Petition update

The Association of Public Health Laboratories (Part 3)

Carl Tuttle
Hudson, NH, United States

Aug 14, 2017 — Please see the letter below from Dr. Sin Lee, Director of Milford Molecular Diagnostics outlining details for establishing a proficiency study to advance the diagnostics of Lyme disease.

The Centers for Disease Control stopped communicating with Dr. Lee after he uncovered a novel Borrelia in one of the serum samples tied to a patient in the Hudson Valley, who had been previously treated for neurologic Lyme disease. The details of what took place can be found in a previous petition update:

Milford Molecular Diagnostics website:

Dr. Lee’s letter to Mr. Scott Becker, Executive Director of the Association of Public Health Laboratories:
From: "Sin Lee"
To: "Scott Becker"
Cc: "Carl Tuttle" , "Troy Willitt | APHL" , "Carol Clark | APHL" , "Eric Blank | APHL" , "Jody DeVoll | APHL" , "Deborah Kim | APHL" , "Peter Kyriacopoulos | APHL" , "Chris Mangal | APHL" , "Lucy Maryogo-Robinson | APHL" , "Julianne Nassif | APHL" , "Eva Perlman | APHL" , "Pandora Ray | APHL" , "Ralph Timperi | APHL" , "Kelly Wroblewski | APHL" , "Patina Zarcone | APHL" , "Chris Whelen" , "Ewa King" , "Chris Atchison" , "Grace Kubin" , "Joanne Bartkus" ,, "Maria Ishida" , "Mark Wade" , "Tamara Theisen" , "Judith Lovchik"
Sent: Sunday, August 13, 2017 2:12:59 PM
Subject: Reliable Lyme test ?

August 13, 2017

Association of Public Health Laboratories
8515 Georgia Avenue, Suite 700
Silver Spring, MD 20910
Attn: Scott Becker, Executive Director

Dear Mr. Becker:

I am most interested in the email exchanges between you and Mr Carl Tuttle on the lack of reliable laboratory tests for Lyme disease.

The excuses commonly used to suppress using and development of direct DNA tests for the diagnosis of Lyme borreliosis include potential sample cross contamination, false identification of target DNA and lack of sensitivity. However, these are not technical issues which cannot be overcome by good laboratory practices. May I suggest that the APHL organize a national proficiency test project to advance the diagnostics in this area. Here is my proposal to the APHL.

1. Prepare a series of EDTA-anticoagulated whole blood samples, each spiked with 1-1000 bacteria per mL from a pure culture of Borrelia burgdorferi sensu stricto, Borrelia mayonii, Borrelia miyamotoi or Borrelia hermsii or with irrelevant bacteria, such as Leptospira or E coli…or none of the above.

2. Distribute these simulated positive and negative samples (3 mL in one test tube), blind-coded, to those laboratories which claim to be able to identify positive blood samples containing spirochetes causing “Lyme borreliosis”.

3. Require each laboratory to generate a report with its best method to identify those blind-coded samples which have been spiked with various strains of known bacteria in 10 working days.

4. The laboratories which can identify the samples spiked with various borrelia strains and the samples without borrelia correctly should be invited to a symposium for further development of a reliable direct test for the diagnosis of Lyme borreliosis in the United States.

The cost to administer such a program would be a few thousand dollars and does not need a Congressional budget approval. You can ask each participating laboratory to pay a fee of $1,000 to defray the expenses involved.

Thank you for your consideration.

Sin Hang Lee, MD
Director, Milford Molecular Diagnostics Laboratory

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