Rapid Covid Tests Saving the Day

Finally, the promise of rapid Covid tests is paying off because public officials put them to use.  An article at Epoch Times explains: Calls Grow for US to Rely on Rapid Tests to Fight Pandemic  Excerpts in italics with my bolds.

When a Halloween party sparked a COVID-19 outbreak at North Carolina Agricultural and Technical State University, school officials conducted rapid screening on more than 1,000 students in a week, including many who didn’t have symptoms.

Although such asymptomatic screening isn’t approved by regulators and the 15-minute tests aren’t as sensitive as the genetic one that can take days to yield results, the testing director at the historically black college credits the approach with quickly containing the infections and allowing the campus to remain open.

Within the span of a week, we had crushed the spread. If we had had to stick with the PCR test, we would have been dead in the water,” said Dr. Robert Doolittle, referring to the polymerase chain reaction test that is considered the gold standard by many doctors and Food and Drug Administration regulators.

Compounding the problem is that an estimated 40% of people infected don’t develop symptoms. It’s among these silent spreaders that Mina says rapid tests have the clear advantage over lab tests. With its medical precision, he argues that the PCR test continues to detect COVID-19 in many people who have already fought off the virus and are no longer contagious. The rapid test, while less sensitive, is better at quickly catching the virus during the critical early days of infection when it can spread explosively through communities.

“This isn’t a clinical test — it’s a public health screening test,” Mina said.

The case for widescale rapid testing is getting a boost from universities and school systems that have used the approach to stay open through the latest waves of the pandemic. And proponents point to apparent success stories like the small European nation of Slovakia, which saw infections drop after screening two-thirds of its roughly 5 million people with the tests.

And from the Jerusalem Post, a report Israel is following the Slovakian approach: Rapid COVID-19 tests reduce morbidity in Slovakia by 60% in one week.  Excerpts in italics with my bolds.

Quidel’s Sofia kits for rapid coronavirus testing. (photo credit: SOFIA ISRAEL)

The Slovakian model for combating the spread of the virus has proven itself time and time again • pandemic could be completely eradicated worldwide within six weeks

Perhaps the most widely used coronavirus rapid test kit is the Sofia kit developed by American company Quidel. In the past couple of months, Israel has been receiving shipments of the rapid test kits and deploying them throughout the country, while connecting them to systems used by the Health Ministry.

“Rapid and large-scale tests have proven to be efficient in dealing with the coronavirus pandemic around the globe, at least until the long-anticipated vaccine reaches the entire population, and probably after as well,” a statement by Sofia Israel said.

The 300 kits of Sofia which were purchased by Israel have been distributed to retirement homes, medical clinics, health funds and IDF bases, as well as to Israel Police and Prison Services facilities. Sofia Israel has noted that this means Israel would be able to adopt the Slovakian model of conducting large-scale rapid tests successfully.

“The importance of receiving immediate results is critical in managing the outbreak, and overpowers the benefits of slow and more accurate lab tests that require several days for providing results,” a Sofia Israel press release said.

Each Sofia kit can administer 40 tests per hour and provide results within 15 minutes. In a day, 960 Israelis can be tested using one kit only. The 300 kits already distributed, working 24/7, have the capacity to test 288,000 Israelis every day.

Background from previous post: Covid Rapid Tests Finally Out from Quebec Storage (200 Scientists Ask)

Our son is working mightily to keep his HVAC enterprise alive during the contagion.  Last week a key employee after visiting a pharmacy where a person tested positive was told to go home and get tested (took two days), and then stay home to wait for results (3 more days).  So a work week was lost and the business hobbled during that time.  So I wondered what happened to all those rapid covid tests that were purchased back in September.

The story came out in the Montreal Gazette January 14, 2021 Scientists publish open letter calling for Quebec to use rapid testing.  Excerpts in italics with my bolds.

“We have 1.2 million of those tests just sitting in a warehouse in Farnham,” Université de Montréal professor Roxane Borgès Da Silva says.

