https://6abc.com/5835756/ Video Here
Even in winter, Lyme ticks can be a threat
Again, the climate change narrative is a joke for ticks.
Regarding this Sophia-2 test and being CLIA waived:
Although the CLIA requires a waived test to be simple and have a low risk for erroneous results, it does not mean that they are completely free from error. Errors can happen during the testing process, especially when the instructions of the manufacturer were not completely followed. An error could also happen when the person conducting the test lacks familiarity with the testing system. Also, the only thing needed to be CLIA-waived is a free pass from the FDA. https://testcountry.com/pages/what-is-clia-waived
For decades the CDC has vilified CLIA-certified labs specializing in Lyme testing. In fact, for years they called these “home-brewed” tests, a label meant to inspire doubt and skepticism. Why? Well, let’s see, could the fact authorities often own the patents on test kits have anything to do with it?
A little background on CLIA certification:
CLIA refers to Clinical Laboratory Improvement Amendments. These amendments were passed by the Congress way back in 1988. These laws stipulate that laboratory testing procedures should ensure timeliness, accuracy, and dependability irrespective of the location of the tests.
Prior to 1988, roughly 25% of patient testing conducted in laboratories was not meeting minimum quality requirements. Studies showed that the laboratories that followed minimum quality standards performed better than the laboratories that did not.
The CLIA standards were created in order to ensure that a patient’s test results would be accurate, timely and reliable, regardless of where in the United States the test would be performed.
Seems to me authorities have it all wrong. FDA approval means little more than cronyism where one health and human services operating division gives another operating division a free pass, whereas, CLIA certification was put in place to at least assure minimum quality standards. If you look at the organizational chart within the FDA you quickly see that the office of vaccine research and review is directly under the office of compliance & biologics quality. https://www.fda.gov/about-fda/fda-organization-charts/center-biologics-evaluation-and-research-organization-chart
Again, quite interesting when you understand the Lyme vaccine debacle and backstory. These people are not to be trusted. At all.
Many people, including doctors, state that certain labs are FDA approved. This is untrue. There are FDA approved tests – NOT LABS. And again, just because the FDA approves the tests doesn’t mean they are good and/or accurate.
For more on the Sofia-2 Test: https://globallymealliance.org/gla-pov-fda-clears-quidel-lyme-disease-immunoassay-sofia-2/
This rapid test is not intended as a stand-alone determinant of B. burgdorferi infection status and a negative result does not preclude infection with B. burgdorferi. Nevertheless, a negative result would save time and expense insofar as testing by the more elaborate and second-tier Western immunoblot assay, which requires subjective interpretation of results, would be contraindicated.
Despite the rapid results obtained using the Sofia Lyme FIA, as pointed out in another GLA POV entitled “Advances in Serodiagnostic Testing for Lyme Disease Are at Hand,” improvements in serologic testing methods or protocols will not differentiate active infection from past exposure. Thus, ideally, use of NextGen tests like Quidel’s Sofia Lyme FIA will be coupled with other diagnostic methods to directly detect the presence of B. burgdorferi and other tick-borne pathogens in patient samples, thereby allowing discrimination between active vs. past infections. GLA is a leader in actively supporting research efforts to develop such direct detection methods.
And as always, testing isn’t perfect.
Please notice the illogic in the statement that a negative result doesn’t preclude infection but that a negative result will save time and money in further testing. Come again? You just said a negative result doesn’t mean you aren’t infected but they expect you to just sit down and take it.