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D. (c)
After incubation, homogenize samples manually. Follow appropriate instructions
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based on heating method.
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Boiling
- Transfer 2-3 mL of the enrichment broth into a tube. Seal the tube. Heat
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in a water bath for 5± 1 minutes at 95-100°C. Cool the tube. Mix the boiled
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broth and transfer 0.5 mL into the sample well of the VIDAS LPT reagent strip.
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Perform the VIDAS test.
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8
Heat and Go
- Transfer 0.5 mL of the enrichment broth into the sample well of
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the VIDAS LPT reagent strip. Heat for 5± 1 minutes (see VIDAS Heat and Go
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User’s Manual). Remove the strip and allow to cool for 10 minutes prior to test
11
initiation. Perform the VIDAS test.
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E. Enzyme Immunoassay
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E. (a)
Enter factory master calibration curve data into the instrument using the master lot
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entry (MLE) card.
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E. (b)
Remove the kit reagents and materials from refrigerated storage and allow them to
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come to room temperature for at least 30 minutes.
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E. (c)
Use one VIDAS LPT Reagent Strip and one VIDAS LPT SPR for each sample,
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control or standard to be tested. Reseal the storage pouch after removing the required
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number of SPRs.
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E. (d)
Enter the appropriate assay information to create a work list. Enter the test code
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by typing or selecting “LPT”, and number of tests to be run. If the standard is to be
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tested, identify the standard by “S1” and test in duplicate. If the positive control is to be
25
tested, identify it by “C1”. If the negative control is to be tested, identify it by “C2”.
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a.
Note: The standard must be tested upon receipt of a new lot of reagents and then
27
every 14 days. The relative fluorescence value (RFV) of the standard must fall
28
within the set range provided with the kit.
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E. (e)
Load the LPT reagents strips and SPRs into the positions that correspond to the
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VIDAS section indicated by the work list. Verify that the color labels with the assay code
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on the SPRs and reagent strips match.
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E. (f)
Initiate the assay processing as directed in the VIDAS operator’s manual.
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E. (g)
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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F. Results and Interpretation
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The results are analyzed automatically by the VIDAS system. A report is printed which
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records the type of test performed, the test sample identification, the date and time, the lot
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number and expiration date of the reagent kit being used, and each sample’s relative
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fluorescence value (RFV), test value, and interpreted result (positive or negative).
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Fluorescence is measured twice in the Reagent Strip’s reading cuvette for each sample
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tested. The first reading is a background reading of the substrate cuvette before the SPR
43
is introduced into the substrate. The second reading is taken after incubating the substrate
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8