list of fda approved covid tests

FDA Advisory No.2021-2094 || List of COVID-19 Test Kits with FDA Special Certification and Performance Validation Conducted and/or Recommended by the Research Institute for Tropical Medicine (RITM) - Food and Drug Administration Covering Phoenix, Mesa, Glendale, Scottsdale, Gilbert, the valley . Rapid tests detect protein. Diagnostic Covid tests fall into two buckets: molecular tests and antigen tests. Over the following month and a half, regulators in various countries approved Pfizer's vaccine for emergency use. More information is available here. Negative results for severe acute respiratory syndrome coronavirus 2 and influenza B, if it is necessary for patient management, should be confirmed with an authorized molecular test performed in an approved laboratory, the FDA said. In 1947, Salk accepted a professorship at the University of Pittsburgh School of . . Before sharing sensitive information, make sure you're on a federal government site. Cinnamon is a spice obtained from the inner bark of several tree species from the genus Cinnamomum.Cinnamon is used mainly as an aromatic condiment and flavouring additive in a wide variety of cuisines, sweet and savoury dishes, breakfast cereals, snack foods, bagels, teas, hot chocolate and traditional foods.The aroma and flavour of cinnamon derive from its essential oil and principal . Since the start of the pandemic, we authorized over 400 tests and collection kits, including: For more information, please visit fda.gov/medical-devices. If you think you need a COVID-19 diagnostic test, you can find a community testing site in your state. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. (a Siemens Healthineers Company), Real-time RT-PCR, Screening, Pooling, Multiple Targets, Real-time RT-PCR, Home Collection, Saliva, Pooling, Multiple Targets, TMA, chemiluminescent, Pooling, Screening, Multiple Targets, Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling, Multiple Targets, RT, Isothermal amplification, Screening, Single Target. The site is secure. Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. In this photo illustration, an at-home COVID-19 test by . Walmart. U.S. FDA 65%8. Any test developer requesting an EUA that intends to leverage data from another developer's EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. , Multiple Targets, RT-PCR, Microarray Hybridization, Home Collection, Multiple Targets, RT, Nested multiplex PCR, Multi-analyte, Multiple Targets, University of California, Los Angeles (UCLA), RT-PCR and electrochemical detection, Multi-analyte, Single Target, RT, qSTAR amplification, Home Collection, Screening, Pooling, Single Target, Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab, Multiple Targets, RT-PCR, chip array and MALDI-TOF Mass Spec, Multiple Targets, Prescription Home Testing, Multiple Targets, Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory, Real-time RT-PCR, Collection Kit, Saliva, Multiple Targets, Stanford Health Care Clinical Virology Laboratory, Laboratory Corporation of America (LabCorp), Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets, RCA Laboratory Services LLC dba GENETWORx, ResearchDx, Inc., DBA Pacific Diagnostics, Real-time TMA, chemiluminescent, Multi-analyte, Multiple Targets, Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA), Single Target, Hospital of the University of Pennsylvania, INNO Diagnostics Reference Laboratory, Ponce Medical School, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Single Target, University of Illinois Office of the Vice President for Economic Development and Innovation, Real-time RT-PCR, Saliva, Serial Screening, Home Collection, Pooling, Multiple Targets, RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening, Single Target, Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard, Real-time RT-PCR, Home Collection, Pooled Serial Screening - Swab, Multiple Targets, Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening, Multiple Targets, STS Lab Holdco (a subsidiary of Amazon.com Services LLC), Real-time RT-PCR, Home Collection, Pooling, Screening, Single Target, University of Louisville Infectious Diseases Laboratory, RT, LAMP, Over the Counter (OTC) Home Testing, Screening, Multiple Targets, Real-time RT-PCR, Screening, Pooled Serial Screening - Swab, Multiple Targets, Real-Time and End-Point RT-PCR, Multiple Targets, Synergy Diagnostic Laboratory, Inc., DBA SynergyDx, Southern California Permanente Medical Group, Real-Time RT-PCR, Saliva, Home Collection, Multiple Targets, RT-PCR, DNA Microarray Hybridization, Multiple Targets, Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets, Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection, Multiple Targets, Harvard University Clinical Laboratory (HUCL), Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening, Multiple Targets, Real-time RT-PCR, Multi-analyte, Home Collection, Single Target, Real-time RT-PCR, Screening, Home Collection, Multiple