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Report On Proficiency Testing

J Lab Med Qual Assur 2019; 41(2): 51-64

Published online June 30, 2019

https://doi.org/10.15263/jlmqa.2019.41.2.51

Copyright © Korean Association of External Quality Assessment Service.

Annual Report of the Korean Association of External Quality Assessment Service on General Chemistry (2018)

Yong-Wha Lee

Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea

Correspondence to:Yong-Wha Lee, Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaruro, Wonmi-gu, Bucheon 14584, Korea, Tel: +82-32-621-5943 Fax: +82-32-621-5944 E-mail: lywmd@schmc.ac.kr

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

In 2018, the general chemistry proficiency testing program of the Korean Association of External Quality Assessment Service consisted of the routine chemistry and urine chemistry programs including 32 and 13 test items, respectively. The test method classification system was revised in the routine chemistry program, and a qualitative test of human chorionic gonadotropin was added in the urine chemistry program. The routine chemistry program was conducted 4 times a year, while the urine chemistry program was conducted twice a year. Statistical analysis data for the test method and reagent companies were reported based on the information and results of the test items provided by each institution. Statistics included the number of participating institutes, mean, standard deviation, coefficient of variation (CV), median, and minimum and maximum values for each group. Each report included tables, histograms, Levey-Jennings charts, and the standard deviation index showing the statistics of each test item. In the routine chemistry program, more than 1,000 institutions performed the 17 test items, and the number is continuously increasing. CV for each test item showed a tendency to increase with decreasing concentration of the proficiency material but was within 10% in most cases. Alkaline phosphatase and lactate dehydrogenase were found to have relatively high CVs because of the differences in results among test methods. In the urine chemistry program, albumin and protein showed high CVs, and the distribution of the test method was different from that of the routine chemistry program.

Keywords: Proficiency testing, General chemistry, Korean Association of External Quality Assessment Service

대한임상검사정도관리협회에서는 2016년부터 새로운 운영방식의 차세대 신빙도조사사업을 시행하고 있다. 2018년에는 6개 대분류하에 64개 프로그램 단위별 운영체계로 확대되어 프로그램별 검사종목도 319항목으로 증가하였다[1-3]. 임상화학 분야는 6개의 대분류 중 하나로서 일반화학검사 등 10 개의 중분류 분야로 구성되고 이들은 일반화학검사와 요화학 검사 등 24개의 세부 프로그램으로 나뉜다. 일반화학검사 프로그램에는 총 32종의 검사항목이 포함되어 있고, 요화학검사 프로그램에는 요 human chorionic gonadotropin (hCG) 정성검사가 추가되어 총 13종의 검사항목이 포함되었다. 일반화학검사 프로그램에 대해서는 검사항목별로 새로운 검사방법 분류체계를 적용하여 각각의 시약들에 대해 새로운 검사방법 명칭을 부여하였다.

저자들은 2018년 대한임상검사정도관리협회의 신빙도조사 사업으로 실시되었던 일반화학검사와 요화학검사에 대한 신빙도조사사업 결과를 분석하여 보고하고자 한다.

1. 대상

일반화학검사 프로그램은 연 4회에 걸쳐 회차별로 3개의 정도관리물질이 이용되어 시행되었다. 물질은 냉장상태가 유지될 수 있도록 아이스팩이 내장된 특수 제작박스에 넣어 참여 등록기관을 대상으로 각 회차별로 2월, 4월, 8월과 10월에 발송되었다. 요화학검사 프로그램은 연 2회에 걸쳐, 회차 별로 3개의 정도관리 물질이 이용되었고 1회차와 2회차를 각각 3월과 9월에 발송하였다.

2. 정도관리물질과 검사항목

일반화학검사의 정도관리물질은 사람 혈청을 기질로 한 분 말제품인 Randox사(Randox Testing Services, London, UK)와 Bio-Rad사(Bio-Rad Laboratories, Hercules, CA, USA)의 사람 혈청을 기질로 한 분말제품을 사용하였다 (Table 1). 검사항목은 성인과 소아의 추정 사구체여과율 항목을 포함하여 총 32항목이었다. 요화학검사의 정도관리물질은 Bio-Rad사의 Lyphochek Quantitative Urine Control (Bio-Rad Laboratories)을 사용하였다(Table 2). 사전에 공지된 일정에 따라 물질을 수령한 참여기관에서는 검사 시행 후 지정된회신 마감일 이내에 대한임상검사정도관리협회 신빙도조사사업 홈페이지(http://eqas.keqas.org)에 결과를 입력하도록 하였다. 기기회사와 시약회사로부터 제공된 검사항목별 검사방법, 기기와 시약에 대해 기초자료를 검토한 바를 토대로 참여 기관이 홈페이지상에서 해당 검사항목에 대한 검사정보 선택과 결과 입력이 가능하도록 전산체계를 구축하였다. 결과 입력 기간 내에 최종 전송을 했더라도 결과 수정이 가능하도록 하였다.

Table 1 . Control materials analyzed and released dates from the trials of general chemistry in 2018.