A group of 213 scientists, professors, health-care workers and patients published an open letter to the Legault government Thursday calling on Quebec to roll out rapid COVID-19 tests to curb outbreaks more quickly and to step up its communications strategy.

“We have 1.2 million of those tests just sitting in a warehouse in Farnham,” Roxane Borgès Da Silva, a professor with the Université de Montréal’s school of public health, said in an interview Wednesday night. “We have reached a point in the evolution of the pandemic where the health system is at the breaking point. It is time that we use every tool at our disposal.

In the letter, the signatories from institutions including the Université de Montréal, McGill, Laval, UQAM and the Institut national de santé publique du Québec (INSPQ), note the partial closure of businesses and restrictions on gatherings have failed to stem the increase in coronavirus cases, hospitalizations and deaths.

With a month-long curfew instituted Saturday, officials must take advantage of the expected decline in cases to counter the spread through better screening, which is “all the more important in a context where possible variants of the SARS-CoV-2 virus, which are more infectious, could spread in Quebec,” the letter reads.

Using rapid tests could help to identify positive cases more quickly, particularly those among asymptomatic patients and those who have been at so-called “super-spreader” events, the letter states

“In this regard, we believe that the simple and widely available access throughout the territory to rapid tests … allowing a result to be obtained in a few minutes could be a game-changer, especially in places of propagation.”

Quebec has been hesitant to use the tests widely because it fears their lack of sensitivity could clear people for COVID-19 when they actually have the virus. But Da Silva said the tests are close to 90-per-cent accurate when used on patients who are in an extremely contagious phase, which is crucial to stopping the most dangerous transmitters. The tests could be used at workplaces, high schools and CHSLDs, or be made available at pharmacies and doctors’ offices to allow the public to get tested quickly, Da Silva said.

As well, the signatories argue the government needs to do a better job of transmitting data and information to the public to improve citizens’ confidence in the science and improve compliance with regulations. They suggest using improved communication campaigns that appeal to the general public and using new strategies that incorporate humour and music.

More from CBC (here): 

The tests, which return a result in as little as 15 minutes, have variously been called a “game-changer” (Ontario Premier Doug Ford) and “less safe” as the gold-standard PCR lab test (Quebec Health Minister Christian Dubé, to Le Devoir).

The chair of McGill University’s bioengineering department, Dr. David Juncker, leans to the Ford end of the spectrum —provided the tests are used effectively. Right now they are not, he said, and it’s to the detriment of the broader testing effort.

“The current testing system isn’t very effective in terms of contact, trace and isolate … it’s too slow, it’s too cumbersome, it has too many delays. That’s one of the reasons we’re failing in containing the spread of the pandemic,” said Juncker, an expert on diagnostic testing.

The main area of concern for the provincial government — also voiced by federal officials — is the the rapid test’s lower accuracy, or sensitivity, and the risk of false negatives.

Those fears are overblown, in Juncker’s view, because the rapid tests can still help ferret out highly infectious people.

“If we just speak about diagnostic performance … the PCR test is the most effective one,” he said. “But if we think about what we want to use this for, as a public health tool that we want to use to contain and detect infectious individuals very quickly and isolate them very fast, that’s where rapid tests can be very helpful.”

My Comment:  The need is to quickly identify people with enough viral load to infect others, and to become sick themselves.  Rapid tests excel at this when applied to people with symptoms that might or might not be Covid19.  Officials have been obsessed with PCR tests which are hyper-sensitive and show people as positive with too little load or even from a trace of dead virus.  Those false positives generate lots of fear and clog the system with people unnecessarily.

Background from Previous Post On Non-Infectious Covid Positives

Daniel Payne writes at Just the News Growing research indicates many COVID-19 cases might not be infectious at all. Excerpts in italics with my bolds.

Elevated ‘cycle thresholds’ may be detecting virus long after it is past the point of infection.