Targets, Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.), Real-time RT-PCR, Home Collection, Screening, Single Target, Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Direct to Consumer (DTC), Home Collection Kit, Screening, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening, Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets, RT-LAMP, Serial Screening, Multiple Targets, Real-time RT-PCR, Quantitative, Multiple Targets, RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target, ADL Diagnostics, Inc., dba Anavasi Diagnostics, The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory), RT, LAMP, Over the Counter (OTC) Home Testing, Multi-analyte, Multiple Targets, Clinical Enterprise SARS-SoV-2-RT-PCR Assay, Helix Diagnostics SARS nCoV-2019 Multiplexed Assay, Rize Laboratory SARS nCoV-2019 Multiplexed Assay, Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay, Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia, Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory, Southwest Regional PCR Laboratory LLC. This test is usually conducted at the point-of-care or a sample is collected and . Download it here. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests. Antigen multi-analyte respiratory panel tests authorized in the table below are assigned the QMN product code. There are two main types of viral tests: nucleic acid amplification tests (NAATs) and antigen tests. Fox News Channel's Jesse Watters interviewed DeSantis Tuesday evening to discuss his book as well as his plans moving forward. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization. Molecular tests are more. LIST OF FDA APPROVED COVID-19 TEST KITS FOR COMMERCIAL USE PRESS STATEMENT March 19, 2020 The Food and Drug Administration (FDA) has released today a list of approved COVID-19 test kits for commercial use. Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests. 1. iHealth COVID-19 Rapid Antigen Test iHealth is another top-rated test brand that has an FDA-authorized at-home test kit for COVID-19. This limits the test's effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. The table includes links to home use instructions for each test. Expired at-home COVID tests can lead to inaccurate or invalid test results, but medical experts say to think twice before throwing them away. More information is available here. This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. The .gov means its official.Federal government websites often end in .gov or .mil. vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. An official website of the United States government, : Different tests are authorized to be used with different types of samples. People with symptoms that began within the last 7 days. The prevalence, and remaining unknowns, of the omicron variant have put people on edge and sent them out for testing in numbers that have caused the site at Barnett Park in Orange County to hit capacity hours before the it was scheduled to close two days in a row. Click here for a full list of FDA approved at-home COVID tests and their up-to-date expiration dates. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Enter any combination of fields and select Search. For more information about this, read our FDA Safety Communication. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Sienna COVID-19 Antigen Rapid Test Cassette, Clarity COVID-19 Antigen Rapid Test Cassette, OVIOS COVID-19 Antigen Rapid Test Cassette, Spring Health COVID-19 Antigen Rapid Test, Salocor COVID-19 Antigen Rapid Test Cassette. KOMU 8 is a full-powered NBC affiliate operating as an independent commercial property. When using a COVID-19 antigen diagnostic test, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. The FDA said the tests. In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test. Lab is submitting data to CalREDIE (either . The .gov means its official.Federal government websites often end in .gov or .mil. Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through CDRH-EUA-Templates@fda.hhs.gov. The FDA said it has authorized over 400 COVID-19 tests and collection kits - 235 molecular, 88 antibody, and 34 antigen tests -- to help ensure the public has access to a wide variety of. designed to detect only one antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein; more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants. Some, but not all manufacturers of approved rapid antigen tests (RATs) have extended the shelf-life of their products. Get hyperlocal forecasts, radar and weather alerts. Since the start of the pandemic, we authorized over 300 tests and collection kits, including: An official website of the United States government, : In Vitro Diagnostic EUAs: Overview and Templates, For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). COVID-19 Testing Update: Today, our administration announced that beginning January 15, 2022, individuals covered by a health insurance plan who purchase an FDA-approved, over-the-counter COVID-19 . As new tests are authorized for use, they are added to these tables so that anyone can access up-to-date information on all authorized tests and collection kits. For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). For details about each authorized COVID-19 diagnostic test, see the lists of authorized Molecular Diagnostic Tests and Antigen Diagnostic Tests, as well as the At-Home COVID-19 Diagnostic Tests webpage. 