list of fda approved covid tests 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 There are several types of SARS-CoV-2 and COVID-19 related IVDs: The web pages below include tables of SARS-CoV-2 and COVID-19 related IVDs with emergency use authorizations (EUAs). 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. The FDA will update this table as additional shelf-life extensions are authorized. This page provides information on types of COVID-19 Tests and Supplies for laboratory personnel. In some cases, the expiration date for a test may be extended. 2023, Charter Communications, all rights reserved. Before sharing sensitive information, make sure you're on a federal government site. The test is to be performed two times over three days (serial testing). The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through CDRH-EUA-Templates@fda.hhs.gov. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Shenzhen New Industries Biomedical Engineering Co., Ltd. Total Antibody, photonic ring immunoassay, Total Neutralizing Antibodies, Blocking ELISA, Semi-quantitative. Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. This infographic provides a visualization of data about the coronavirus (COVID-19) diagnostic tests authorized by the FDA. Some tests, including most antigen tests, can be performed completely at home, giving you results within minutes, without needing to send your sample to a laboratory. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing). "This is a huge milestone," Dr. Michael Mina, a Harvard epidemiologist who has been. BD Veritor At-Home COVID-19 Test The Food and Drug Administration prohibited 65 manufacturers from selling masks for medical use. Get the best experience and stay connected to your community with our Spectrum News app. Using the search box in the EUA tables, you can use keywords to search and filter the type of test or collection kit you are looking for. 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. Click here for a full list of FDA approved at-home COVID tests and their up-to-date expiration dates. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA-authorized at-home COVID-19 diagnostic test, Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Understanding at-home OTC antigen test results, CLIA (Clinical Laboratory Improvement Amendments). Also in May, it received EUA from the FDA for a molecular COVID-19 test for use on the company's Alinity molecular laboratory instrument. On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA. The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021. Our Spectrum News app is the most convenient way to get the stories that matter to you. Skip to main content . Antibody tests should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. 3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay, CMIA = chemiluminescent microparticle immunoassay; ELFA = enzyme-linked fluorescence assay. For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). The site is secure. To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization. vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Tests with "single target" in the attribute column are: Tests with "multiple targets" in the attribute column are: 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. 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. 8/24/2021. Self-tests for COVID-19 give rapid results and can be taken anywhere, regardless of your vaccination status or whether or not you have symptoms. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Before sharing sensitive information, make sure you're on a federal government site. vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. You can read more about the individual types of tests, safety communications and how to interpret your test results at the links below: The FDA encourages health care professionals and patients to report adverse events or side effects as well as performance issues related to the use of COVID-19 tests or other medical products to the FDAs MedWatch Safety Information and Adverse Event Reporting Program: Subscribe to receive FDA Consumer Update email notifications. Before sharing sensitive information, make sure you're on a federal government site. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. To see complete information on smaller screens, select the blue plus (+) button beside the test name. 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. RT-PCR = reverse transcriptase polymerase chain reaction; LAMP = loop-mediated isothermal amplification; MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight; TMA = Transcription Mediated Amplification; qSTAR = Selective Temperature Amplification Reaction; CRISPR = clustered regularly interspaced short palindromic repeats; Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. There's a new federal resource to get free FDA-authorized coronavirus test kits. Before sharing sensitive information, make sure you're on a federal government site. The most important thing to consider when looking for an updated expiration date is the brand or manufacturer of the at-home COVID test. An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. 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. But the move came after tests last month showed the masks didn't meet standards. During the discussion, Watters asked DeSantis to respond to Donald Trump's comments about him in recent weeks. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. It quickly pivoted to a health professionals-only test and then rereleased its kit to the public after the. Since August 9, 2022, the standard regimen has also been authorized for people aged <18 years under . , 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. Cases, data, and surveillance to track and analyze COVID-19. More research is needed to determine what, if anything, antibody tests can tell us about a persons immunity. "COVID-19 is characterized by high levels of inflammatory markers, including C-reactive protein (CRP), and increased levels of inflammatory cytokines and chemokines. There are two common types of COVID-19 diagnostic tests: Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. People without symptoms. Everlywell was one of the first brands to release its at-home coronavirus test kit. Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of 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 individuals, including individuals without symptoms or other reasons to suspect COVID-19 and placed in individual vials when tested at least once per week. . People with symptoms that began within the last 7 days. You can find information about each home or lab test that FDA has approved or cleared by searching FDAs Database of In Vitro Diagnostic (IVD) Tests. KOMU 8 is a full-powered NBC affiliate operating as an independent commercial property. OTC - Over The Counter. Learn More. The. 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. Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test, Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test, Alternate brand name: QuickFinder COVID-19 Antigen Self Test. Since the start of. Authorized devices in the table below are assigned the QKO product code. Another way to find the updated list of expiration dates is on the FDA's website. The test is to be performed two times over three days (serial testing). For more information about antibody testing, visit Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers. The TGA has now published the shelf-life information in the table below. 