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The Need for Rapid COVID Tests

 08/04/2020

With the ongoing surge in incidence of COVID cases affecting both rural and urban areas, it is considered essential that the U.S. should have available a rapid home-deployable, inexpensive test kit to provide results within minutes, without requiring any form of reader or equipment other than perhaps a cell phone.

 

In recognition of the imperative to have rapid tests available, the National Institutes of Health is investing $250 million in technology to detect SARS-CoV-19 the virus responsible for COVID-19.  This is in recognition of the futility of having potentially exposed individuals in a community having to wait for up to to three days for a test and then enduring a turnaround time of 3 to 12 days.  The purpose of testing is to identify potentially infective individuals, irrespective of systems so that they can be quarantined and their contacts can be traced.  This is especially relevant given the imminent reopening of schools, businesses and entertainment.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), within the National Institutes of Health, is tasked with developing and accelerating the application of biomedical technology.  The NIBIB will undertake implementation of the RADx Advanced Technology Program coordinating federal agencies and industry.

 

Recently Alex Azar, Secretary of the Department of Health and Human Services, stated, “RADx has moved quickly to select promising technologies through its ‘Shark Tank’ approach investing in technologies that could boost America’s COVID-19 testing capacity.”  He added, “These technologies will help deliver faster results from labs and more and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes.”

 

Dr. Francis S. Collins, Director of the NIH, commented, “The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed.”

 

Current tests under development are classified according to point-of-care or laboratory-based systems.

 

The point-of-care devices comprise:

  • Mesa Biotech has developed the Accula SARS-COV-2 test using RT-PCR that can detect viral RNA using a removable cartridge with a 30 minute response time.
  • Quidel will market the Sofia SARS antigen lateral flow immunoassay kit requiring an analyzer, but providing results within 15 minutes. Sofia analyzers are currently in use.
  • Talis Biomedical point-of-care kit uses a multiplex cartridge detecting viral antigen applying isothermal amplification of viral RNA through an optical detection system, yielding a result in 30 minutes.

 

The laboratory-based tests include:

 

  • Ginkgo Bioworks applying next-generation sequencing technology.  The company intends providing seamless sample collection and reporting of results within 48 hours with a projected throughput of 100,000 tests per day by December.
  • Helix OpCo will apply next-generation sequencing to process up to 100,000 samples per day by December with a 48 hour turnaround.
  • Fluidigm, their BioMark HD microfluidics employs an integrated fluidic chip.  Existing fluidigm instruments are installed in research laboratories and it is anticipated that the company will be able to process 100,000 tests per day by the fourth quarter of 2020.
  • Mammoth Biosciences Inc applies CRISPR technology to provide faster assays compared to PCR.

 

Point-of-care tests are acceptable for hospitals, physicians’ offices, and senior homes.  Laboratory assays require collection and submission of specimens and a system to inform patients of their results.  Both approaches presume either presentation at a medical facility, or a delay following submission of a specimen.  The obvious advantages of a low cost test are self -evident even if it lacks sensitivity,.  It is indeed disappointing that NIH, through the NIBIB, has not seen fit to allocate part of the $1.5 billion received to develop a lateral flow immunoassay kit, similar to a pregnancy or influenza test.  It is hoped that this deficiency will be overcome either by government support or entrepreneurial initiative.