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73 | Chapter 5 : Instrument Qualification Process
Fluorescence Testing
For models with fluorescence capability, BioTek provides two options for testing the
fluorescence system. One uses a solid state Fluorescence Test Plate (package PN
1400501*). The other uses liquid plates, the materials for which are available for purchase
from BioTek (see
Materials for Conducting Liquid Tests on page 5).
*Fluorescence Test Plate PN 7092092 cannot be used for these tests.
BioTek Fluorescence Test Plate
The Fluorescence Test Plate simplifies the process for conducting fluorescence intensity
qualification tests on the
Synergy LX . The test plate is solid and therefore immune to the
pipetting errors, evaporation issues, and costs experienced with conventional Liquid Tests.
The test plate package includes Gen5 protocols designed specifically for use with the test
plate. The protocols include embedded Microsoft Excel spreadsheets to automatically
calculate results and determine pass/fail. The protocols and their spreadsheets were fully
validated in accordance with BioTek Instruments' Product Validation policies and
procedures.
The package also contains a user guide that describes the test methods, helps you get
started with using the plate, and provides important information for cleaning and
maintaining the test plate. The guide also provides troubleshooting tips and information on
the annual recalibration program.
Results Analysis
Refer to the Fluorescence Test Plate User Guide for descriptions of the data reduction
calculations for each test. The tests must meet the following criteria to pass:
Fluorescence Intensity (FI) Tests
Corners %CV < 3.0
Linearity R
2
>= 0.9500
Sensitivity, filter-based system:
Sodium Fluorescein analogue Detection Limit <= 20 pM
Methylumbelliferone analogue Detection Limit <= 0.16 ng/mL
Synergy LX User Manual
1501000N Revision A BioTek Instruments, Inc.