Bio-Rad Bio-Plex System Validation and Calibration Tools - Manual (Page 6)

Section 3
Specifications
General specifications for the validation kit are listed below. Certain specifications
for the Bio-Plex validation kit may differ from lot to lot. For a complete listing of the
current specifications, please refer to the package insert provided with your
validation kit.
Parameter Specification
Optics Validation
DD mean See insert
CL1 mean See insert
CL1 CV% (Coefficient of Variable) 3–7%
CL2 mean See insert
CL2 CV% 4–8%
RP1 mean See insert
RP1 CV% 5–10%
Fluidics Validation
% carryover < or = 4.0%
Reporter Validation
Dynamic range 4.15–4.28
Linearity >0.995
Slope of response
0.0593–0.0799
Accuracy of response >90%
Sensitivity <200 MESF
Classify Validation
Classify Bead 34, 38, 54, 73, 77 >80.0%
DD Efficiency
% Efficiency > or = 75%
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 4°C storage and
dispense into the MCV plate. Return to 4°C storage immediately following use to
preserve shelf life. All components are guaranteed for 6 months from the date of
purchase when stored as specified in this manual.
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