Tag Archives: False Positives

November Pandemic Perspective

18 Wednesday Nov 2020

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I hope readers share my compulsion to see updated COVID numbers. It’s become a regular feature on this blog and will probably remain one until infections subside, vaccine or otherwise. Or maybe when people get used to the idea of living normally again in the presence of an endemic pathogen, as they have with many other pathogens and myriad risks of greater proportions, and as they should. That might require more court challenges, political changes, and plain old civil disobedience.

So here, then, is an update on the U.S. COVID numbers released over the past few days. The charts below are attributable to Don Wolt (@tlowdon on Twitter).

First, reported deaths began to creep up again in the latter half of October and have escalated in November. They’ve now reached the highs of the mid-summer wave in the south, but this time the outbreak is concentrated in the midwest and especially the upper midwest.

Reported deaths are the basis of claims that we are seeing 1,500 people dying every day, which is an obvious exaggeration. There have been recent days when reported deaths exceeded that level, but the weekly average of reported deaths is now between 1,100 and 1,200 a day.

It’s important to understand that deaths reported in a given week actually occurred earlier, sometimes eight or more weeks before the week in which they are reported. Most occur within three weeks of reporting, but sometimes the numbers added from four-plus weeks earlier are significant.

The following chart reproduces weekly reported deaths from above using blue bars, ending with the week of November 14th. Deaths by actual date-of-death (DOD) are shown by the orange bars. The most recent three-plus weeks always show less than complete counts of deaths by DOD. But going back to mid-October, actual weekly deaths were running below reported deaths. If the pattern were to follow the upswings of the first two waves of infections, then actual weekly deaths would exceed reported deaths by perhaps the end of October. However, it’s doubtful that will occur, in part because we’ve made substantial progress since the spring and summer in treating the disease.

To reinforce the last point, it’s helpful to view deaths relative to COVID case counts. Deaths by DOD are plotted below by the orange line using the scale on the right-hand vertical axis. New positive tests are represented by the solid blue line, using the left-hand axis, along with COVID hospitalizations. There is no question that the relationship between cases, hospitalizations, and deaths has weakened over time. My suspicions were aroused somewhat by the noticeable compression of the right axis for deaths relative to the two charts above, but on reviewing the actual patterns (peak relative to troughs) in those charts, I’m satisfied that the relationships have indeed “decoupled”, as Wolt puts it.

Cases are going through the roof, but there is strong evidence that a large share of these cases are false positives. COVID hospitalizations are up as well, but their apparent co-movement with new cases appears to be dampening with successive waves of the virus. That’s at least partly a consequence of the low number of tests early in the pandemic.

So where is this going? The next chart again shows COVID deaths by DOD using orange bars. Wolt has concluded, and I have reported here, that the single-best short-term predictor of COVID deaths by DOD is the percentage of emergency room visits at which patients presented symptoms of either COVID-like illness (CLI) or influenza-like illness (ILI). The sum of these percentages, CLI + ILI, is shown below by the dark blue line, but the values are shifted forward by three weeks to better align with deaths. This suggests that actual COVID deaths by DOD will be somewhere around 7,000 a week by the end of November, or about 1,000 a day. Beyond that time, the path will depend on a number of factors, including the weather, prevalence and immunity levels, and changes in mobility.

I am highly skeptical that lockdowns have any independent effect in knocking down the virus, though interventionists will try to take credit if the wave happens to subside soon for any other reason. They won’t take credit for the grim lockdown deaths reaped by their policies.

Despite the bleak prospect of 1,000 or more COVID-attributed deaths a day by the end of November, the way in which these deaths are counted is suspect. Early in the pandemic, the CDC significantly altered guidelines for the completion of death certificates for COVID such that deaths are often improperly attributed to the virus. Some COVID deaths stem from false-positive PCR tests, and again, almost since the beginning of the pandemic, hospitals were given a financial incentive to classify inpatients as COVID-infected.

It’s also important to remember that while any true COVID fatality is premature, they are generally not even close to the prematurity of lockdown deaths. That’s a simple consequence of the age profile of COVID deaths, which indicate relatively few life-years lost, and the preponderance of co-morbidities among COVID fatalities.

