Choose Health, an Austin-based consumer healthcare provider, is the first U.S. company to offer premium, ELISA-validated COVID-19 Antibody tests to healthcare practitioners and healthcare organizations using a self-collection device. This test sample can be collected in clinic or at a residence in less than 10 minutes using a finger-prick blood test and sent back to a CAP and CLIA accredited, high complexity, lab to detect the presence of IgG and IgM antibodies, specific to epitopes from SARS-CoV-2. Results are provided digitally to the patient and the provider, and automatically submitted to the CDC directly from the lab. Patients may optionally connect directly with Choose Health's 3rd-party telehealth partner to review their results.
According to the FDA, high-quality antibody serology tests, like the one being offered by Choose Health, can help us understand a person and population's exposure to COVID-19 and is most effective 14 days after contraction of the virus. These tests differ from PCR tests, which are used to detect the presence of an antigen in the early stages of contracting the virus.
"A new study offers a glimmer of hope in the grim fight against the coronavirus: Nearly everyone who has had the disease — regardless of age, sex or severity of illness — makes antibodies to the virus." - NY Times, May 7, 2020
The FDA issued new guidelines on May 4th due to the rapid influx of unvalidated antibody tests into the U.S. healthcare system. The FDA now requires all antibody tests to submit the required validations by May 14th, and it is anticipated that many of the "rapid tests" will be recalled or revoked in the coming weeks. Choose Health's COVID-19 Antibody Test is analyzed by a US based laboratory using a validated ELISA.
Where Are We Today?
The scale of the global health and economic implications of the COVID-19 pandemic are unprecedented. As many countries are beginning to gradually re-open their economies with the belief that the curves have been substantially flattened and healthcare capacity has been adequately increased to deal with any subsequent surges in cases, there has yet to be a consensus on the role that testing will play in the process. Many scientists and healthcare practitioners around the world are working together to answer important questions like:
- How can testing help determine optimal stay at home order timelines?
- Can we use antibody testing to determine if societies are safe to resume normal activity?
- What percentage of the population have already contracted SARS-CoV-2 including those who have recovered without requiring medical treatment?
- How long does immunity last, if at all, post-recovery from the virus?
- How will we prepare more effectively to manage a potential second wave of the virus?
"Health officials in several countries, including the United States, have hung their hopes on tests that identify coronavirus antibodies to decide who is immune and can go back to work. People who are immune could replace vulnerable individuals, especially in high-transmission settings like hospitals, building what researchers call “shield immunity” in the population." (NY Times)
Choose Health Test Kit Information
Beginning today, healthcare practitioners can purchase COVID-19 antibody testing for their patients through Choose Health. We have been working hard to create a seamless testing experience for both physicians and their patients and to make these tests available at our true cost.
1. Validations and FDA submissions
The tests are being offered in partnership with our US-based CAP and CLIA accredited, high complexity laboratory, that has validated the COVID-19 ELISA serology test. The test measures your body's immune response to the novel coronavirus SARS-COV-2 by detecting the presence of two antibodies, IgG and IgM, specific to epitopes from SARS-CoV-2. The primary ELISA validations and submissions under FDA EUA were conducted by Epitope Diagnostics and have sensitivity and specificity of 100% to detect SARS-CoV-2 IgG (when sample is taken ≥2 weeks after symptom onset). Our laboratory partner has validated sensitivity and specificity of 100% using a patented self-collection device and capillary sample against the primary ELISA validations from Epitope diagnostics.
2. Simple Collection and Results Reporting Process
The test is required to be ordered and administered by a registered practitioner. The sample can either be collected with physician oversight in the clinic or self-collected by the end-user and sent back to the lab in the self-addressed envelope provided.
The test includes:
- Individually packed kits including self-collection device and medical supplies.
- Shipping both ways, to the practitioner and back to the lab.
- Results provided digitally to both patient and practitioner.
- Automatic submission of positive results to the CDC directly from the Lab.
Informing the CDC is vital in the national fight against SARS-CoV-2, as it allows public health officials to determine how well we have controlled the spread.
To maximize the accessibility to testing, Choose Health is pricing the test at the true cost of $130 per unit. For transparency, costs will cover all of the features above plus Choose Health’s operating costs to make the test available.
