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1Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
2Cancer Research Institute, Seoul National University, Seoul, Korea.
3Center for Genome Science, Korea National Institute of Health, Osong, Korea.
4Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.
5Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
6Department of Biomedical Science, Seoul National University Graduate School, Seoul, Korea.
© 2011, Korean Society of Epidemiology
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The authors have no conflicts of interest to declare for this study.
This article is available from: http://e-epih.org/.
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; creatinine; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride.
1Using 40 serum samples, the standardized serological samples were prepared from the number of specimens predetermined according to the range of test values. We prepared each sample twice, and thus 80 serum samples were acquired in this study; 2The maximum value that could be detected by each instrument; 3Albumin, γ-GTP, and cholesterol were divided into four categories based on both the KoGES data and normal ranges for the general Korean population.
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride; CV, coefficient of variation; ICC, intra-class correlation.
1Calculated as the absolute value of the difference in the mean of two duplicated test values at each center (n=80); 2Calculated as the absolute value of the difference in the mean of two duplicated test values at Center X (n=80) and the mean of two duplicated test values at Center Y (n=80).
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride; KoGES, Korean Genome and Epidemiology Study; KSLM, Korean Society for Laboratory Medicine; QC, quality control; NA, not applicable.
1Sums of residuals were all zero; 2Equation forms are represented by (value of Center Y)=α (intercept)+β (slope)× (value of Center X).
3The quadruplicated standardized samples from 40 samples; 4Three standardized samples were tested for external QC four times a year by the KSLM; 5Different QC methods applied in the two laboratories in 2005 and 2006.
Group A |
Group B |
Group C |
Group D |
Group E |
||||||
---|---|---|---|---|---|---|---|---|---|---|
Range of test value | Samples (%) | Range of test value | Samples (%) | Range of test value | Samples (%) | Range of test value | Samples (%) | Range of test value | Samples (%) | |
Albumin3 | <3 | 4 (10) | 3-4 | 16 (40) | 4-5 | 16 (40) | >5 | 4 (10) | - | - |
ALT | < 20 | 8 (20) | 20-40 | 8 (20) | 20-40 | 16 (40) | 80-160 | 4 (10) | 161-SL2 | 4 (10) |
AST | < 20 | 8 (20) | 20-40 | 12 (30) | 20-40 | 12 (30) | 80-160 | 4 (10) | 161-SL2 | 4 (10) |
γ-GTP3 | 0-30 | 16 (40) | 31-60 | 16 (40) | 120-240 | 4 (10) | 241-SL2 | 4 (10) | - | - |
BUN | <15 | 4 (10) | 15-25 | 16 (40) | 26-50 | 8 (20) | 51-100 | 8 (20) | 100-SL2 | 4 (10) |
Creatinine | 0-1.0 | 8 (20) | 1.1-2.5 | 12 (30) | 2.5-5.0 | 8 (20) | 5-10 | 8 (20) | 11-SL2 | 4 (10) |
Uric acid | < 3.0 | 8 (20) | 3-5 | 8 (20) | 5-8 | 8 (20) | 8-10 | 8 (20) | 11-SL2 | 4 (10) |
FBS | < 50 | 4 (10) | 51-110 | 16 (40) | 111-150 | 12 (30) | 151-250 | 4 (10) | 251-SL2 | 4 (10) |
Cholesterol3 | 120-180 | 8 (20) | 181-220 | 12 (30) | 221-260 | 12 (30) | 261-400 | 8 (20) | - | - |
TG | < 75 | 4 (10) | 75-125 | 12 (30) | 125-200 | 12 (30) | 200-300 | 8 (20) | 301-SL2 | 4 (10) |
Intra-rater reliability |
Inter-laboratory reliability |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Absolute value of mean (CV) of difference in two duplicated test values1 at Center X |
Absolute value of mean (CV) of difference in two duplicated test values1 at Center Y |
Absolute value of mean (CV) of difference between the two test values of Center X and Y2
|
||||||||
Mean (CV) of difference | Correlation coefficient | ICC coefficient (95% CI) | Mean (CV) of difference | Correlation coefficient | ICC coefficient (95% CI) | Mean (CV) of difference | Correlation coefficient | ICC coefficient (95% CI) | Kappa coefficient (95% CI) | |
