Bio-Rad Bio-Plex System Validation and Calibration Tools - Manual (Page 5)

Section 3
Specifications
Specifications for the Bio-Plex ® validation kit may differ from lot to lot. Please refer
to the package insert provided with your validation kit for specifications.
Section for Software Installation
The Bio-Plex validation kit 4.0 includes a BizCard CD containing files with the
specifications for the validation beads along with additional information. The file
information is automatically loaded into Bio-Plex Manager™ 4.0 and later versions
upon installation.
Section 4
Storage and Handling
The Bio-Plex ® validation kit beads are stable if stored at 4°C protected from light.
When using the Bio-Plex validation kit, remove beads from storage and dispense
into the MCV plate. Return to 4°C storage immediately following use to preserve
shelf life. All components are guaranteed for 18 months from the date of
manufacture when stored as specified in this manual.
Section 5
Principle of Optics Validation
Principle
The Bio-Plex ® array reader is a laser-based fluorescence detection system
containing sensitive optics components. Alignment of the laser/optics system is
critical for optimal instrument performance. A method for the assessment of the
optics alignment is included in the validation kit. Acceptable specifications for the
alignment procedure are listed in the product insert.
Impact on Assay Performance
The alignment of the optics bench of the Bio-Plex array reader is critical for proper
assay performance. Misalignment of the reporter optics path can result in 1)
reduced assay sensitivity or 2) poor well-to-well assay precision. Misalignment of
the classification optics path can lead to 1) increased read times or 2)
misclassification of one assay into another, leading to false positive or negative
results. Correlation studies have been performed to determine the direct effect of
misalignment on assay performance.
3
4110185B.qxp 9/25/2007 11:55 AM Page 3