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Analyzing batches and multi-batches – Luminex IS Version 2.3 (IVD) User Manual

Page 77

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MAP Technology

Luminex 2.3 Software

PN 89-00002-00-254 Rev. B

67

To export a lot from an existing template:

1. On the Home tab, click New Lot. The Open Template dialog

box opens.

2. Double-click the template containing the lot to export. The

Update Lot Information dialog box opens. See Figure 39.

3. Click Export Lot. A standard or control confirmation dialog box

opens verifying that you want to export the current lot for the
standard or control.
If you want to export the lot information for the standards, click
Yes. If you only want to export the lot controls, click No. A
second dialog box opens to verify if you want to export the
current control lot, or current lot for a control.

After responding to the confirmation dialog boxes, regarding
standards or controls, a Save As dialog box opens.

4. Click the drop-down arrow to select the Save in: location where

you want to save the lot information.

5. Enter the lot file name into the File Name: box.

6. Click Save. The system saves the lot.

Analyzing Batches and
Multi-Batches

You can analyze an acquired batch using the analysis features of
Qualitative and Quantitative algorithms. The algorithm is determined
by the kit manufacturer during template creation.

A Qualitative analysis determines results as either positive or
negative, reactive or non-reactive, and so on. Result ranges can be
negative, low positive, high positive, and so on. Refer to the IVD kit
manufacturer instructions for use.

A Quantitative analysis determines the sample concentrations from
standard curves using regression methods, such as 4P or 5P logistic
curve fitting. Refer to the IVD kit manufacturer instructions for use.

There are two main assay types: non-competitive (such as a “capture
sandwich”) and competitive. In a non-competitive assay, the slope of
a concentration versus Mean Fluorescent Intensity (MFI) standard
curve is a positive number. That is, low concentrations result in low
MFIs and high concentrations result in high MFIs. Conversely,
competitive assays generate a standard curve with a negative slope,
the endpoints of which are high MFI/low concentration on the left,
and low MFI/high concentrations on the right.