Albumin | 0.027 (1.85) | 0.997 | 0.997 (0.996-0.998) | 0.018 (2.22) | 0.998 | 0.998 (0.997-0.999) 0.095 (0.84) | 0.986 | 0.984 (0.975-0.990) | 0.962 (0.888-1.000) | |
ALT | 0.437 (1.30) | 0.999 | 1.000 (1.000-1.000) | 2.173 (1.55) | 0.996 | 0.997 (0.995-0.998) 2.693 (1.06) | 0.997 | 0.997 (0.995-0.998) | 1.000 (1.000-1.000) | |
AST | 7.387 (4.12) | 0.842 | 0.836 (0.755-0.891) | 3.125 (2.34) | 0.989 | 0.990 (0.984-0.993) 9.168 (2.80) | 0.872 | 0.871 (0.807-0.915) | 0.754 (0.567-0.941) | |
γ-GTP | 0.325 (1.75) | 0.999 | 1.000 (1.000-1.000) | 1.050 (1.09) | 0.999 | 1.000 (0.999-1.000) 4.700 (0.62) | 0.999 | 0.994 (0.796-0.999) | 0.786 (0.637-0.934) | |
BUN | 0.175 (2.34) | 0.999 | 1.000 (1.000-1.000) | 0.700 (1.17) | 0.999 | 0.999 (0.999-1.000) 3.532 (1.02) | 0.999 | 0.987 (0.901-0.996) | 0.975 (0.925-1.000) | |
Creatinine | 0.028 (1.79) | 0.999 | 1.000 (1.000-1.000) | 0.031 (1.61) | 0.999 | 1.000 (1.000-1.000) 0.138 (0.87) | 0.999 | 0.999 (0.995-1.000) | 0.873 (0.765-0.981) | |
Uric acid | 0.085 (2.59) | 0.997 | 0.997 (0.996-0.998) | 0.038 (1.84) | 0.999 | 1.000 (1.000-1.000) 0.562 (1.03) | 0.984 | 0.970 (0.893-0.987) | 0.925 (0.842-1.000) | |
FBS | 1.262 (1.42) | 0.999 | 1.000 (1.000-1.000) | 0.725 (1.53) | 0.999 | 1.000 (1.000-1.000) 6.968 (0.87) | 0.999 | 0.995 (0.952-0.998) | 0.871 (0.761-0.981) | |
Cholesterol | 2.162 (0.86) | 0.998 | 0.998 (0.997-0.999) | 2.587 (2.04) | 0.992 | 0.992 (0.988-0.995) 5.850 (0.75) | 0.992 | 0.988 (0.946-0.995) | 0.876 (0.771-0.980) | |
TG | 1.000 (1.03) | 0.999 | 1.000 (1.000-1.000) | 1.500 (2.43) | 0.999 | 0.999 (0.998-0.999) 9.737 (0.65) | 0.995 | 0.991 (0.914-0.997) | 0.974 (0.922-1.000) |
KoGEStrial3 | External QC data by KSLM4
|
Range of slope difference | |||
---|---|---|---|---|---|
Year 2007 | Year 2006 | Year 2005 | |||
Albumin | 0.97 | 0.95 | 0.97 | 0.95 | 0.050-0.133 |
ALT | 0.99 | 0.99 | 0.98 | 0.99 | 0.001-0.043 |
AST | 0.70 | 0.99 | 1.00 | 1.00 | 0.011-0.206 |
γ-GTP | 1.00 | 1.00 | 1.00 | 0.99 | 0.022-0.083 |
BUN | 1.00 | 1.00 | 1.00 | 0.99 | 0.077-0.158 |
Creatinine | 1.00 | 1.00 | 1.00 | 0.99 | 0.081-0.125 |
Uric acid | 0.97 | 0.99 | 1.00 | 0.97 | 0.009-0.115 |
FBS | 1.00 | 1.00 | 1.00 | 0.98 | 0.009-0.078 |
Cholesterol | 0.98 | 0.99 | 1.00 | 0.96 | 0.007-0.030 |
TG | 0.99 | 0.99 | Not fitted5 | Not fitted5 | NA |
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; creatinine; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride. 1Using 40 serum samples, the standardized serological samples were prepared from the number of specimens predetermined according to the range of test values. We prepared each sample twice, and thus 80 serum samples were acquired in this study; 2The maximum value that could be detected by each instrument;
3Albumin, γ-GTP, and cholesterol were divided into four categories based on both the KoGES data and normal ranges for the general Korean population.
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride; CV, coefficient of variation; ICC, intra-class correlation. 1Calculated as the absolute value of the difference in the mean of two duplicated test values at each center (n=80); 2Calculated as the absolute value of the difference in the mean of two duplicated test values at Center X (n=80) and the mean of two duplicated test values at Center Y (n=80).
ALT, alanine transaminase; AST, aspartic acid transaminase; γ-GTP, gamma-glutamyl transpeptidase; BUN, blood urea nitrogen; UA, uric acid; FBS, fasting blood sugar; TG, triglyceride; KoGES, Korean Genome and Epidemiology Study; KSLM, Korean Society for Laboratory Medicine; QC, quality control; NA, not applicable. 1Sums of residuals were all zero; 2Equation forms are represented by (value of Center Y)=α (intercept)+β (slope)× (value of Center X). 3The quadruplicated standardized samples from 40 samples; 4Three standardized samples were tested for external QC four times a year by the KSLM; 5Different QC methods applied in the two laboratories in 2005 and 2006.