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12

of

17

Discussion

The 3M

MDA 2 -

E. coli

O157 accurately detected

E. coli

O157:H7 from raw ground

beef at 10 hour time point. The MDA 2 -

E. coli

offers the benefits of extremely high

sensitivity and high specificity for the detection of

E. coli

O157 while reducing the overall

time to presumptive results. The MDA 2 -

E. coli

O157 also reduces the total analyst

time required to obtain final results by implementing a single heat lysis step and cool

step, followed by a single transfer to molecular reaction tubes. The small foot print of the

Molecular Detection System requires minimal space, making it easy to move the

instrument or pair additional MDS units to perform multiple MDA runs concurrently. The

updated software is user friendly with easy to interpret results. Also, the ability to

examine Relative Light Unit (RLU) curves makes troubleshooting more streamline if

problems occur during testing. There was no significant, statistical difference observed

at the 10 hour time point for the evaluation of raw ground beef.

Conclusion

The data from the study, within the statistical uncertainty, support the product claims of

the 3M

MDA 2 -

E. coli

O157 in the selected food matrix.

The results obtained by the POD analysis of the method comparison study

demonstrated that there were no statistically significant differences between the number

of positive samples detected by the candidate and the reference method for the raw

ground beef food matrix for 10 hour time point.

References

[1] U.S. Department of Agriculture Food Safety and Inspection Service Microbiology

Laboratory Guidebook, Revision 5.09

Isolation and Identification of Escherichia