Journal of Laboratory Medicine and Quality Assurance

일반화학 프로그램 신빙도조사 결과보고(2017)

Yong-Wha Lee

Additional article information

Abstract

2017년 대한임상검사정도관리협회 신빙도조사사업에서 임상화학분야에는 요화학검사 프로그램이 추가되어 총 24개의 프로그램으로 구성되었다. 일반화학검사 프로그램은 삼투압(osmolality), 총 이산화탄소(total CO2)와 추정 사구체여과율검사가 추가된 총 32개의 검사항목으로 구성되었고, 요화학검사 프로그램은 알부민검사 등 총 12개의 검사항목으로 구성되었다. 각 기관에서 입력된 검사항목에 대한 정보와 결과를 기반으로 검사방법, 기기, 시약에 따른 통계분석 자료가 보고되도록 하였다. 제시된 통계에는 각 그룹별 참여기관 수, 평균, 표준편차, 변이계수, 중앙값, 최소값과 최대값이 포함되도록 하였고 개별보고서는 각 검사항목별로 통계치를 보여주는 표, 히스토그램, 레비-제닝스 차트와 표준편차지수로 구성되도록 하였다. 1,000개 이상의 기관이 참여하는 검사항목은 알부민 등 총 14개의 검사항목에 대해서 1,000개 이상의 기관이 참가하고 있고 참가기관 수가 지속적으로 증가하는 추세이다. 변이계수는 각 검사항목별 회차별로 정도관리물질의 농도가 낮을수록 높은 경향을 보였으나 대부분 10% 이내의 변이계수를 보였다. 알칼리인산분해효소(alkaline phosphatase)와 젖산탈수소효소(lactate dehydrogenase)는 검사법 간에 결과의 차이가 유의하게 커서 변이계수도 상대적으로 매우 큰 것으로 관찰되었다. 일반화학검사항목에 있어서 측정법의 분포는 전체적으로 전년도와 큰 차이는 없었고, 요화학검사항목 중 알부민, 포도당, 인(phosphorus), 단백은 측정법의 분포가 일반화학검사와 차이가 있었다.

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

서 론

대한임상검사정도관리협회에서는 2016년부터 새로운 운영방식의 차세대 신빙도조사사업을 시행하고 있다. 가장 큰 변화는 6개 대분류하에 46개 프로그램 단위별 운영체계로 전환하여 검사항목을 확대한 점이 되겠다[1-3]. 2017년도에는 임상화학 분야에는 3개의 프로그램이 추가되어 일반화학검사 프로그램을 비롯하여 총 24개의 프로그램으로 구성되었다. 일반화학검사 프로그램에는 삼투압(osmolality)검사와 총 이산화탄소(total CO2)검사가 추가되었고 3회차부터 성인과 소아의 추정 사구체여과율검사가 시범사업으로 추가되어 총 32개의 검사항목으로 확대되었다. 또한 일반화학검사 프로그램 외에 요화학검사 프로그램이 신설되어 알부민검사 등 총 12개의 검사항목에 대한 신빙도조사가 2회에 걸쳐 시행되었다.

저자들은 2017년 대한임상검사정도관리협회의 신빙도조사사업으로 실시되었던 일반화학검사와 요화학검사에 대한 신빙도조사사업 결과를 분석하여 보고하고자 한다.

재료 및 방법

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 1회차와 2회차는 3월 27일에 발송되었고 3회차와 4회차는 10월 16일에 발송되었다. 요화학검사 프로그램은 연 2회에 걸쳐 회차별로 3개의 정도관리물질이 이용되었고 1회차와 2회차를 각각 6월 13일과 9월 18일에 발송하였다.