TrialMaterial no.ManufacturerProduct nameLot no.Released date
1stCC-18-01RandoxHuman low serum 5 mL273ULCM26 February
CC-18-02RandoxHuman normal serum 5 mL1250UNCM
CC-18-03RandoxHuman elevated serum 5 mL973UECM
2ndCC-18-04RandoxHuman low serum 5 mL274ULCM23 April
CC-18-05RandoxHuman normal serum 5 mL1251UNCM
CC-18-06RandoxHuman elevated serum 5 mL974UECM
3rdCC-18-07Bio-RadLyphochek assayed & unassayed chemistry control2644120 August
CC-18-08Bio-RadLyphochek assayed & unassayed chemistry control26442
CC-18-09Bio-RadLyphochek assayed & unassayed chemistry control26432
4thCC-18-10Bio-RadLyphochek assayed & unassayed chemistry control288311 October
CC-18-11Bio-RadLyphochek assayed & unassayed chemistry control28832
CC-18-12Bio-RadLyphochek assayed & unassayed chemistry control26452

The instruments were from the following companies: Randox Laboratories (London, UK) and Bio-Rad Laboratories (Hercules, CA, USA). .


Table 2 . Control materials analyzed and released dates from the trials of urine chemistry in 2018.

TrialMaterial no.ManufacturerProduct nameLot no.Released date
1stCUC-18-01Bio-RadLyphochek quantitative urine control6338112 March
CUC-18-02Bio-RadLyphochek quantitative urine control63382
CUC-18-03Bio-RadLyphochek quantitative urine control63383
2ndCUC-18-04Bio-RadLyphochek quantitative urine control6342110 September
CUC-18-05Bio-RadLyphochek quantitative urine control63422
CUC-18-06Bio-RadLyphochek quantitative urine control63411

The instruments were from the following company: Bio-Rad Laboratories (Hercules, CA, USA). .


3. 검사법 신분류체계 적용

일반화학검사 프로그램의 검사항목별 검사방법 분류체계의 현황과 기기시약별 지정된 검사방법과 동료집단 설정상의 개선점을 분석하였고, 일반화학검사 관련 국내·외 주요 관련 자료와 문헌 및 검사기기와 시약업체로부터 제공되는 설명서를 검토함으로써 참가기관에서 제공하는 검사방법에 대한 정보 및 신빙도조사 결과에 대해서 정확한 동료집단 분류 및 통계분석의 기초가 될 수 있는 새로운 검사방법 명칭과 분류체계를 정립하여 일반화학검사 프로그램에 적용하였다.

4. 결과 판정 및 분석

일반화학검사와 요화학검사 각각에 대해서 각 기관에서 입력한 각 검사항목에 대한 정보와 결과를 기반으로 검사방법, 기기, 시약에 따라 통계분석을 시행하였고 이를 전체 참여기관의 특성을 보여주는 공통보고서와 개별기관의 평가자료를 보여주는 기관별 보고서로 나누어 보고하였다. 공통보고서는 3단계로 그룹화하여 통계치를 제시하였다. 전체 참여기관에 해당하는 통계, 검사방법을 기준분류로 한 그룹의 통계와 검사방 법별로 시약회사를 세 분류한 그룹의 통계를 각각 제시하였다. 제시된 통계에는 각 그룹별 참여기관 수, 평균, 표준편차, 변 동계수, 중앙값, 최소값과 최대값이 포함되도록 하였고 참여 기관 수, 중앙값, 최소값과 최대값은 이상치를 제거하지 않은 수치를 제시하였고 평균, 표준편차와 변동계수는 각 그룹별로 이상치를 제거한 후 산출된 수치를 사용하였다. 또한 해당 분류에서 이상치를 제거한 후 기관 수가 8개 미만인 경우 평균, 표준편차와 변동계수를 제시하지 않았고 기관 수가 3개 미만인 경우 중앙값도 제시하지 않았다. 이상치는 각 해당 분류 에서 75퍼센타일 값(Q3)과 25퍼센타일 값(Q1)의 차(Q3-Q1, interquartile range [IQR])의 1.5배를 초과하여 Q1보다 낮거나 Q3보다 높은 결과값(<Q1-1.5×IQR 또는 >Q3+1.5× IQR)으로 설정하였다.

개별보고서는 각 검사항목별로 통계치를 보여주는 표, 히스토그램과 레비-제닝스 차트로 구성되도록 하였다. 통계치를 제시한 표에는 각 기관의 결과값과 각 분류별 통계치를 제시하고 기준분류와 세분류에서는 표준편차지수(standard deviation index, SDI)를 함께 제시하였다. 전체 결과에 대해서는 SDI를 제시하지 않았고 각 그룹에서 이상치 제거 후 기관 수가 8개 미만일 경우 SDI를 제시하지 않았다. 표준편차가 0이지만 기관의 결과값이 평균과 다를 경우에도 SDI를 제시하지 않았다.

히스토그램에서는 전체 기관의 분포와 기준 분류별 분포를 제시하였고 각 기관의 위치를 표시하였다. 레비-제닝스 차트는 기준 분류별 SDI를 이용하여 작성하였다.

