Antigen tests, typically performed rapidly at the point of care, detect the presence of viral proteins, rather than testing for an immune response in the patient, are a significant factor in the market for COVID-19 testing already, according to market researcher Kalorama Information, part of Science and Medicine Group. In its latest COVID-19 Update report , Kalorama Information said that volume was up in labs and among IVD vendors, new technologies are available. The firm projects a 10.5 billion-dollar market for COVID-19 in vitro diagnostic test products, including PCR, antigen tests and other types of tests. This is an increase of over one billion dollars from the firm’s August update, with much of the increase based on the production and usage of antigen tests.
With over a million deaths worldwide, the COVID-19 crisis has continued to unfold with great challenges for the healthcare system and its suppliers. But creative solutions have been emerging at labs to help ease the load during a difficult time Antigen tests are among those, and major companies have launched such tests in the last six months. They are already seeing a market, according to Kalorama.
Antigen tests can offer some major benefits in the effort to control the SARS-CoV-2 pandemic. The decision to apply antigen tests in certain situations as opposed to others is complicated and is still being completely sorted out. The decision to apply antigen testing depends on variables including: sensitivity and specificity of the test, prevalence/ outbreak of COVID-19 in the given population, remote location, availability of laboratories/ hospitals, cost, ability to perform serial testing, and other factors.
The scarcity of various diagnostic test related products during the COVID-19 pandemic has further driven home the reality that different testing methods are best allocated for different situations.
“While antigen tests have been criticized for the lower performance characteristics compared to antibody and molecular tests, these metrics are not always the most significant,” said Justin Saeks, analyst for Kalorama Information and author of the report’s antigen test section. “Antigen tests often can have sensitivity lower than 85% while the specificity needs to be fairly high, in the range of 98% or higher. Although a sensitivity of roughly 80% seems striking as a low number, in fact the negative predictive value can still be sufficient if the disease prevalence is appropriately matched.”
The frequency with which PCR tests were launched and authorized in the early part of the year is now being seen with antigen tests, Kalorama said. Millions of tests are in production at the current time and more tests are in development.
Antigen tests marketed or in development include:
- Abbott Laboratories -BinaxNow COVID-19 Ag Card & Navica app
- BD-BD Veritor System for Rapid Detection of SARS-CoV-2
- BIOHIT SARS-CoV-2 Antigen Rapid Test Kit (CE)
- Edinburgh Genetics – ActivXpress+ COVID-19 Antigen Complete Testing Kit
- FenHe Technology -reOpenTest COVID-19 Rapid Antigen Test
- LumiraDx – SARS-CoV-2 Ag Test
- Menarini Diagnostica/ Boditech Med – iChroma COVID-19
- OraSure Technologies – at-home test (announced)
- Ortho Clinical Diagnostics – VITROS (EUN to FDA accepted)
- Qiagen – QIAreach™ SARS-CoV-2 Antigen Test (announced launch)
- Quidel – Sofia 2 SARS-COV-2 Antigen Test
- Roche – SARS-CoV-2 Rapid Antigen Test (CE)
- Sona Nanotech – Sona COVID-19 Rapid Antigen Test
- Tigsun Diagnostics – COVID-19 Antigen Saliva Rapid Test
In addition to these tests, Roche has announced its intention to launch a lab-based antigen test, Ortho Clinical Diagnostics has submitted notice for emergency use of a lab-based antigen test on its VITROS system, and Quidel has submitted a rapid, visually read SARS-CoV-2 antigen test on its QuickVue product line to the EUA.
Kalorama’s report said that antigen tests will not replace PCR but both testing types will fuel growth until the disease recedes or a pharmaceutical intervention is found, widely distributed and changes disease patterns. Kalorama’s report can be found here: https://kaloramainformation.com/product/covid-19-update-clinical-testing-telehealth-vaccines-and-other-markets/
About Kalorama Information:
Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, healthcare, medical devices, and pharmaceuticals. Science and Medicine Group supports companies seeking to commercialize the rapidly changing marketplace at the intersection of science, medicine, and technology. Comprised of industry-leading brands, Science and Medicine Group serves analytical instrument, life science, imaging, and clinical diagnostic companies by helping them create strategies and products to win markets and provide platforms to digitally engage their markets through a variety of innovative solutions. Kalorama Information produces 30 reports a year. The firm offers a Knowledge Center, which provides access to all published reports.