2. 정도관리물질과 검사항목

일반화학검사의 정도관리물질은 사람 혈청을 기질로 한 분말제품인 Randox사(London, UK)와 Bio-Rad사(Bio-Rad Laboratories, Hercules, CA, USA)의 사람 혈청을 기질로 한 분말제품을 사용하였다(Table 1). 검사항목은 1회차와 2회차는 총 30항목이었고 3회차와 4회차는 성인과 소아의 추정 사구체여과율 항목이 추가되어 총 32항목이었다. 요화학검사의 정도관리물질은 Bio-Rad사의 Lyphochek Quantitative Urine Control을 사용하였다. 검사항목은 알부민 등 총 12항목이었다(Table 2). 사전에 공지된 일정에 따라 물질을 수령한 참여기관에서는 검사 시행 후 지정된 회신 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 참여기관이 홈페이지상에서 해당 검사항목에 대한 검사정보 선택과 결과 입력이 가능하도록 전산체계를 구축하였다.

Table 1
Table 2

Control materials provided for analysis and released dates from the routine chemistry trials in 2017

Trial Material no. Manufacturer    Product name   Lot no. Released date
1st CC-17-01 Randox * Human low serum 5 mL level 1 229ULCM
CC-17-02 Randox Human norm serum 5 mL level 2 1128UN 27 March
CC-17-03 Randox Human Elev serum 5 mL level 3 875UE
2nd CC-17-04 Randox Human low serum 5 mL level 1 256ULCM
CC-17-05 Randox Human norm serum 5 mL level 2 1090UN 27 March
CC-17-06 Randox Human Elev serum 5 mL level 3 845UE
3rd CC-17-07 Bio-Rad Lyphochek assayed & unassayed chemistry control 28811 (level 1)
CC-17-08 Bio-Rad Lyphochek assayed & unassayed chemistry control 26441 (level 2) 16 October
CC-17-09 Bio-Rad Lyphochek assayed & unassayed chemistry control 26442 (level 3)
4th CC-17-10 Bio-Rad Lyphochek assayed & unassayed chemistry control 26431 (level 1)
CC-17-11 Bio-Rad Lyphochek assayed & unassayed chemistry control 26432 (level 2) 16 October
CC-17-12 Bio-Rad Lyphochek assayed & unassayed chemistry control 28812 (level 3)

Randox Laboratories (London, UK),

Bio-Rad Laboratories (Hercules, CA, USA).

Control materials provided for analysis and released dates from the urine chemistry trials in 2017

Trial Material no. Manufacturer    Product name   Lot no. Released date
1st CUC-17-01 Bio-Rad * Lyphochek quantitative urine control 63371 (level 1)
CUC-17-02 Bio-Rad Lyphochek quantitative urine control 63381 (level 1) 13 June
CUC-17-03 Bio-Rad Lyphochek quantitative urine control 63382 (level 2)
2nd CUC-17-04 Bio-Rad Lyphochek quantitative urine control 63391 (level 1)
CUC-17-05 Bio-Rad Lyphochek quantitative urine control 63392 (level 2) 18 September
CUC-17-06 Bio-Rad Lyphochek quantitative urine control 63372 (level 2)

Bio-Rad Laboratories (Hercules, CA, USA).

3. 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 검사방법별로 시약회사를 세분류한 그룹의 통계를 각각 제시하였다.

제시된 통계에는 각 그룹별 참여기관 수, 평균, 표준편차, 변동계수, 중앙값, 최소값과 최대값이 포함되도록 하였고 참여기관 수, 중앙값, 최소값과 최대값은 이상치를 제거하지 않은 수치를 제시하였고 평균, 표준편차와 변동계수는 각 그룹별로 이상치를 제거한 후 산출된 수치를 사용하였다. 또한 해당 분류에 속한 기관 수가 10개 미만인 경우 평균, 표준편차와 변동계수를 제시하지 않았고 기관 수가 3개 미만인 경우 중앙값도 제시하지 않았다. 이상치는 각 해당 분류에서 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 참가기관의 수가 10개 미만일 경우 SDI를 제시하지 않았다.

히스토그램에서는 전체기관의 분포와 기준분류별 분포를 제시하였고 각 기관의 위치를 표시하였다. 히스토그램은 20개의 막대로 구성하였고 첫 번째와 마지막 막대는 각각 전체 참여기관의 결과분포에서 2.5퍼센타일 미만과 97.5퍼센타일 이상에 해당하며 중간 막대들은 2.5퍼센타일 값과 97.5퍼센타일 값의 범위를 동일한 간격으로 나누어 분포를 나타내었다. 레비-제닝스 차트는 기준분류별 SDI를 이용하여 작성하였다.

