Create kit, Create lot, Import lot – Luminex xPONENT 3.1 Rev 2 (IVD) User Manual

Page 98

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For assay reagents specified in protocols, you can create new lots, edit lot information, select
pre-existing lots for reuse, import lots, and export lots.

Assay kits include standards and/or controls. Once you enter the assay kit information, it can
be used in multiple protocols. However, you should create separate kits specific for use with
each protocol.

Create Kit

1. Open the Protocols page, then open the Protocols tab.

2. Click on the protocol that you want to use for the kit, then click New Std/Ctrl. The Std/

Ctrl Details tab opens.

3. Type the name of the kit in the Name box, the lot number in the Std/Ctrl Kit Lot# box,

the expiration date using MM/DD/YY format in the Expiration box, and the manufacturer
in the Manufacturer box.

4. Click Apply Std Lot if you wish to apply a standard lot. The Select Lot dialog box opens.

Click a lot and select OK.

5. Click Apply Ctrl Lot to apply a control lot. The Select Lot dialog box opens. Click a lot

and click OK.

6. Alternatively, type the appropriate information in the Assay Standard Information and

Assay Control Information sections. The number of standards and/or controls in these
sections is defined in the protocol. If your batch uses controls, select Expected, Low, or
High from the Show Value options. Use the Apply Values arrows to apply values down
or across the range of analytes.

7. Click Save.

Create Lot

To create lots, you must use a protocol that uses either Quantitative or Qualitative analysis
settings.

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab, then

click Create New Std/Ctrl Lots.

2. In the Select Protocol dialog box, select the protocol you want to use for this lot, then

click OK. The Std/Ctrl Details tab opens.

3. If the protocol uses standards, type the appropriate information for each standard in the

Assay Standard Information section. In each analyte column, type the expected
concentration for the analyte.

4. Alternatively, click Apply Std/Ctrl Kit and select a lot from the Select Lot dialog box.

Click OK to apply the lot.

5. If your batch uses controls, select Expected, Low, or High from the Show Value

options. Use the Apply Values arrows to apply values down or across the range of
analytes.

6. Click Save.

Import Lot

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab, and

then click Import.

2. In the Open dialog box, navigate to the file, then click Open.

xPONENT

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3.1 Rev. 2 Software User Manual

88

For In Vitro Diagnostic Use

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