W - Patient care settings operating under a CLIA Certificate of Waiver. The test is to be performed two times over three days (serial testing). In some cases, the expiration date for a test may be extended. 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. 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. 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. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. . 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. "Most manufacturers have an ability where you can call or check online," Morrissey said. 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 test is to be performed two times over three days (serial testing). 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. 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. The expiration date is set at the end of the shelf-life. (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. 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. designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome; more likely to continue to perform well when new variants emerge. 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). You can use the Test Type drop down box to select a Type of Test. . 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. Quidel QuickVue At-Home OTC . And not every authorized vaccine becomes fully approved. 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. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Blood Specimen Collection Tube Shortage: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Medical Device Supply Chain Notifications During the COVID-19 Pandemic, Medical Device Shortages During the COVID-19 Public Health Emergency, Supplies of Medical Devices for COVID-19: Frequently Asked Questions, Medical Device Types to Help Determine Section 506J Notification Obligations, Non-contact Temperature Assessment Devices During the COVID-19 Pandemic, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, Contacts for Medical Devices During the COVID-19 Pandemic, COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic, 63 home collection: Tests and collection kits where samples are collected at home and sent to a lab for processing, 32 pooling: Tests that process samples from multiple people at one time, 55 point-of-care: Tests and rapidly return a result at your doctor's office or other health care setting, 19multi-analyte: Tests that detect the virus that causes COVID-19 and other viruses like flu, 13 at-home: Tests performed at home with a self-collected sample, 38 home collection: Tests and collection kits where samples are collected at home and sent to a lab for processing, 18 pooling: Tests that process samples from multiple people at one time, 17 point-of-care: Tests and rapidly return a result at your doctor's office or other health care setting, 11 multi-analyte: Tests that detect the virus that causes COVID-19 and other viruses like flu, 3 at-home: Tests performed at home with a self-collected sample. . An official website of the United States government, : Templates for EUA submissions for several types of COVID-19 tests are available to help facilitate the preparation, submission, and authorization of an EUA request: These templates are part of the Policy for Coronavirus Disease-2019 Tests (Revised),which also includes additional policies specific to this public health emergency. "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. This page provides information on types of COVID-19 Tests and Supplies for laboratory personnel. Since the start of the pandemic, we authorized over 300 tests and collection kits, including: An official website of the United States government, : 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. H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Enter any combination of fields and select Search. For best results, the company says to wait at least 24 hours (but no more than 48 hours) in between tests. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. 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 Walmart. Before sharing sensitive information, make sure you're on a federal government site. 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. To see complete information on smaller screens, select the blue plus (+) button beside the test name. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). Covering Phoenix, Mesa, Glendale, Scottsdale, Gilbert, the valley . vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Currently the FDA HAS NOT approved any at-home or self-test kits. To see complete information on smaller screens, select the blue plus (+) button beside the test name. At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target,Telehealth Proctor Supervised (optional), Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Multiple Targets, Lateral Flow, Visual Read, Serial Screening, Single Target, Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target, Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target, Microfluidic Immunofluorescence Assay, Instrument Read, Serial Screening, Single Target, Lateral Flow, Visual Read, Single Target, Serial Screening, Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target, Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA), Single Target, Lateral flow immunoluminescent assay, instrument read, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target, Chemiluminescence Immunoassay, Instrument Read, Single Target, Lateral Flow, Visual Read, Multi-analyte, Single Target, Lateral Flow, Visual Read, Prescription Home Testing, Single Target, Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target, Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Serial Screening, Single Target, Lateral Flow, Visual Read, Serial Screening, Multiple Targets, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Single Target, Lateral Flow, Visual Read,Serial Screening, Single Target, Digital Lateral Flow, Fluorescence, Instrument Read, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target. 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. 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. To be on this list, a lab must meet 4 criteria: Lab has a valid California clinical laboratory license and a CLIA certificate. They detect current infection and are sometimes also called "home tests," "at-home tests," or "over-the-counter (OTC) tests.". The newly authorized tests in the fight against COVID-19 are Abbott's BinaxNOW test and Quidel's QuickVue. This table includes information about authorized SARS-CoV-2 serology/antibody tests and other adaptive immune response teststhat have been authorized individually. . The tests detect different parts of the Covid virus and vary in sensitivity. The most important thing to consider when looking for an updated expiration date is the brand or manufacturer of the at-home COVID test. 263a, that meet requirements to perform high complexity tests. This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. 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. