LAB Department -- City Pharmacy

Linearity Summary
Reportable

Instrument Analyte Linearity Accuracy Range Precision

DXH520 HGB Pass -- -- --

PLT Pass -- -- --
RBC Pass -- -- --
WBC Pass -- -- --

Required parameters are missing. Experiment 'fails' (or not enough results).
Experiment 'passes' (or adequate number of results).

EP Evaluator 12.3.0.2 Copyright 1991-2021 Data Innovations LLC

Dar Alhikmah/Dar Alhikmah Medical Lab taawun Printed: 22 Jan 2024 17:50:04 Page 1
 HGB
Instrument DXH520
LAB Department -- City Pharmacy

Linearity
Scatter Plot Residual Plot

Linearity Summary
N Slope Intercept Error
Overall 5 1.000 -0.151 -- (conc) or 0.8%
LINEAR within SEa of -- (conc) or 3.5%

Statistical Analysis and Experimental Results

Assigned Pct Est Mean Residual Linear? Measured Concentrations
Level 1 2.3 -- 2.148 2.167 0.018 Pass 2.17 2.17 2.16
Level 2 3.5 -- 3.348 3.320 -0.028 Pass 3.35 3.29 3.32
Level 3 5.8 -- 5.648 5.650 0.002 Pass 5.67 5.63 5.65
Level 4 11.9 -- 11.746 11.847 0.100 Pass 11.87 11.74 11.93
Level 5 19.8 -- 19.645 19.697 0.052 Pass 19.78 19.73 19.58
See User's Specifications for Pass/Fail criteria
X: Excluded from calculations
T: Exceeds Allowed Total Error
User's Specifications Supporting Data
Allowable Total Error -- (conc) or 7.0% Analyst Staff
Systematic Error Budget 50% Date 03 Jan 2024
Allowable Systematic Error -- (conc) or 3.5% Value Mode Pre-Assigned
Units g/dL
Controls --
Reagent --
Calibrators --
Comment
Evaluation of Results
The Linearity of HGB was analyzed on DXH520 over a measured range of 2.167 to 19.697 g/dL. Accuracy and Reportable
Range were not evaluated in this experiment. Allowable systematic error (SEa) was -- (conc) or 3.5%. The results are LINEAR.

Accepted by:
Signature Date
EP Evaluator 12.3.0.2 (...L) Copyright 1991-2021 Data Innovations LLC
Dar Alhikmah/Dar Alhikmah Medical Lab taawun Printed: 22 Jan 2024 17:50:03 Page 2
 PLT
Instrument DXH520
LAB Department -- City Pharmacy

Linearity
Scatter Plot Residual Plot

Linearity Summary
N Slope Intercept Error
Overall 6 1.042 -4.95 -- (conc) or 4.4%
LINEAR within SEa of -- (conc) or 12.5%

Statistical Analysis and Experimental Results

Assigned Pct Est Mean Residual Linear? Measured Concentrations
Level 1 10.0 -- 5.46 5.23 -0.23 Pass 5.6 4.9 5.2
Level 2 28.0 -- 24.22 25.33 1.12 Pass 25.7 25.6 24.7
Level 3 170.0 -- 172.14 173.07 0.93 Pass 172.6 169.9 176.7
Level 4 438.0 -- 451.32 455.23 3.91 Pass 449.1 476.8 439.8
Level 5 1463.0 -- 1519.08 1454.87 -64.21 Pass 1468.7 1430.4 1465.5
Level 6 1820.0 -- 1890.97 1840.90 -50.07 Pass 1858.7 1812.5 1851.5
See User's Specifications for Pass/Fail criteria X: Excluded from calculations
User's Specifications T: Exceeds Allowed Total Error
Supporting Data
Allowable Total Error -- (conc) or 25.0% Analyst Staff
Systematic Error Budget 50% Date 03 Jan 2024
Allowable Systematic Error -- (conc) or 12.5% Value Mode Pre-Assigned
Units 10^3/uL
Controls --
Reagent --
Calibrators --
Comment
Evaluation of Results
The Linearity of PLT was analyzed on DXH520 over a measured range of 5.23 to 1840.90 10^3/uL. Accuracy and Reportable
Range were not evaluated in this experiment. Allowable systematic error (SEa) was -- (conc) or 12.5%. The results are
LINEAR.

