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. The information in this field has been changing rapidly. Before using any test or service discussed below, confirm the information with the provider and/or other reliable information source
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
. There are two type of virus tests: the PCR and antigen test. Both tests need to be analyzed in a laboratory or with a special rapid, portable machine.
The PCR test
uses a technique that amplifies 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 type of virus test is the antigen test
. It identifies a protein (or "antigen") that is specifically found on the virus. Advantages of the antigen test are that it can provide results in just 15 minutes and can be produced at lower cost, lending itself to wider use in screening. In addition, only a nasal swab is needed from the nostrils, not a much deeper, nasopharyngeal swab. The downside with antigen tests is that they are more likely to provide a false negative result than a gene amplification test; that is, it's more likely to identify your sample as negative when you are actually positive. Consequently, negative results from an antigen test may need to be confirmed with a gene amplification test — but a positive result is highly likely to be accurate. So far, the FDA has authorized only four antigen tests, the Sofia 2 SARS Antigen FIA from Quidel Corporation, the BD Veritor System for Rapid Detection of SARS-CoV-2, the LumiraDx SARS-CoV-2 Ag Test, and, most recently, the Abbott BinaxNOW COVID-19 Ag Card. The first three require equipment to be read, but the Abbott test is simply a card. There appears to be a significant difference in the accuracy of these tests. [Sign in
for our comparison of the accuracy of the Sofia (Quidel) and BD antigen tests, which differ.]
This test 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, although even test strips must be used in an authorized facility, not at home. 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
). These tests look for antibodies to specific parts of the virus, namely its spike proteins
(proteins on the outside of the virus that can bind to receptors on human cells) or nucleocapsid proteins
(proteins inside the virus). An advantage to testing for antibodies to the nucleocapsid is that these antibodies can be easier to detect, however, antibodies to the spike proteins are believed to be more important in conferring immunity against the virus, as these antibodies may block viral entry into cells — although antibodies to nucleocapsid proteins may still serve as proxies for immunity. See Finding the Best COVID-19 Test
to learn which marketed tests target each protein. [Note: Avoid taking large doses -- 10,000 mcg or more -- of biotin
(a B vitamin) for several days before an antibody test, as biotin may skew results
Another way our bodies fight the virus is with T cells. Preliminary research suggests that even if antibody levels are too low to be detected, people previously infected with the virus may produce enough T cell response to provide immunity (Sekine, MediRxiv 2020
). However, currently authorized tests do not measure this type of immunity, and one should still apply distancing and health precautions regardless of test results.
Some labs may provide you with an index value
that reflects the strength of the antibody signal produced from your test. Higher antibody levels generate higher signals and higher index values. The interpretation of these index values depends on the test used. For example, for a particular test the cut-offs could be "less than 1.01" for negative, "1.01 to less than 1.21" for indeterminate, and "greater than or equal to 1.21" for positive (Theel, J Clin Microbio 2020
). Or, there could just be a single cut-off index value of, say, 1.40 for positive, with anything below being negative (Example: Abbott Alinity -- https://www.fda.gov/media/137910/download
). If you would like to know your index value, be sure to check that the lab you use provides the value.
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 authorized" tests. The FDA allowances are based on data submitted by the test manufacturers
, but the National Institutes of Health (NIH) and other government laboratories are now conducting independent tests of these tests and the FDA has been making the results public (see results in the Finding the Best COVID-19 Test
section and watch for further 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.
Be aware that in June 2020 the FDA warned consumers
about at-home antibody tests being sold without FDA clearance or approval and issued warning letters to three companies selling these tests. Some of these tests were falsely labeled as FDA approved. [Update (August 19, 2020): The U.S. Department of Health and Human Services (HHS) announced that CLIA- certified laboratories are no longer required to notify the FDA, nor request its authorization, for tests they develop in-house. It is not clear what information about such tests will be maintained or published. This change could allow for novel tests to become available more quickly but eliminates oversight by the FDA, creating more of a buyer-beware situation. Labs may, voluntarily, still choose to apply to the FDA, and the FDA will continue to publish information about tests submitted this way. If in doubt, ask your doctor or lab if the test you are considering is authorized for use by the FDA. (Links to the FDA information are provided in the Finding the Best COVID-19 Test section.
Where to Get COVID-19 Tests
To date, the FDA has permitted the use of over 90 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.
- Rite Aid Pharmacies in some locations are participating in Project Baseline, providing testing at no cost to anyone 18+ years of age.
- CVS (including MinuteClinic and HealthHUB) had originally offered drive-up, rapid testing using the Abbott ID NOW system, a small, portable device that yields results in 13 minutes or less. Unfortunately, this system was 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). Virus testing is still offered, but specimens are now sent to independent, third-party labs for processing, and test results are available in approximately three to four days.
- Walgreens offers drive-up testing in which you perform your own nasal swab. You sample is sent to a laboratory and you are notified by email or phone when results are available. (Originally results were promised within 24 hours).
- Kroger Health offers public drive-thru and walk-up COVID-19 testing.
The FDA has authorized three fully self-administered virus kits for use at home (and a third test kit that requires professional supervision via phone app):
At-home sample collection
- Ellume COVID-19 Home Test is an antigen test that does not require a prescription and provides results within 15 minutes at home via a smartphone app. It has been shown to correctly identify 96% of positive samples and 100% of negative samples in people with symptoms, and 91% of positive samples and 96% of negative samples in people without symptoms. Positive results are most accurate within the first six days of symptoms. Samples can be self-collected by nasal swab, except for children ages 2 to 16 for whom an adult must collect the sample. The test is expected to be available in early January 2021, possibly through a major retailer such as Walgreens, CVS or Walmart, at a cost of about $30.
