Setting up Assay Kit Information

When reading certain assays in LDMS, you will be required to select kit lot information. For some of these assays, you will need to manually enter the kit information into LDMS using the Kit Entry tool; for newer assays, LDMS will automatically load kit information from your result file (though you will still need to use the Kit Entry tool to enter a few pieces of information that are not in assay result files).

The following table shows which assays require kit information when they are being read. It then breaks those assays down between those where kit information must have been entered manually prior to reading the assay and those where kit information can be read automatically from the output file.

Table 1. Assays Requiring Kit Information
Assay Manual Automatic
Abbott Realtime HIV-1 -- X
COBAS TaqMan HCV -- X
COBAS TaqMan HIV-1 -- X
Nuclisens HIV RNA QT X  
Roche Amplicor Monitor HIV RT PCR X --
Roche COBAS Amplicor X --
Roche COBAS UltraSensitive X --
Roche UltraSensitive HIV RT PCR X --
Important:

For assays where kit information is pulled from the result file automatically, you still must use the Kit Entry tool to enter the Date Rec[eived] and Storage Temp[erature] for the kit, as this information is not in the result file.

Figure: Kit Lot Entry Screen. The kit entry screen for the Abbott Realtime HIV-1 assay.



Important:

The fields available for kits and types of kits will vary, depending on the assay selected. The process of using the kit entry tool is the same for every assay; it is the fields that are unique.

Manually creating a new kit lot:

  1. Access the Kit Entry tool by clicking QA/QC > Kit Entry from the LDMS menu bar.

  2. Select the assay for the kit you are creating from the Assay drop-down list.

  3. (If applicable) Select the type of kit from the drop-down list next to the assay. This field will not be displayed for assays that do not need it.

  4. Complete all of the fields at the bottom of the screen using the information from your kit. The precise fields that are available will vary from assay to assay.

  5. Click the button from the LDMS toolbar.

Kits can be updated after creating them. If you have read an assay that automatically collects kit information from the assay output file, modifying the existing kit is how you would complete the fields that are not read from the output. This update would only need to be done the first time the kit was used.

Modifying an existing kit:

  1. Access the Kit Entry tool by clicking QA/QC > Kit Entry from the LDMS menu bar.

  2. Select the assay for the kit you are modiying from the Assay drop-down list.

  3. (If applicable) Select the type of kit from the drop-down list next to the assay. This field will not be displayed for assays that do not need it.

  4. Select the kit that you want to modify from the list of existing kits. The fields at the bottom of the screen will be populated with the values for the selected kit.

  5. Make the necessary changes to the kit fields.

  6. Click the button from the LDMS toolbar.

One of the options available when modifying kits is to deactivate them. This prevents them from being selected when reading an assay without actually removing the kit from LDMS. If a kit has not yet been used, it can also be deleted by selecting the kit, and then clicking the button from the LDMS toolbar. Once an assay has been run with a kit, however, that kit cannot be deleted.