Here is the link. This tech looks great, nice idea to use monoclonal Ab for a specific viral envelope marker. Read current biophysics/bioelectronics/materials science journals and you’ll see that many biosensor technologies have used a similar design. Concept has been validated in these additional studies.
I agree it would be refreshing to see false positive and false negative rates. But from what I’ve read, there can be a relatively large margin of error and FDA can still deem the test effective. These types of diagnostic tests have less stringent efficacy criteria than molecular amplification-based diagnostics.
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