VITEK MS Collaborative Study Outline - eBook

VITEK MS Collaborative Study

June 2019

plate before analysis and various suppliers of the agar media. Overall results indicate that the VITEK MS method is an acceptable automated method for the identification of microorganisms 1.3 Co-Study Directors for the Collaborative Study Ron Johnson and John Mills bioMérieux, Inc. 595 Anglum Road, Hazelwood, MO, 63042 Email: ron.johnson@biomerieux.com ; john.mills@biomerieux.com Phone: 314-452-3241 2 Collaborators A minimum of 10 valid data sets are needed for the successful completion of this study. Approximately 15 collaborators will be solicited to participate. Qualified analysts, familiar with the VITEK MS Microbial Identification System, will act as collaborators. All collaborators have been, or will be, thoroughly 3.2 The study will include a minimum of 5 test sites, but preferably 10-12, with no more than 3 collaborators at any individual site. The collaborators at each site will share the use of a VITEK MS Microbial Identification system. Multiple collaborators at any site will be required to work independently. 3.3 Thirty-six (36) strains will be used in the evaluation. Twelve (12) of the strains evaluated will be Gram-positive organisms , 12 of the strains evaluated will be Gram-negative organisms, and 12 of the strains will be fungal organisms. Testing will be separated into 3 separate panels, with each panel evaluated during a separate week. 3.4 Collaborators will streak isolates onto agars as listed in Table 1, and after incubation, evaluate an isolate from each plate (if growth is present) on the VITEK MS Microbial Identification System. All strains within a set will be randomized and blind coded so that the collaborators do not know the identity of the strain. The randomization will be different for each collaborator. trained prior to participation. 3 Collaborative Study Design

Table 1. Test scheme for each collaborator

Number of strains per Type

Types of agar to be evaluated with each strain Tryptic Soy Agar with 5% Sheep Blood (TSAB), Modified Oxford Agar (MOX) Agar Listeria according to Ottavani and Agosti (ALOA) BACARA CHROMID S. aureus Elite agar (SAIDE)

Week of Analysis

Targets

Gram-positive, Gram-negative

1

12 – Gram-positive

and fungal organisms

4