Again, COVId deaths are bad enough, but we are seeing an unacceptable and ongoing level of lockdown deaths. This is now to the point where they may account for almost all of the continuing excess deaths, even with the fall COVID wave. It’s probable that public health would be better served with reduced emphasis on COVID-mitigation for the general population and more intense focus on protecting the vulnerable, including the distribution of vaccines.

The Favored Cause of Death

19 Monday Oct 2020

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The CDC changed its guidelines on completion of death certificates on April 5th of this year, and only for COVID-19 (C19), just as infections and presumed C19 deaths were ramping up. The substance of the change was to broaden the definition under which death should be attributed to C19. This ran counter to CDC guidelines followed over the previous 17 years, and the change not only makes the C19 death counts suspect: it also makes comparisons of C19 deaths to other causes of death unreliable, since only C19 is subject to the new CDC guidance. That’s true for concurrent and historical comparisons. The distortions are especially bad relative to other respiratory diseases, but also relative to other conditions that are common in mortality data.

The change in the CDC guidelines was noted in a recent report prepared for the Florida House of Representatives. It was brought to my attention by a retweet by Justin Hart linked to this piece on Andrew Bostom’s site. Death certificates are divided into two parts: Part 1 provides four lines in which causes of death are listed in reverse clinical order of events leading to death. Thus, the first line is the final clinical condition precipitating death. Prior clinical events are to be listed below that. The example shown above indicates that an auto accident, listed on the fourth line, initiated the sequence of events. Part 2 of the certificate is available for physicians or examiners to list contributing factors that might have played a role in the death that were not part of the sequence of clinical events leading to death.

The CDC’s change in guidelines for C19, and C19 only, made the criteria for inclusion in Part 1 less specific, and it essentially eliminated the distinction between Parts 1 and 2. The following appears under “Vital Records Criteria”:

“A death certificate that lists COVID-19 disease or SARS-CoV-2 as a cause of death or a significant condition contributing to death.”

How much difference does this make? For one thing, it opens the door to C19-attributed deaths in cases of false-positive PCR tests. When large cohorts are subject to testing — for example, all patients admitted to hospitals — there will always be a significant number of false positives even when test specificity is as high as 98 – 99%.

The elimination of any distinction between Parts 1 and 2 causes other distortions. A review of the Florida report is illustrative. The House staff reviewed almost 14,000 certificates for C19-19 attributed deaths. Over 9% of those did not list C19 among the clinical conditions leading to death. Instead, in those cases, C19 was listed as a contributing factor. Under the CDC’s previous guidelines, those would not have been counted as C19 deaths. The Florida House report is conservative in concluding that the new CDC guidelines inflated C19 deaths by only those 9% of the records examined.

There are reasons to think that the exaggeration was much greater, however. First, the Florida House report noted that nearly 60% of the certificates contained information “recorded in a manner inconsistent with state and national guidance”. In addition, almost another 10% of the fatalities were among patients already in hospice! Do we really believe the deaths of all those patients whose diseases had reached such an advanced stage should be classified as C19 fatalities? And another 1-2% listed non-C19 conditions as the immediate and underlying causes.

Finally, more than 20% of the certificates listed C19 alone as a cause of death despite a range of other contributing conditions or co-morbidities. This in itself may have been prompted by the change in the CDC’s guidelines, as the normal standards often involve a “comorbidity” as the initial reason for hospitalization — in that case a clinical event ordinarily listed in Part 1. The high rate of errors and the fact that roughly two-thirds of the deaths reviewed occurred in the hospital, where patients are all tested and often multiple times, raises the specter that up to 20% more of the C19 deaths were either erroneous and/or misclassified due to false positives.

(An exception may have occurred in New York, where an order issued in March by Governor Andrew Cuomo to return C19-positive residents of nursing homes (including suspected C19 cases) back to those homes, The order was made before the change in CDC guidelines and wasn’t rescinded until later in April. There is reason to believe that some of the C19 deaths among nursing home residents in New York were undercounted.)

All told, in the Florida data we have potential misclassification of deaths of 9% + 9% + 2% + 20% = 40%, or inflation relative to actual C19 deaths of up to 40%/60% = 67%! I strongly doubt it’s that high, but I would not consider a range of 25% – 50% exaggeration to be unreasonable.

