Some at-home rapid tests on the FDA-approved list that could arrive . The .gov means its official.Federal government websites often end in .gov or .mil. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. dba MicroGen DX, Columbia University Laboratory of Personalized Genomic Medicine, BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the. People without symptoms. 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. Covering Phoenix, Mesa, Glendale, Scottsdale, Gilbert, the valley . 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. 3. Skip to main content . The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. COVID-19 Tests and Collection Kits Authorized by the FDA. Travel . For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance page. , 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. UPDATE. . . vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. 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. For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). 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. But the move came after tests last month showed the masks didn't meet standards. 263a, that meet requirements to perform moderate complexity tests. . H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. "As more testing has been done, they've been able to evaluate those tests for a longer period of time," she said. Walmart. The most important thing to consider when looking for an updated expiration date is the brand or manufacturer of the at-home COVID test. "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. databases. 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. Diagnostic Covid tests fall into two buckets: molecular tests and antigen tests. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. In 1947, Salk accepted a professorship at the University of Pittsburgh School of . If you think you need a COVID-19 diagnostic test, you can find a community testing site in your state. 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. SAN DIEGO Pilot projects launched last year to examine how information warfare gurus can enhance submarine operations may yield long-term plans. In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test. Here is the commission's guidance as well as how to understand the tests: Check whether the COVID-19 test is FDA-approved . The FDA has 17 authorized at-home rapid tests for detecting COVID-19 and advises people only use authorized tests to avoid false negatives. . 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. Lab is submitting data to CalREDIE (either . In a statement, the agency is urging people to stop using the LuSys Laboratories COVID-19 Antigen Test and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates. 263a, that meet requirements to perform high complexity tests. 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. This test is usually conducted at the point-of-care or a sample is collected and . The .gov means its official.Federal government websites often end in .gov or .mil. W - Patient care settings operating under a CLIA Certificate of Waiver. Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Ag Card Home Test, Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Antigen Self Test, Access Bio, Inc.:CareStart COVID-19 Antigen Home Test, ACON Laboratories, Inc:Flowflex COVID-19 Antigen Home Test, Aptitude Medical Systems Inc.:Metrix COVID-19 Test, Becton, Dickinson and Company (BD):BD Veritor At-Home COVID-19 Test, Celltrion USA, Inc.:Celltrion DiaTrust COVID-19 Ag Home Test, CTK Biotech, Inc.:ImmuView COVID-19 Antigen Home Test, Cue Health Inc.:Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Genabio Diagnostics Inc.:Genabio COVID-19 Rapid Self-Test Kit, iHealth Labs, Inc.:iHealth COVID-19 Antigen Rapid Test, InBios International Inc:SCoV-2 Ag Detect Rapid Self-Test, Lucira Health, Inc:Lucira CHECK-IT COVID-19 Test Kit, Maxim Biomedical, Inc.:MaximBio ClearDetect COVID-19 Antigen Home Test, Mologic, Inc.:COVI-Go SARS-CoV-2 Ag Self-Test, OraSure Technologies, Inc.:InteliSwab COVID-19 Rapid Test, PHASE Scientific International, Ltd.:INDICAID COVID-19 Rapid Antigen At-Home Test, Quidel Corporation:QuickVue At-Home OTC COVID-19 Test, SD Biosensor, Inc.:Pilot COVID-19 At-Home Test 1, Siemens Healthineers:CLINITEST Rapid COVID-19 Antigen Self-Test, Watmind USA:Speedy Swab Rapid COVID-19 Antigen Self-Test, Xiamen Boson Biotech Co., Ltd.:Rapid SARS-CoV-2 Antigen Test Card, ANP Technologies, Inc.:NIDS COVID-19 Antigen Home Test, Beijing Hotgen Biotech Co., Ltd.:Hotgen COVID-19 Antigen Home Test, Azure Biotech Inc.:Fastep COVID-19 Antigen Home Test, Oceanit Foundry LLC:ASSURE-100 Rapid COVID-19, Advin Biotech Inc.:Advin COVID-19 Antigen Test @Home, GenBody Inc.:GenBody COVID-19 Ag Home Test, Lucira Health, Inc.:Lucira COVID-19 & Flu Home Test, An official website of the United States government, : There's a new federal resource to get free FDA-authorized coronavirus test kits. The test is to be performed three times over five days (serial testing). Rapid tests detect protein. More information is available here. If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. In Vitro Diagnostic EUAs: Overview and Templates. Our Spectrum News app is the most convenient way to get the stories that matter to you. 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. The FDA is actively researching the accuracy of at-home and self-test kits. 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. 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. Authorized devices in the table below are assigned the QKO product code. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. As the number of people wanting to get tested for COVID-19 ahead of the holidays has spiked in recent days, many people have gone looking for an alternative that doesn't involve sitting in a line of cars for hours at a time. 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