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. View graphs and map for Testing in U.S. for COVID-19. Molecular tests are more. Find All FDA-Approved Home and Lab Tests You can find information about each home or lab test that FDA has approved or cleared by searching FDA's Database of In Vitro Diagnostic (IVD). In this photo illustration, an at-home COVID-19 test by . The standard regimen is the FDA-approved dosing regimen. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. More information is available here. Everything you need to know about Florida's theme parks and the all-new Attractions Insider podcast! {or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}, See Appendix A table below for a list of tests authorized under this EUA. Rapid tests detect protein. The site is secure. The. 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. Requires a Cue Cartridge Reader (sold separately). Individuals ages 14 and older . 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. 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. These include molecular tests,. The FDA is actively researching the accuracy of at-home and self-test kits. The FDA has updated expiration dates for those tests. 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. The shelf-life is how long the test should work as expected and is measured from the date the test was manufactured. Different tests are authorized to be used with different types of samples. People with symptoms that began within the last 7 days. 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 . The .gov means its official.Federal government websites often end in .gov or .mil. The site is secure. The templates reflect the FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. (August 2022) Everything you need to know about the next launch and detailed coverage on space missions. 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. There's a new federal resource to get free FDA-authorized coronavirus test kits. People with symptoms that began within the last 5 days. To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. . 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.. This test is usually conducted at the point-of-care or a sample is collected and . Sara Humm, the senior planner with the Columbia/Boone County Public Health and Human Services said originally, the at-home tests had an expiration date between four and six months. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). Get hyperlocal forecasts, radar and weather alerts. For Test Name and Manufacturer: enter a single word (e.g., analyzer) or an exact phrase (e.g., acme analyzer). 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. Before sharing sensitive information, make sure you're on a federal government site. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. Learn More. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. People with symptoms that began within the last 4 days. 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. 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. The types of samples include: Saliva samples are collected by spitting into a tube rather than using a nose or throat swab. Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUArequest to CDRH-EUA-Templates@fda.hhs.gov. On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from. Authorized at-home OTC tests are available without a prescription and are typically available online or at local stores. 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. 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. HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi. The .gov means its official.Federal government websites often end in .gov or .mil. Age 2 years and older when collected by an adult, Requires supervision of a telehealth proctor and a smartphone or computer, People with symptoms that began within the last 7 days, People without symptoms. 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. In Vitro Diagnostic EUAs: Overview and Templates. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. USGC Saliva Test Kit, hims/hers Saliva Test Kit, AZOVA At-Home COVID-19 Test Collection Kit, Wellness 4 Humanity SDNA-1000 Saliva Collection Kit, AZOVA P23 At-Home COVID-19 Test Collection Kit, binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting, Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 . <section jsaction="rcuQ6b: trigger.EGZ8Jb" jscontroller="ThIs3" jsshadow class="XzbSje m586Kb JGNgFd VLrnY eO2Zfd " aria-labelledby="_ypbgzc_i1 _Eq2Xzc_i2" data . 263a, that meet requirements to perform moderate complexity tests. The FDA said the tests. COVID-19 Tests and Collection Kits Authorized by the FDA. Before sharing sensitive information, make sure you're on a federal government site. Appendix J - Sample Updated Fact Sheet for Health Care Providers, Appendix K - Sample Updated Fact Sheet for Patients, EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing, Appendix L - Fact Sheet for Health Care Providers (Template), Appendix M - Fact Sheet for Patients (Template), Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19), Orig3n 2019 Novel Coronavirus (COVID-19) Test, Biocollections Worldwide SARS-Co-V-2 Assay, Avera Institute for Human Genetics SARS-CoV-2 Assay, Real-time RT-PCR, Home Collection, Saliva, Multiple Targets, RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets, Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling, Laboratory Corporation of America (Labcorp), Direct to Consumer (DTC), Real-time RT-PCR, Multi-analyte, Home Collection, Single Target, End-Point RT-PCR, Screening, Multiple Targets, Home Collection Kit, Screening, Single Target, Real-time RT-PCR, Home Collection, Screening, Multiple Targets, RT, LAMP, Lateral Flow Strips, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Real-time RT-PCR, Multi-analyte, Multiple Targets, Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets, Yale School of Public Health, Department of Epidemiology of Microbial Diseases, Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target, Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Real-time RT-PCR, Home Collection, Multiple Targets, The Mount Sinai Hospital, Center for Clinical Laboratories, Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets, Centers for Disease Control and Prevention's (CDC), Real-time RT-PCR, Pooling, Multiple Targets, Wadsworth Center, New York State Department of Public Health, RT-PCR and electrochemical detection, Single Target, Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets, Real-time RT-PCR, Pooling, Screening, Multiple Targets, RT, Nested multiplex PCR, Pooling, Saliva, Multiple Targets, Real-time RT-PCR, Pooling, Screening, Saliva, Multiple Targets, RT, Isothermal amplification, Single Target, RT-PCR, Collection Kit, Saliva, Multiple Targets, RT-PCR, CoPrimer technology, Single Target, Real-time RT-digital PCR, Multiple Targets, Real-time RT-PCR, Screening, Multiple Targets, RT, Isothermal amplification, Multiple Targets, RT-PCR, Home Collection, Saliva, Single Target, Fast Track Diagnostics Luxembourg S..r.l. OTC - Over The Counter. The .gov means its official.Federal government websites often end in .gov or .mil. Additional information can be found on the FAQs on Testing for SARS-CoV-2 page. 263a, that meet requirements to perform moderate complexity tests. Viral Mutation Revision Letter September 23, 2021.