Luminex IS Version 2.3 (IVD) User Manual

Page 34

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Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use

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MAP Technology

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on the three tabs of the Analysis window is determined by the test
selected under the Standards tab.

The Standards tab displays the quantitative batch’s standard curve. It
displays qualitative batches as a graph plotting the assay standard.
Above the graphical information, the tab displays the formula that it
used to calculate batch data. Below the graphical information, the tab
displays the Standards and Controls values for the selected test.

Figure 17 Analysis Window - Standards Tab Open

When a median fluorescence intensity (MFI) value for an unknown
sample or control lies outside the standard curve MFI range, the
concentration is not calculated. The unknown sample or control
result is reported as less than (<) or greater than (>) next to the
corresponding standard expected concentration. The out-of-range
samples and controls will also have a “Sample High/Low” statement
in the comment column. If a sample lies within the standard curve
MFI range, but the sample’s MFI value does not intersect the curve,
the result will be reported as “Error”. A “cannot calculate inverse
function” statement displays in the comments column. This error
condition usually occurs when a standard curve “flattens out” at the
high or low end. Examples of out-of-range sample labeling for non-

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