3. Telehealth Partnership
Upon viewing their results, physicians have the option to reach out to their patients directly to discuss the results or allow their patients to connect directly with our third party telehealth provider. The patient can select the option to speak to a physician and receive a call back within 60 minutes to discuss their results. The cost of this service is included with the test.
The Choose Health service broadens access to COVID-19 antibody testing in the United States. Registered physicians can request more information at email@example.com or by requesting more information through the form on our COVID-19 webpage. Each request is reviewed within 24hrs and, if appropriate, an order for tests can be submitted by a licensed practitioner.
Details required to begin testing:
1) Practitioner Ordering Name
2) NPI Number
3) Practitioner Email Address For Results Sharing
5) Quantity Required
Relevance and Importance of Antibody Testing
With the Choose Health service, individuals may gain some awareness into whether or not they have been exposed to COVID-19 and have developed antibodies. According to the U.S. FDA, although we do not yet know whether the development of antibodies provides protection from re-infection, or how long such protection lasts:
"High-quality antibody tests (a type of serological test) can help us understand a person’s and population’s exposure to COVID-19. A person who has been exposed to, and recovered from, COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood." - U.S. FDA
Similar tests have been used for many years to detect HIV (AIDS), Dengue Fever, and other diseases and infections.
"Our purpose for making these kits available to our community is to empower physicians and their patients to make more informed personal decisions about their risk of infection and of spreading the virus. We believe that antibody testing can provide important demographic information to the healthcare system and in turn allow cities, states, and businesses to make better decisions for the benefit of public safety and the economy." -Mark Holland, CEO of Choose Health
Further, research demonstrates that antibody levels and immunity tend to be closely tied to one another.
"Having antibodies is not the same as having immunity to the virus. But in previous research, Dr. Krammer’s team has shown that antibody levels are closely linked with the ability to disarm the virus, the key to immunity." (NY Times)
To help patients fully understand their results, Choose Health is working in collaboration with Amaze telehealth services, an independent national network of physicians to provide a free, post-test consultation option.
Comparison to PCR Tests
PCR tests are used to directly detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies. The PCR tests detect the genetic information of the virus. At present, PCR and antibody testing are the dominant ways that global healthcare systems are testing citizens for Covid-19.
PCR testing is most accurate at the early stages of contracting the virus as can be seen in the graph below, whereas antibody testing is more relevant for detecting population information on those who may have previously contracted the virus and have developed antibodies.
Ref for the graph above.
Lab Antibody Tests and Point of Care Antibody ‘Rapid Tests’
An updated regulatory guidance document was released by the US FDA on the 4th of May, as an update to the March 16th Policy, that aims to create more regulatory control around the distribution of antibody tests and the requirement to submit test validations within 10 days of the notice.
This notice was partly issued in response to the unvalidated supply of tests being distributed into the US healthcare system. “In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis, a fact that remains true today. However, flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
The vast majority of serology tests submitted under policy outlined in section IV.D of the FDA EUA program related to COVID-19 testing are lateral flow chromatography or ‘Rapid Tests’. Many of these tests may be recalled or revoked by the FDA in accordance with the recent policy guidance.
There is a use case for both laboratory analyzed tests and rapid tests in the ongoing battle to manage our country's response to the pandemic. At this time, the physician advisors at Choose Health have decided that the added security of having a CAP and CLIA accredited laboratory conducting the testing and submission of positive results directly to the CDC is the best antibody testing option for our community. Informing the CDC is vital in the national fight against COVID-19, as it allows public health officials to determine how well we have controlled spread.
Please reach out to us with any questions, comments or suggestions at firstname.lastname@example.org. We appreciate your continued support and thank you for all the hard work you continue to provide on the front lines of this pandemic.
This test may be helpful if you:
- Have had a positive test for COVID-19 and it has been at least 14 days and you want to know if you have detectable levels of IgG antibodies
- Have not experienced a fever or felt feverish in the last 3 days
- Have not experienced new or worsening symptoms of COVID-19 in the past 10 days: loss of smell or taste, shortness of breath or difficulty breathing, feeling weak or lethargic, lightheadedness or dizziness, vomiting or diarrhea, slurred speech, and/or seizures
This test may NOT be helpful if you are:
- Feeling sick or have had a fever within the last 3 full days, please contact a healthcare provider
- Trying to diagnose COVID-19, please contact a healthcare provider
- Less than 7 days since being tested for and diagnosed with COVID-19
- Directly exposed to COVID-19 for the first time within the past 14 days