Creating a Customized Virology Assay Template

With the exceptions of Abbott and TaqMan, virology assays in LDMS are based around templates. Templates are custom configurations that you can create for an assay, with controls and settings for your specific assay needs. The following virology assays in LDMS utilize templates:

  • NASBA HIV RNA QT

  • Nuclisens HIV RNA QT

  • Roche Amplicor Monitor HIV RT PCR

  • Roche COBAS Amplicor

  • Roche COBAS UltraSensitive

  • Roche UltraSensitive HIV RT PCR

  • Roche HIV DNA PCR (versions 1 and 1.5)1

Some templates lock specific features during template creation for certain assays (for example, you cannot modify the controls on some templates). User templates are listed under their respective assay, and are shown in the Assay List in all upper case.

Figure: Virology assay selection list. In this example, FS ASSAY is a user-created template for the Roche Amplicor assay; Roche Amplicor (Kit Controls) is a system template that comes with LDMS for the same assay.



Creating a virology assay template:

  1. On the Assay Selection tab, find the existing assay that you want to use as the basis of your customizations.

  2. Select the Design check box.

  3. Click the button; this will automatically take you to the Design tab.

  4. Make the changes that you need, such as adding plates, modifying controls, and toggling wells.

  5. Enter a name for your custom assay template into the Assay Name field, and then click the button.

Attention:

You must make all your changes to the assay before clicking the button. You cannot modify and re-save assay templates after they have been created.

Virology assay template design screen



A typical plate layout. Each cell represents one well on the plate. The Assay Options window is also shown.

You can use the buttons in the Plate Controls section to add and remove plates from the assay, as well as change between plates. The current plate and total number of plates also appears at the bottom of the screen.

Individual wells can be enabled and disabled by selecting them, and then clicking the button. Disabled wells appear as black boxes on the plate. If you want to select multiple rows, hold down the Ctrl key. You can select an entire column by clicking the header row above the column.

Adding, deleting, and modifying controls is done by clicking the button. To add a control, you'll need to specify the Control Number and Expected Value for the control. While the control number will appear as written on the well in the template, they are also assigned a sequential control number in LDMS (1, 2, 3, etc.). If you need to modify or delete a control later, you'll need to know that sequential number. So, while you can technically enter anything for the Control Number, it's a good idea to use the number of the next available control. If you want to see what the next available control number is, select the Modify a control option, and then look in the Specimen ID list. That list shows the current controls. Now, change to the Add a control option and use the next number in the sequence.

Note:

Modifying controls on the assay is not available for all templates. If the feature is not available for the assay that you have selected, the Options button will be disabled.

The Compress and Compress Wells options will remove empty wells by moving other wells to fill them. Wells will be moved right to left to fill out the empty space.

Important:

When a new virology template is create, an assay reader device must be associated with it before it can be run in LDMS.

1

This assay appears in LDMS under the category DNA PCR; all other virology assays are in the category Viral Load RNA.