결과 및 고찰

2017년에는 4회에 걸쳐 시행된 일반화학검사 프로그램과 2회에 걸쳐 시행된 요화학검사 프로그램의 외부정도관리 분석결과가 회차마다 추가 가입 여부에 따라 참여기관 수와 회신율이 달랐기에 각 프로그램별로 매 회차마다 회신된 기관을 대상으로 통계분석이 되었다. 정도관리물질은 회차마다 각각 서로 다른 로트번호를 갖는 물질을 이용하였고 회차별로 높은 농도와 낮은 농도가 다양한 순서로 섞이도록 하였다.

일반화학검사 프로그램에서는 1,000개 이상의 기관이 참여하는 검사항목은 알부민, 알칼리인산분해효소(alkaline phosphatase, ALP), 알라닌아미노전이효소(alanine amino춗ransferase, ALT), 아스파르테이트아미노전이효소(aspartate aminotransferase, AST), 혈액요소질소(blood urea nitrogen, BUN), 총 콜레스테롤, 크레아티닌, 감마글루타밀전이효소(gamma-glutamyl transferase), 포도당, 고밀도지단백콜레스테롤(high-density lipoprotein cholesterol, HDL-C), 총 단백, 총 빌리루빈, 중성지방과 요산(uric acid) 등이었고 1회차와 2회차에 비해 3회차와 4회차의 참가기관 수가 증가하였다(Table 3).

Table 3

Number of laboratories that participated in each routine chemistry test in 2017

   Test Trial

1st 2nd 3rd 4th
Alanine transaminase 1,416 1,420 1,585 1,569
Albumin 1,302 1,305 1,463 1,447
Alkaline phosphatase 1,241 1,244 1,401 1,389
Amylase 733 733 798 788
Aspartate aminotransferase 1,415 1,419 1,584 1,568
Bilirubin, direct 728 725 783 774
Bilirubin, total 1,305 1,308 1,468 1,452
Calcium 662 664 712 702
Chloride 876 878 986 977
Cholesterol, total 1,407 1,411 1,572 1,557
Creatine kinase 622 614 654 652
Creatinine 1,356 1,358 1,524 1,514
Gamma-glutamyl transferase 1,385 1,388 1,540 1,525
Glucose 1,400 1,403 1,561 1,544
High density lipoprotein cholesterol 1,308 1,309 1,447 1,432
Iron 388 393 408 406
Lactate dehydrogenase 831 824 886 878
Lipase 394 392 406 400
Low density lipoprotein cholesterol 834 829 903 890
Magnesium 269 273 284 283
Osmolality 129 135 143 143
Phosphorus 617 617 664 658
Potassium 888 891 999 990
Protein, total 1,284 1,290 1,447 1,429
Sodium 888 890 999 990
Total CO2 177 185 199 199
Total iron-binding capacity 350 356 371 369
Triglyceride 1,379 1,381 1,531 1,516
Urea nitrogen 1,351 1,350 1,512 1,498
Uric acid 1,103 1,098 1,201 1,191
Estimated glomerular filtration rate (adult) 280 270
Estimated glomerular filtration rate (child) 181 166

요화학검사 프로그램에서는 크레아티닌검사에 참여하는 기관이 가장 많았고 1회차에 비해 2회차의 참가기관 수가 많았다(Table 4).

Table 4

Number of laboratories that participated in each urine chemistry test in 2017

   Test Trial

1st 2nd
Albumin 123 135
Calcium 117 131
Chloride 131 148
Creatinine 142 161
Glucose 112 123
Magnesium 97 101
Phosphorus 114 122
Potassium 132 149
Protein 129 144
Sodium 132 150
Urea nitrogen 123 136
Uric acid 116 127

