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International Journal of Human Nutrition and Functional Medicine


2014 Final PDF

assays and offer them commercially with the

nomenclature of Lab Developed Tests (LDTs). They

offer these assays under the banner of a CLIA licensed

laboratory and provide a disclaimer on the patient report

stating that the “Assay is not FDA cleared and results

should not be used for patient diagnosis.” Such is the

case for the laboratory that is the subject of this study.

The results from the stool analysis are labeled with the

following disclaimer: “These test results are not for the

diagnosis of disease. They are intended to provide

nutritional guidelines to qualified healthcare

professionals with full knowledge of patient history and

concerns to assist in their design of an appropriate

healthcare program.” However, when a sample of

physicians who use the Subject laboratory for stool

analysis were asked if they use the results from the

Subject laboratory for patient diagnosis they all said yes

and pointed to the fact the laboratory was CLIA licensed

so they concluded that the test results must be valid. We

should point out that there is no proficiency testing

survey available for the assay that is performed by the

Subject laboratory, the method being used is proprietary

and has not been published and the laboratory is not

willing to provide their verification study data to their


Although there is a need to develop rapid

molecular testing assays for characterization of the gut

microbiome, physicians and patients need to be aware

that all stool analysis assays may not be valid and users

of these assays should demand to see verification study

data in order to discern the claims of the commercial

entity offering the lab developed assay. The claims

made by the Subject Laboratory that their DNA

assessment of stool samples is specific and accurate,

could not be supported by this independently conducted

proficiency challenge.

Editor's note

: The poster presentation from these

authors is presented immediately below; readers can

magnify the image for better viewing of details.

Citations to Research:

1. Asai, Y., T. Jinno, H. Igarashi, Y. Ohyama, and T. Ogawa. 2002. Detection and quantification of oral treponemes in subgingival

plaque by real-time PCR.

J. Clin. Microbiol

. 40:3334–3340.

2. Bélanger, S.D., M. Boissinot, N. Clairoux, F.J. Picard, and M.G. Bergeron. 2003. Rapid detection of

Clostridium difficile

in feces

by real-time PCR.

J. Clin. Microbiol

. 41:730–734.

3. Bieche, I., M. Olivi, M.H. Champeme, D. Vidaud, R. Lidereau, and M. Vidaud. 1998. Novel approach to quantitative polymerase

chain reaction using real-time detection: application to the detection of gene amplification in breast cancer.

Int. J. Cancer