2018년 일반화학검사 프로그램의 특징으로 검사항목별로 새로운 검사방법 명칭과 분류체계를 적용하여 이를 기반으로 통계분석 및 결과를 보고한 점과 요화학검사 프로그램에 요 hCG 정성검사를 추가한 점을 들 수 있다. 기존 검사방법 분류 체계로서는 수용 안 되는 시약이 증가함에 따라 검사방법을 기타 방법으로 선택하는 사례가 증가하였고, 일부 검사항목에 대해서 현재에는 사용되지 않는 과거의 검사방법이 그대로 적용 되거나 제조사 명칭이 검사방법 명칭으로 사용된 사례가 있었 다. 검사방법 명칭과 관련된 국내·외 관련 자료를 수집하고 분석하여 검사항목별 신 분류안을 적용함으로써 정확한 동료 집단 설정과 데이터 오분류 및 누락 방지를 통해 신뢰할 수 있는 신빙도조사 결과를 제공할 수 있게 되었다.

일반화학검사 프로그램에서는 1,000개 이상의 기관이 참여하는 검사항목은 alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), total bilirubin, chloride, total cholesterol, creatinine, gamma-glutamyl transferase, glucose, high-density lipoprotein (HDL) cholesterol, potassium, total protein, sodium, triglyceride, urea nitrogen과 uric acid 등이었고 1회차와 2회차에 비해 3회차와 4회차의 참가기관 수가 증가하였다(Table 3). 요화학검사 프로그램에서는 새로 추가된 검사항목인 요 hCG 정성검사에 참여하는 기관이 가장 많았고 creatinine검사가 뒤를 이었다(Table 4).

Table 3 . Number of laboratories that participated in each test of general chemistry in 2018.

TestTrials

1st2nd3rd4th
Alanine aminotransferase1,5681,6391,6761,660
Albumin1,4431,5121,5481,534
Alkaline phosphatase1,3851,4511,4791,467
Amylase800825820814
Aspartate aminotransferase1,5671,6381,6751,659
Bilirubin, direct782813813809
Bilirubin, total1,4561,5211,5571,543
Calcium698724736734
Chloride9911,0341,0511,046
Cholesterol, total1,5571,6261,6621,646
Creatine kinase652667676673
Creatinine1,5201,5951,6401,628
Gamma-glutamyl transpeptidase1,5201,5881,6221,608
Glucose1,5431,6141,6511,635
High density lipoprotein cholesterol1,4431,5011,5331,519
Iron403416421419
Lactate dehydrogenase871899916909
Lipase392399408403
Low density lipoprotein cholesterol880911920916
Magnesium280283290290
Osmolality146151151149
Phosphorus649676693687
Potassium1,0041,0481,0641,060
Protein, total1,4291,4941,5291,516
Sodium1,0041,0481,0641,060
Total CO2201209216214
Total iron-binding capacity367376382381
Triglyceride1,5151,5871,6171,601
Urea nitrogen1,4991,5701,6021,591
Uric acid1,1851,2421,2621,254
Estimated glomerular filtration rate, adult279287295293
Estimated glomerular filtration rate, child180184189193

Table 4 . Number of laboratories that participated in each test of urine chemistry in 2018.

TestTrials

1st2nd
Albumin166172
Calcium151155
Chloride177183
Creatinine206209
Glucose135137
Magnesium109108
Phosphorus138139
Potassium178184
Protein173177
Sodium180186
Urea nitrogen152156
Uric acid145146
Urine human chorionic gonadotropin (qualitative)210215

일반화학검사 프로그램에서 변동계수는 각 검사항목별 회차별로 상대적으로 정도관리물질의 농도가 낮을수록 높은 경향을 보였다(Table 5). 대부분 10% 이내의 변동계수를 보였지만 alkaline phosphatase, amylase, direct bilirubin, lactate dehydrogenase (LDH), lipase, HDL cholesterol, low-density lipoprotein cholesterol과 triglyceride 등의 일부 방법에서 10% 이상의 높은 변동계수를 보였다. 물론 동일한 검사법을 사용하는 그룹 내에서는 비교적 작은 변동계수를 보였으나 alkaline phosphatase와 LDH는 검사법 간에 결과의 차이가 유의하게 큼으로써 변동계수도 상대적으로 큰 것으로 관찰되었다(Table 5). 요화학검사 프로그램에서 각 검사항목 별 변동계수는 대부분 10% 이내의 값을 보였으나 albumin과 protein은 상대적으로 높은 변동계수를 보였다(Table 6). 변 동계수는 각각 기관의 상대적 위치를 나타내는 SDI와도 관련 되므로 변동계수가 큰 경우 SDI는 상대적으로 작아질 수 있으므로 결과해석 시 고려되어야 한다.

Table 5 . Peer-group coefficients of variation (%) for the tests and trials of general chemistry in 2018.