일반화학검사 프로그램에서 변이계수는 각 검사항목별 회차별로 상대적으로 정도관리물질의 농도가 낮고 참여기관의 수가 적을수록 높은 경향을 보였다(Table 5). 대부분 10% 이내의 변이계수를 보였지만 ALP, 아밀라아제, 젖산탈수소효소(lactate dehydrogenase, LD), 직접빌리루빈, HDL-C, 저밀도지단백콜레스테롤(low-density lipoprotein cholesterol)과 중성지방 등의 일부 방법에서 10% 이상의 높은 변이계수를 보였다. 물론 동일한 검사법을 사용하는 그룹 내에서는 비교적 작은 변이계수를 보였으나 ALP와 LD는 검사법 간에 결과의 차이가 유의하게 커서 변이계수도 상대적으로 매우 큰 것으로 관찰되었다(Table 5).

Table 5

Peer-group coefficients of variation (%) according to the test and trials of routine chemistry in 2017

   Test Trial

CC-17-01 CC-17-02 CC-17-03 CC-17-04 CC-17-05 CC-17-06 CC-17-07 CC-17-08 CC-17-09 CC-17-10 CC-17-11 CC-17-12
Alanine aminotransferase 5.9 10.6 7.1 6.6 13.1 5.8 6.5 6.4 5.8 6.7 6.2 6.2
Albumin 5.2 5.4 3.9 3.9 5.7 5.2 4.9 4.9 5.1 4.9 5.8 5.2
Alkaline phosphatase 46.1 61.2 48.2 43.7 65.2 40.4 44.5 44.2 37.7 45.1 38.7 36.5
Amylase 18.2 17.5 15.7 15.8 15.6 18.0 13.0 13.1 19.1 13.3 19.0 19.2
Aspartate aminotransferase 5.2 5.5 6.7 6.4 9.3 5.4 5.4 5.2 4.4 6.1 4.7 4.6
Bilirubin, direct 15.3 20.4 15.0 13.6 16.6 16.4 20.3 18.7 20.1 9.0 21.3 15.2
Bilirubin, total 6.9 8.3 8.8 7.6 9.4 6.4 9.4 9.9 6.7 11.1 6.5 6.6
Calcium 2.3 3.6 2.8 2.6 4.3 2.3 4.2 3.6 2.7 4.4 2.9 2.5
Chloride 2.0 3.1 2.6 2.9 3.4 1.9 3.3 2.8 2.5 3.0 2.6 2.5
Cholesterol (total) 2.6 3.1 2.9 2.7 3.2 2.9 3.0 3.0 4.9 2.9 5.2 4.8
Creatine kinase 5.5 5.7 6.2 5.7 5.3 5.2 4.3 3.9 4.7 4.3 5.0 5.0
Creatinine 5.0 12.9 6.9 5.7 10.5 5.2 14.0 11.5 7.9 12.3 7.7 8.0
Gamma-glutamyl transferase 5.5 9.4 5.8 5.9 9.1 5.4 7.8 7.2 7.3 7.6 7.5 7.7
Glucose 3.1 3.5 3.3 3.0 4.0 3.1 3.8 3.7 3.1 3.9 3.3 3.2
High density lipoprotein cholesterol 21.6 27.4 7.5 7.0 31.4 12.6 14.2 10.8 13.3 12.6 14.5 13.6
Iron 3.7 3.4 3.6 3.2 3.6 3.5 3.5 3.3 4.0 3.2 3.8 3.5
Lactate dehydrogenase 37.9 37.9 37.0 37.8 36.6 38.3 36.0 37.7 40.0 36.1 40.3 40.3
Lipase 12.0 15.6 11.8 11.2 11.2 11.4 7.5 4.9 14.0 7.0 15.3 16.2
Low density lipoprotein cholesterol 29.3 39.2 15.1 15.2 41.1 22.5 8.0 8.4 8.9 8.0 8.2 7.2
Magnesium 2.3 5.2 3.5 3.2 4.7 3.4 3.9 3.8 3.4 4.0 2.2 2.7
Osmolality 1.2 1.6 1.6 1.3 1.2 1.4 1.6 1.3 1.1 1.4 1.3 1.3
Phosphorus 3.3 5.4 3.2 2.0 4.9 3.2 2.5 3.5 2.3 2.3 2.4 2.7
Potassium 1.6 3.8 1.9 1.9 4.7 1.5 1.9 1.9 2.2 1.9 1.6 1.5
Protein, total 3.5 3.3 3.1 2.3 2.3 3.3 2.8 3.3 3.7 3.3 4.1 4.2
Sodium 1.7 1.8 1.5 1.5 1.5 1.4 1.3 1.2 1.3 1.3 1.3 1.4
Total CO2 6.7 8.9 7.0 9.2 9.5 7.4 6.1 5.5 5.6 6.0 5.5 5.5
Total iron-binding capacity 2.7 4.7 4.8 4.3 4.3 3.3 3.2 2.8 3.7 3.6 3.2 3.2
Triglyceride 42.8 51.1 29.2 28.7 60.7 50.8 3.6 3.6 5.3 4.0 5.7 5.3
Urea nitrogen 5.2 4.8 4.5 4.2 5.5 5.8 5.3 4.8 4.4 5.7 5.7 4.9
Uric acid 4.3 7.2 4.7 4.3 5.9 4.4 4.1 4.1 3.7 4.1 4.1 3.7
Estimated glomerular filtration rate (adult) NA 16.0 14.2 17.6 13.2 13.4
Estimated glomerular filtration rate (child) 55.2 NA NA NA NA NA

