Bio-Rad Bio-Plex System Validation and Calibration Tools - Manual (Page 22)

your product insert for values specific to your product control number..
Parameter Specification Measured Value Pass/Fail
DD Median 4774 - 6593 6133 Pass
CL1 Median 3383 - 4135 3615 Pass
CL1 CV% 2.00 - 7.00 3.52% Pass
CL2 Median 3520 - 4302 3883 Pass
CL2 CV% 3.00 - 8.00 6.93% Pass
RP1 Median 3509 - 4290 3878 Pass
RP1 CV% 4.00 - 10.00 8.89% Pass
Parameter Specification Measured Value Pass/Fail
% Carryover < or = 4.0% 1.3% Pass
A. Calculated Values B. Raw Values
Parameter Specification Measured Value Pass/Fail Bead Median FI
Dynamic Range 4.33 - 4.45 4.40 Pass Blank 2
Linearity > 0.995 1.000 Pass 1 8
Slope 33.94 - 39.42 37.57 Pass 2 54
Accuracy > 90.00% 96.94% Pass 3 656
Threshold < 6 MFI 2 Pass 4 1576
5 4453
6 25059
A. Classify Efficiency
Classify Bead Specification Measured Value Pass/Fail
Bead A (1) > 80.0% 98.1% Pass
Bead B (4) > 80.0% 93.5% Pass
Bead C (40) > 80.0% 90.5% Pass
Bead D (54) > 80.0% 95.3% Pass
Bead E (100) > 80.0% 93.0% Pass
B. DD Efficiency
Parameter Specification Measured Value Pass/Fail
DD Efficiency > or = 75.0% 96.7% Pass
Comments:
Reviewed by: Date:
III. Reporter Validation
IV. Classify Validation
II. Fluidics Validation
Test Performed by: JPocekay Date/Time: 04-Aug-04 11:55 AM
Expiration Date: 15-Oct-06
Reader Serial #: LX10000266002 Access Level: Unrestricted
Validation Kit Control #: 999999 (Low)
RP1 Target Value: 3885 RP1 PMT Voltage: 571.67
Result: Passed
Result: Passed
Result: Passed
Result: Passed I.Optics Validation
Suspension Array System Validation Report
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