TestTrials

CC-18-01CC-18-02CC-18-03CC-18-04CC-18-05CC-18-06CC-18-07CC-18-08CC-18-09CC-18-10CC-18-11CC-18-12
Alanine transaminase7.49.26.17.59.26.56.65.85.85.87.36.0
Albumin5.24.45.23.64.35.14.85.45.45.64.95.5
Alkaline phosphatase43.640.637.144.841.037.444.136.838.235.844.936.0
Amylase15.915.018.315.414.418.712.718.918.817.912.918.6
Aspartate aminotransferase6.78.55.36.38.15.05.14.14.34.35.04.3
Bilirubin, direct17.214.713.914.318.012.220.717.418.719.418.615.8
Bilirubin, total12.08.96.110.58.25.99.46.06.36.310.16.5
Calcium3.12.72.33.13.02.33.33.02.92.94.42.7
Chloride3.03.02.43.13.32.32.93.03.23.03.32.8
Cholesterol, total3.02.93.13.42.73.13.05.05.14.83.14.7
Creatine kinase5.25.55.14.94.84.93.64.44.34.53.54.6
Creatinine9.48.15.58.57.65.411.77.67.77.213.47.3
Gamma-glutamyl transpeptidase6.36.25.86.25.65.47.67.77.57.87.87.4
Glucose3.33.33.23.63.43.04.03.13.02.74.13.0
High density lipoprotein cholesterol8.311.311.27.610.211.811.112.613.814.112.612.8
Iron3.53.83.53.43.53.23.44.13.83.63.13.8
Lactate dehydrogenase37.638.439.137.638.439.237.939.840.140.437.540.6
Lipase9.212.318.010.213.717.98.813.914.014.410.214.1
Low density lipoprotein cholesterol15.713.220.814.312.721.87.37.86.310.49.05.9
Magnesium3.55.42.90.03.12.13.83.23.13.95.53.2
Osmolality1.21.21.21.01.10.91.31.21.21.31.31.3
Phosphorus4.93.23.03.32.92.92.42.62.32.52.32.3
Potassium2.91.92.33.01.92.41.92.32.32.31.92.2
Protein, total2.12.83.63.22.83.93.33.84.03.83.43.7
Sodium1.91.21.41.91.21.31.11.21.31.31.21.4
Total CO29.27.85.28.88.26.86.26.55.75.05.15.7
Total iron-binding capacity3.84.03.33.73.73.23.22.93.43.23.33.5
Triglyceride33.419.446.833.120.346.34.05.75.55.34.05.5
Urea nitrogen4.04.04.15.14.04.34.73.94.94.25.24.3
Uric acid6.94.03.85.83.73.83.43.63.33.64.23.5
Estimated glomerular filtration rate, adultNA10.55.812.310.2NA10.0NA6.56.5NA0.0
Estimated glomerular filtration rate, child42.6NANANANA38.4NA56.1NANA44.7NA

Abbreviation: NA, not applicable..


Table 6 . Peer-group coefficients of variation (%) for the tests and trials of urine chemistry in 2018.

TestTrials

CUC-18-01CUC-18-02CUC-18-03CUC-18-04CUC-18-05CUC-18-06
Albumin30.019.019.414.220.332.5
Calcium4.02.72.34.32.63.4
Chloride8.82.52.59.02.48.7
Creatinine5.54.94.85.24.95.1
Glucose2.22.22.23.32.61.3
Magnesium3.02.83.53.33.63.6
Phosphorus2.52.62.92.62.82.8
Potassium2.13.13.41.83.61.9
Protein11.09.08.69.99.010.5
Sodium2.81.21.12.21.12.3
Urea nitrogen2.92.82.33.33.13.2
Uric acid4.33.53.64.63.74.5

일반화학검사에 있어서 한 가지 검사방법이 전체의 80%를 넘는 검사로는 albumin의 dye binding bromocresol green법, ALT의 LDH without pyridoxal-5-phosphate (P5P)법, AST의 malate dehydrogenase without P5P법, total cholesterol 의 cholesterol esterase법, gamma-glutamyl transpeptidase 의 gamma-glutamyl-carboxy-nitroanilide법, magnesium의 colorimetry-xylidyl blue법, osmolality의 freezing point depression osmometer법, total protein의 biuret법, total CO2의 phosphoenolpyruvate carboxylase법, urea nitrogen 의 urease with glutamate dehydrogenase (GLDH)법과 uric acid의 uricase법이 있었다(Table 7).

Table 7 . Distribution of analytical methods (principle) and coefficients of variation (%) for the principles of general chemistry in 2018.

