Blind Study Project Summary

Blind Study Support > Project Summary

Site Map


Sponsored by Health Canada, Hans Yu, Departmental Representative

Micah I. Krichevsky, Bionomics International, Principal Investigator

Before a microorganism can be regulated, investigated, modified, sold or otherwise distributed, the holders of the organism must describe the organism in sufficient detail to enable evaluation of the organism. The more detailed the available information, the better is the reasoning process. Thus, the data describing these entities require capture, management, analysis, and communication.

Taxonomists name organisms. Taxonomists write conflicting (and valid) treatments and the rationale for each treatment, pleasing taxonomists. They develop the concept of "species". The regulator wants one species name for a biological specimen. That is, the regulator wants an unequivocal identification as to the species name of the organism in question.

Underlying this wish is the idea that the species name predicts the existence of hazard. However, the basis for most modern microbial taxonomy is phylogenetic (i.e., the overall genetic history of the organism) coupled with some unique characteristics which allow differentiation from related organisms. Hazardous characteristics (e.g., pathogenicity, allergenicity, and other adverse characteristics) may be associated with specific species whose names are neither predictive nor definitive. For example, strains of E. coli range from innocuous to life threatening.

Health Canada, recognizing these facts, organized the present international double blind study of isolates representative of the genera Pseudomonas, Burkholderia and other related organisms with the long term aim of establishing one or more databases to support regulatory deliberations. The databases will associate genera, species, pathovars, serovars, difficult to identify isolates, etc. The primary observations used to delineate and associate the groups and relationships will be the base data. Analyses will yield information on: 1) relationships among known species and hard to identify isolates (of both medical and ecological interest), 2) consistency of characteristics overall and within groups, and 3) a median set of characteristics for further analyses.

The main aims of the study are to:

1. Ascertain ability to identify to "species" or below

2. Find features robust to error and differing methodologies

3. Delineate useful methods of identification protocols

Not among the aims are:

1. Compare (evaluate) laboratories

2. Standardize test procedures

Last Modified: January 08, 2011
Bionomics International
3023 Kramer Street
Wheaton, Maryland 20902