- BinaxNOW COVID-19 Ag Card Home Test is an antigen test that requires a prescription and must be conducted under the supervision of a healthcare provider via a smartphone app. Nasal swab samples for the test can be self-collected by people age 15 or older (or collected by an adult for children age 4 or older). It should be conducted within the first seven days of symptom onset. Results are available on the app within 15 minutes. In people with symptom onset of seven days or less, this test has been shown to correctly identify 91.7% of positive samples and 100% of negative samples. It should not be confused with the Abbott BinaxNOW COVID-19 Ag Card, a similar, prescription antigen test that must be administered in a healthcare setting. The cost of the test and healthcare provider service is $25, and the test is expected to be available in early 2021.
- Lucira COVID-19 All-In-One-Test Kit, which uses PCR, requires a prescription. It may also be used in point-of-care settings, like a doctor's office, which is the only setting in which it may be used on children younger than 14 years old. The test, which costs $50, works by swirling a self-collected nasal swab sample (from the inside walls of both nostrils) in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. The test will not be available until spring 2021, other than in Sutter Health in Northern California and Cleveland Clinic Florida. (Sign in to get more details about the test in the full answer.)
- Pixel from LabCorp allows users to collect their own nasal swab samples and mail them 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) is sent to users after completing an online eligibility questionnaire. The kit allows users 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 available in Maryland, New Jersey, New York or Rhode Island.
- Kroger Health COVID-19 Test Home Collection Kit is currently available to Kroger employees and will soon be available to non-employees. Based on results of an online screening, a healthcare professional will issue a prescription and the home collection kit is shipped to the home within 24-48 hours. The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory. Upon receipt of the home collection kit, a healthcare professional guides the home collection process video chat. The patient will then ship their sample overnight to Gravity Diagnostics, which has developed an FDA authorized virus test yielding results 96.8% and 100% in agreement with the CDC's own tests, respectively, on positive and negative samples. Results are provided online or by phone within 24-48 hours.
- 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.
- Quest Diagnostics Self-Collection Kit for COVID-19 +Flu received FDA authorization in December 2020 and allows users to collect their own nasal swab sample and return it to Quest Diagnostics laboratory for analysis for the SARS-CoV-2 virus as well as influenza A and B. Compared to nasopharyngeal samples collected by healthcare professionals, results using this kit have an extremely high percent agreement (99.6+%) for influenza samples and somewhat less but still fairly high agreement for SARS-CoV-2 (96.4% positive agreement and 98% negative agreement). 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 authorized 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. The FDA has authorized one rapid antibody test for use at point-of-care settings, i.e., non-laboratory medical settings such as in medical offices and pharmacies.
Through a local healthcare provider
Your healthcare provider can arrange for you to get an antibody test if deemed 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.
Be aware than in many cases, the cost of antibody tests may be covered by insurance
if ordered by your physician or health care provider. Some labs will require payment for consumer-initiated tests, while others will bill your insurance. Be sure to check the payment policy of the lab you plan to use if requesting your own test. You can also check if your insurance company covers COVID-19 testing. Medicare often covers the full cost of COVID-19 virus and antibody tests. If you are uninsured, health care providers can submit a claim to have virus and antibody tests covered by the Families First Coronavirus Response Act.
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.
also allows consumers to request a test directly through its website. According to the website
, there is no up-front out-of-pocket cost for consumer initiated tests, but you will be charged a $10 fee for physician oversight services (there is no physician oversight fee if the test order comes directly from your own physician or healthcare provider). Labcorp will "bill the cost of the COVID-19 IgG antibody test directly to your insurance carrier, or if uninsured, to the appropriate government program." Antibody tests offered by Labcorp include Abbott SARS-CoV-2 IgG, Roche Elecsys Anti-SARS-CoV02 (IgG), and DiaSorin SARS-CoV-2.
The American Red Cross
announced that it is providing free antibody testing, with a 7 to 10 day turnaround, to those who donate blood. The test used is Ortho-Clinical Diagnostics VITROS (IgG).
is the first pharmacy to offer a rapid, 15-minute antibody test for $25 with no prescription required. The test used is the Assure COVID-19 IgG/IgM Rapid Test. The test is available at Kroger pharmacies in California (Ralphs) and Michigan and will be available at all Kroger pharmacies and clinics in 35 states by the end of November.
You can see how each of these tests compare in the Finding the Best COVID-19 Test
Rapid, home tests
The FDA has not yet approved or authorized 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 90 virus tests (including a recently approved saliva test
) and 22 antibody tests for COVID-19 authorized by the FDA. ConsumerLab has reviewed the data on their performance and assessed which appear to be the best antibody tests for COVID-19
. 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.
What Does a Negative Antibody Test Mean?
If you took a coronavirus antibody test and it came back negative, it can mean one of several things:
- The test was not sensitive enough to detect antibodies that existed. This is more likely if the test had a sensitivity of less than 100% (see Finding the Best COVID-19 Test — Antibody Test for sensitivities of FDA-authorized tests);
- You may have never had COVID-19;
- You took the test too early -- generally less than 20 days after first disease symptoms, although, according to the CDC, some people may take longer; or
- You didn't develop levels of antibodies high enough to be detected by tests -- which preliminary research suggests may happen in mild and asymptomatic cases (Long, Nature Med 2020).
There is currently not enough data to know if a negative result could result from taking the test too late.
More research is needed to determine how long significant levels of antibodies to SARS-CoV-2 persist.
The CDC cautions, "Regardless of whether you test positive or negative, the results do not confirm whether or not you are able to spread the virus that causes COVID-19. Until we know more, continue to take steps to protect yourself and others."
This article will be updated as new information is obtained.