Abbreviation: NA, not applicable.

요화학검사 프로그램에서 각 검사항목별 변이계수는 대부분 10% 이내의 값을 보였으나 알부민과 단백은 상대적으로 높은 변이계수를 보였다(Table 6). 변이계수는 각 각 기관의 상대적 위치를 나타내는 SDI와도 관련되므로 변이계수가 큰 경우 SDI는 상대적으로 작아질 수 있으므로 결과해석 시 고려되어야 한다.

Table 6

Peer-group coefficients of variation (%) according to the test and trials of urine chemistry in 2017

   Test Trials

CUC-17-01 CUC-17-02 CUC-17-03 CUC-17-04 CUC-17-05 CUC-17-06
Albumin 36.1 38.0 23.6 49.6 22.9 23.3
Calcium 3.6 3.1 3.0 3.5 2.5 2.4
Chloride 8.1 9.3 3.1 8.6 2.7 2.8
Creatinine 5.3 5.7 5.5 4.8 4.5 4.7
Glucose 3.3 3.4 2.4 3.7 2.4 2.7
Magnesium 3.5 4.5 6.3 3.4 4.1 4.9
Phosphorus 3.0 3.1 3.3 2.8 2.7 2.9
Potassium 2.2 2.5 4.0 2.4 4.0 4.3
Protein 14.3 14.6 9.4 13.5 8.8 9.6
Sodium 2.5 2.5 1.2 2.4 1.2 1.2
Urea nitrogen 3.8 3.7 3.3 3.5 3.4 3.0
Uric acid 4.8 5.6 4.3 4.6 3.7 3.6

일반화학검사항목에 있어서 측정법의 분포는 전체적으로 전년도와 큰 차이는 없었고, 한 가지 검사방법이 전체의 80%를 넘는 검사는 알부민의 dye binding bromocresol green법, ALT와 AST의 ultra violet (UV) without pyridoxal-5-phosphate법, BUN의 urease with glutamate dehydrogenase법, 총 콜레스테롤의 효소측정법, 나트륨, 칼륨과 염소 등의 전해질의 ion selective electrode법, 마그네슘의 비색법(dye-xylidyl blue/magon), 총 단백의 biuret법과 요산의 uricase법이었다. 2017년도에 추가로 신설된 삼투압과 총 이산화탄소검사도 freezing point depression osmometer법과 phosphoenolpyruvate carboxylase법이 측정법의 대부분을 차지하였다(Table 7).

