896-897 / 1195
3
General Referee
1
2
Thomas Hammack
3
Microbial Methods Development Branch
4
Division of Microbiology
5
Office of Regulatory Science
6
Center for Food Safety and Applied Nutrition
7
Food and Drug Administration
8
5100 Paint Branch Parkway, Rm 3E-021
9
College Park, MD 20740
10
11
Expert Reviewers
12
13
Michael Brodsky
14
Brodsky Consultants
15
73 Donnamora Crescent
16
Thornhill, Ontario L3T 4K6
17
Canada
18
19
Wayne Ziemer
20
415 Jessica Way
21
Athens, GA 30606
22
23
Test Principle
24
VIDAS® LMX test is an enzyme immunoassay for use on the automated VIDAS® system for the detection of
Listeria
25
monocytogenes
using the Enzyme Linked Fluorescent Assay (ELFA) method.
26
27
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device. The interior of the SPR® is coated with
28
anti-
L. monocytogenes
antibodies adsorbed on its surface. Reagents for the assay are ready-to-use and pre-dispensed in the sealed
29
reagent strips.
30
31
The VIDAS instrument performs all of the assay steps automatically. An aliquot of the enrichment broth is dispensed into the reagent
32
strip. The reaction medium is cycled in and out of the SPR® several times. Target antigens present will bind to the anti-
Listeria
33
monocytogenes
antibodies, which are coated on the interior of the SPR®. Unbound sample components are washed away. The
34
detector antibody conjugate is cycled in and out of the SPR® and will bind to any
L. monocytogenes
antigens which are bound to the
35
antibodies on the SPR® wall. Further wash steps remove unbound conjugate. During the final detection step, the substrate (4-
36
PTM Certification Report