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» LymeNet Flash » Questions and Discussion » Medical Questions » lyme pcr test

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Author Topic: lyme pcr test
hund
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Is the Lyme (B burgdorferi) PCR test medically proven as an effective way to test for lyme? My insurance company Aetna says it's not and hence not covering it:

http://www.aetna.com/cpb/medical/data/200_299/0215.html

If it is could you please let me know some documentations I can support that it is.

--------------------
HunD

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kidsgotlyme
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They do this because they can, not because it is not a good test.

My recommendation is to pay for it yourself and then file it with your insurance and see if they will give partial reimbursement.

I did the DNA Connections test and it showed positive for Lyme, Babesia, and Bartonella. It was worth the $500 I paid out of pocket.

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symptoms since 1993 that I can remember. 9/2018 diagnosed with Borellia, Babesia Duncani, and Bartonella Hensalae thru DNA Connections.

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Bartenderbonnie
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Sorry hund but you will not find any documentation that supports PCR or any other test other than the ELISA or the Western Blot that is CDC approved. And if a test is not CDC approved, insurances companies will fight to provide that coverage. They are literally killing and causing the suffering of millions of Lyme patients throughout the world.

This is from the CDC website for "Recommendations For The Test Performance and Interpretation From The Second National Conference On Serological Diagnosisnof Lyme Disease". ( October 27 - 29, 1994)

https://www.cdc.gov/mmwr/preview/mmwrhtml/00038469.htm

Conference recommendations were grouped into 4 categories;
1. Serologic performance and interpretation
2. Quality-assurance practices
3. New test evaluations and clearance
4. Communications of developments in Lyme Disease testing

This from the CDC website "Caution Regarding Testing for Lyme Disease"

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5405a6.htm

"Only intial positive or equivocal ELSIA followed by positive standardized Western Blot are recognized."

The FDA has cleared over 70 serologic assays to aid in the diagnosis of Lyme disease yet the CDC refuses to acknowledge any of them.

This from the CDC website "Laboratory Tests Not Recommended"

https://www.cdc.gov/lyme/diagnosistesting/labtest/otherlab/index.html

Herein lies (LYES !!!) the problem.
There have been NO new diagnostic tests approved by the CDC since 1994. Some research shows up to 90% failure rate in diagnosising Lyme disease according to these flawed tests.

Therefore the CDC has FAILED their own recommendations;
1. FAILED to conduct serological test performances and interpretations
2. FAILED to conduct quality-assurance practices
3. FAILED to review new test evaluations and clearances
4. FAILED to communicate the latest developments in Lyme disease testing

Your insurance company, Aetna, along with other insurance companies and the IDSA are now facing litigation in a ground-breaking class-action lawsuit filed in Texarcana, Texas filed November 2017;

https://www.courthousenews.com/wp-content/uploads/2017/11/LymeDisease.pdf

Testing;
According to the IDSA guidelines, a physician diagnoses Lyme disease in 2 ways;
1. The patient must exhibit an EM rash
2. The patient must test positive with a two-tiered serology

"All defendants know that many Lyme patients will never develop an EM rash and that the guideline requirement of a positive lab test is problematic because the two-tiered serology tests fail to detect up to 90% of Lyme cases."

IMPORTANT - CDC website clearly states;

"Health care providers are reminded that a diagnosis of Lyme disease should be made after evaluation of a patient's CLINICAL PRESENTATIONS and a risk of exposure to infected ticks."

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Bartenderbonnie
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Here is an update on the HHS Lyme and Tick Borne Disease Working Group's recommendations for NEW diagnostics;

https://www.cdc.gov/lyme/diagnosistesting/HHS-research-updates.html

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Lymedin2010
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And yet the shmucks use it for the detection of the Zika virus:

The Trioplex rRT-PCR is a laboratory test designed to detect Zika virus, dengue virus, and chikungunya virus RNA. The Food and Drug Administration (FDA) has authorized the use of this test under an Emergency Use Authorization (EUA). More information on the Trioplex rRT-PCR assay can be found on the Lab Guidance webpage."

https://www.cdc.gov/zika/hc-providers/types-of-tests.html

_______________________

The prominent Mayo Clinic trusts PCR for the detection of Borrelia spirochetes. Sad they they don't mention the new Borrelia spirochete Borrelia miyamotoi though.

