The Coronavirus Testing Debate

Edo Naito April 13, 2020

Japan’s Ministry of Health (“MOH”) has announced they are increasing the capacity to conduct 20K PCR tests per day. Some will say “too little too late”. Others will say “I told you so” or “I have been saying this from the beginning”. Most will not understand why the capacity is being added now at this stage of the outbreak or what it is designed to do almost 90 days to the date the first COVID-19 case was confirmed in Japan on January 15.  

The debate over testing has divided countries and groups within countries. Even within Japan. While there is much about the COVID-19 virus that experts still do not understand it is hard to find an issue in this pandemic that is more misunderstood by average citizens than testing.  

The testing debate basically has two opposite sides but there are of course many versions that sit between them. And BOTH approaches may be used by a country depending upon what phase of the epidemic your country may be in, containment, early mitigation, late mitigation, final closeout.

Do you test massively to try and contain the spread once you are into mitigation mode as you would with infectious diseases that have a cure? The test, test, test approach.

Or, when the disease has no cure, and COVID-19 has no cure at this time, and you are into mitigation mode, do you test to save lives by the early ID of patients who MAY require hospitalization and especially those who MAY require ICU beds, and thereby also protect your hospitals and medical staff?

Let me first state some obvious points,

1.     Testing does not in and of itself convey any immunity. Only catching the disease and recovering from it does that. And no one is quite sure how long the immunity will last. (For SARs the immunity lasted up to 3 years, for MERs and H1N1 it was up to 1 year.) https://www.fiercebiotech.com/medtech/current-covid-19-antibody-tests-aren-t-accurate-enough-for-mass-screening-say-oxford

2.     The accuracy of the tests being used has clear accuracy issues with many false negatives and false positives. And for most countries, it takes more than one test to confirm a negative. The reported testing data is quite inconsistent as some countries report the number of "cases2, some the number of "tests" and some the number of "people" tested. And then many countries use a CT scan as part of the process as well. Oxford Medicine Professor Bell suggests none of the tests they have reviewed are accurate enough for mass testing. https://www.fiercebiotech.com/medtech/current-covid-19-antibody-tests-aren-t-accurate-enough-for-mass-screening-say-oxford

3.     The COVID-19 virus currently has no known cure. Every major pharmaceutical company on the planet is looking for one.

4.     It is arguably impossible for countries with any sizeable population to test more than 1-5% of their population given the 12-14 day incubation period thus leaving the vast majority of their populations untested with some significant number of them infected and contagious. (Of the four countries who have tested the most, as of April 10, South Korea has tested 495K in total and this only represents a bit under 1% of its population, Germany has conducted an estimated 1.6M tests and this represents 1.8%, Italy 853K and that is 1.4%, the US has tested 2.3M which is only 0.07%). Given point 1, every person tested and deemed free of the virus could walk out and become infected the very next day, if not in the line at the hospital paying the bill. The fact is that this virus spreads so much faster than any country’s capacity to test.

Now some less obvious points.

·       There is evidence that extensive testing is effective in the early days of containment when you are attempting to stop the virus from taking hold in your country. This debate is not about whether you should test or not test. (When WHO on March 17 said “test, test, test” ALL SUSPECTED CASES were they speaking to Japan or South Korea, the earliest affected countries outside of China, or to those countries where the virus had still yet to take hold and they were urging preparedness. Africa, parts of South America, etc.?) https://www.reuters.com/article/us-healthcare-coronavirus-who-idUSKBN2132S4

·       There is no evidence to suggest massive testing alone is effective in containing the spread once the virus has taken hold and you are battling in the mitigation phase. In fact, there is no evidence that it is even one of the 3 or 4 most important things to do once you are deep into mitigation.

·       There is, however, strong evidence to suggest social distancing, avoidance of poorly ventilated crowded spaces, a strong emphasis on hygiene, masks, quarantining, stay at home, closing schools, clear focus on identifying suspected infection clusters early and specialized teams to deal with each one, etc. IS effective at containing its further spread. https://medicalxpress.com/news/2020-03-combined-social-distancing-effective-covid-.html                                                                                    https://www.upi.com/Health_News/2020/03/24/Study-Social-distancing-might-reduce-COVID-19-spread-by-as-much-as-99/4381585056247/

·       There is no evidence that massive testing directly leads to a lower number of actual deaths. Massive testing will reduce your “fatality rate” as that is a math calculation that divides actual deaths into confirmed cases. And it is a given that the more you test the more cases you will find albeit the overwhelming number being light or asymptomatic. Other than Switzerland, Germany has tested a higher percentage of its population than any country (more than 2X on per capita basis than South Korea and the USA) and still have over 3000 deaths while Switzerland has over 1100 deaths. When this is all over who was able to minimize the number of their citizens who died will be the only thing that matters. There will be no prizes given out for “best testing”.