Accepted by:
Signature Date
EP Evaluator 12.3.0.2 (...L) Copyright 1991-2021 Data Innovations LLC
Dar Alhikmah/Dar Alhikmah Medical Lab taawun Printed: 22 Jan 2024 17:50:03 Page 3
 RBC
Instrument DXH520
LAB Department -- City Pharmacy

Linearity
Scatter Plot Residual Plot

Linearity Summary
N Slope Intercept Error
Overall 6 1.001 0.017 -- (conc) or 1.2%
LINEAR within SEa of -- (conc) or 3.0%

Statistical Analysis and Experimental Results

Assigned Pct Est Mean Residual Linear? Measured Concentrations
Level 1 0.77 -- 0.788 0.783 -0.005 Pass 0.79 0.78 0.78
Level 2 1.16 -- 1.179 1.177 -0.002 Pass 1.18 1.18 1.17
Level 3 1.96 -- 1.980 1.957 -0.023 Pass 1.98 1.93 1.96
Level 4 3.90 -- 3.923 3.970 0.047 Pass 3.96 3.95 4
Level 5 6.43 -- 6.456 6.380 -0.076 Pass 6.43 6.4 6.31
Level 6 8.05 -- 8.078 8.043 -0.035 Pass 8.03 8 8.1
See User's Specifications for Pass/Fail criteria X: Excluded from calculations
User's Specifications T: Exceeds Allowed Total Error
Supporting Data
Allowable Total Error -- (conc) or 6.0% Analyst Staff
Systematic Error Budget 50% Date 03 Jan 2024
Allowable Systematic Error -- (conc) or 3.0% Value Mode Pre-Assigned
Units 10^6/uL
Controls --
Reagent --
Calibrators --
Comment
Evaluation of Results
The Linearity of RBC was analyzed on DXH520 over a measured range of 0.783 to 8.043 10^6/uL. Accuracy and Reportable
Range were not evaluated in this experiment. Allowable systematic error (SEa) was -- (conc) or 3.0%. The results are LINEAR.

Accepted by:
Signature Date
EP Evaluator 12.3.0.2 (...L) Copyright 1991-2021 Data Innovations LLC
Dar Alhikmah/Dar Alhikmah Medical Lab taawun Printed: 22 Jan 2024 17:50:04 Page 4
 WBC
Instrument DXH520
LAB Department -- City Pharmacy

Linearity
Scatter Plot Residual Plot

Linearity Summary
N Slope Intercept Error
Overall 6 0.995 -0.018 -- (conc) or 2.1%
LINEAR within SEa of -- (conc) or 7.5%

Statistical Analysis and Experimental Results

Assigned Pct Est Mean Residual Linear? Measured Concentrations
Level 1 0.5 -- 0.480 0.490 0.010 Pass 0.49 0.5 0.48
Level 2 5.9 -- 5.854 5.733 -0.121 Pass 5.75 5.82 5.63
Level 3 12.3 -- 12.225 12.333 0.109 Pass 12.34 12.29 12.37
Level 4 39.5 -- 39.297 39.557 0.259 Pass 39.22 39.83 39.62
Level 5 79.9 -- 79.509 80.703 1.195 Pass 81.46 80.5 80.15
Level 6 99.3 -- 98.818 100.950 2.132 Pass 100.95 100.83 101.07
See User's Specifications for Pass/Fail criteria X: Excluded from calculations
User's Specifications T: Exceeds Allowed Total Error
Supporting Data
Allowable Total Error -- (conc) or 15.0% Analyst Staff
Systematic Error Budget 50% Date 03 Jan 2024
Allowable Systematic Error -- (conc) or 7.5% Value Mode Pre-Assigned
Units 10^3/uL
Controls --
Reagent --
Calibrators --
Comment
Evaluation of Results
The Linearity of WBC was analyzed on DXH520 over a measured range of 0.490 to 100.950 10^3/uL. Accuracy and
Reportable Range were not evaluated in this experiment. Allowable systematic error (SEa) was -- (conc) or 7.5%. The results
are LINEAR.

Accepted by:
Signature Date
EP Evaluator 12.3.0.2 (...L) Copyright 1991-2021 Data Innovations LLC
Dar Alhikmah/Dar Alhikmah Medical Lab taawun Printed: 22 Jan 2024 17:50:04 Page 5
LAB Department -- City Pharmacy

Linearity
Report Interpretation Guide

In EP Evaluator, Linearity experiments are experiments that somewhere in between.

