Update March 28, 2020 – On March 24, 2020, the FDA released a more detailed statement about novel coronavirus COVID-19 testing which includes the following statement:
The FDA has also seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the only way to be tested for COVID-19 is to talk to your health care provider. The FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. You will risk unknowingly spreading COVID-19 or not getting treated appropriately if you use an unauthorized test. The FDA knows that having a home test for COVID-19 would be very helpful and is actively working with test developers on this. But currently the FDA has not authorized any home test for COVID-19.
So, as of March 28, 2020, there are no home tests available. I will leave the rest of the post information, in case some of these companies are allowed to offer home testing in the future.
I am a physician and am trained in Internal Medicine, but I am not a specialist in Infectious Disease. I’m using this page as a way to share information and not to provide medical advice. Please consult with your own physician for medical advice. If any information here is wrong, please add a comment and I will correct the information ASAP.j
With the rapid spread of COVID-19 (novel coronavirus or SARS-CoV-2) getting testing has been a priority for many regions to help isolate and contain the disease. Most experts agree that accurate testing early in the pandemic will help. As a result, the FDA has eased many quality assurance steps in order to make tests more readily available. This is a double edged sword as most people agree that testing is critical right now, but having inaccurate tests will do more harm than good. With home tests coming available, what should people do? I haven’t decided yet for myself, but will update this as I make decisions. I wanted to use this post as a way to summarize what is known about the various home test kits. As a physician, I have the ability to order some of these, but I’m not sure how I would use them and how much I would trust the results in people that are the “worried well” with minimal or no symptoms. If you are like me and my family, we have numerous family and friends who have had relatively mild colds since February 2020 and we wonder, “Is it possible that I had a mild case of COVID-19?” It would be great to do an antibody test and see that we are now immune, but how reliable are these antibody tests? And how likely is it that our recent cold was COVID-19? Maybe I’ll try to address some of those questions in a separate post if there is interest, but for now, here are the soon to be available home test kits.
Nurx – https://www.nurx.com/coronavirus-testing/ – Website says testing is currently paused as of 13:20 CST on March 22, 2020. I’m not sure at this time why they paused testing. Either they were overwhelmed, or they are trying to get clarification from the FDA regarding the ambiguous letter. They offer a $35 physician consultation followed by a $100 test, with shipping costing $46 for a total cost of $181. You fill out an online health questionnaire, they have a “provider” review whether home health testing is appropriate. If so, they overnight ship a test kit to you. You collect your sample via throat swab. Within 48 hours of your sample arriving back at their lab they will have a “member of our medical team” inform you of the results and next steps.
Based on the sample collection method, I believe they are doing a PCR based test to identify presence of the actual COVID-19 virus. The website says the sensitivity and specificity of their test both exceed 95%. I’m trying to find more specific information on the method of their test and the accuracy data.
The test is performed through their partner, Molecular Testing Lab, which is CAP accredited and CLIA licensed.
Carbon Health – announced on March 20, 2020 that they started to send out home test kits to people in their service area in California, at a cost of $167.50. It includes submitting a saliva sample, so I assume it is a PCR based test. They have already been providing in person testing at their clinics in California.
LetsGetChecked – not much info yet, but they said it could take 2-3 days before a test kit gets sent out.
Everlywell – 30,000 kits will be available online starting March 23, 2020. The cost will be $135 which includes a telehealth consultation, materials sent out to you, return shipping, and processing of the test with results provided online. I am still trying to find details, but it appears they send you a swab for specimen collection, so I believe they are doing a PCR based test which will be run through various independent labs.
Scanwell Health in partnership with Lemonaid – The test is $70 including the consultation and shipping. The test kit is manufactured by INNOVITA. You complete an online consultation and if appropriate they send out a test kit next day shipping. You follow the instructions, using a drop of blood, and the test will indicate if you have IgM and IgG antibodies against novel coronavirus SARS-CoV-2. Unlike the above PCR based tests which identify the virus, this test will identify antibodies to the virus. The test may be negative if done before you have developed antibodies. A positive test will not be able to determine if you remain contagious and need to remain in isolation.