In its COVID-19 Update report, Kalorama Information said that volume was up in labs and among IVD vendors, new technologies are available.  Kalorama projects a 10.5 billion-dollar market for COVID-19.  This is a 1 billion dollar increase from previous estimates.

For most aspects of the diagnostic testing process, there has still been a learning curve for all involved. Even in the fall of 2020, there are capacity limitations, questions about testing accuracy, and challenges with sample collection. But creative solutions have been emerging at labs to help ease the load during a difficult time.  With over a million deaths worldwide, the COVID-19 crisis has continued to unfold with great challenges for the healthcare system and its suppliers.

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.

Rapid antigen tests are one of the factors driving growth; these tests can offer some major benefits in the effort to control the SARS-CoV-2 pandemic. The decision to apply antigen tests in certain situation 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
  • Turnaround time of the test
  • Cost of the test
  • Ability to perform serial testing

The momentum of cases and tests, since our Kalorama’s COVID-19 Update in May has not slowed, sadly.  There are over 45 million cases worldwide; 9 million of them in the United States. The trend is troubling as well, and there are fears of increases as the U.S. influenza season has arrived. (perhaps mitigated, perhaps not by reports of a milder flu season based on the experience in the southern hemisphere).

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. 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.

Marketed Tests

Marketed tests include:

  • Abbott Laboratories -BinaxNow COVID-19 Ag Card & Navica app
  • Access Bio -CareStart COVID-19 Antigen
  • BD-BD Veritor System for Rapid Detection of SARS-CoV-2
  • BIOHIT -HealthCare SARS-CoV-2 Antigen Rapid Test Kit
  • Confirm BioSciences -Verasure COVID-19 Antigen Rapid Swab Test
  • Dynamiker Biotechnology – Dynamiker SARS-CoV-2 Ag Rapid Test
  • Edinburgh Genetics – ActivXpress+ COVID-19 Antigen Complete Testing Kit
  • FenHe Technology -reOpenTest COVID-19 Rapid Antigen Test
  • JOYSBIO Biotechnology – COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
  • LumiraDx – SARS-CoV-2 Ag Test
  • Menarini Diagnostica/ Boditech Med – iChroma COVID-19
  • OraSure Technologies – at-home test
  • Roche – SARS-CoV-2 Rapid Antigen Test
  • Sensitest – Corona Antigen Rapid Test
  • Sona Nanotech – Sona COVID-19 Rapid Antigen Test
  • Tigsun Diagnostics – COVID-19 Antigen Saliva Rapid Test

Unique and Proprietary Technologies

In addition to the standard formats such as lateral flow and ELISA, there are also a number of unique technologies being applied for SARS-CoV-2 antigen testing. These include the following examples of companies and their products/ technologies that are either available or in development:

  • AmonMed Biotechnology – Rare Earth Nano Fluorescence Immunochromatography Avacta/ Adeptrix with Cytiva (Danaher) – working on rapid
  • POC saliva test for self-testing and large scale population screening
  • Celltrion – Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA) technology – CLIA high and medium complexity
  • E25Bio – paper based nasal swab test
  • Ellume – working with Qiagen on test cartridges for home use, POC, and high throughput system
  • Genspeed Biotech – micro-ELISA
  • Luminostics – antigen immunoassay that uses glow-in-the-dark nanomaterials
  • New Gene (Hangzhou) Bioengineering – novel ligand-receptor chromatography test kit

In October, the FDA provided a template to help test developers applying for EUA for SARS-CoV-2 antigen tests. The template provides a range of recommendations as well, for example in order to show the test suppliers how to handle their validation data. Many of these are suggested but not required.   The template recommends that antigen tests should have a sensitivity of at least 80%, but noted that serial testing could allow for results of lower-performing tests (e.g. 70% sensitivity) to be calculated cumulatively.

Vendor Moves

The shift to antigen testing introduces different vendors into the COVID-19 market than are present in PCR. BD and Quidel for instance, are players in antigen testing and have systems with significant placements worldwide.

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. 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.

Becton Dickinson (BD) BD and Quidel, as well as Roche and Abbott are significant players in antigen testing; there are scores of others.  On July 6, 2020 BD announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System. The launch of this new assay that delivers results in 15 minutes on a portable instrument. BD Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states, per the company.

Earlier in the year, Quidel earned an EUA for The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. Now the company has received a U.S. Food and Drug Administration emergency use authorization (EUA) for a rapid diagnostic that can simultaneously identify influenza A, influenza B, and the novel coronavirus. The ABC Test, also known as the Sofia 2 Flu + SARS Antigen FIA, is a cartridge-based, point-of-care diagnostic that works with both nasopharyngeal and nasal swab specimens. The test is designed for use in individuals with suspected respiratory viral infection within five days of symptom onset, according to the company. The three-way test works with the Sofia 2 Fluorescent Immunoassay Analyzer (FIA) and provides results within 15 minutes.

Abbott: On August, 26th, 2020, Abbott Launched its sixth COVID-19 test, the BinaxNOW™ COVID-19 Ag Card rapid antigen test – a fast, reliable, affordable and portable rapid test that Abbott will produce at mass scale to greatly expand access to testing to people who need it. The company said they would ship millions in September, ramping production to 50 million tests a month in October. This test offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on an optional app for iPhone and Android devices called NAVICA™. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.

Roche Diagnostics has a rapid antigen test and recently announced that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.

On November 5th, Ortho Clinical Diagnostics announced that the FDA   accepted the company’s Emergency Use Notification (EUN) for the new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection. The company has also submitted an Emergency Use Authorization (EUA).    The company said that with high sensitivity and specificity,ii Ortho’s SARS-CoV-2 antigen test offers exceptional utility for mass-scale testing where appropriate. The company is promoting it’s ability to detect infectious patients based on viral load. Per OrthoClinical Diagnostics, studies showed that samples with PCR cycle threshold (CT— a measure of viral load) levels at 30 – 33 or greater carry little to no live virus, suggesting these patients may no longer be infectious. Compared to PCR, the company says Ortho’s test may be better able to identify individuals with COVID-19 who are infectious because the test is offered with 100 percent sensitivity with samples with a CT count of less than 34.

Kalorama’s report says the jury is out on how much antigen tests like those by Quidel or Ortho are replacing and would replace molecular detection methods. They have different purposes for the most part. Right now the most likely path is that both methods would see usage into 2021, until the disease were to recede or significant and widely distributed pharmaceutical solutions were available.  Kalorama’s report is available at: https://kaloramainformation.com/product/covid-19-update-clinical-testing-telehealth-vaccines-and-other-markets/

 

 

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