We know that reports of C19 deaths lag actual dates of death by anywhere from 1 to 8 weeks, sometimes even more. This is misleading when no effort is made to explain that difference, which I’ve never heard out of a single journalist. We also know that false positive tests inflate C19 deaths. The Florida report gives us a sense of how large that exaggeration might be. In addition, the Florida data show that the CDC guidelines inflate C19 deaths in other ways: as a mere contributing factor, it can now be listed as the cause of death, unlike the treatment of pneumonia as a contributing factor, for instance. The same kind of distortion occurs when patients contract C19 (or have a false positive test) while in hospice.

There is no doubt that C19 led to “excess deaths” relative to all-cause mortality. However, many of these fatalities are misclassified, and it’s likely that a large share were and are lockdown deaths as opposed to C19 deaths. That’s tragic. The CDC has done the country a massive disservice by creating “special rules” for attributing cause-of-death to C19. If reported C19 fatality rates reflected the same rules applied to other conditions, our approach to managing the pandemic surely would have inflicted far less damage to health and economic well being.

Fall Coronavirus Season

16 Friday Oct 2020

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We’ve known for some times that COVID-19 (C19) follows seasonal patterns typical of the flu, though without the flu’s frequent antigenic drift. Now that we’re moving well into autumn, we’ve seen a surge in new C19 case counts in Europe and in a number of U.S. states, especially along the northern tier of the country.

The new case surge began in early to mid-September, depending on the state, and it’s been coincident with another surge in tests. From late July through early October, we had a near doubling in the number of tests per positive in the U.S. An increase in tests also accompanied the previous surge during the summer, which claimed far fewer lives than the initial wave in the early spring. In the summer, infections were much more prevalent among younger people than in the spring. Vitamin D levels were almost certainly higher during the summer months, our ability to treat the virus had also improved, and immunities imparted by prior infections left fewer susceptible individuals in the population. We have many of those advantages now, but D levels will fade as the fall progresses.

As for the new surge in cases, another qualification is that false positives are still a major testing problem; they inflate both case counts and C19-attributed deaths. In the absence of any improvement in test specificity, of which there is no evidence, the exaggeration caused by false positives grows larger as testing increases and positivity rates fall. So take all the numbers with that as a caveat.

How deadly will the virus be this fall? So far in Europe, the trends look very promising. Kyle Lamb provided the following charts from WHO on Twitter yesterday. (We should all be grateful that Twitter hasn’t censored Kyle yet, because he’s been a force in exposing alarmism in the mainstream media and among the public health establishment.) Take a look at these charts, and note particularly the lag between the first wave of infections and deaths, as well as the low counts of deaths now:

If the lag between diagnosis and death is similar now to the spring, Europe should have seen a strong upward trend in deaths by now, yet it’s hardly discernible in most of those countries. The fatality rates are low as well:

As Lamb notes, the IFRs in the last column look about like the flu, though again, the reporting of deaths and their causes are often subject to lags.

What about the U.S.? Nationwide, C19 cases and attributed death reports declined after July. See the chart below. More recently, reported deaths have stabilized at under 700 per day. Note again the relatively short lags between turns in cases and deaths in both the spring and summer waves.

Clearly, there has been no acceleration in C19 deaths corresponding to the recent trend in new cases. Northeastern states that had elevated death rates in the spring saw no resurgence in the summer; southern states that experienced a surge in the summer have now enjoyed taperings of both cases and deaths. But with each season, the virus seems to roll to regions that have been relatively unscathed to that point. Now, cases are surging in the upper Midwest and upper mountain states, though some of these states are lightly populated and their data are thin.

A few state charts are shown below, but trends in deaths are very difficult to tease out in some cases. First, here are new cases and reported deaths in Michigan, Wisconsin, and Minnesota. There is a clear uptrend in cases in these states along with a very slight rise in deaths, but reported deaths are very low.

Next are Idaho, Montana, North Dakota, and South Dakota. A slight uptrend in cases began as early as August. Idaho and Montana have had few deaths, so they are not plotted in the second chart. The Dakotas have had days with higher reported deaths, and while the data are thin and volatile, the visual impression is definitely of an uptrend in deaths.

The following states are somewhat more central in latitude: Colorado, Illinois, and Ohio. There is a slight upward trend in new cases, but not deaths. Illinois is experiencing its own second wave in cases.

Out of curiosity, I also plotted Massachusetts, Pennsylvania, and New Jersey, all of which suffered in the first wave during the spring. They are now experiencing uptrends in cases, especially Massachusetts, but deaths have been restrained thus far.