Test/methodTrials

1st2nd3rd4th




Lab*CC-18-01CC-18-02CC-18-03LabCC-18-04CC-18-05CC-18-06LabCC-18-07CC-18-08CC-18-09LabCC-18-10CC-18-11CC-18-12
Alanine aminotransferase1,5687.49.26.11,6397.59.26.51,6766.65.85.81,6605.87.36.0
 Dry chemistry1111.116.63.41212.815.02.2103.63.23.2103.428.82.4
 LDH with P5P1316.616.63.31413.712.31.5157.02.82.0140.513.63.6
 LDH without P5P1,4617.49.06.01,5576.99.26.31,6166.65.75.71,6015.77.25.9
 Other method837.611.38.2568.07.88.3358.07.68.3357.97.47.7
Albumin1,4435.24.45.21,5123.64.35.11,5484.85.45.41,5345.64.95.5
 Dye binding-BCG1,3805.14.35.11,4633.64.35.11,5144.85.45.31,4995.64.95.5
 Dye binding-BCP74.84.26.075.84.75.984.42.95.585.64.26.2
 Other method566.44.85.8425.24.13.0265.02.52.9274.75.15.8
Alkaline phosphatase1,38543.640.637.11,45144.841.037.41,47944.136.838.21,46735.844.936.0
 Other method7337.035.932.54839.637.233.32645.036.937.52619.441.419.1
 PNPP, AMP buffer78013.214.716.283013.214.516.085613.716.316.884715.812.615.9
 PNPP, DEA buffer14714.915.512.915411.511.811.516410.39.79.816011.512.711.0
 PNPP, EAE buffer3854.03.93.54194.53.93.64335.74.75.24344.35.34.8
Amylase80015.915.018.382515.414.418.782012.718.918.881417.912.918.6
 Dry chemistry85.04.12.2811.94.45.373.42.61.273.38.53.3
 Hydrolysis of 2-chloro-4-nitrophenylazido-deoxy-maltopentaoside62.81.52.1416.918.516.950.60.21.041.28.32.1
 Hydrolysis of 2-chloro-4-nitrophenyl-galactopyranosylmaltoside941.62.01.41011.91.81.71062.31.41.31031.82.11.6
 Hydrolysis of 2-chloro-4-nitrophenyl-α-D-maltotrioside1983.23.42.92055.13.02.42122.82.31.92152.93.23.1
 Hydrolysis of 4,6-ethylidene-4-nitrophenyl-maltoheptaose3183.64.64.13424.14.73.73454.33.63.83423.94.33.6
 Hydrolysis of 4-nitrophenylbenzyl-α-maltopentaose13015.715.417.013115.914.818.613412.818.418.213118.413.118.4
 Other method4615.716.217.53416.213.819.91115.219.219.21219.813.120.5
Aspartate aminotransferase1,5676.78.55.31,6386.38.15.01,6755.14.14.31,6594.35.04.3
 Dry chemistry1112.813.13.8129.75.35.6100.00.61.3102.01.72.2
 MDH with P5P1322.527.79.61423.625.910.2154.13.85.7147.45.44.9
 MDH without P5P1,4646.68.55.11,5616.38.04.91,6185.14.14.11,6034.24.94.3
 Other method798.09.28.2517.79.56.4325.97.06.5327.47.26.5
Bilirubin, direct78217.214.713.981314.318.012.281320.717.418.780919.418.615.8
 Copper ion oxidation3815.911.59.6459.814.513.1482.26.49.64710.61.28.6
 Diazonium salt with blank2968.76.212.43146.78.011.532522.65.25.33255.718.85.4
 Diazo-sulfanilic acid with blank3043.943.428.94635.628.027.94835.034.134.14727.632.726.8
 Diazo-sulfanilic acid without blank1536.953.430.11638.141.923.41438.625.027.01529.034.827.1
 Enzymatic oxidation59.57.83.759.15.68.3622.15.15.4622.022.321.0
 Other method7430.020.825.14621.322.421.62228.717.415.12221.021.629.1
 Vanadate oxidation3243.99.76.334111.09.29.035014.212.112.03479.711.913.7
Bilirubin, total1,45612.08.96.11,52110.58.25.91,5579.46.06.31,5436.310.16.5
 Copper ion oxidation667.74.94.1734.65.04.7856.44.44.1865.16.05.3
 Diazo-caffeine, sodium benzoate with blank716.815.49.2717.018.810.587.910.310.487.27.512.0
 Diazo-dimethyl sulfoxide with blank12514.013.06.613514.013.57.21288.86.27.01236.56.76.7
 Diazo-dimethyl sulfoxide without blank8517.016.29.39713.916.86.710713.15.55.71085.814.75.9
 Diazo-dyphylline with blank1218.413.34.61214.29.35.91014.55.94.5108.87.42.8
 Diazonium salt-surfactant with blank45213.610.05.647612.09.75.148911.46.15.74856.310.66.7
 Diazonium salt-surfactant without blank379.25.711.6387.810.19.74017.412.312.33910.912.810.7
 Enzymatic oxidation246.35.64.1274.44.35.1246.77.37.4246.17.75.5
 Other method7215.512.58.65411.612.37.6399.74.65.5396.510.66.2
 Vanadate oxidation5763.15.24.66022.75.34.36262.84.34.36204.56.14.2
Calcium6983.12.72.37243.13.02.37363.33.02.97342.94.42.7
 Colorimetry arsenazo III1324.02.83.61444.33.63.91523.73.13.31553.72.73.5
 Colorimetry_methylxylenol blue203.02.43.6232.62.62.7231.51.31.1221.61.61.9
 Colorimetry_OCPC4082.92.51.84223.02.12.24273.02.92.64222.63.62.8
