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CLIA ยท CLSI EP09-A3 ยท CAP GEN.55400 โ Method Comparison
Report Number
VTL-LTL-20260821-2C7D
Date: 2026-08-21
Performed by: Maria Gonzalez, MLS(ASCP)
โ
Approved
๐ METHOD COMPARISON REPORT โ CLSI EP09-A3
Analyte: Glucose
Reference Method: Roche cobas c503 (Reagent Lot A)
New/Test Method: Roche cobas c503 (Reagent Lot B)
Samples (n): 30 used / 30 total
Reference Method: Roche cobas c503 (Reagent Lot A)
New/Test Method: Roche cobas c503 (Reagent Lot B)
Samples (n): 30 used / 30 total
Bias Limit: ยฑ15.0%
TEa: 10.0%
Outlier Method: Tukey IQR (k=1.5), n=0 detected, flagged only
Regression Methods: Deming & Passing-Bablok
TEa: 10.0%
Outlier Method: Tukey IQR (k=1.5), n=0 detected, flagged only
Regression Methods: Deming & Passing-Bablok
โ
PASS โ Methods are Comparable
Bias โ
ยท Rยฒ โ
ยท Deming Slope โ
0.9998
Pearson r
Rยฒ = 0.9996 โฅ0.95 โ
1.97%
Mean Bias %
Limit ยฑ15.0% โ Pass
1.011
Deming Slope
Ideal 1.00 โ Pass
๐ Scatter Plot โ Deming & Passing-Bablok Regression
๐ Bland-Altman Plot (Limits of Agreement)
๐ Percent Bias Plot
๐ Regression Statistics
Deming Regression (Parametric)
| Slope | 1.011 (SE 0.0045) |
| Intercept | 1.4212 (SE 1.0729) |
| SEE | 1.8112 |
| Rยฒ (Pearson) | 0.9996 |
Passing-Bablok Regression (Non-Parametric)
| Slope | 1.0106 (95% CI: 1.0007 โ 1.0177) |
| Intercept | 1.3544 (95% CI: -0.3585 โ 3.7337) |
| Slope โ 1.0? | โ No โ proportional bias |
| Intercept โ 0? | โ Yes |
โ๏ธ Bias & Bland-Altman Statistics
| Parameter | Value | Interpretation |
|---|---|---|
| Mean Bias (absolute) | 3.8133 | Average difference New โ Reference |
| Mean Bias % | 1.97% | Limit: ยฑ15.0% โ Pass |
| SD of Bias | 2.0319 | Precision of bias estimate |
| SD of %Bias | 1.7% | |
| Bland-Altman Upper LoA | 7.7959 | +1.96 ร SD โ 95% upper limit of agreement |
| Bland-Altman Lower LoA | -0.1693 | โ1.96 ร SD โ 95% lower limit of agreement |
๐ Descriptive Statistics by Method
| Parameter | Reference Method (Reference_Method) | New/Test Method (New_Method) |
|---|---|---|
| Mean | 218.0 | 221.8133 |
| SD | 90.9624 | 91.9603 |
| CV% | 41.73% | 41.46% |
| n | 30 samples (0 excluded as outliers if applicable) | |
๐ฏ Quality Goals (TEa-Based)
๐ Quality Goals from TEa = 10.0%
TEa (Total Allowable Error)
10.0%
SEa (Allowable Systematic Error = TEa/2)
5.0%
Bias 1.97% โ โ โค SEa
REa (Allowable Random Error = TEa/2)
5.0%
Total Error (|Bias| + 1.65รCV)
70.81%
โ > TEa
Six Sigma (ฯ)
ฯ 0.19 โ Poor
๐ Clinical Interpretation
Analyte: Glucose
Reference Method: Roche cobas c503 (Reagent Lot A)
New/Test Method: Roche cobas c503 (Reagent Lot B)
โ The new method is acceptable for clinical use. The mean percent bias (1.97%) is within the acceptance limit of ยฑ15.0%. The Pearson correlation (r = 0.9998, Rยฒ = 0.9996) indicates excellent correlation. The Deming regression slope (1.011) is near ideal (1.00), indicating no significant proportional bias.
โ ๏ธ Passing-Bablok analysis indicates proportional bias (CI for slope does not include 1.00: 1.0007 โ 1.0177).
Reference Method: Roche cobas c503 (Reagent Lot A)
New/Test Method: Roche cobas c503 (Reagent Lot B)
โ The new method is acceptable for clinical use. The mean percent bias (1.97%) is within the acceptance limit of ยฑ15.0%. The Pearson correlation (r = 0.9998, Rยฒ = 0.9996) indicates excellent correlation. The Deming regression slope (1.011) is near ideal (1.00), indicating no significant proportional bias.
โ ๏ธ Passing-Bablok analysis indicates proportional bias (CI for slope does not include 1.00: 1.0007 โ 1.0177).