A growing body of research suggests that a significant number of confirmed COVID-19 infections in the U.S. — perhaps as many as 9 out of every 10 — may not be infectious at all, with much of the country’s testing equipment possibly picking up mere fragments of the disease rather than full-blown infections.

Yet a burgeoning line of scientific inquiry suggests that many confirmed infections of COVID-19 may actually be just residual traces of the virus itself, a contention that — if true — may suggest both that current high levels of positive viruses are clinically insignificant and that the mitigation measures used to suppress them may be excessive.

Background from previous post: New Better and Faster Covid Test

Kevin Pham reports on a breakthrough in coronavirus testing. Excerpts in italics with my bolds.

Another new test for COVID-19 was recently authorized — and this one could be a game-changer.

The Abbot Diagnostics BinaxNOW antigen test is a new point-of-care test that reportedly costs only $5 to administer, delivers results in as little as 15 minutes, and requires no laboratory equipment to perform. That means it can be used in clinics far from commercial labs or without relying on a nearby hospital lab.

That last factor is key. There are other quick COVID-19 tests on the market, but they have all required lab equipment that can be expensive to maintain and operate, and costs can be prohibitive in places that need tests most.

This kind of test is reminiscent of rapid flu tests that are ubiquitous in clinics. They’ll give providers tremendous flexibility in testing for the disease in not just clinics, but with trained and licensed medical professionals, in schools, workplaces, camps, or any other number of places.

So what’s new about this test? Most of the current tests detect viral RNA, the genetic material of SARS-CoV-2. This is a very accurate way of detecting the virus, but it requires lab equipment to break apart the virus and amplify the amount of genetic material to high enough levels for detection.

The BinaxNOW test detects antigens — proteins unique to the virus that are usually detectable whenever there is an active infection.

Abbott says it intends to produce 50 million tests per month starting in October. That’s far more than the number tested in July, when we were breaking new testing records on a daily basis with approximately 23 million tests recorded.

There’s a more important reason to be encouraged by this test coming available.  The viral load is not amplified by the test, so a positive is actually a person needing isolation and treatment.  As explained in a previous post below,  the PCR tests used up to now clutter up the record by showing as positive people with viral loads too low to be sick or to infect others.

Background from Previous Post The Truth About CV Tests

The peoples’ instincts are right, though they have been kept in the dark about this “pandemic” that isn’t.  Responsible citizens are starting to act out their outrage from being victimized by a medical-industrial complex (to update Eisenhower’s warning decades ago).  The truth is, governments are not justified to take away inalienable rights to life, liberty and the pursuit of happiness.  There are several layers of disinformation involved in scaring the public.  This post digs into the CV tests, and why the results don’t mean what the media and officials claim.

For months now, I have been updating the progress in Canada of the CV outbreak.  A previous post later on goes into the details of extracting data on tests, persons testing positive (termed “cases” without regard for illness symptoms) and deaths after testing positive.  Currently, the contagion looks like this.

The graph shows that deaths are less than 5 a day, compared to a daily death rate of 906 in Canada from all causes.  Also significant is the positivity ratio:  the % of persons testing positive out of all persons tested each day.  That % has been fairly steady for months now:  1% positive means 99% of people are not infected. And this is despite more than doubling the rate of testing.

But what does testing positive actually mean?  Herein lies more truth that has been hidden from the public for the sake of an agenda to control free movement and activity.  Background context comes from  Could Rapid Coronavirus Testing Help Life Return To Normal?, an interview at On Point with Dr. Michael Mina.  Excerpts in italics with my bolds. H/T Kip Hansen

A sign displays a new rapid coronavirus test on the new Abbott ID Now machine at a ProHEALTH center in Brooklyn on August 27, 2020 in New York City. (Spencer Platt/Getty Images)

Dr. Michael Mina:

COVID tests can actually be put onto a piece of paper, very much like a pregnancy test. In fact, it’s almost exactly like a pregnancy test. But instead of looking for the hormones that tell if somebody is pregnant, it looks for the virus proteins that are part of SA’s code to virus. And it would be very simple: You’d either swab the front of your nose or you’d take some saliva from under your tongue, for example, and put it onto one of these paper strips, essentially. And if you see a line, it means you’re positive. And if you see no line, it means you are negative, at least for having a high viral load that could be transmissible to other people.