 NM-BAPTA1212.02.11.61261.81.71.31301.61.51.61311.41.71.6
 Other method163.93.93.384.33.22.245.63.92.642.64.02.2
Chloride9913.03.02.41,0343.13.32.31,0512.93.03.21,0463.03.32.8
 ISE, diluted5393.02.41.85572.92.61.65672.32.12.05692.53.62.5
 ISE, undiluted4132.02.22.14422.51.91.94522.42.63.24482.63.12.8
 Other method393.42.21.9352.12.62.7323.35.05.3292.81.52.8
Cholesterol, total1,5573.02.93.11,6263.42.73.11,6623.05.05.11,6464.83.14.7
 Cholesterol esterase1,4813.02.93.11,5743.32.73.11,6293.05.05.11,6144.83.14.7
 Other method763.33.32.9523.33.03.4334.04.55.8325.93.44.1
Creatine kinase6525.25.55.16674.94.84.96763.64.44.36734.53.54.6
 Creatine phosphate to creatine2013.84.52.92113.73.33.02173.52.42.82142.53.02.8
 Creatine phosphate to creatine with activator4115.55.75.64285.25.05.54373.55.14.84395.13.65.1
 Dry chemistry61.76.34.066.46.55.468.29.18.964.57.78.1
 Other method347.06.35.1226.06.46.7164.03.94.4143.66.54.2
Creatinine1,5209.48.15.51,5958.57.65.41,64011.77.67.71,6287.213.47.3
 Enzymatic method664.15.55.6746.96.23.87813.13.64.5764.731.75.7
 Kinetic Jaffe with compensation33310.86.63.835710.66.23.837110.86.87.53686.011.96.5
 Kinetic Jaffe without compensation8127.66.97.08676.66.66.69057.37.07.38956.511.46.0
 Other method6513.213.812.14713.512.311.02811.210.310.63112.39.010.3
 Rate blanked compensated kinetic Jaffe method2444.24.13.42504.14.22.82584.53.43.52583.16.13.2
Gamma-glutamyl transpeptidase1,5206.36.25.81,5886.25.65.41,6227.67.77.51,6087.87.87.4
 Gamma-glutamyl-carboxy-nitroanilide1,4186.36.15.71,5116.25.65.41,5637.67.77.81,5497.77.67.4
 Gamma-glutamyl-p-nitroanilide149.18.58.81710.17.59.81612.011.812.6168.99.410.4
 G-glutamyl-p-nitroanilide (dry chemistry)122.421.66.51221.43.611.7104.31.71.6102.46.82.3
 Other method766.77.36.7487.06.04.7338.57.06.6339.511.39.0
Glucose1,5433.33.33.21,6143.63.43.01,6514.03.13.01,6352.74.13.0
 Glucose oxidase3845.45.04.14165.15.04.24414.44.04.24313.74.34.0
 Hexokinase1,0843.02.82.71,1472.82.72.61,1793.62.62.71,1732.43.52.4
 Other method755.24.74.1514.84.13.0316.35.64.9315.25.55.5
High density lipoprotein cholesterol1,4438.311.311.21,5017.610.211.81,53311.112.613.81,51914.112.612.8
 Enzymatic with detergent5194.76.36.05524.05.86.65788.710.09.95788.78.88.5
 Enzymatic with immunoinhibition2043.84.04.82184.44.56.62213.63.43.52223.54.03.3
 Enzymatic with others1899.39.915.21978.89.115.521011.313.313.120313.511.412.5
 Enzymatic with polyanion precipitation16715.914.419.018117.315.619.018517.19.59.317910.813.29.3
 Enzymatic with polyethylene glycol2896.25.39.52999.17.49.83105.15.56.53079.87.46.2
 Other method7410.812.613.55311.012.211.0289.213.913.3299.215.112.3
Iron4033.53.83.54163.43.53.24213.44.13.84193.63.13.8
 Bathophenanthroline without deproteinization1371.92.01.61422.12.21.61451.42.52.31432.11.42.3
 Ferene with deproteinization36.77.16.5310.010.20.032.58.13.832.10.40.8
 Ferrozine without deproteinization1372.32.22.11422.33.12.41462.03.62.41462.71.83.0
 Nitroso-PSAP without deproteinization341.91.91.8422.51.91.4431.73.12.7432.91.73.2
 Pyridyl AZO dye ascorbate without deproteinization219.013.59.3317.611.510.928.728.32.525.00.80.0
 Tripyridyltriazine without deproteinization772.11.61.6802.31.91.4811.42.82.6802.10.92.3
Lactate dehydrogenase87137.638.439.189937.638.439.291637.939.840.190940.437.540.6
 Lactate to pyruvate4434.74.74.44604.64.54.14854.95.25.14804.94.84.8
 Other method3934.034.035.22737.335.934.31132.331.932.11234.031.133.2
 Pyruvate to lactate3827.57.89.34067.68.29.54147.17.27.44117.27.17.3
 Pyruvate to lactate (dry chemistry)753.453.253.169.09.19.261.53.01.964.52.55.1
Lipase3929.212.318.039910.213.717.94088.813.914.040314.410.214.1
 Hydrolysis of 1,2-diglyceride with quinone dye1007.79.313.31047.510.88.41034.25.06.1822.83.82.3
 Hydrolysis of 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6’-methylresorufin) ester2595.44.96.92736.35.97.32858.813.213.430214.98.414.7
 Hydrolysis of 1-oleoyl-2,3-diacetyl glycerol92.14.15.994.04.25.982.72.42.882.64.32.0