Table 7

Distribution of analytical methods (principle) participated and coefficients of variation (%) according to routine chemistry principles in 2017

   Items/methods Trials

1st 2nd 3rd 4th




Lab * CC-17-01 CC-17-02 CC-17-03 Lab CC-17-04 CC-17-05 CC-17-06 Lab CC-17-07 CC-17-08 CC-17-09 Lab CC-17-10 CC-17-11 CC-17-12
Alanine aminotransferase 1,415 1,420 1,585 1,569
 Enzymatic, colorimetric (Vitros) 10 7.3 7.4 13.7 10 7.1 10.4 1.3 11 18.0 11.6 0.5 11 7.5 1.0 1.0
 Other method 104 7.9 12.8 8.6 96 9.5 19.4 7.0 96 6.7 6.8 6.9 95 7.4 7.1 7.2
 UV with P5P 11 5.4 18.1 10.4 12 10.5 27.2 8.6 15 14.9 12.3 3.3 15 12.0 4.0 3.9
 UV without P5P 1,290 5.8 10.3 6.9 1,302 6.6 12.8 5.7 1,463 6.5 6.4 5.7 1,448 6.7 6.1 6.1
Albumin 1,302 1,305 1,463 1,447
 Dye binding (BCG) 1,206 5.2 5.4 3.9 1,218 3.8 5.6 5.2 1,382 5.0 4.9 5.1 1,366 4.9 5.7 5.1
 Dye binding (BCP) 11 7.9 7.3 2.6 10 2.1 5.5 5.3 9 2.9 4.7 6.9 10 5.1 3.1 5.0
 Other method 85 4.5 5.5 3.9 77 3.8 6.1 5.2 72 4.7 4.8 6.4 71 5.0 6.0 6.7
Alkaline phosphatase 1,240 1,244 1,401 1,389
 Other method 111 51.2 57.2 52.8 109 45.1 61.9 40.9 119 43.9 43.6 38.8 116 44.8 40.9 38.4
 PNPP (AMP buffer) 658 23.1 17.2 21.7 660 16.7 23.2 18.1 756 14.2 14.2 17.2 755 14.9 17.5 17.0
 PNPP (DEA buffer) 140 11.4 18.8 10.5 143 12.1 20.5 12.2 147 12.2 12.0 9.6 149 14.5 11.6 12.4
 PNPP (EAE buffer) 331 6.4 8.4 6.0 332 5.4 15.6 5.6 379 5.8 5.8 4.9 369 6.7 5.3 4.8
Amylase 733 733 798 788
 Hydrolysis of 2-chloro-p-nitrophenyl-α-D-maltotrioside (CNP-G3) 227 4.4 5.7 4.3 227 8.1 9.7 8.3 241 5.5 6.7 4.3 241 5.0 5.1 4.7
 Hydrolysis of 4,6-ethylidene-4-nitrophenyl (4-NP)-maltohetaose (G7) substrate 264 3.2 12.6 3.3 264 2.5 7.5 3.5 283 3.1 2.1 3.3 273 2.5 3.6 3.2
 Hydrolysis of 4-nitrophenyl (4-NP)-maltohetaose (G7) substrate 4 7.4 11.3 4.0 3 1.0 7.7 1.1 5 2.0 2.5 1.9 6 5.9 4.9 1.0
 Other method 238 21.9 13.7 18.0 239 17.6 12.2 22.5 269 13.0 13.6 20.0 268 13.2 20.2 20.1
Aspartate aminotransferase 1,414 1,419 1,584 1,568
 Enzymatic, colorimetric (Vitros) 10 9.3 4.4 5.9 10 4.7 6.0 2.9 11 2.5 3.6 0.7 11 4.2 2.7 2.7
 Other method 100 6.8 12.7 8.6 92 8.3 13.3 6.7 91 4.9 5.4 5.0 90 6.9 5.6 6.2
 UV with P5P 11 11.3 21.8 18.2 12 18.7 24.8 6.4 15 5.0 3.1 2.5 15 3.3 5.5 5.1
 UV without P5P 1,293 5.2 5.5 6.6 1,305 6.4 9.1 5.3 1,467 5.4 5.2 4.3 1,452 5.5 4.7 4.5
Bilirubin (direct) 723 723 783 773