Regulatory Reference: CLIA ยง493.1253(b)(3) ยท CLSI EP09-A3 ยท CAP GEN.55400
Statistical Methods: Deming Regression (parametric, ฮป=1) ยท Passing-Bablok (non-parametric) ยท Bland-Altman Limits of Agreement ยท Pearson r ยท Tukey IQR Outlier Detection
Acceptance Criteria: Bias โค ยฑ15.0% ยท Rยฒ โฅ 0.95 ยท Deming slope 0.90โ1.10 ยท Passing-Bablok 95% CI includes slope=1 and intercept=0
Statistical Methods: Deming Regression (parametric, ฮป=1) ยท Passing-Bablok (non-parametric) ยท Bland-Altman Limits of Agreement ยท Pearson r ยท Tukey IQR Outlier Detection
Acceptance Criteria: Bias โค ยฑ15.0% ยท Rยฒ โฅ 0.95 ยท Deming slope 0.90โ1.10 ยท Passing-Bablok 95% CI includes slope=1 and intercept=0
๐ Raw Data
โถ Show / Hide Raw Data (30 samples)
| # | Sample ID | Reference_Method (Reference) | New_Method (New Method) | Difference | % Bias | Flag |
|---|---|---|---|---|---|---|
| 1 | S01 | 42.7 | 46.6 | 3.9 | +9.13% | โ |
| 2 | S02 | 51.1 | 52.6 | 1.5 | +2.94% | โ |
| 3 | S03 | 81.2 | 80.5 | -0.7 | -0.86% | โ |
| 4 | S04 | 90.3 | 90.0 | -0.3 | -0.33% | โ |
| 5 | S05 | 90.3 | 90.6 | 0.3 | +0.33% | โ |
| 6 | S06 | 112.0 | 116.1 | 4.1 | +3.66% | โ |
| 7 | S07 | 143.8 | 147.5 | 3.7 | +2.57% | โ |
| 8 | S08 | 149.4 | 154.6 | 5.2 | +3.48% | โ |
| 9 | S09 | 152.5 | 154.9 | 2.4 | +1.57% | โ |
| 10 | S10 | 179.5 | 183.8 | 4.3 | +2.40% | โ |
| 11 | S11 | 197.2 | 202.9 | 5.7 | +2.89% | โ |
| 12 | S12 | 197.4 | 200.8 | 3.4 | +1.72% | โ |
| 13 | S13 | 205.2 | 210.6 | 5.4 | +2.63% | โ |
| 14 | S14 | 209.6 | 212.3 | 2.7 | +1.29% | โ |
| 15 | S15 | 239.3 | 243.2 | 3.9 | +1.63% | โ |
| 16 | S16 | 241.3 | 245.2 | 3.9 | +1.62% | โ |
| 17 | S17 | 243.5 | 245.3 | 1.8 | +0.74% | โ |
| 18 | S18 | 244.7 | 250.8 | 6.1 | +2.49% | โ |
| 19 | S19 | 268.5 | 272.6 | 4.1 | +1.53% | โ |
| 20 | S20 | 279.3 | 284.8 | 5.5 | +1.97% | โ |
| 21 | S21 | 280.6 | 287.2 | 6.6 | +2.35% | โ |
| 22 | S22 | 285.7 | 292.3 | 6.6 | +2.31% | โ |
| 23 | S23 | 292.1 | 299.3 | 7.2 | +2.46% | โ |
| 24 | S24 | 293.9 | 299.2 | 5.3 | +1.80% | โ |
| 25 | S25 | 315.4 | 320.3 | 4.9 | +1.55% | โ |
| 26 | S26 | 321.1 | 326.9 | 5.8 | +1.81% | โ |
| 27 | S27 | 323.3 | 325.1 | 1.8 | +0.56% | โ |
| 28 | S28 | 329.7 | 332.2 | 2.5 | +0.76% | โ |
| 29 | S29 | 339.6 | 342.6 | 3.0 | +0.88% | โ |
| 30 | S30 | 339.8 | 343.6 | 3.8 | +1.12% | โ |
Electronically Signed By: Maria Gonzalez, MLS(ASCP), MLS-004821
Chemistry
Date: 2026-08-21 10:40
Maria Gonzalez, MLS(ASCP)
Medical Laboratory Technologist / Analyst Signature
Submitted: 2026-08-21T10:40
Medical Laboratory Technologist / Analyst Signature
Submitted: 2026-08-21T10:40
Electronically Signed By: Dr. Jane Sample, MD, MD-119284
Director / Supervisor of Clinical Laboratory
Date: 2026-08-22 08:55
Dr. Jane Sample, MD
Laboratory Director Approval Signature
Approved: 2026-08-22T08:55
Laboratory Director Approval Signature
Approved: 2026-08-22T08:55
Example Regional Medical Center โ Clinical Laboratory
123 Laboratory Way, Sample City, ST 00000
CLIA: 00D0000000
ยท State Lic.: CLS-000000
ยท (555) 000-0000
Laboratory Director: Dr. Jane Sample, MD
Example Regional Medical Center โ Clinical Laboratory
Generated by ValidToolsLab ยท CLIA ยง493.1256 Compliant
Report: VTL-LTL-20260821-2C7D ยท 2026-08-21