White TSH - New Line Medical

EP Evaluator
New Century Diagnostics, Inc.
TSH
Instrument: Centaur
Sample Name: MED
Alternate Precision
Within
Run
Precision Estimate
User's Concentration: 0.3719
Between
Run
Between
Day
Total
Std. Dev 0.0224 0.0000 0.0202 0.0302
% CV 6.0 0.0 5.4 8.1
df 18 -- -- 13
Precision Plot
Outlier Rejection Criteria
SD
0.0328 (calculated)
Multiplier 5.5
Max difference
between duplicates 0.1804
SD Index
Preliminary estimate of precision
Mean 0.3681
SD 0.0328
CV 8.9%
N 12
Results:
.334 .393 .352 .359 .357
.332 .365 .333 .416 .347
.416 .413
Upper 95% tolerance limit for 95% of user estimates
df for user's
experiment
within run
SD
total
SD
10 0.0303 0.0407
20 0.0280 0.0377
30 0.0269 0.0362
40 0.0265 0.0356
50 0.0260 0.0350
60 0.0258 0.0347
70 0.0256 0.0344
80 0.0253 0.0341
90 0.0251 0.0338
100 0.0249 0.0335
Day Number
This table provides
data for a manufacturer
to include in
published materials
for users.
Supporting Data
Analyst
mp
Analysis Date 22 Jul 2008 to 17 Dec 2008
Days (total/excl) 6 / 0
Runs per Day 1
Reps per Run 4
Critical Value 95%
Reagent BioRAD, Lot 40202
Calibrator
SAME, Lot SAME
Units
mIU/L
Verify Mode Establish Claim
Allowable Total Error --
Random Error Budget --
Allowable Rand Error --
Comment
Accepted by:
Signature
Date
TSH Printed: 19 Dec 2008 21:37:54
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