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. 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. Some antibody tests use blood samples from a finger stick. Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket, People with symptoms that began within the last 6 days. People have the option to buy an over-the-counter home COVID-19 test, but experts say they should make sure what they get has been approved by the U.S. Food and Drug Administration. Buy BinaxNOW Covid19 Antigen Self $19.88. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 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. This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. designed to detect more than one section of the proteins that make up SARS-CoV-2; more likely to continue to perform as labeled as new variants emerge. Innovita (Tangshan) Biological Technology Co., Ltd. IgM and IgG, lateral flow, Fingerstick Whole Blood, IgG, Fluoroenzyme Immunoassay, Semi-quantitative, IgG, ELISA, Home Collection, Fingerstick Dried Blood Spot, Total Antibody, Lateral Flow, Fingerstick Whole Blood, Total Antibody, Fluorescence Immunoassay, Fingerstick Whole Blood, Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette, CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette, Ecotest COVID-19 IgG/IgM Rapid Test Device, Fastep COVID-19 IgG/IgM Rapid Test Device, Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette, Sienna COVID-19 IgG/IgM Rapid Test Cassette, Telepoint SARS-CoV-2 IgG/IgM Rapid Qualitative Test. 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. UPDATE. It does not detect the virus. Please keep in mind that merely contacting Nelson Mullins Riley & Scarborough LLP will not establish an attorney-client relationship. 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. Real-time RT-PCR, Saliva, Multiple Targets, University of Alabama at Birmingham Fungal Reference Lab, Home Collection Kit, Direct to Consumer (DTC), Screening, Centers for Disease Control and Prevention (CDC), Real-time RT-PCR, Multi-analyte, Single Target, UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin, Real-time RT-PCR, Home Collection, Single Target, TMA, chemiluminescent, Home Collection, Multiple Targets, RT, LAMP, Home Collection, Screening, Multiple Targets, Real-time RT-PCR, Home Collection, Saliva, Single Target, University of California San Diego Health, RT-PCR and MALDI-TOF Mass Spec., Home Collection, Multiple Targets, TMA, chemiluminescent, Pooling, Multiple Targets, George Washington University Public Health Laboratory, Real-time RT-PCR, Multiple Targets, Home Collection, Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media, Multiple Targets, RT, non-isothermal nucleic acid amplification qSTAR, Single Target, Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target, Texas Department of State Health Services, Laboratory Services Section, RT-PCR, Home Collection, Saliva, Multiple Targets, RT, amplification, T2 Magnetic resonance, Single Target, Home Collection Kit, Screening, Multiple Targets, Real-time RT-PCR, Pooling, Home Collection, Multiple Targets. The newly authorized tests in the fight against COVID-19 are Abbott's BinaxNOW test and Quidel's QuickVue. "Most manufacturers have an ability where you can call or check online," Morrissey said. Jonas Edward Salk (/ s l k /; born Jonas Salk; October 28, 1914 - June 23, 1995) was an American virologist and medical researcher who developed one of the first successful polio vaccines.He was born in New York City and attended the City College of New York and New York University School of Medicine.. In Vitro Diagnostic EUAs: Overview and Templates. To see complete information on smaller screens, select the blue plus (+) button beside the test name. Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. GK Pharmaceuticals Contract Manufacturing Operations, Real-time RT-PCR, Saliva, Pooling, Multiple Targets, Real-time RT-PCR, Multiple Targets, Pooled Serial Screening Media, RT-PCR and MALDI-TOF Mass Spec. More information is available here. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device. 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 . The impacts of flu, COVID-19, and respiratory syncytial virus have underscored the importance of having tests . The test is to be performed two times over three days (serial testing). For best results, the company says to wait at least 24 hours (but no more than 48 hours) in between tests. . The Ohio State University Wexner Medical Center. Below are the lists of RT-PCR, antigen, and antibody rapid test kit brands that the Philippine Food and Drug Administration (FDA) has approved for commercial use, based on the performance. Seagen back in M&A talks after Merck walked away: WSJ Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul FDA hands first emergency authorization to over-the-counter test for both COVID and flu Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio BioCryst hits another hurdle, delays . 263a, that meet requirements to perform moderate complexity tests. Everything you need to know about Florida's theme parks and the all-new Attractions Insider podcast! HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi. On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. UPDATE. The site is secure. The FDA has updated expiration dates for those tests. The .gov means its official.Federal government websites often end in .gov or .mil. Jiangsu Bioperfectus Technologies Co., Ltd. Travel . Test attributes are listed in the "Attributes" column. The announcement made Pfizer and BioNTech the first companies to develop and test a working vaccine for COVID-19. "As more testing has been done, they've been able to evaluate those tests for a longer period of time," she said. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. COVID-19 Tests and Collection Kits Authorized by the FDA. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 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. The test is to be performed three times over five days (serial testing). Health Canada 50.5%. People with symptoms that began within the last 7 days. The standard regimen is the FDA-approved dosing regimen. 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. You can use the Test Type drop down box to select a Type of Test. Please help by moving some material from it into the body of the article. medical devices. The .gov means its official.Federal government websites often end in .gov or .mil. Expired at-home COVID tests can lead to inaccurate or invalid test results, but medical experts say to think twice before throwing them away. This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The types of samples include: Saliva samples are collected by spitting into a tube rather than using a nose or throat swab. "There's a page on their website where you can look up by the name of the test, and see what that expiration date extension is," Humm said. 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. According to the FDA's website, Elabscience at-home tests have yet to be FDA-approved. 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). Below is a list of the 11 tests currently approved by the FDA for use at home: The Food and Drug Administration has released the most current list of approved at-home COVID-19 tests.