Sid Shares His Experience from the Natural Health Product Research Conference

6/13/18

Our CSO, Dr. Sidney Sudberg recently attended and presented at the 16th Annual Natural Health Product Research Conference in Guelph Ontario Canada.  We are happy to share a summary with you.

There was a one day invitation-only workshop on “DNA Testing: Assessing the State of the Science” with Bob Hanner (Director of Canadian Barcode of Life Network, BIO, Guelph) adjacent the 16th Annual Natural Health Product Research Conference, Guelph Ontario, May 14th-17th, 2018.

The session, facilitated by Dr. Joseph Betz, Director, Analytical Methods and Reference Materials Program, National Institutes of Health – Office of Dietary Supplements (ODS-NIH) and soon to be Interim Director of ODS, was an extension of on-going discussions stemming from publications and media attention on DNA testing. It is intended to build on the information presented at the AHPA Botanical Congress held September 29th, 2017 at Supply Side West to further evaluate the researcher needs to support DNA testing; its application, capabilities and limitations. The intention was to assess the State of the Science and perform a Gap Assessment in the use of DNA-based methods for the authentication and adulteration of food and natural health products. An outcome of this workshop will be establishing a consensus lexicon concerning the disambiguation of terms (e.g. identity from purity), the role of existing scientific techniques (e.g. ddPCR vs. sequencing) and relevant applications for them (e.g. authentication of an ingredient vs quantitation of an adulterant).

The goals of the meeting were 1) to prepare a “white paper” that identifies relevant gaps and how to address them, 2) plan for a larger follow-up conference to address the various challenges with additional subject matter experts, and 3) consolidate a core team of interested parties that could collaborate to address the scientific challenges identified, e.g. concerning the development, characterization and dissemination of standard biological reference materials and related SOPs.

At the 16th Annual Natural Health Product Research Conference, Sidney Sudberg, President & CSO, Alkemist Labs, presented a summary of preliminary data for current research being conducted at Alkemist Labs that is intended to assist the Dietary Supplement, Botanical and Food Industry sort out which analyses would be most Fit-for-Purpose or most appropriate and/or reliable for a given Herb of Commerce or food as a function of the strengths and/or weaknesses of each method used in these studies, described below.

Title: “Efficacy of DNA, HPTLC and Microscopy in discriminatingM. piperita fromM. spicata: A single laboratory botanical identification study.

Abstract:  ‘A small-scale single laboratory study was carried out to illustrate methodology for establishing equivalence between different analytical methods used for identifying botanicals. Samples of different lots from different sources of known inclusion (known positive) and exclusion (known negative) species were obtained, and measurements made in replicate by DNA, HPTLC and microscopy on each sample. Special statistical methodology for proving the claim of equivalency among methods is illustrated and the results discussed.’

Peppermint, Mentha x piperitavs. Spearmint, Mentha spicata were chosen for this study.  These two botanicals were chosen due to the fact that they are very closely related species and prone to misidentification.

The initial dataset revealed that the High Performance Thin-Layer Chromatography (HPTLC) was able to make an accurate determination of the correct species for this botanical, except for 1 sample that may qualify as an acceptable ‘outlier’, by contrast to the Microscopic analysis, and for now, the preliminary DNA sequencing data.  Further DNA results are pending and will be added to the analysis.

The statistic of interest being used in this study is the probability of identification (POI); also know as the probability of detection (POD).  The best estimate of the POI is to be reported with 90% and 95% confidence intervals.

A typical ‘sensitivity’ performance requirement might be: ‘The true POI for M. x piperitashould be 0.90- or more with 95% confidence.’  This will be met if a 2-sided 90% confidence interval is entirely above 0.90.

A typical ‘specificity’ performance requirement might be: ‘The true POI for M. spicatashould be 0.10 or less with 95% confidence.  This will be met if a 2-sided 90% confidence interval is entirely below 0.10.

The conclusions drawn were that botanical identification is ‘simple’ to implement, and provides useful information even when used in a single laboratory. Preliminarily speaking, the performance of all methods was poorer than expected, although the HPTLC method was close to acceptable.  The study will be expanded to include more samples to clarify results and complete the study for publication

Sidney Sudberg
CSO/President

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