1 Authorized settings include the following: 2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary. Antibody (or serology) tests look for antibodies in your blood that your immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows: Repeat Testing Revision Letter - November 1, 2022, An official website of the United States government, : Another way to find the updated list of expiration dates is on the FDA's website. It's an antigen test that gives you results in. This article's lead section may be too long for the length of the article. Please keep in mind that merely contacting Nelson Mullins Riley & Scarborough LLP will not establish an attorney-client relationship. As such, KOMU 8 is the only major network affiliate in the United States that acts as a university-owned commercial television station utilizing its newsroom as a working lab for students. Tests Used In Clinical Care, Recalls, Market Withdrawals and Safety Alerts, Safety Issue on Magellan Diagnostics LeadCare Testing Systems, enter a search term (for example the type of test, name, company, or other key word) in the blank space, review the listing of products that match your search term, select any products for additional information (including Decision Summaries). Test attributes are listed in the "Attributes" column. The site is secure. On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests. Blood samples are only used to test for antibodies and not to diagnose COVID-19. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. Go to COVIDtests.gov or call 1-800-232-0233 (TTY 1-888-720-7489) to order your free COVID test kits from the federal government. Most Food and Drug Administration approved at-home COVID tests have a longer lifespan than previously anticipated. You can use the Test Type drop down box to select a Type of Test. View graphs and map for Testing in U.S. for COVID-19. Warner-Lambert, which merged with Pfizer in 2000, . 263a, that meet requirements to perform high complexity tests. Find the original expiration date on the box label of your test and then look for the new expiration date in the "updated expiration dates" table for your test. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. On November 1, 2022, the U.S. Food and Drug Administration (FDA) updated the emergency use authorizations (EUAs) of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing. The types of samples include: Saliva samples are collected by spitting into a tube rather than using a nose or throat swab. The Food and Drug Administration has authorized the first over-the-counter at-home test that can detect and differentiate between a test result for flu and a test result for COVID-19. "So if you have tests at home that you've had for a while, and they look like they just expired, or they're expiring soon, you can check in with that manufacturer.". ORAL) saliva collection devices, Express Gene 2019-nCoV RT-PCR Diagnostic Panel, Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, Pixel by LabCorp COVID-19 Test Home Collection Kit, Letter Granting EUA Revision(s) (April 1, 2022), Letter Granting EUA Revision(s) (July 8, 2022), Letter Granting EUA Revision(s) (November 1, 2022), Letter Granting EUA Revision(s) (February 12, 2021), Letter Granting EUA Revision(s) (November 17, 2021), Letter Granting EUA Revision(s) (February 24, 2021), Letter Granting EUA Revision(s) (February 14, 2023), Letter Granting EUA Revision(s) (March 9, 2021), Letter Granting EUA Revision(s) (March 25, 2021), Letter Granting EUA Revision(s) (May 5, 2022), Letter Granting EUA Revision(s) (April 30, 2021), Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit, Letter Granting EUA Revision(s) (March 3, 2021), BD MAX COVID-19 ASSAY (Authorized by HHS/OASH), PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH), Letter Granting EUA Revision(s) (March 4, 2022), Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits, Everlywell COVID-19 Test Home Collection Kit DTC, Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Letter Granting EUA Revision(s) (June 10, 2021), Letter Granting EUA Revision(s) (July 1, 2021), Letter Granting EUA Revision(s) (February 7, 2022), Letter Granting EUA Revision(s) (March 30, 2022), NxTAG Respiratory Pathogen Panel + SARS-CoV-2, Letter Granting EUA Revision(s) (January 4, 2023), CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 -Amendment Letter, Gravity Diagnostics COVID-19 Test Home Collection Kit, Color COVID-19 Self-Swab Collection Kit DTC, Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC, NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, Letter