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2020 MEDICAL YEAR
           IN REVIEW



        Testing for Evidence of the



        COVID-19 Virus



        By Alan Preston, MHA, Sc.D.



             Ever since COVID-19 was present in the USA, the challenge was to determine how fast would
            it spread and what harm could it cause, and to whom? In the world of epidemiology, we look at
            the incidence rate of a disease as the first onset of the disease.  The prevalence of a disease is the
            number of people who have already acquired the disease. Capturing the rate of transmission of
            any given communicable disease requires an understanding of both.



          Early this year (i.e., February 2020), the   (CLI) should be tested to rule in/out   to 40 to indicate a positive COVID-19?
        news agencies reported the number of cases   COVID-19. When over 90% of the tests are   The implication is many people are labeled
        every day based on those tested. The prob-  negative, that suggests the public has a high   positive for COVID-19 when they should be
        lem, in the beginning, was that the correct   degree of fear and desire to understand   labeled negative.  They should be labeled neg-
        number of cases in the general population   whether they are infected. Their ILI symp-  ative because of the viral load. The PCR test
        was at least ten times more than the number   toms may be related to allergies, a superficial   amplifies genetic matter from the virus in cy-
        of cases being reported. This created two sig-  sinus infection or a postnasal drip that causes   cles. If you find a high amount of viral load
        nificant problems; one underestimated the   a cough or sneezing unrelated to COVID-  in a person, fewer cycles are required. The
        number of infected individuals and overesti-  19. The challenge for many healthcare pro-  greater the viral load, the more likely the pa-
        mated the death rate (i.e., case fatality rate   fessionals is when to perform a test and what   tient is to be contagious. And if it takes 40
        CFR) since the death rate is based on the   kind of test should they perform?   cycles to detect a small amount of viral load,
        number of infected cases.  And not until mid-  There are primarily two categories of   then the likelihood that the "infected" person
        March did the testing begin in earnest to   COVID-19 tests; the PCR test and the An-  can pass the virus is significantly negligible.
        more accurately determine how many people   tibody test. The PCR test is appropriate for   Unfortunately, the number of amplifica-
        may be infected. The number of tests before   current diagnosis for the most part, which I   tion cycles needed to find the virus is never
        mid-March was less than 60 per day, which   will explain in a bit, and the Antibody test is   included in the results sent to doctors. If it
        increased to 127,000 per day on March 18,   used to determine if someone had COVID-  were, doctors could tell how infectious the
        2020. As of November 2020, there have been   19 in the past.             patients are. It is difficult to estimate the
        over 1,327,000 per day in the U.S., or   The challenge with the PCR test is that the   number of tests suggesting a patient is posi-
        156,318,000 COVID-19 cumulative tests   results are binary; positive or negative. As   tive when, in fact, they are, for all practical
        performed. The more people tested, the more   most physicians understand, a laboratory test   purposes, negative. A September 2020 NY
        people will test positive; however, as a per-  often has ranges. The ranges help physicians   Times article looked at three sets of testing
        centage of tested individuals, it will hold   understand the acuity of the patient based on   data that include cycle thresholds. What they
        steady and predictable, as it has for a while at   a lab value range. The PCR test also has a   found was astonishing; in Massachusetts,
        6 to 10% tested positive. That suggests that   range. The range is based on a cycle threshold   New York and Nevada, up to 90 percent of
        those who think they are infected with   (CT). The current cutoff on most PCR tests   people testing positive barely carried any
        COVID-19 find out that 90 to 94% of that   is close to 40 CT. Suppose the CT is over 40,   virus. Tests with cycle thresholds so high de-
        population are COVID-19 negative.      which suggests a negative test. If the CT is   tect genetic fragments that pose no particular
          Why would someone get tested, and   under 40, that means positive. However,   risk to the public. Yet the public policy man-
        what kind of test are they receiving?  The   most PCR tests for other types of viruses are   dates have enormous economic consequences
        CDC suggests that anyone with influenza-  closer to 30 to 35 on the high end. What are   when data is overstated, and politicians rely
        like illness (ILI) or COVID-like illness   the implications of allowing a PCR CT of 30   on data (overstated or otherwise) for man-


         22     SAN ANTONIO MEDICINE  • December 2020
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