COBAS TaqMan HIV-1 Qualitative

About this task

The COBAS TaqMan HIV-1 Qualitative assay (not to be confused with the COBAS TaqMan HIV-1) can be found DNA PCR category. This assay is setup and the results are read differently than most other assays in LDMS. The result file is read during the setup process and LDMS will attempt to match results to individual specimens and controls by global specimen ID or other specimen ID and will show you any results that could not be automatically matched. You will have the opportunity to associate unmatched results by hand or simply ignore them.

You can either setup a 24-item run or a 48-item run. Like the name implies, these two options set the maximum number of specimens that can be tested in LDMS to either 24 or 48. Controls are automatically added to runs. The table below shows the number and types of controls that will automatically be added to a run.

Table 1. 24 and 48 item run comparisons
Control	24 item run	48 item run
VQA blinded controls	Two	Four (two per rack)
Kit positive	One	Two (one per rack)
Kit negative	One	Two (one per rack)
VQA copy control	Four	Four
Maximum number of testing specimens (less controls)	16	36

VQA controls will only be added for certain groups. For example, if you tested specimens for an internal group, the VQA controls would not be added and you could test four additional specimens on the run.

Procedure

Create a new COBAS TaqMan HIV-1 Qualitative run and add assigned specimens to it.
Select either 24 item run or 48 item run from the bottom of the screen.
To add more specimens, VQA copy controls, or VQA blinded controls, click the Add Item button.
Select the kit lot number for any VQA copy controls by right-clicking on the specimen and selecting Select VQA lot number.
You can either select an existing lot number or enter a new one.
Specify the VQA blinded control that were used by selecting the appropriate VQA blinded control from the drop-down list next to each.
Click the Select Result File button.
A window will appear allowing you to choose to the result file created when you ran the assay.
Complete specimen matching. Specimens in the result file will automatically be matched to specimens.

This will be shown by the Result ID column. Specimens without a result ID listed were not automatically matched. Unmatched results will appear on the left. To associate a result with a specimen, drag it from the list on the left to the desired specimen on the right. You can also drag results back to the unmatched results to remove it, or move it to a different specimen.

All specimens added to the run in LDMS must have an associated Result ID, however, there may be unused results in the file that are not associated with a specimen.
In the Assay Version box, select the version of the assay.
In the Tech Initials box, enter the initials of the assay technician.
In the Run Date box, enter the date that the assay was run.
Click Commit Results.

Results

After committing the results, they will be immediately saved to your LDMS database. A screen will then appear, showing you the results and any censors that may have been automatically applied by LDMS. You can enter comments and reviewer information, and then click the Save button from the LDMS toolbar.

You can apply a censor to a specimen (or the entire run) by right-clicking on a specimen and selecting Censor Specimen or Censor Run respectively. To see a list of what individual censor codes mean, click the Options button. Because this assay can be run with multiple racks, it is possible for one rack to have a system assigned censor code applied to it while another rack has no censors.

There are two reports available after the TaqMan HIV-1 Qualitative assay has been run:

assay results report: Available by clicking the Reports button from the LDMS toolbar.
patient report: Click the Options button, and then select Print Patient Report.

These reports can be accessed at any time after results have been read by using the Review/Edit option on the Assay Selection tab.