The upshot is that states having little previous exposure to the virus are seeing an uptrend in deaths this fall. The same does not seem to be happening in states with significant prior exposure, at least not yet.

There are major questions about the reasons for the lingering death counts in the U.S.. But consider the following: first, the infection fatality rate (IFR) keeps falling, despite the stubborn level of daily reported deaths. Second, deaths reported have increasingly been pulled forward from deaths that actually occurred in the more distant past. This sort of “laundering” lends the appearance of greater persistence in deaths than is real. Third, again, false positives exaggerate not just cases, but also C19 deaths. Hospitals test everyone admitted, and patients who test positive for C19 are reimbursed at higher rates under the CARES Act; Medicare reimburses at a higher rates for C19 patients as well.

We’re definitely seeing a seasonal upswing in C19 infections in the US., now going on five weeks. In Europe, the surge in cases began slightly earlier. However, in both Europe and the U.S., these new cases have not yet been associated with a meaningful surge in deaths. The exceptions in the U.S. are the low-density upper mountain states, which have had little prior exposure to the virus. The lag between cases and deaths in the spring and summer was just two to three weeks, and while it’s too early to draw conclusions, the absence of a surge in deaths thus far bodes well for the IFR going forward. If we’re so fortunate, we can thank a combination of factors: a younger set of infecteds, earlier detection, better treatment and therapeutics, lower viral loads, and a subset of individuals who have already gained immunity.

Virus Visuals and Non-Pharmaceutical Interventions

19 Saturday Sep 2020

Posted by in Government Failure, Pandemic

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There are a bunch of nice graphs below summarizing the course of the coronavirus (C19) pandemic in different countries, as well as their policy responses. The charts are courtesy of Kyle Lamb, who has been an unlikely (in my mind…) but forceful voice regarding the pandemic over the past few months. I’m sorry if the resolution in some of the charts is poor, but I hope you can click on them for a better view.

The data reported in the charts goes through September 12. The first few charts below are “mirror charts”: they show newly diagnosed C19 cases by day on top, right-side up; on the bottom of each chart are C19-attributed deaths, but the vertical axis is inverted to create the “mirror effect”. The scales on the bottom are heavily stretched compared to the top (deaths are much smaller than cases), and the scales for different countries aren’t comparable. The patterns are informative nevertheless, and I’ll provide per capita deaths separately.

Let’s start with the U.S., where the early part of the pandemic in the spring was quite deadly, while the second, geographically distinct “wave” of the pandemic was less deadly. It looks bad, but the high number of deaths in the spring was partly a consequence of mismanagement by a few prominent government officials in the Northeast, most glaringly Governor Andrew Cuomo of New York. The full pattern for the U.S. combines different waves in different regions. The overall outcome to-date is 622 deaths per million of population.

Then we have charts for (deaths/mil in parens): the UK (628), Italy (591), Spain (653), France (467), Germany (114), the Netherlands (364), and Switzerland (240), which all have had second waves in cases, of but hardly any noticeable second wave in deaths, at least not yet:

And finally, we have Sweden (576), which had many deaths during the first wave, but very few now. Overall, to-date, Sweden has faired better than the U.S., Spain, the UK, and Italy — not to mention Belgium (870), for which I don’t have mirror charts.

There are several points to make about the charts:

First, the so-called second wave this summer has not been as deadly as the virus was in the spring. The U.S. is not an exception in that regard, though it did have more C19 deaths than the other countries. The count of U.S. deaths in the summer was partly due to C19 false positives under a much heavier testing regime, as well as “death laundering” by public health authorities that looks suspiciously like a politicization of the attribution process: C19 deaths over the summer have been well in excess of what would be expected from C19 hospitalizations and ICU admissions. It’s also evident that deaths are being reallocated to C19 from other natural causes, as this chart from The Ethical Skeptic shows (compare the bright line for 2020 to the (very) dim but tightly clustered baselines from prior years):

Second, most of the charts for Europe (not Sweden) show a late summer escalation in cases, though cases in Spain and Germany appear to have crested already. If an uptrend in deaths is to follow, it should become noticeable soon. Thus far, the wave certainly looks less threatening. 