An antigen is one of the proteins in the virus. And so unlike the PCR test, which is what most people who have received a test today have generally received a PCR test. And looking those types of tests look for the genome of the virus to RNA and you could think of RNA the same way that humans have DNA. This virus has RNA. But instead of looking for RNA like the PCR test, these antigen tests look for pieces of the protein. It would be like if I wanted a test to tell me, you know, that somebody was an individual, it would actually look for features like their eyes or their nose. And in this case, it is looking for different parts of the virus. In general, the spike protein or the nuclear capsid, these are two parts of the virus.

The reason that these antigen tests are going to be a little bit less sensitive to detect the virus molecules is because there’s no step that we call an amplification step. One of the things that makes the PCR test that looks for the virus RNA so powerful is that it can take just one molecule, which the sensor on the machine might not be able to detect readily, but then it amplifies that molecule millions and millions of times so that the sensor can see it. These antigen tests, because they’re so simple and so easy to use and just happen on a piece of paper, they don’t have that amplification step right now. And so they require a larger amount of virus in order to be able to detect it. And that’s why I like to think of these types of tests having their primary advantage to detect people with enough virus that they might be transmitting or transmissible to other people.”

The PCR test, provides a simple yes/no answer to the question of whether a patient is infected.
Source: Covid Confusion On PCR Testing: Maybe Most Of Those Positives Are Negatives.

Similar PCR tests for other viruses nearly always offer some measure of the amount of virus. But yes/no isn’t good enough, Mina added. “It’s the amount of virus that should dictate the infected patient’s next steps. “It’s really irresponsible, I think, to [ignore this]” Dr. Mina said, of how contagious an infected patient may be.

We’ve been using one type of data for everything,” Mina said. “for [diagnosing patients], for public health, and for policy decision-making.”

The PCR test amplifies genetic matter from the virus in cycles; the fewer cycles required, the greater the amount of virus, or viral load, in the sample. The greater the viral load, the more likely the patient is to be contagious.

This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients, although if it was, it could give them an idea of how infectious the patients are.

One solution would be to adjust the cycle threshold used now to decide that a patient is infected. Most tests set the limit at 40, a few at 37. This means that you are positive for the coronavirus if the test process required up to 40 cycles, or 37, to detect the virus.

Any test with a cycle threshold above 35 is too sensitive, Juliet Morrison, a virologist at the University of California, Riverside told the New York Times. “I’m shocked that people would think that 40 could represent a positive,” she said.

A more reasonable cutoff would be 30 to 35, she added. Dr. Mina said he would set the figure at 30, or even less.

Another solution, researchers agree, is to use even more widespread use of Rapid Diagnostic Tests (RDTs) which are much less sensitive and more likely to identify only patients with high levels of virus who are a transmission risk.

Comment:  In other words, when they analyzed the tests that also reported cycle threshold (CT), they found that 85 to 90 percent were above 30. According to Dr. Mina a CT of 37 is 100 times too sensitive (7 cycles too much, 2^7 = 128) and a CT of 40 is 1,000 times too sensitive (10 cycles too much, 2^10 = 1024). Based on their sample of tests that also reported CT, as few as 10 percent of people with positive PCR tests actually have an active COVID-19 infection. Which is a lot less than reported.

Here is a graph showing how this applies to Canada.

It is evident that increased testing has resulted in more positives, while the positivity rate is unchanged. Doubling the tests has doubled the positives, up from 300 a day to nearly 600 a day presently.  Note these are PCR results. And the discussion above suggests that the number of persons with an active infectious viral load is likely 10% of those reported positive: IOW up from 30 a day to 60 a day.  And in the graph below, the total of actual cases in Canada is likely on the order of 13,000 total from the last 7 months, an average of 62 cases a day.

 

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