Pathologist Dr. Lester Simon has is seeking to put the practice of rapid covi-19 testing into perspective.
He addressed the issue of the rapid antibody tests being carried out by some private medical practitioners in a detailed explanation on his Facebook page.
Here is the full post by Dr Simon.
THE CLEAR VIEW
1. Why is it so difficult to get into our Clearview Psychiatric Hospital? In a genuine effort to understand what is happening with Covid-19 testing in Antigua and Barbuda, some of us have resorted to a kind of illogic and craziness that is driving the rest of us crazy.
2. Let’s get the rapid tests for Covid-19 out of the way. We will look at the PCR test some other time. There are currently two different rapid antigen tests in Antigua and Barbuda. One is called Sofia2 and the other is called BD Sensor. Sofia2 will be used by the government and BD Sensor is being used privately.
3. Separate and apart from the two rapid antigen tests listed above, two separate private agencies here were/are testing for Covid-19 using antibody tests. These rapid antibody tests are so inferior at this stage of their development, they should be disregarded.
4. The antibody tests are blood tests. The antigen tests use a nasal or throat swab similar to the specimen required for the gold standard PCR test. Apart from using similar specimens, the similarities between the antigen tests and the PCR tests are few and far apart.
5. It was CARPHA, our reference lab, that noted that as demand and supply separate there will be need for rapid Covid-19 tests separate and apart from the PCR gold standard. Hence CARPHA sent out to all its 26 member states a Guidance Evaluation document. It lists 14 parameters to mark from zero to two, to arrive at a total score and category for the evaluated test.
6. The categories run from A to E. Category A rapid test can be treated like the gold standard PCR test. Category E is a total waste of time, effort and money.
7. When we heard Antigua and Barbuda was getting the Sofia2 test, we asked CARPHA to kindly do the evaluation of Sofia2 for us. It should be noted that this was an evaluation based on what the manufacturer claimed in the insert that comes with the test. Oftentimes these data are not realized as represented and one must do a practical evaluation using similar tests that the manufacturer used to see if the listed claims are reproduceable.
8. In lieu of the practical evaluation, and using the manufacturers data, Sofia2 was placed in category C. This is what is said about category C:
Category C:
For results between 17 to 26 points (with sensitivity values less than 90%): The kit can only be used for specific situations where other better alternatives are not available.
Examples: Remote areas with no access to a local laboratory, conveyances where the disease among passengers is suspected or reported, etc. Samples, especially those with negative results, must be sent to a regional, national or reference laboratory for confirmation. It is recommended that 30-40% of negative samples are confirmed by the reference lab.
9. The local, privately used antigen test, BD Sensor, has not been evaluated by CARPHA or locally using the listed claims by the manufacturer. It does not meet at least two of the 14 parameters listed by CARPHA, and met by Sofia2. It is not authorized by FDA. It is not authorized by the European union. It claims self-declaration by the European Union.
Self-declaration means that the manufacturer regards the parameters for declaration by the European Union and without sending samples to the European Union for evaluation and authorization, they make the claim themselves. It’s almost like someone regarding the requirement to enter Clearview and declaring to themselves (deliberately plural), (and to others) that they are a patient of Clearview.
10. It may very well be that SD Sensor might fall into category D, when evaluated using the guidelines sent out by CARPHA. This is what is written about category D:
Category D:
For scores between 11 to 16 points: The kit can be used for specific situations where other better alternatives are not available, however, at least 50% of all negative results must be confirmed by another kit or test that meets the requirements for category A or B.
And yet, all sorts of unsubstantiated claims that have not been independently evaluated, as yet, by agents such as FIND (Foundation for Innovate New Diagnostics), are being made by the gospels of Matthew, Mark, Luke and John.
11. The madness about all of this is that we have been here before. With HIV tests we did the hard work. Yes, we had some rogue operators then too, which was why some of us simply stopped dealing very extensively with HIV. But generally, we waited for good rapid tests and we evaluated the rapid tests practically against the HIV gold standard.
We did this to the successful extent that peripheral labs and clinics away from the central hospital lab have been doing these rapid HIV test for years. And this is the key… We did this with excellent cooperation and collaboration between the peripheral, public and private testing sites and the central hospital lab and CARPHA our reference lab, so that we arrived at national and regional and international data that are comparable and useful.
12. But Covid-19 is not HIV. With HIV we can do our ABC: abstain, be faithful or use a condom. Or all three. We can abstain, and be faithful just to ourselves, with or without a condom. With Covid-19, we cannot abstain from breathing. I breathe therefore I am. And this is where the madness starts.
The nexus between the need to breathe to live, and some other needs to live, is arriving at a conjunction that is somewhere between Clare Hall and St. Johnston Village.
14. When and where the madness ends, might change the requirements to enter, or leave, Clearview.
Yes, it should have been #13; but we have enough bad luck already!
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In absence of the PCR test, what is one to do?? You can not get this test even though you know you may have been exposed and have called the Covid hotline, they take your information and say someone will call you back in 24 hours but 5 days later still no call. Is there anyway for someone to get the PCR test done by just paying for it? Tell us Dr. Simon please……
Mr. Simon and other government officials….I have been trying to understand the logics behind some of your protocol announcements. The fact that buses and other public transport can go back to normal with 100 % full capacity and churches and other businesses have to adhere to social distancing; leaves me to wonder about your thinking. It brings to consider that you really DO NOT KNOW what you are doing.
Have you really sat down and consider the decisions that you make ? Do you not realise that many of your decisions here make absolutely no sense whatsoever.
Even the prime minister does not want to go out in the public and assemble with the people. Yet still he decides to put public transport back to full capacity.
Are you Antiguans so foolish indeed ? Your misleaders do not care anything about you.
Big fools, you are !
The small child in primary school would do a much better job at deciding on how to come up with protocols that are fair and beneficial to all people.
You are all making a mockery of your professions.
Remember again, that all of us will one day soon HAVE TO give account for our stewardship of this life.
Wake up, Antiguans. You have a bunch of misleaders captaining the ship and you are foolishly following them.
Yes…you…I am talking to you. The truth does hurt….but it also saves if you are willing to accept it and change.
All of the people who continue to jump high and low to the dictates of your politrickians….calypsonians, Air traffic controllers, ministers of religion, business people, statutory board members, civil servants…..you are just as corrupt as them and you will answer to the Creator soon.
A word to the foolish to wake up and face the truth is sufficient.
WORLS “CRYSIS”: END SOON COME !
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