Finally, it’s noteworthy that Sweden’s early experience, which was plagued by mismanagement of the virus’ threat to the nursing home population, later transitioned to a dramatic fading of cases and deaths. There has been no late summer wave in Sweden as we’ve seen elsewhere. This despite Sweden’s far less stringent non-pharmaceutical interventions (NPIs). Sweden’s deaths per million of population are now less than in the US, the UK, Italy, Spain, and Belgium, and most of those differences are growing.

All of the other countries discussed above have had far more stringent lockdown policies than Sweden, and at far greater economic cost. The following charts show some cross-country comparisons of an Oxford University index of NPI stringency over time. It combines a number of different dimensions of NPIs, such as mask mandates, restrictions on public gatherings, and school closures. The first chart below shows the U.S. and the UK contrasted with Sweden. The other countries discussed above are shown in separate charts that follow. 

In the U.S., there has been tremendous variation across states in terms of stringency due to the federalist approach required by the U.S. Constitution, but overall, the Oxford measure for the U.S. has been broadly similar to the UK over time, with the largest departures from one another at the start of the pandemic.   

   

The stringency of NPIs over the full pandemic depends on their day-by-day strength as well as their duration at various levels. One could measure stringency indices and deaths at various points in time and produce all kinds of conflicting results as to the efficacy of NPIs. On the whole, however, these charts suggest that stringent NPIs hold no particular advantage except perhaps as a way to temporarily avoid overwhelming the health care system. Even the original “flatten the curve” argument acknowledged that the virus could not be avoided indefinitely at a reasonable cost via NPIs, especially in an otherwise free society.

Note that most of these countries eased their NPIs after the initial wave in the spring, but several remained far more stringent than Sweden’s policies. That did not prevent the second wave of cases, though again, those were far less deadly.

As Jacob Sullum writes, and what is increasingly clear to honest observers: lockdowns tend to be ineffective and even destructive over lengthy periods.

A working paper from the National Bureau of Economic Research finds that four different “stylized facts” about the growth in C19 deaths are consistent across countries and states having different policy responses to the virus. The authors say:

“… failing to account for these four stylized facts may result in overstating the importance of policy mandated [non-pharmaceutical interventions] for shaping the progression of this deadly pandemic.“

Here’s Bill Blain’s discussion of the inefficacy of lockdowns. And here is Donald Luskin’s summary of his firm’s research that appeared in the WSJ, which likewise casts extreme doubt on the wisdom of stringent NPIs.

The virus is far from gone, but this summer’s wave has been much more docile in both Europe and the U.S. There are reasons to think that subsequent waves will be dampened in many areas via the cumulative immunity gained from exposure thus far, not to mention improvements in treatment and knowledge regarding prophylaxis such as Vitamin D supplements. Government authorities and their public health advisors should dispense with the pretense that stringent NPIs can mitigate the impact of the virus at a reasonable cost. These measures are constitutionally flawed, impinge on basic freedoms, and look increasingly like government failure. Risk mitigation should be practiced by those who are either vulnerable or fearful, but for most people, particularly children and people of working age, those risks no longer appear to be much worse than a bad year for influenza.  

False Positives, False Cases, False Deaths

14 Monday Sep 2020

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The tremendous increase in testing for COVID-19 (C19) this summer was associated with an increase in cases. Most of these tests were so-called PCR tests with samples collected via deep nasal swabs. More testing did not fully explain the increased case load, but false positives (FPs) still accounted for a substantial share. That’s especially true in light of the decline in positivity rates, which reflected a decline in the actual prevalence of active infections. FPs also account for a substantial share of the deaths attributed to COVID, which are obviously cases of false attribution. If a test for C19 is positive, it will be listed on the death certificate.  

COVID Case Inflation

The exaggeration of confirmed cases due to FPs is more substantial as the prevalence of active infection declines. That’s because the share of true positives in the tested population declines, while the share of false positives must rise due to the greater share of uninfected individuals in the population.

Now, as the contagion is waning in former hot spots, there is a danger that FPs create the impression of persistence in the case counts. That’s costly not just for those incorrectly diagnosed, but also in terms of medical resources, for communities subject to excessive public intervention, such as inappropriate lockdowns, and in terms of the fear promoted by these inaccuracies.