Granting EUA Revision(s) (December 17, 2021), SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH), Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit, Letter Granting EUA Revision(s) (March 3, 2022), Letter Granting EUA Revision(s) (November 4, 2022), PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit, Clinical Enterprise SARS-CoV-2 RT-PCR Assay, Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC, Letter Granting EUA Revision(s) (May 6, 2021), Color COVID-19 Self-Swab Collection Kit with Saline, Letter Granting EUA Revision(s) (January 31, 2022), Letter Granting EUA Revision(s) (June 15, 2022), Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, Letter Granting EUA Revision(s) (June 2, 2021), Kaiser Permanente High Throughput SARS-CoV-2 Assay, Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, WREN Laboratories COVID-19 Saliva Test Collection Kit DTC, cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2), Everlywell COVID-19 & Flu Test Home Collection Kit, Letter Granting EUA Revision(s) (March 1, 2022), Letter Granting EUA Revision(s) (September 21, 2022), Letter Granting EUA Revision(s) (October 22, 2021), Kwokman Diagnostics COVID-19 Home Collection Kit, Life Sciences Testing Center COVID-19 Test, Letter Granting EUA Revision(s) (March 25, 2022), Letter Granting EUA Revision(s) (August 2, 2022), Letter Granting EUA Revision(s) (September 9, 2022), Letter Granting EUA Revision(s) (November 8, 2022), Quest COVID-19 PCR Test Home Collection Kit, Letter Granting EUA Revision(s) (July 7, 2022), Letter Granting EUA Revision(s) (October 6, 2022), Test Yourself DC At-Home COVID-19 Collection Kit, Letter Granting EUA Revision(s) (May 25, 2022), OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2), Labcorp Seasonal Respiratory Virus RT-PCR Test, Letter Granting EUA Revision(s) (November 23, 2022), cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems, Diversified Medical Healthcare SARS-CoV-2 Assay, Hi-Sense COVID-19 Molecular Testing Kit 1.0, BD Respiratory Viral Panel for BD MAX System, LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay, The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector. To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). An antigen test, frequently used for rapid testing, detects viral proteins found in SARS-CoV-2. Most authorized at-home OTC COVID-19 tests are antigen tests, and there are also a small number of authorized at-home OTC COVID-19 molecular tests. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. 263a, that meet requirements to perform high complexity tests. Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal, oropharyngeal, or saliva samples. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. Viral Mutation Revision Letter September 23, 2021. For more information about antibody testing, visit Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers. The FDA authorized three COVID-19 vaccines (Pfizer, Moderna and Johnson & Johnson) to answer an urgent need to protect people from the coronavirus pandemic, which was (and continues to be) a public health emergency. Buy BinaxNOW Covid19 Antigen Self $19.88. SAN DIEGO Pilot projects launched last year to examine how information warfare gurus can enhance submarine operations may yield long-term plans. "They wanted it to be better safe than sorry," Morrissey said, "but it's been extended on many of those products, where they're actually good. The .gov means its official.Federal government websites often end in .gov or .mil. KBIA | The list of FDA-authorized tests includes both rapid tests and polymerase chain reaction (PCR) tests, which are the two types offered at most testing sites. COVID-19 Tests and Collection Kits Authorized by the FDA The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs, Remote or Wearable Patient Monitoring Devices EUAs, Ventilators and Ventilator Accessories EUAs, Emergency Use Authorizations for Medical Devices, Molecular Diagnostic Tests for SARS-CoV-2, Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2, Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2, Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing, EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests, Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2, Antigen EUA Revision for Serial (Repeat) Testing, Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2, Individual EUAs for Genotyping Tests for SARS-CoV-2, Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Molecular Diagnostic EUA Cover Sheet Template, Molecular Diagnostic Home Specimen Collection Template, Molecular and Antigen Home Use Test Template, Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing, Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies, Policy for Coronavirus Disease-2019 Tests (Revised), Coronavirus (COVID-19) and Medical Devices, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other details that may help you decide what test is right for you.