VITEK MS Collaborative Study Outline - eBook

VITEK MS Collaborative Study

June 2019

TSAB, ASAP, Xylose Lysine Deoxycholate (XLD), CHROMID Salmonella , Enterobacter Selective Isolation Agar (ESIA) CHROMID EHEC

12 – Gram-negative

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12 – fungal

Sabouraud Dextrose Agar (SDA)

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3.5 Study schedule 3.5.1 All media and reagents as outlined in Appendix 8.3 will be provided by the study sponsor. 3.5.2 Test strains will be shipped by overnight courier to each test site to arrive the week before testing. 3.5.3 All collaborators will begin analyses on the following Monday. 3.5.4 Data forms will be completed and emailed to the co-Study Director within 2 weeks of initiation of analyses. Table 2 provides an overview of the study schedule. Table 2. Study Schedule Collaborator Activity Receipt of Test Strain Set Initiation of Analyses Submission of Data Report Form Panel 1 Week 1, Wed-Friday Week 2, Monday Week 4, Monday

Week 2, Wed-Friday Week 3, Wed-Friday

Week 3, Monday Week 4, Monday

Week 5, Monday Week 6, Monday

Panel 2

Panel 3

4 Test Portion Preparation and Analysis 4.2 Test Portion Preparation 4.2.1 The Coordinating Laboratory will streak each strain for isolation on a non-selective agar. Well isolated colonies will be transferred to non-selective agar slants. Slants will be incubated to produce optimal growth of the organisms. Slants will be blind coded with a 3-digit identification number and then randomized. Each set of strains will be shipped to arrive the week prior to testing. Strains will be stored at refrigeration temperature (2-8 o C) until analysis is initiated the following Monday. A list of strains to be used in the validation study is provided in Table 3.

Table 3. Test Microorganisms Gram Positive (Panel 1 – Week 1)

Gram Negative (Panel 2 – Week 2)

Fungal (Panel 3 – Week 3)

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