AOAC RI ERP Final Action Recommendations

Report data on data report form labeled “

BAX

System Collaborative Study Test portion Data

Report Form”

for all test portions.

Upon completion of analysis of each food type, the laboratory will fax or email the completed

data form result sheets to Patrick Bird at: (513)-471-5600 o

r pbird@qlaboratories.com

Important Information

Read the methods carefully. If you have any questions, contact one of the co-Study Directors.

It is advised to make at least one practice run before the trial using your own materials so that

you can minimize errors in manipulations. Check that all pipets, equipment, and BAX

System

supplies are on hand.

Make the determination during the specified time. Store the test portions according to the

instructions. It is essential for the validity of the trial that all collaborators commence the

analysis of each test portion on the

MONDAY

of each week. Immediately upon receiving each

shipment, confirm the contents with the Study Director by faxing the form provided in the

shipment.

THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE

FOLLOWED AS CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS

DESCRIBED, NO MATTER HOW TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT

FORM.

Report all of your results as soon as analyses are completed. Do not do more or less than

indicated in the instructions. For example, do not do duplicate analysis and report the best or

average result. More or fewer results complicate the statistical analyses and may invalidate

your results. Data sheets are provided with these instructions and indicate which results are to

be reported. Upon completion of the study, collaborators are encouraged to complete the

“

BAX

System Collaborative Study Collaborator Comments Form”

in Appendix 10.4. Any

comments regarding study design or the BAX

System method are encouraged to allow the

Study Sponsor to fully understand the needs of the end user. Any results that were derived

from modified protocols should be included but must be separated from the main report.

Results and comments should be returned to the Study Director immediately upon completion

of each portion of the study.

See safety precautions in the BAX

System Real-Time PCR Assay for

Salmonella

package inserts

(refer to the following sections in the package insert: Warnings and Precautions and Waste

Disposal). The proprietary test kit is testing for the enumeration of

Salmonella

which could

include potentially pathogenic organisms. Although the test kit itself does not contain any

pathogenic components, the inoculated test strip may contain the target organism. Therefore,

Collaborative Study Approved Protocol

Expert Review Panel Use Only