At-Home Testing: COVID-19 Trends and Future Potential
This first edition report At-Home Testing: COVID-19 Trends and Future Potential provides an overview of trends and developments in the home testing industry for the pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This report covers trends that have occurred since the pandemic was declared in 2020 to the recent present – March 31, 2021.
For the purpose of this report, Kalorama Information concludes that the accepted definition of a home or self-test is one whereby the individual takes the sample, performs the test and then interprets the test result either alone or with the aid of an online consultation service. As of the time of publication in Spring 2021, the major market for COVID-19 self-tests is the United States, therefore the discussion presented in the report focuses on that geography.
Many non-instrumented point-of-care (POC) COVID-19 tests use immunoassays and molecular technologies. They have not been officially designated as home tests but do have the potential to migrate to home-based tests as is deemed necessary by public health agencies. These COVID-19 point-of-care molecular tests are therefore included in this Kalorama Information report.
The report discusses COVID-19 tests and technologies that are currently available and those that are expected to take their place. The report covers trends and issues concerning:
- government support for COVID-19 home tests
- COVID-19 home test sample types
- COVID-19 home test modalities
- OTC and DTC trends in COVID-19 testing
- Abbott Laboratories
- Becton Dickinson & Company (BD)
- bioMérieux / BioFire Diagnostics
- Cepheid, A Danaher Company
- Fluidigm Corporation
- GenMark Diagnostics, Inc., A Roche Diagnostics Company
- LetsGetChecked/PrivaPath Diagnostics Limited
- Lucira Health
- LumiraDx
- Mesa Biotech
- OraSure Technologies, Inc.
- QIAGEN N.V.
- Quidel Corporation
- Roche Diagnostics
- Sherlock Biosciences
- Siemens Healthineers
- Executive Summary
- Background
- Scope and Methodology
- United States of America
- Canada
- Europe
- United Kingdom
- Definitions
- Point of View
- Government Support for COVID- 19 Home Tests
- Background
- U.S. EUA Tests and Home Test Services
- Canada's COVID-19 Test Initiative
- Table Number of Canada Authorized COVID-19 Testing Devices, by Device Type
- Resources
- COVID-19 Test Initiatives in Europe and the UK
- Table Selected CE Marked Rapid, POC COVID-19 Tests, by Company
- COVID-19 Home Test Sample Types
- Background
- Table Major Sample Types Used in Rapid Diagnostic Tests For COVID-19, by Percent
- Sample Self Collection Kits
- Table Selected COVID-19 Authorized Sample Collection Kits, by Company
- Nasal Swabs Maintain Market Dominance
- Table Selected COVID-19 Self-Tests Using A Nasal Swab, by Company
- Saliva Sampling Gains Popularity
- Table Selected Saliva-Based Self-Tests for COVID-19, by Company
- Alternative Sampling Innovations
- Table Selected COVID-19 Tests Using Alternate Samples, by Company
- Background
- COVID-19 Home Test Modalities
- Background
- Table Major Test Technologies Used in Rapid Diagnostic Tests for COVID-19, by Percent
- Traditional Molecular - PCR, LAMP
- Table Selected Home and POC Molecular COVID-19 Tests, by Company
- CRISPR & Biosensors
- Table Selected CRISPR and Biosensor-Based Devices for COVID-19 Testing, by Company
- COVID-19 Antigen Testing By Immunoassay
- Table Selected FDA EUA and CE Marked COVID-19 Antigen Immunoassays, by Company
- COVID-19 Antibody Tests by Immunoassay
- Table Selected FDA EUA and CE Marked COVID-19 Antibody Immunoassays, by Company
- Background
- Rapid COVID-19 Tests Migrate to Over the Counter (OTC) and Direct to the Consumer (DTC) Venues
- Background
- OTC and DTC Initiatives
- Table Selected OTC and DTC COVID-19 Test Initiatives, by Company
- And Now For Something a Little Bit Different
- Table Selected Novel COVID-19 Test Initiatives, by Company
- COVID-19 Self and Home Testing in the Post Pandemic Era
- Background
- What Is The Status Quo
- The Future for Home Covid-19 Tests
- Company Summaries
- Background
- Abbott Laboratories
- Becton Dickinson & Company (BD)
- bioMérieux / BioFire Diagnostics
- Cepheid, a Danaher Company
- Fluidigm Corporation
- GenMark Diagnostics, Inc.
- LetsGetChecked/PrivaPath Diagnostics Limited
- Lucira Health
- LumiraDx
- Mesa Biotech
- OraSure Technologies, Inc.
- QIAGEN N.V.
- Quidel Corporation
- Roche Diagnostics
- Sherlock Biosciences
- Siemens Healthineers
- From At-Home COVID-19 to Other Testing Areas?
- What Test Categories May Benefit From At-Home Testing Trend?
- Table Test Categories Ranked by At-Home Potential Opportunity
- Cancer
- COVID-19
- Coagulation
- H. Pylori
- UTI
- STI
- Flu and Respiratory
- HIV
- Cholesterol
- Table Projected Percentage of Tests Conducted at Home by Test Category, 2021
- What Test Categories May Benefit From At-Home Testing Trend?
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