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VIDAS LMX & LPT Collaborative Study
April 19, 2013
OMA-2013-Apr-XXX
6.7.6
Thoroughly mix the standard, controls and boiled samples before use. It is
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essential that all enrichment broths be heated on the Heat and Go for 5 ± 1
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min then cooled to room temperature before being dispensed into the
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sample well.
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6.7.7
Pipette 500 µL of standard or control into the sample well of the reagent
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strip.
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6.7.7.1 NOTE: Test samples and controls singly and standard in
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duplicate.
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6.7.8
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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6.7.9
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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6.7.10
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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6.8
Interpretation and Test Result Report
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6.8.1
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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6.8.2
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
24
threshold (0.05) and indicates that the sample does not contain
Listeria
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spp. or contains
Listeria
spp. at a concentration below the detection limit.
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A “positive” result has a test value equal to or greater than the threshold (≥
27
0.05) and indicates that the sample is contaminated with
Listeria
spp. If
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the background reading is above a pre-determined cut-off, then the result
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is reported as invalid.
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6.9
Confirmation
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All positive VIDAS® LPT 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 flowchart). 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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7.0
Reporting Raw Data
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7.1
Report data using the data report form in Appendix 9.2.
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7.2
Upon completion of the study, the laboratory will fax or email the completed data
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form to the Study Director.
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7.3
Copies of all related test results (data sheets, VIDAS printouts and confirmation
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results) should be retained by the collaborating labs for a minimum of one year.
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DRAFT DOCUMENT
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