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COVID-19 Virus and Antibody Tests Compared and Where to Get Them
Question: How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free?
Answer: These are great questions, as many people want to know if they are currently infected or have already been infected with coronavirus that causes COVID-19 and have developed antibodies due to immune response. There has been much confusion and about tests for coronavirus and the FDA has reported that some test developers have falsely claimed their tests are FDA approved or authorized and that many commercial tests are performing poorly, so it is important to sort out the facts.
Before we get into specifics, let's start with a quick overview of the types of tests for coronavirus.
Types of COVID-19 Tests
There are basically two types of tests for the coronavirus that causes COVID-19:
This test detects the virus (SARS-CoV-2) to determine if you have an active infection and are infectious, i.e., you can spread the virus. Although you can be infectious before showing any symptoms, the virus is best detected during the first week of symptoms (which is about two weeks after becoming infected from exposure) (Sethuraman, JAMA 2020).
The virus test is best done by collecting a sample of mucous from a swab (typically from the nasopharynx or nostril) or saliva. This sample then needs to be analyzed in a laboratory or with a special rapid, portable machine using a technique that amplifies the genetic material (RNA) from the virus. This can take as little as a few minutes or several hours. The FDA has begun allowing some at-home sampling kits to be sold by which you can collect your own sample and drop it off or mail it to a lab, which will report the results back to you.
The other detects antibodies to the virus and requires blood — either a drop or a vial — to determine if you have been infected in the past and have developed some level of immunity. This test (also called a serology test) can be run in a laboratory or on a test strip. However, the accuracy of test strips has been found to vary, so you need to be careful if using a home-based test. None have been allowed by the FDA. As it takes time to develop antibodies that can be detected, antibody tests are most accurate when performed at least 20 days after the first disease symptoms. Tests focus on levels of the antibody IgG, which persists without much decline for several weeks, but may include levels of IgM which fall off more rapidly (Sethuraman, JAMA 2020). [Note: Avoid taking large doses -- 10,000 mcg or more -- of biotin for several days before an antibody test, as biotin may skew results.]
Who is checking these tests?
To speed the availability of tests, rather than put these through its normal approval process, the FDA has provided a special emergency use allowance (EUA) for tests that, although imperfect, may be useful at this time. So there are actually no FDA "approved" SARS-CoV-2 virus tests, but a list of "FDA allowed" tests. The FDA allowances are based on data submitted by the test manufacturers, but the has FDA announced that government laboratories, including those at the National Institutes of Health (NIH) are now conducting independent tests of these tests and the FDA expects to make the results public (which we will post when available — so watch for announcements in our newsletter.)
Several other organizations around the world have been testing the test and/or certifying virus and antibody tests. The European Union's has been certifying tests, conferring on them its CE (Conformité Européenne) mark, and the Chinese National Medical Products Administration (NMPA) has been doing the same. Researchers in California, Denmark, and elsewhere have been testing the antibody tests.
Where to Get COVID-19 Tests
To date, the FDA has permitted the use of over 60 virus tests. The vast majority must be performed on a sample collected in a medical setting, such as in a doctor's office, a diagnostic laboratory, or a drive-through facility, but the FDA has also begun authorizing at-home sample collection tests for the virus.
Local testing (often free)
Although you can ask your doctor for a virus test, you may be able to arrange to get a virus test for free from your state or local government. You can also go to a diagnostic laboratory or testing center, including some pharmacies. The test may be covered by your insurance or the government based on an assessment of your risk level. Here are some examples of testing programs around the country.
Project Baseline works with community based screening programs in locations in several states to offer free virus testing. You must fill out an online questionnaire and be accepted. You will then be given an appointment at local testing center where a sample will be collected with a self-nasal swab or a nasopharyngeal swab. The project is sponsored by the parent company of Google through its health unit, Verily, and a Google email account is needed to complete questionnaire online.
CVS (including MinuteClinic and HealthHUB) offers drive-up, rapid testing in which you can receive results within 30 minutes. Patients must pre-register online and qualify, and testing is on a drive-through basis, no walk ups. (CVS uses the Abbott ID NOW system, a small, portable device that yields results in 13 minutes or less. Unfortunately, this system has been reported to yield a high percentage of false negative results due to lower sensitivity than other systems. That is, a negative result may need to be confirmed using another test (Basu, bioRxiv 2020 preprint). (For more details, see Finding the Best COVID-19 Test, below).
Walgreens offers drive-up testing in which you perform your own nasal swab. You sample is sent to a laboratory and you will receive results within 24 hours.
At-home sample collection
Pixel from LabCorp allows users to collect their own nasal swab samples and mail it to LabCorp for testing. This product costs $119. It was initially only available to healthcare workers and first responders but is now available for consumer purchase. No prescription is necessary, although you need to complete a simple online questionnaire and meet eligibility criteria demonstrating need for the test. You may be covered by your insurance for the cost. Due to state restrictions, it is not be available in Maryland, New Jersey, New York and Rhode Island.
Everlywell COVID-19 Test Home Collection Kit ($109) will be available for individual purchase by the end of May. After completing an online eligibility questionnaire users are sent the kit to collect their own nasal swab samples. Samples are then sent directly to an accredited laboratory. The company promises online results within 3-5 days from purchase and results are reviewed by a physician. It is not be available in Maryland, New Jersey, New York and Rhode Island.
Rutgers Clinical Genomics Laboratory allows users to collect their own saliva sample using a special collection device and return it for testing at Rutgers. This test requires a prescription.
As with virus tests, many laboratories have received FDA approval to conduct antibody tests, some of which are very accurate. Although the FDA has not approved or allowed rapid, home tests for antibodies, many such tests are available in other parts of the world and some have been sold in the U.S.
Through a local healthcare provider
Your healthcare provider can arrange for you to get an antibody test if they believe is it appropriate. Blood would be drawn either by your provider or at nearby diagnostic laboratory. Similarly, many walk-in, urgent care centers can arrange for you to have the test, for a fee, which may be covered by your insurance. The samples are typically sent to a commercial laboratory, so results can take a few days.
Consumer-initiated testing QuestDirect allows consumers to request a COVID-19 IgG antibody test and pay for it online ($119 plus a $10.30 physician oversight fee). An appointment is made for a blood draw at one of Quest Diagnostics 2,200 patient service centers and test results are available online one to two days later. Interested consumers must not have experienced symptoms of COVID-19 for at least 10 days. Quest has stated that the testing will initially rely on antibody tests run on the Abbott Architect and EUROIMMUN systems (see how these compare in the Finding the Best COVID-19 Test section below).
Rapid, home tests The FDA has not yet approved or allowed of the use of any rapid, home antibody tests but several have been approved by the European Union, which provides its CE mark (Conformité Européenne) and/or by the Chinese National Medical Products Association (NMPA). In addition, research groups have been evaluating these tests. Some of these tests have been marketed in the U.S. without FDA approval or allowance.
Finding the Best COVID-19 Test
There are now more than 60 virus tests and 11 antibody tests for COVID-19 allowed by the FDA. ConsumerLab has reviewed the data on their performance and assessed which appear to be the best. We've added this information for ConsumerLab members. Sign in as a member or become a member now to learn how specific brands of virus and antibody tests compare, which currently appear to be the best, and where to get them.