depending on the test and how it is administered. The test we use, for example, has an overall accuracy rating of 99%. Our phlebotomists also take blood from a vein instead of a finger prick test. Finger prick tests release a lot of interstitial fluid that dilutes the blood, making some tests less reliable.

(CDC Antibody Testing Documentation)

COVID-19 antibody tests also must be administered 14 or more days after suspected symptoms start. Antibody tests administered prior to this 14-day window have a much great chance of giving incorrect results (as the body still has the virus or hasn’t produced enough detectable antibodies).

And remember: A COVID-19 antibody test does not test for COVID-19. It only tests for antibodies present in your blood.

Should I get a COVID-19 Antibody Test if I have COVID-19 Symptoms?

NO! If you are experiencing COVID-19 symptoms (including fever, cough, muscle pain, shortness of breath, loss of smell or taste, sore throat, extremity numbness, vomiting, diarrhea, or others) an antibody test is not what you need. If you are experiencing COVID-19-like symptoms you need to call your doctor and get a professional opinion.

Important: If you are experiencing any COVID-19-related symptoms, DO NOT show up to a doctor’s office (or any other professional health service) without an appointment! You may be putting yourself or others at risk if you do this. Call your doctor, urgent care center, or hospital and speak to a medical professional to learn what you should do next.

Am I Immune to COVID-19 if I have Antibodies?

NO! There is currently no evidence to support COVID-19 antibodies being linked to true immunity. In fact, medical researchers are still unsure if people can contract COVID-19 multiple times.

(CDC COVID-19 Serology Overview)

A positive antibody test does not give people the ability to safely go back to life-as-we-knew-it. You still need to practice social distancing and PPE safety guidelines regardless of your antibody test results. This is for your own safety as well as those around you.

COVID-19 Herd Immunity will Come Soon, Right?

A lot of people and media pundits have been talking and asking about ‘herd immunity.’ Mayo Clinic describes herd immunity as “immunity occur[ing] when a large portion of a community (the herd) becomes immune to a disease, making the spread of disease from person to person unlikely.”

Herd immunity requires either more infections or more vaccines. Currently, the US has ~5 million confirmed coronavirus cases. The total US population is around 330 million. The current confirmed cases make up just ~1.5% of the population. Mayo Clinic experts estimate that over 70% of the US Population would need to recover from COVID-19 for any kind of herd immunity situation to become feasible.

A vaccine could speed up a herd immunity process, but research is still ongoing in the COVID-19 vaccine department with no ETA.

(Mayo Clinic “Herd Immunity & Coronavirus”)

Can I Safely go back to School or Work After a COVID-19 Antibody Test?

The short answer is no. This is not because you did or did not test positive for antibodies—it is because most other people have not been tested. Safely going back to any situation involving many people involves enforcing strict social distancing and PPE guidelines.

There is no way to 100% ensure safety—a positive antibody test does not mean you are immune to COVID-19—but simple social distancing and PPE practicing go a long way in preventing the spread. Make sure that you or anyone in charge of large social gatherings has a plan to mitigate the potential spread of COVID-19.

(University of California San Francisco)

What COVID-19 Antibody Test does Oswald’s Pharmacy Use?

We are currently using the Assure Tech POC Covid-19 IgG/IgM Rapid Test Device. It’s a mouthful, but the overall testing accuracy is rated at 99% by the FDA (positive agreement/negative agreement/sensitivity/specificity tests).

  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has not been FDA cleared or approved.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • 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.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.

Documentation:

Assure Tech POC Covid-19 IgG/IgM Rapid Test Device Fact Sheet for Recipients

Assure Tech POC Covid-19 IgG/IgM Rapid Test Device Fact Sheet for Healthcare Providers

How Long Does a COVID-19 Antibody Test Take?

COVID-19 antibody tests are mostly given as ‘rapid antibody tests,’ meaning you get your results in 15-60 minutes.

The paperwork usually takes 2-5 minutes, depending on the sections you need to fill out.

The antibody tests at Oswald’s Pharmacy give results in 15 minutes. The blood drawing itself takes about 2 minutes. We have a team of licensed phlebotomists to take blood from veins as opposed to finger-prick tests (which can be inaccurate due to interstitial fluids from the puncture site mixing with the blood).

After the results come back you will be supplied with paperwork containing your test information. A brief 1-2-minute explanation by a phlebotomist will follow.

The entire antibody testing appointment takes about 25 minutes, from paperwork to results.

Schedule a COVID-19 Antibody Test Today

 

Book an Appointment

If you need to get a COVID-19 antibody test, speak to one of our team members or sign up for an appointment slot online. We are also accepting walk-in appointments—click here for the walk-in schedule.

If you have any other questions, please send us an email. We love getting your feedback!

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