Luminex IS Version 2.3 (IVD) - Manual (Page 106)

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use x MAP Technology
96
Statistics Definitions
Statistical calculations are performed for each test in each sample.
The number of events to collect for each test in a sample is defined in
the template from which the batch was created. In any equations
listed below, N indicates the number of events that were collected for
an individual test in a single sample. The trimmed distribution
represents the events that were collected for an individual test in a
single sample with the lowest 5% and highest 5% of the data points
removed to help eliminate outliers.
Results This field has no associated value. It is used to indicate the
beginning of the statistical results section of the Output.CSV
file.
DataType:,"type” This field is the name of the statistic represented in the
Sample (versus the Test data block immediately below this
field). Possible values for DataType include: Median, Result,
Count, Mean, %CV, Peak, Std Dev, Trimmed Count, Trimmed
Mean, Trimmed %CV, Trimmed Peak, Trimmed Std Dev, and
Avg Result. See Table 2 - Statistics Definitions
CRC Entry (Optional) CRC indicator for the file data. Used to detect
external changes to the file.
Table D-1 Field Definitions (Continued)
Field Name Field Value Description
Table D-2 Statistics Definitions
Statistic Description
Median The middle value in the distribution of data
Result The final test result based on a qualitative or quantitative analysis. This value
could have units associated with it, as defined in the template. It may also
indicate some error condition in the analysis, such as the sample was beyond
the range of the curve fit, a divide by zero error occurred, etc. Some example
include:
- "Invalid" - the user invalidated this sample, or a single test within a sample
- "<10 pg/mL" - the result could not be calculated because it fell outside the
valid range of the curve fit
- ">10000 pg/mL" - the result could not be calculated because it fell outside
the valid range of the curve fit
- "ERROR" - some mathematical error occurred, such as an MFI value that
does not intersect the concentration curve.
N/A - a result is not applicable for this sample (i.e. a background sample)
Count The number of data points in the distribution (N). The number of gated events
that fell within the test's specified region.
Mean (Optional) The sum of the data points in the distribution divided by the number
of data points.
Mean =
x
i
/ N