 Other method2421.321.020.51322.015.415.6128.712.012.6115.114.19.8
Low-density lipoprotein cholesterol88015.713.220.891114.312.721.89207.37.86.391610.49.05.9
 Enzymatic with detergent58716.112.522.461814.912.423.96427.47.36.464010.99.85.8
 Enzymatic with others22913.211.015.323311.710.815.92307.37.26.92297.16.07.5
 Enzymatic with polyethylene glycol329.79.721.2347.44.119.1346.48.29.9337.75.65.5
 Other method3214.313.621.22614.415.021.4146.38.57.51412.48.49.8
Magnesium2803.55.42.92830.03.12.12903.83.23.12903.95.53.2
 Colorimetry_Xylidyl blue2683.45.32.92740.03.12.22863.83.23.12863.95.43.2
 Dry chemistry46.15.45.332.94.41.328.31.71.623.211.53.1
Osmolality1461.21.21.21511.01.10.91511.31.21.21491.31.31.3
 Freezing point depression osmometer1281.31.11.31341.11.20.91381.21.01.21381.41.31.3
 Other method181.21.41.2170.80.61.8131.31.01.1111.61.82.0
Phosphorus6494.93.23.06763.32.92.96932.42.62.36872.52.32.3
 Enzymatic52.72.22.2411.610.79.772.21.91.773.41.82.7
 Molybden blue colorimetry1393.31.82.31470.01.92.21572.42.21.91552.02.32.1
 Other method184.47.57.91111.39.37.632.63.33.244.46.97.4
 Phosphomolybdate4873.43.12.55143.31.92.25262.42.22.35212.22.32.2
Potassium1,0042.91.92.31,0483.01.92.41,0641.92.32.31,0602.31.92.2
 ISE, diluted5412.51.81.35592.41.71.25691.81.41.65711.51.81.4
 ISE, undiluted4243.02.82.64543.02.12.84632.11.62.54601.52.11.5
 Other method395.73.53.8353.12.43.4322.54.23.9292.62.13.5
Protein, total1,4292.12.83.61,4943.22.83.91,5293.33.84.01,5163.83.43.7
 Biuret method1,3702.12.83.51,4513.22.83.91,5023.33.84.01,4873.83.33.7
 Other method595.55.26.3433.73.84.7274.55.84.7295.14.65.2
Sodium1,0041.91.21.41,0481.91.21.31,0641.11.21.31,0601.31.21.4
 ISE, diluted5041.21.11.05261.21.00.95370.71.11.15391.21.11.2
 ISE, undiluted4611.81.61.44871.81.61.54941.21.41.64911.51.41.7
 Other method391.91.42.2351.91.41.9331.92.11.8301.81.52.0
Total CO22019.27.85.22098.88.26.82166.26.55.72145.05.15.7
 Other method108.65.39.575.45.97.7612.110.24.355.07.14.7
 Phosphoenolpyruvate carboxylase1919.27.65.72029.28.46.62106.26.45.62094.94.65.7
Total iron-binding capacity3673.84.03.33763.73.73.23823.22.93.43813.23.33.5
 Bathophenanthroline1233.32.72.31312.42.22.11361.62.52.51342.12.02.9
 Chromazural B182.32.04.5193.22.83.2173.62.82.9173.44.33.0
 Ferrozine1053.53.53.91084.43.53.11122.43.03.41143.32.83.2
 Nitroso-PSAP972.32.22.11043.12.32.21102.52.42.71082.22.92.1
 Other method244.26.85.6142.42.17.378.511.010.0812.14.712.0
Triglyceride1,51533.419.446.81,58733.120.346.31,6174.05.75.51,6015.34.05.5
 Enzymatic with free glycerol elimination4885.75.37.15185.56.07.05262.83.33.25273.12.82.6
 Enzymatic without free glycerol elimination9524.74.54.31,0194.74.14.01,0614.86.76.61,0456.44.56.3
 Other method7535.719.746.15033.220.344.1306.06.26.5295.74.43.3
Urea nitrogen1,4994.04.04.11,5705.14.04.31,6024.73.94.91,5914.25.24.3
 Other method697.75.03.6485.36.16.1296.89.47.22910.08.97.9
 Urease with colorimetry187.94.45.6199.67.76.9186.08.99.1179.56.18.7
 Urease with GLDH1,4114.03.84.11,5025.04.04.21,5544.73.84.91,5444.25.14.3
Uric acid1,1856.94.03.81,2425.83.73.81,2623.43.63.31,2543.64.23.5
 Other method487.26.25.2336.15.14.5208.65.97.0205.17.84.5
 Uricase1,1316.94.03.81,2035.93.63.81,2363.33.63.31,2283.44.23.5
 Uricase (dry chemistry)61.71.71.963.41.81.761.11.31.260.62.52.0
Estimated glomerular filtration rate, adult27910.55.828712.310.229510.06.52936.50.0
 Others1915.10.01710.615.71816.621.31717.228.2
 CKD-EPI488.75.1518.310.4538.96.5535.80.0
 Cockcroft-Gault108.97.0118.111.9811.325.198.88.5
 MDRD 4 variable (IDMS-traceable)1329.25.413511.610.31429.96.01410.00.0
 MDRD 4 variable (non IDMS-traceable)698.95.27210.28.57111.57.3719.78.9
 MDRD 6 variable11318.54.920.00.0
Estimated glomerular filtration rate, child4542.64538.44356.14444.7
 Others1870.31653.01663.91561.9
 Cockcroft-Gault512.850.04134.448.9
 Schwartz1615.51617.01519.11720.4
 Updated bedside Schwartz61.384.687.288.0