·       There is growing evidence that prioritized testing in the mitigation phase when combined with a strong and flexible medical system does save lives. Japan has tested far fewer numbers but has done so in a highly “prioritized” targeted way to protect the most vulnerable portions of our population and has around 100 community deaths. The criterion used was broadly mischaracterized abroad as testing only serious cases. It was, in fact, designed to try and anticipate which patients MAY eventually need hospitalization and especially those who MAY need critical care attention. It was all about saving lives and keeping the Japanese medical system able to manage its moderate and serious cases. (See the Japan testing criteria below.)

There is a lot still to be understood about this virus. Why some countries will come out of this with far fewer lives lost versus others will take years to sort out. It is very likely to be a complex set of factors, not just one or a few.

What this does suggest to this layman is that the role of testing, both the quantity and the target of the testing, needs to change depending upon the stage your country is in - heavy testing when you have a reasonable hope to contain it before it has spread, and then more targeted testing combined with social distancing, hygiene, etc. once you are fighting the battle to keep your hospital system viable, not just for COVID-19 but all of the other patients who require medical care.

South Korea is perhaps a good example. In the first 40 days after its first case, it had only tested 20K cases in total. After the Daegu explosive outbreak became apparent on February 23, it embarked on a very aggressive testing program that had ramped in 10 days to 126K by Mar. 3. It also introduced very strong social distancing and quarantine measures. By April 3, one month later, it had tested 433K cases in total. But over the past week, the total daily tests have gradually slowed. With less than half the population of Japan, South Korea has suffered 217 deaths.

With respect to Japan, it is very clear that from day 1 of this outbreak Japan picked the second path, test to save lives and protect your medical system not just for the COVID-19 patients but for 28.3% of Japan’s population that is 65 years or older. In addition, it was clear to many that Japan had been thoroughly infected by the estimated 800K Chinese tourists who arrived in Japan between Jan. 1 and Jan. 23, including many thousands from Wuhan. In short, Japan never had any reasonable shot at containment and was already in the mitigation phase at the time WHO finally admitted that human to human transmission was present with COVID-19 and the Wuhan shutdown was then announced. 

So why is the MOH now doubling its test capacity to 20K per day? They have not explained the reasoning in detail but it can only be for two reasons. First, as a contingency, to have it available IF new cases suddenly increase exponentially. Or, secondly, to use for random testing of the population as the first step in trying to eventually estimate what percentage of all Japanese have been infected – 5%, 10% or perhaps 25-30% for use in future vaccination development. 

Germany has just begun a program to undertake blood tests in hot spots and then selectively around the country to try and establish an estimated percentage of the entire German population (PCR tested or not) that has developed an immunity. In short, they caught the disease whether they knew it or not, whether they were tested or not, and recovered. In one German town, based on confirmed PCR type tests they had in hand, and the timeframe involved. they had expected about 5% of the town would have developed an immunity and instead with the blood tests were stunned to find it was already 15%. Japan should be putting together the plan to conduct the same kind of nationwide systematic blood tests to develop an estimate of how many Japanese have developed immunity, most of them unknowingly. https://wgno.com/news/health/coronavirus/germany-plans-to-conduct-tests-to-determine-covid-19-impact/

I am not a medical or public health professional and do not offer any professional opinions. I do know is that there are recognized experts on both sides of this testing chasm that are equally passionate. And they are all right and they are all wrong depending upon what stage of the epidemic your country is in.

We will see in about 4-6 months whether Japan picked the right approach FOR Japan. I pray every day that is the case. And that the decisions other countries have picked are best FOR them.

MOH increasing its testing capacity to 20K per day.

https://www3.nhk.or.jp/nhkworld/en/news/20200409_09/

Notes/Other Attachments

Japan Testing Criteria: Here are the actual testing criteria that have been in effect in Japan since the first case was confirmed on January 15: Japan has prioritized testing to those 1. Who had been in direct personal contact with Hubei/Wuhan (should now be zero), 2. Elderly (70 or over) with existing medical conditions with quite slight symptoms (fever 37.5C) over 24 hours, 3. Elderly (70 or older) with no pre-existing medical conditions who show slight symptoms (fever over 37.5C. coughing, etc.) over 36 hours, and 4. Other patients (especially those with pre-existing medical conditions) that show symptoms suggesting they MAY eventually require hospitalization.

Country testing data source: 

https://ourworldindata.org/covid-testing

Deaths and ICU Numbers By Country, Population Adjusted, Average Deaths Per Day Since First Death, Recoveries On Per Capital Basis - Based on Data as of April 12, 2020. Updated daily by Edo Naito.