use specimens with defined concentrations. The Linearity
module can also evaluate Calibration Verification, Accuracy,
Reportable Range and Precision. This means that you can Linearity
verify three of the four major CLIA '88 requirements with one Several definitions are in common use. Among them:
properly designed experiment.  Traditional Linearity (CAP Visual Inspection): Draw a
User-selectable options determine which of these analytical scatter plot with assigned values on the X-axis and
properties the report verifies. Also, the user may request measured mean on the Y-axis. If it looks like a straight
Pass/Fail flags against a specific allowable error criterion, or line, the method is linear.
he/she may simply report selected statistical measures.  Statistical Linearity (CLSI EP6P and EP6-A): These
Experiment Procedure: Replicate measurements are made procedures determine acceptability based on statistical
on 3-11 specimens, with (known) concentrations spread significance (i.e., p-values) rather than medical
across the reportable range. Ideally, the lowest and highest significance. EP Evaluator does not compute Statistical
specimens should challenge the limits of the range. Linearity.
 Clinical Linearity: The method is linear if it is possible
Accuracy (or Recovery) to draw a straight line that passes within a user-defined
Definition: The ability to recover the correct amount of allowable error of each specimen point.
analyte present in the specimen. Related concepts:
Verification process: Accuracy can be verified only when  Best Fit Line: If the user opts to verify Linearity, this line
the "correct" amount of analyte (the Assigned Value) is is obtained using the Clinical Linearity algorithm.
known. While it is possible to evaluate recovery using a Otherwise it is a regular linear regression line.
single replicate, assaying 2 to 4 replicates provides a more
reliable estimate.  Outliers: When verifying Linearity, the program first
tries to determine an acceptable line using all
Key statistic: Recovery = 100 x Measured Mean / Assigned specimens. If it fails, it then tries to find some subset of
Value at least three specimens that are linear within allowable
error. Specimens not in this acceptable subset are
Reportable Range classified as outliers.
Definition: As used in CLIA, Reportable Range refers to the  Slope and Intercept: Coefficients of the Best Fit Line.
Analytical Range or Assay Range -- the maximum range of The ideal slope is 1.00; the ideal intercept is zero.
values that can be assayed accurately without dilution. The  Observed Error: For Clinical Linearity, this is the
CAP term "Analytical Measurement Range" (AMR) is a minimum allowable error that could be defined for a data
synonym for Reportable Range. set and still have it be linear.
Verification Procedure: Reportable Range is verified if two  Standard Error of Estimate: For regular regression,
conditions are met: 1) the assigned values of the lowest and this measures the dispersion of the data points around
highest specimens are within proximity limits of the the Best Fit Line.
Reportable Range limits, and 2) these two specimens are
acceptably accurate.  Residual: The difference between the best fit line and
Proximity Limits: Proximity Limits define how close the
either an individual result or a mean measured value,
lowest and highest specimens must be to the Reportable depending on context.
Range limits.  RSQ: The coefficient of determination r-squared (rsq)
appears in the report's "Linearity Summary" or detail
screen plot when enabled in the Preferences\Reports
Calibration Verification menu. It does not appear when "Clinical Linearity" is
Calibration Verification verifies whether a method is properly selected.
calibrated by verifying both Accuracy and Reportable Range.
The report is titled to match the CAP and CLIA regulatory
requirements. Precision
Definition: Ability to obtain the same result upon repeated
CLIA requires a minimum of three specimens, each assayed measurement of a specimen.
in duplicate. Two specimens challenge the lower and upper
limits of the reportable range. The third specimen is Verification Process: Measure the specimen many times.
EP Evaluator 12.3.0.2 Copyright 1991-2021 Data Innovations LLC
Printed 22 Jan 2024 17:50:04 Page 6
LAB Department -- City Pharmacy

Linearity
Report Interpretation Guide

Compute the SD and CV, and verify that they are acceptably Limits, and 2) these two specimens also pass accuracy.
small. While 2-4 replicates are adequate for assessing
accuracy, a minimum of 10 (and preferably 20 or more) is
required to verify Precision. Preliminary Report
The word PRELIMINARY printed diagonally across the
report indicates that the data is incomplete, and the report is
The Precision Index is the ratio of SD to Allowable Random not acceptable as a final report. Some or all of the statistics
Error (defined below). The ideal -- and probably unattainable may be missing.
-- Precision Index is zero. A value of 1.00 indicates The Linearity report is preliminary if there are less than three
borderline acceptability. Any further increase in SD would specimens.
exceed allowable error.
The 95% Confidence Interval (CI) for the Precision Index
indicates how much sampling variation might be expected.
The CI narrows as the number of replicates increases.

Allowable Total Error (TEa), and the Error

Budget
TEa states the laboratory's policy for how much error is
medically (or administratively) acceptable. Regulatory
requirements represent an upper limit. Example: the CLIA
limit for Sodium is 4 mmol/L.
Total Error has two major components: Systematic Error
(synonym Bias) and Random Error (synonym Imprecision).
The Error Budget allocates a fraction of the Allowable Total
Error for Systematic Error, and the remaining fraction for
Random Error. Establishing an appropriate Error Budget
allows the lab to control accuracy and precision separately,
with reasonable confidence that Total Error will also remain
in control. The recommended upper value for the Systematic
Error Budget is 50%; for the Random Error Budget it is 25%.

Pass or Fail?
The program reports Pass/Fail for Accuracy and Linearity
based on Allowable Systematic Error (SEa). Pass/Fail for
Precision is based on Allowable Random Error (REa).
 A specimen passes Accuracy if its mean measured
value is within SEa of the Assigned Value. Note that if
the lowest standard has an assigned value of zero, then
the TEa conc must not be blank or "0". Otherwise the
experiment will fail.
 The experiment passes Linearity if it is possible to draw
a straight line (on the scatter plot of mean measured
value vs. assigned value) that passes within +/- SEa of
each specimen point.
 A specimen passes Precision if SD does not exceed
REa.
 The experiment passes Reportable Range if 1) the
assigned values of the lowest and highest specimens
are within proximity limits of the Reportable Range
EP Evaluator 12.3.0.2 Copyright 1991-2021 Data Innovations LLC
Printed 22 Jan 2024 17:50:04 Page 7