Users can enter PK test results by navigating to the Test
Results tab, clicking the Test Results module,
selecting a test, and then clicking Edit.
Assay Name: The Assay Name is a free entry field that
the user can define. This name will be used to group assays together on certain
reports and in the PK Control Charting Module.
Run Type:
Certain Run Types are used for different scenarios. For example,
Routine and Routine/Proficiency are used to report network results whereas
Calibration and Stability may be used when validating a new method.
Add Analyte: When adding an analyte the user
may choose to add these individually for each run or they can select an Analyte
Setup that was previously defined in the PK Templates module.
Note: The
analyte setup can be modified for each run and for each item on the run. For
example, a PK Template may have defined the analyte range as 10-1,000 but a
special run today may need the range to be 100-100,000. The user can modify the
range for any run as needed. Individual specimens and controls may also need
range adjustments. For example a specimen analyte range may use ng/mL but the
controls may use a range in ng/sample. The LDMS will allow the user to change
the limits for each individual item on the Results tab.
Add Control Lot:This will allow a user to add a Control Lot
to this run. The user can either add a predefined set of controls created in the PK
Control Lots module or, if a preset lot of controls have not previously been defined
in the PK Control Lots module, the user can create it for this individual run. If
the user chooses to not add or create the entire lot of controls here, they can add
individual controls on the Results tab.
Add Control: The user can click Add Control to add
additional controls to this run. Even if the user added a Control Lot on the
general tab they can use this feature to include additional controls now.
Add Specimens: The user can choose to add specimens onto
this run.
Note: Dilution will default to 1 for all specimens added to a PK Run. If the
specimen was tested with a dilution the user can choose to change the value
here. Any result that has a dilution modified from 1 will be assigned a U
censor.
Specify Limits Per Specimen: If any specimen on the run
needs to use a limit range other than what was defined at the analyte level this
option can be used to change the limit for each individual specimen.
Setting Limits in the Result Grid: The user can set the
Target and +/- for each control or they can set a specific Lower and Upper
limit. If the user has checked to Specify Limits per Specimen they can also set
the lower and upper limit for each specimen.
Note: If a specimen was diluted the LDMS will account for the dilution when
comparing the input result to the limits. The user should not change the
standard limits for a specimen to account for dilution as the LDMS will do this
automatically.
Important: If a result was not obtained for a specific specimen, leave the result field
for that row Blank/Null. LDMS will allow the user to apply a User Censor to this
result when Reviewing the run. Leaving a result Blank/Null may be necessary in
scenarios such as a template including an analyte that was not tested for, a
sample on the run having insufficient volume, or an issue in interpreting the
final result.
Upload File: An example PK assay test result file is shown
below.
Unmatched Results From File: Any result from the file that could
not be automatically matched to an item on the run in LDMS will be available in this
grid to drag-and-drop to match.
Manually Setting Results: If a file is not used or if the LDMS
contains more results than are found in the result file, the user can manually enter
results to LDMS by typing directly into the field.
Note: Results from diluted specimens must be entered to LDMS pre-calculated to account
for dilution. LDMS will not change the input result to account for dilution. LDMS
will adjust the limits based on dilution for purposes of calculating the A and B
censors but LDMS expects the user to input the final result pre-calculated to
account for the dilution.