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Why This Detail is Critical to Accurately Diagnosing COVID-19
March 22, 2020 Edit
This evening, we were notified by our lab partner, Curative Inc, that the 3/21/2020 FDA update for COVID 19 testing clarified that at-home sample collection is not covered under the EUA. Carbon Health is discontinuing distribution of the at-home sample collection kits effective immediately. We are contacting our 50 initial patients to schedule expedited testing in our clinics.
The FDA supports at home sample collection but requires additional data to validate its accuracy. We continue to perform a large number of COVID-19 tests in our clinics and are continually looking for additional ways to expand our testing capacity to meet the needs of our patients. We remain hopeful that the FDA will approve at home sample collection as one of the tools to address this pandemic.
As a medical professional working on the frontlines of the coronavirus outbreak and seeing the impact firsthand, I know our work is far from over.
On Thursday, March 19, 2020, Carbon Health was the first medical provider to begin shipping COVID-19 test kits in the United States that allows patients to collect their own samples. The COVID-19 Home Test Kits have gotten a tremendous amount of positive support as more and more people are realizing the importance of being able to collect samples from the safety of their homes without exposing healthcare workers or the community at large to the virus.
Unrelated, on March 20, 2020, the Food and Drug Administration (FDA) put out the following statement:
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space. ”
Per the FDA’s statement, Carbon Health was very proud to launch our home collection kit with our partners, Curative Inc. and Alto Pharmacy for eligible patients throughout California. Curative Inc. has developed the tests per FDA guidelines and is providing laboratory testing while Alto Pharmacy is providing delivery fulfillment. Since insurance does not currently cover this kit, we are offering it at-cost at $167.50. This breaks down to the price of the kit itself plus shipping. Both Carbon providers and the Alto team are not charging for their services. We know this is a hefty fee for many, and Carbon plans to refund our patients if insurance companies begin to offer coverage in the future.
When patients are concerned about a coronavirus infection, they are able to use our free Coronavirus Assessment Tool to access the COVID-19 Home Test Kit. After answering a series of questions, they will get a response from a Carbon Health provider with next steps. If a patient is assessed, found to need COVID-19 testing and is eligible for at-home sample collection, they can request to have an order placed by their Carbon provider and have a test kit mailed to their home. 100% of the tests are ordered by clinicians so that we can make sure the test is appropriate and that our patients have proper follow up if their test turns out to be positive.
So how does this differ from going into a clinic?
The only difference is where you swab for the sample. Instead of going into the back of your throat or through your nose, you swab your own cheeks and roof of your mouth. We take a sample of the saliva from your oral mucosa, which is the the mucous membrane lining inside your mouth. Then the sample is safely shipped to our laboratory partner for analysis. You stay at home, preventing risk of additional exposure by visiting a hospital or other testing facility. Shipping of the test kits will take 1–3 days and once the sample reaches the lab, a Carbon provider will reach out to patients with results in 1–2 days.
Our laboratory partners Quest, LabCorp, and Curative Inc., are running an RT-PCR based test and the data indicate comparable performance between home saliva collection and the typical nasopharyngeal or throat swabs. Laboratory testing through Curative has been validated in a high-complexity CLIA-certified laboratory as per the Centers for Disease Control and Prevention (CDC) and FDA’s guidance on validation methods for COVID-19 testing. Furthermore, the swabs used for the saliva testing aren’t encumbered by the supply chain constraints that are plaguing the throat and nasal swabs, allowing us to more quickly reach a larger group of patients and curb this pandemic.
So, how is this different from “at-home testing”?
At-home tests claim to provide patients with immediate results at home and typically can be ordered directly from an at-home testing company often based outside of the US. Oftentimes companies providing these tests may not require a screening or assessment by a provider which can be a major red flag. As the FDA announced yesterday, there are currently no COVID-19 tests that can be performed and resulted at home. Currently, all samples, whether they are collected at a clinic or at home, must be sent to a lab and handled by clinicians.
For our COVID-19 Home Test Kit, the Carbon provider will continue to monitor the patients’ symptoms through the Carbon app, while they wait for their lab results. The test results will be communicated via phone, video or chat through the app and the provider will continue to follow-up with the patient as needed. From initial assessment to testing, to delivering results and follow-ups, our providers are with our patients every step of the way. The at-home sample collection is another way for us to expand the availability of COVID-19 testing while allowing sick or vulnerable people to stay safely at home, and opening up clinic and hospital capacity for those that most need it.
If you think you are experiencing any coronavirus symptoms, I strongly encourage you to go through the Coronavirus Assessment Tool first and, if needed, reach out to our virtual care providers. We’re currently providing free video visits for coronavirus related concerns. Our continued mission is to make high quality healthcare accessible to as many people as possible, and we hope that the launch of our COVID-19 Home Test Kit, in addition to our current suite of tools, will serve to expand care to more people across California.
Thank you and stay safe,
Caesar Djavaherian, MD
CO-founder and Medical Director, Carbon Health