Abbreviations: LDH, lactate dehydrogenase; P5P, pyridoxal-5-phosphate; BCG, bromocresol green; BCP, bromocresol purple; PNPP, para nitrophenylphosphate; AMP, 2-amino-2-methyl-1-propanol; DEA, diethanolamine; EAE, 2-ethylaminoethanol; MDH, malate dehydrogenase; OCPC, o-creolphthalein complexone; NM-BAPTA, 5-nitro-5’-methyl-BAPTA; ISE, ion-selective electrodes; Nitroso-PSAP, 2-nitroso-5-(N-propyl-N-sulfopropylamino)-phenol; GLDH, glutamate dehydrogenase; CKD-EPI, chronic kidney disease epidemiology collaboration; MDRD, modification of diet in renal disease; IDMS, isotope-dilution mass spectrometry..

*Number of laboratories that participated in the Korean External Quality Assessment Service 2018.


요화학검사항목 중 albumin과 protein은 측정법의 분포가 일반화학검사와 차이가 있었다. Albumin의 측정법으로는 immunoturbidimetry법이 주로 이용되었고 protein의 측정 법으로 dye binding using pyrogallol red법과 turbidimetry using benzethonium chloride법이 이용되었다(Table 8).

Table 8 . Distribution of analytical methods (principle) and coefficients of variation (%) for the principles of urine chemistry in 2018.

Test/methodTrials

1st2nd


Lab*CUC-18-01CUC-18-02CUC-18-03Lab*CUC-18-04CUC-18-05CUC-18-06
Albumin16630.019.019.417214.220.332.5
 Dye binding-BCG215.712.713.2233.926.344.7
 Immunoturbidimetry15529.717.718.016013.918.630.0
Calcium1514.02.72.31554.32.63.4
 Arsenazo III dye194.13.02.7222.34.03.4
 Cresolphthalein complexone793.83.02.7773.92.43.3
 MXB method (methylxylenol blue)42.01.11.857.30.95.4
 NM-BAPTA472.11.71.8492.81.92.8
Chloride1778.82.52.51839.02.48.7
 ISE, diluted (indirect)1708.52.52.51768.62.48.5
 ISE, undiluted (direct)48.511.612.1415.415.715.2
Creatinine2065.54.94.82095.24.95.1
 Compensated kinetic Jaffe method502.02.72.5501.82.32.3
 Enzymatic method102.43.13.5102.33.13.3
 kinetic Jaffe method565.15.24.5574.24.64.1
 Rate blanked compensated kinetic Jaffe method893.73.73.4913.83.53.6
Glucose1352.22.22.21373.32.61.3
 Hexokinase1342.22.22.21363.32.72.6
Magnesium1093.02.83.51083.33.63.6
 Chlorophosphonazo III213.01.20.8
 Colorimetrc test-Xylidyl blue113.51.11.7114.33.75.8
 Colorimetric (Dye-Xylidyl blue/magon)953.02.93.6963.13.63.5
Phosphorus1382.52.62.91392.62.82.8
 Phosphomolybdate with any reduction method32.20.91.840.42.51.2
 Phosphomolybdate, UV1352.52.62.81352.62.82.9
Potassium1782.13.13.41841.83.61.9
 ISE, diluted (indirect)1712.13.13.51771.83.71.9
 ISE, undiluted (direct)44.211.912.545.521.04.7
Protein17311.09.08.61779.99.010.5
 Biuret method514.312.19.345.67.39.2
 dye binding using pyrogallol red9713.310.39.210212.510.015.0
 turbidimetry using benzethonium chloride695.33.63.8705.33.55.1
Sodium1802.81.21.11862.21.12.3
 ISE, diluted (indirect)1722.81.21.01782.21.12.3
 ISE, undiluted (direct)53.73.34.154.32.60.0
Urea nitrogen1522.92.82.31563.33.13.2
 Enzymatic UV test (urease-GLDH)95.51.83.795.45.72.8
 Urease with GLDH (coupled enzymes)1432.82.52.31473.03.23.1
Uric acid1454.33.53.61464.63.74.5
 Uricase1434.43.53.61444.63.74.5

Abbreviations: BCG, bromocresol green; NM-BAPTA, 5-nitro-5’-methyl-BAPTA; ISE, ion-selective electrodes; UV, ultra violet; GLDH, glutamate dehydrogenase..

*Number of Laboratories participated in Korean External Quality Assessment Service 2018.


2018년 일반화학검사 프로그램과 요화학검사 프로그램의 신빙도조사 결과에 대해 보다 자세한 통계분석 결과는 대한임상검사정도관리협회 신빙도조사사업 홈페이지(http://eqas. keqas.org)에서 조회가 가능하다.

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