VITEK MS Collaborative Study Outline - eBook

℠  011501

VITEK ® MS Method for the Rapid Identification of Microorganisms 

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AOAC Performance Tested Method

Abstract   4  VITEK ®  MS was validated according to AOAC guidelines for Performance Tested Methods and Official  5  Methods precollaborative studies for the identification of microorganisms. In the combined internal and  6  independent laboratory studies 359 different claimed organisms (representing 208 Gram negative, 123  7  Gram positive and 28 yeast) were evaluated by the VITEK MS method. All test strains were cultured on  8  appropriate agar medium and growth conditions before analyzing on the VITEK MS instrument. Overall  9  percent correct identification in the combined Internal and Independent studies (6122/6413 VITEK MS  10  results from the 359 different organisms) was 95.5%. For each specific group of microorganisms tested  11  the percent correct identification was 94.4% for Gram‐negative organisms, 96.1% for Gram‐positive  12  organisms and 97.5% for yeast. The VITEK MS reagents were stable over 12 month time studies and  13  provided reproducible results when compared between lots.  Assay ruggedness was demonstrated for  14  three critical parameters, including the use of 1‐µL loops from two different suppliers, the age of the  15  culture on an agar plate before analysis and various suppliers of the agar media. Overall results indicate  16  that the VITEK MS method is an acceptable automated method for the identification of microorganisms.   

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Method Authors  

Ronald Johnson, John Mills, Pat Rule, Tom Bortz 

bioMérieux, Inc., 595 Anglum Road, Hazelwood, MO 63042 

Submitting Company 

bioMérieux, Inc., 595 Anglum Road, Hazelwood, MO 63042 

Independent Laboratory   26  Laboratory Services Division, University of Guelph, 95 Stone Road West, Guelph, Ontario H1H 8J7  27  Canada 

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Reviewers

Jim Agin, 1400 Harrison Avenue, Cincinnati, OH 45214  Wayne Ziemer, 1301 Kristen Lane, Loganville, GA 30052  32  Thomas Hammack, Microbial Methods Development Branch, Division of Microbiology, Office of  33  Regulatory Science, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100  34  Paint Branch Parkway, Rm 3E‐021, College Park, MD 20740 

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Scope of method  

( a ) Target organisms. – 359 Gram‐negative and Gram‐positive, aerobic and anaerobic  38

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