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VIDAS LMX & LPT Collaborative Study
April 19, 2013
OMA-2013-Apr-XXX
control is to be tested, identify it by “C2.”
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5.7.5.1 NOTE: The standard must be tested upon receipt of a new lot of
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reagents and then every 14 days. The relative fluorescence value
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(RFV) of the standard must fall within the set range provided with
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the kit.
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5.7.6
Thoroughly mix the standard, controls and boiled or unboiled samples
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before use.
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5.7.7
Pipette 250 µL of standard or control into the sample well of the reagent
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strip.
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5.7.7.1 NOTE: Test samples and controls singly and standard in
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duplicate.
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5.7.8
Insert the SPRs and reagent strips into the instrument. Verify that the
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color labels with the assay code on the SPRs and reagent strips match.
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5.7.9
Initiate the assay as directed in the Operator’s Manual. The instrument
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performs all assay steps and data interpretation automatically.
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5.7.10
After the assay is completed, remove the SPRs and reagent strips from the
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instrument and dispose of properly.
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5.8
Interpretation and Test Result Report
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5.8.1
Retrieve printed report containing type of test performed, sample
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identifications, date and time, lot number and expiration date of the
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reagents, the RFV, test value and interpreted result (positive or negative)
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for each sample.
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5.8.2
The test value is calculated by the instrument and is equal to the sample
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RFV/standard RFV. A “negative” result has a test value less than the
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threshold (0.05) and indicates that the sample does not contain
L.
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monocytogenes
spp. or contains
L. monocytogenes
spp. at a concentration
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below the detection limit. A “positive” result has a test value equal to or
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greater than the threshold (≥ 0.05) and indicates that the sample is
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contaminated with
L. monocytogenes
spp. If the background reading is
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above a pre-determined cut-off, then the result is reported as invalid.
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5.9
Confirmation
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All positive VIDAS® LMX results must be confirmed. Confirmation should be
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performed using the non-boiled enrichment on a selective agar, ALOA, or
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equivalent (see attached flow diagram). Choose 5 typical or suspect colonies, or if
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there are <5 such colonies, choose all to confirm
Listeria
.
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6.0
VIDAS® UP
Listeria
(LPT) Method
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6.1
Applicability
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DRAFT DOCUMENT
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