Rapid Response Antigen Test - Is it Accurate?



 I am writing this blog post as a mother, whose two children were each sent home with "Rapid Response  Covid-19 Antigen" test kits before the winter break.

I found it quite concerning that the schools were handing out medical test kits, that clearly state on the insert under "Intended Use" that these rapid response Covid-19 Antigen Test Device "is intended for use by trained laboratory personnel or health care professionals."  How many students at the schools in Waterloo region (or anywhere in Canada for that matter) have parents or relatives that are trained laboratory personnel or are a health professional? Are there things about this test that we should be concerned about? Are people sure that they can perform them accurately? 

But the real astonishing quote from the insert that came with this package is:

"Positive results do not rule out bacterial infection or co-infection with other viruses." (emphasis mine).

What? Were the students that were given these tests by their teachers told that these test kits can ALSO check for bacterial or other viral infections? Does the general public know this?

Reading further through the package insert I found some other important information under "Limitations of the Test", namely "Both viable and nonviable SARS-CoV-2 viruses are detectable with the Rapid Response COVID-19 Antigen Rapid Test Device" so basically, both dead and alive, both infectious and non-infectious matter can give a positive result 

And finally, under the section "Limitations of the Test" from the package insert (#7-9), it says that the performance of this device has not been assessed on specimens from individuals who have been infected with emerging variants, that the performance of this device has not been assessed in a population vaccinated against COVID-19, and that this assay is not intended for home testing (or self-testing).

I'm surprised this test is allowed to be used.  This test kit that was handed out through the school board on directive from "Public Health" can test positive from live and dead viral particles that may or may not cause symptoms, it can also test positive from bacterial infections and other viral infections (not just SARS-CoV-2). This Rapid Response test has not been assessed for testing emerging variants and has not been assessed in people who have been vaccinated against COVID-19 and this assay (analysis) is not intended for home or self testing.  

So as a mom from what I read from the package insert, this test isn't just a test for SARS-Co-V-2, it can test for other microorganisms, it can test for live and dead viruses, and its unknown if this test is accurate for emerging variants. 

We all have bacteria and viruses inside and outside of us, this test can't be used on new varriants which is what we are all exposed to and this test has no data based on a population that has already been vaccinated against COVID-19. 

I don't think we can conclude anything of value if this test comes back positive or negative. 







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