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Prominent epidemiologists and medical professionals are advocating the introduction of inexpensive rapid antigen immunoassay tests, similar to a home pregnancy test. Prototypes of tests are currently under evaluation, but will lack the sensitivity of laboratory PCR assays. The demand for rapid tests is based on the reality that PCR assays may not yield a result for most citizens even those wit symptoms for periods up to 10 days. It is critical to establish whether an individual is infectious at a point in time and to initiate quarantine and contact tracing based on a positive assay. Opening schools, fitness clubs, and many other applications that will be required to establish a semblance of normalcy obviously requires rapid results from testing.
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Rapid, Lateral Flow Immunoassay device to detect COVID antigen |
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 We would be in a more favorable position to limit COVID-19 with a $3 test, providing results in 15 minutes with 70 percent sensitivity, than attempting to limit infection in the face of rising incidence rates using a PCR assay with 98 percent sensitivity, costing $100 and providing results in four to ten days. The antigen detection test can in any event be repeated using PCR assay in a laboratory. The major restraint to adoption will be FDA approval although there are provinsions for emergency and expedited review. The National Institute of Health has funded new technology for point-of-care and laboratory use to the value of $250 million with anticipated introduction in the fourth quarter. The U.S. needs a simple and inexpensive lateral flow antigen test for home use yielding results in less than 30 minutes.
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Laboratory-based PCR assays |