FPs are extremely disruptive when testing is relied upon in critical situations such as health care staffing, or even among sports teams. For example, at the University of Arizona, out of 25 positive tests on September 3, only 10 were confirmed as positives in later tests. The NFL has also had its share of false positives. 

Lax Testing Standards

There is evidence that testing standards under CDC guidance are so broad that a large number of inactive, non-infectious cases are being flagged as positives (see the chart above for the intuition, as well as the graphic at the bottom of this post). The tests sometimes amount to a coin flip when it comes to evaluating positives; some of the positives might even come from non-novel coronaviruses such as the common cold! This paper by Andrew N. Cohen, Bruce Kessel, & Michael G. Milgroom – CKM) questions the guidance of public health authorities on testing more generally. From the abstract (my emphasis):

“Unlike previous epidemics, in addressing COVID-19 nearly all international health organizations and national health ministries have treated a single positive result from a PCR-based test as confirmation of infection, even in asymptomatic persons without any history of exposure. …  positive results in asymptomatic individuals that haven’t been confirmed by a second test should be considered suspect.”

False Positive Math

When I wrote about “The Scourge of False Positives” in July. I noted that a test specificity of 95% implies that 5% of uninfected individuals will falsely test positive. Unfortunately, that still produces a huge number of FPs when testing is broad. That’s NOT a good reason to avoid broad testing; it just means that positive tests should be confirmed by another test. (In this case, two tests with the same specificity reduce a 5% false positive rate to 0.25%. That’s why fast, cheap tests are necessary for confirmation.

Again, exaggerated case counts due to FP’s become more severe as a contagion wanes. That’s because FPs become an increasingly large share of positive test results and overstate the persistence of the virus. If active infections fall to 1% of 750,000 daily tests, or 7,500 true cases, the 5% specificity implies 37,125 FPs: true positives would be only 17% of positive cases. Much worse than a coin flip! And again, which cases are infectious?

How Bad Are FPs, Really?

This recent research, also authored by CKM, explains the reasons why FPs are usually an issue in the real world, despite the tests’ reportedly perfect reactivity to anything other than the virus’ genetic fragments. CKM find that the median FP rate in their sample of “tests of tests” was 2.3%. That means 23 out of every 1,000 uninfected people tested will test positive.

If that seems small to you, suppose the true prevalence of active infection in a population is 4%. If 1,000,000 people are tested and there are no false negatives (unlikely), then 40,000 infected people will be identified by the test. However, another 22,000 uninfected people will also test positive ((1,000,000 – 40,000 infected) x 0.023). That means the number of positive tests will be inflated by 55%. They’ll all receive some form of treatment or ordered into quarantine. Expanded Testing and FPs This summer, the volume of daily tests increased from about 150,000 a day in early April to more than 750,000 a day in July. That’s a 400% increase, but the true prevalence of active infection in the expanded test population during the summer was almost certainly lower than in the spring. Suppose active infections fell from 10% of the test population in the spring to 5% in the summer. That means the daily number of “true positives” would have risen from 15,000 to 35,000 in the expanded test population (and again I assume no false negatives for simplicity). The number of FPs, however, would have risen from 3,105 to 16,445. Therefore, FPs would have accounted for 40% of the increase in “confirmed” cases between spring and summer.

False COVID Deaths

FPs are also inflating COVID death counts. PCR tests are routinely given at hospital admission for any cause, and even after sudden death, especially as the availability of tests increased late in the spring. This subset of the tested population will certainly have its share of FPs. If such a patient dies, regardless of underlying cause, it might well be attributed to COVID-19 as it will still appear on the death certificate. The same has occurred in the case of traffic fatalities, suicides, and other sudden deaths.

Antibody Tests

The FP problem also plagues tests of seroprevalence, which determine whether an individual has had the virus or is cross-protected against the virus by antibodies acquired via non-novel coronavirus infections. The consequences of these antibody FPs can be serious as well, because it means a positive test might not ensure immunity. As the exposed share of the population increases, however, the FP share of antibody tests is diminished.

Conclusion

As long as testing is required, dealing with FPs (and false negatives, of course) requires repeated testing, as CKM state unequivocally. And the tests must be fast to be of any use. The current testing regime must be overhauled to prevent false positives from costly impositions on the lives of uninfected patients, consuming unnecessary medical resources, making unrealistic assessments of cases and deaths, and unnecessary suspensions of normal human social activity and liberty.