"Method Name
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization"
"Useful For
Confirmation of active Lyme disease"
"Clinical Information
Lyme disease is a multisystem and multistage tick-transmitted infection caused by spirochetal bacteria in the Borrelia burgdorferi sensu lato (Bbsl) complex.(1) Nearly all human infections are caused by 3 Bbsl species; Borrelia burgdorferi sensu stricto (hereafter referred to as Borrelia burgdorferi) is the primary cause of Lyme disease in North America, while Borrelia afzelii and Borrelia garinii are the primary causes of Lyme disease in Europe. Recently, Candidatus Borrelia mayonii has been identified as a second cause of Lyme disease in the United States."
"Therefore, detection of Bbsl DNA using PCR may be a useful adjunct to serologic testing for detection of acute disease. PCR has shown utility for detection of Borrelia DNA from skin biopsies of EM lesions, as well as DNA from synovial and cerebrospinal fluid in late-stage disease. Borrelia DNA can also, rarely, be detected from blood.(6)"

https://www.mayomedicallaboratories.com/.../Clinica.../87973

_______________________

"METHODS:

The study involved 94 blood samples of patients with suspected LD. From each sample, 1.5 ml of blood was used for the isolation of bacterial DNA and PCR real time am- plification and its equivalent, in nested version. The remaining part earmarked for serologi- cal testing. Optimization of the reaction conditions made experimentally, using gradient of the temperature and gradient of the magnesium ions concentration for reaction real time in nested-PCR and PCR version.
RESULTS:

The results show that the nested-PCR real time, has a much higher sensitivity 45 (47.8%) of positive results for the detection of B. burgdorferi compared to the single- variety, without a preceding pre-amplification 2 (2.1%). Serological methods allowed the detection of infection in 41 (43.6%) samples." https://www.ncbi.nlm.nih.gov/pubmed/28146622

_______________________
The PCR DNA/RNA testing is universally used in all science & industries. It is used throughout the world.

"Polymerase chain reaction (PCR) is a widely used technique used in molecular biology to exponentially amplify a single copy or a few copies of a specific segment of DNA to generate thousands to millions of copies of a particular DNA sequence. PCR is now a common and often indispensable technique used in medical laboratory and clinical laboratory research for a broad variety of applications including biomedical research and criminal forensics .[1][2] It was developed in 1983 by Kary Mullis,[3][4] who was an employee of the Cetus Corporation, and was later awarded the Nobel Prize in Chemistry along with Michael Smith in 1993 [5] for his work in developing the method. "

https://en.wikipedia.org/wiki/Polymerase_chain_reaction
_______________________

_______________________

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Lymedin2010
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NEW & cheap DNA Lyme test ($150) for Lyme Disease.

This tests for multiple Borrelia strains and even Borrelia mayonii that was just recently discovered in 2016. Not approved yet, but the DNA testing is standard & approved in all branches of academia already (using Borrelial 16S ribosomal RNA gene sequence). This same type of DNA/RNA testing was also recommended & approved over standard antibody Zika virus testing and the info about it can be seen here.

One needs to be off antibiotics for a while in order to increase the chance of a positive test when the infection is present.

http://www.dnalymetest.com/lymediseasediagnostics.html

At time 13:34 is the news coverage for Dr. Sin Hang Lee, the developer & crusader of the test, who is now suing the CDC for $57 million over neglecting to look into a viable testing method.

https://youtu.be/40EWjpREeXY?t=814

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