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I CRINGED when I learned my GIRLFRIEND underwent a pre-surgical PROCEDURE that appears to have put LUCIFERASE inside of her body WITHOUT HER CONSENT

Posted By: NaturalWisdom
Date: Sunday, 26-Sep-2021 20:29:08
www.rumormill.news/183422

My girlfriend told me the procedure severely irritated her nostrils. What in blazes prompted the clinic to test her for MRSA? Is that what many hospitals are testing for these days prior to major surgery? (She is scheduled to have repair work done on her hip implant on Tuesday)
-NW

FDA NEWS RELEASE

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA
For Immediate Release:
December 05, 2019

[snip]

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR cobas vivoDx MRSA pp. 2-3
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN190016.pdf

Special conditions for use statement(s):
For prescription use only.
cobas vivoDx MRSA is only for use with nasal samples collected with cobas vivoDx MRSA Collection and Transport Kits.

I. Device Description:
The MRSA Reagent Cap comprises two reagent-filled blisters, one containing Staphylococcus aureus-specific bacteriophage-based Smarticles that encode the enzyme luciferase, and the other, a luminescent substrate. The cobas vivoDx Instrument
automatically completes incubation of the cartridge, addition of the Smarticles and substrate to the test sample, as well as measurement and analysis of the luminescent signal. Results are reported as “Positive” (MRSA detected) or “Negative” (no MRSA detected).

p. 20 of the above PDF indicates that PCR technology is used with this MRSA test and that false positive and negative results were noted.

Table 16. Performance of the cobas vivoDx MRSA compared to culture, stratified by study
site

PPA: Positive Percent Agreement; NP A: Negative Percent Agreement

1. 15/21 subjects with false negative cobas vivoDx MRSA test results were MRSA positive only by enriched culture, suggesting the presence of low level colonization (<10 CFU/mL based on the theoretical limit of detection of the direct culture method)
2. 13/51 subjects with false positive co bas vivoDx MRSA test results compared to the Reference Method were MRSA positive by alternative methods (i.e., PCR and/or nonselective direct and enrichment culture)
3. 26/64 subjects with false positive co bas vivoDx MRSA test results compared to Direct Culture were MRSA positive by alternative methods (i.e., PCR and/or nonselective direct and enrichment culture)


SOURCE




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