VITEK MS Collaborative Study Outline - eBook

The purpose of this study is to monitor the stability of the VITEK MS‐CHCA reagent and validate the  1  recommended storage and transport conditions.  Stability of the VITEK MS‐CHCA lots was monitored for  2  13.2 months (410 days) by measuring the performance of the kit and solvent evaporation.  Additionally,  3  the consistency of test kit production is evaluated using 3 different kit lots during the evaluation.  4  To measure the performance of each kit, 12 known strains (Table 20) were tested in quadruplicate (i.e.  5  one 48‐well plate).  To evaluate the evaporation of the solvent, one bottle out of five from each kit was  6  weighed at time=0 then again after time=410 days.    7  For lot 1 there were 38 kits (37 assay kits and 1 control kit), lot 2 there were 7 kits and lot 3 there were 7  8  kits.  Lot 1 kits were exposed to various conditions including simulated thermal shock during transport,  9  opening CHCA tube on various days. Lots 2 and 3 were held at storage conditions, 2‐8 ° C until use.  See  10  Table 20 for study design details.    11  Results  12  The performance results obtained from time=0 to time=410 days (13.2 months) all passed the  13  acceptance criteria (the correct organism ID for each strain tested) for the 3 CHCA lots evaluated:  14  I229/10, I230/10 and I231/10. The VITEK MS CHCA reagents have been determined to be stable: 1) for  15  one week after opening and storage at 2‐8 ° C in original boxes and 2) for one week at ambient  16  temperature having opened the tube for up to 5 hours. Evaporation analysis determined that after  17  opening the tube for 7 hours, total evaporation was below the 15% value recommended.  Since the  18  performance from time=0 to time=410 days met expectations, the VITEK MS‐CHCA will have a 365 day  19  (12 month) shelf‐life at 2‐8 ° C in original boxes. See Appendix 6, Tables 20‐22 for study details and  20  results.

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Conclusion  23  Overall results indicate that the VITEK MS method is an acceptable automated method for the rapid  24  identification of microorganisms. 

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References   27  1. AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological   28  Methods for Food and Environmental Surfaces  (2012) Official Methods of Analysis of AOAC  29  INTERNATIONAL , 19th Ed., Appendix J, AOAC INTERNATIONAL, Gaithersburg, MD,  30  http://www.eoma.aoac.org

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2. VITEK MS FDA Clinical Trial Decision Summary, 

http://www.accessdata.fda.gov/cdrh_docs/reviews/K124067.pdf

3. VITEK MS FDA Clinical Trial 510 (k) Approval Letter,  http://www.accessdata.fda.gov/cdrh_docs/pdf12/K124067.pdf 

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