100% Specificity. 100% Sensitivity.

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This includes items that one of my dedicated blog readers, Alana, asked me in private. I’m guessing many of you had similar questions.

East Coast.  West Coast.  Jennifer Doudna.  Feng Zhang.  UC Berkeley.  MIT.

By now, if you are at all technologically aware, you know I am talking about CRISPR (clustered regularly interspaced short palindromic repeats), a method of rapidly analyzing, duplicating, or manipulating the genomes of prokaryotic organisms.

And, 12 days ago, the FDA approved a CRISPR gene-editing device that can rapidly detect SARS-CoV-2, the novel coronavirus that causes COVID-19.  Right now, only highly capable laboratories are allowed to effect this test, though.

The test was conceived by Dr. Zhang and his cohorts at MIT, Harvard, Ragon Institute, and the Howard Hughes Medical institute (HHMI)- but will be marketed by Zhang’s company (Sherlock Biosciences, Boston).  And, they (that’s Zhang, Jonathan Gootenberg and Omar Abudayyeh) are working on a much simpler method that will let almost anyone run the diagnostic (for point of care and home use).

Sherlock Biosciences

(By the way, Zhang’s firm is called Sherlock because of the variant of the CRISPR device they employ.  SHERLOCK stands for Specific High-sensitivity Enzymatic Reporter unlocking, which targets RNA, rather than DNA.  In this case, the device is seeking a specific RNA sequence that is endemic to SARS-CoV-2.)

As for now, the process employs a CRISPR-developed (i.e., engineered) molecule that recognizes the genetic signature of the SARS-CoV-2 virus.  And, in so doing, the enzyme is activated and produces a signal to notify the assayer that the virus is present.

The FDA (and the rest of us) has a goal- not only to have a rapid test  – and one that is simple- but one that can analyze more than thousands of samples each and every day.

CRISPR Coronavirus Test

This test has 100% specificity and sensitivity- a highly desirable result.  (100% specificity- only reacts to the desired item, in this case, SARS-CoV-2;  100% sensitivity- reacts to the presence and not to the absence of SARS-CoV-2.) Results from the 3 step test are available in an hour.  The steps involve incubation (25 minutes) and recombinase polymerase amplification of the genetic material that is swabbed from a patient [isothermal reaction], a 30 minute step where the viral RNA is amplified and tagged with a fluorescent monitor, and then 2 minutes later the results are manifested on a paper dipstick.

It’s about time we can test folks quickly and accurately.

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8 thoughts on “100% Specificity. 100% Sensitivity.”

  1. This is very good news.Hope India can get access to such a good testing method soon.We need to test more.

  2. It’s about time. It is PAST about time. Especially when I saw saliva could be used. My brother in law has now had four of the swab tests: the initial diagnostic test and now three more to see if (after his hospitalization) he is finally negative. At this point, the tests here still take a good 24 hours and you have to be in several named classes to be eligible for testing. This testing is exactly what we need.
    Alana recently posted..Wildflower Wednesday Spring #WordlessWednesday

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