 Colorimetric test (DCA/DPD) 18 11.4 10.6 10.0 17 12.6 3.7 9.5 14 12.3 12.9 12.1 15 4.5 13.3 13.7
 Diazonium salt/diazonium ion with blank 248 12.1 9.2 4.7 251 4.3 9.4 14.3 278 22.7 19.5 3.8 278 18.3 5.0 6.3
 Enzymatic bilirubin oxidase 14 10.4 15.7 16.2 15 9.6 2.2 15.7 17 18.5 18.2 14.1 17 2.7 15.1 13.3
 Evelyn-Malloy method with blank 19 34.6 32.5 15.9 18 13.4 27.5 17.5 24 32.5 35.8 17.5 22 28.9 14.6 14.5
 Evelyn-Malloy method without blank 11 21.3 13.4 26.3 9 22.2 30.1 33.4 10 16.4 14.9 24.4 10 16.6 14.6 16.3
 Jendrassik-Grof method with blank 3 13.4 11.2 17.3 3 20.8 28.7 18.7 3 22.8 27.3 17.7 3 27.5 14.5 19.4
 Other method 93 27.8 31.3 20.2 87 14.1 21.7 25.6 80 23.8 21.1 36.7 76 5.7 38.0 35.4
 Other method (modified Jendrassik-Groff using surfactant as an accelerator) 4 49.9 72.1 69.2 5 25.7 33.7 31.5 8 21.3 36.1 34.7 10 19.3 28.6 14.4
 Oxidation 23 9.0 12.2 0.7 24 7.0 0.0 3.2 26 0.0 2.5 4.2 26 19.8 5.4 6.9
 Oxidation direct bilirubin 5 6.1 22.2 8.9 3 17.3 15.7 14.4 5 39.1 39.1 0.0 5 22.8 6.7 6.7
 Vanadate oxidation 285 11.9 14.0 10.9 291 8.9 4.3 7.0 318 14.3 12.7 13.1 311 3.5 11.2 13.2
Bilirubin (total) 1,305 1,308 1,467 1,451
 Colorimetric test (DCA/DPD) 37 8.1 11.2 9.9 39 6.8 5.9 6.9 42 6.7 5.7 6.2 42 7.5 6.7 5.7
 Diazo-dimethyl sulfoxide with blank 57 8.1 15.5 18.8 62 14.3 15.3 6.1 72 6.3 7.9 5.1 76 10.7 4.8 5.3
 Diazonium salt/diazonium ion with blank 374 5.7 7.7 8.2 374 6.8 9.8 5.5 405 10.1 11.4 6.3 404 12.8 6.0 6.3
 Diazonium salt/diazonium ion without blank 29 8.9 10.0 11.3 33 7.4 11.8 8.1 38 13.8 18.0 13.8 38 14.4 10.8 10.6
 Diazonium salt-dyphylline (Vitros) 10 3.0 12.9 12.0 9 7.1 21.4 2.9 11 10.6 13.6 6.0 11 10.2 5.2 5.6
 Enzymatic bilirubin oxidase 25 4.6 6.3 4.3 27 5.5 1.7 5.2 30 9.6 8.0 5.9 30 11.1 5.4 5.5
 Evelyn-Malloy method with blank 53 8.6 11.3 9.4 50 8.2 8.7 9.8 61 10.7 9.5 6.6 57 9.6 7.6 7.5
 Evelyn-Malloy method without blank 74 7.8 15.5 14.3 72 12.1 13.9 8.5 97 12.5 17.7 6.8 94 16.6 5.5 6.3
 Jendrassik-Grof method with blank 7 2.3 13.6 0.0 7 2.0 12.5 8.2 9 3.2 6.8 10.4 9 14.8 10.6 11.9
 Other method 88 10.3 9.8 12.2 81 10.0 12.3 7.4 78 16.7 14.3 8.6 77 17.3 9.6 8.7
 Oxidation 89 4.8 4.3 4.5 86 4.7 1.1 4.5 76 10.6 10.7 6.7 77 12.3 7.2 7.0
 Vanadate oxidation 459 5.7 6.1 7.6 465 5.7 4.8 5.3 546 5.5 4.3 4.8 534 5.8 4.8 4.4
Calcium 661 663 712 702
 Arsenazo III dye 106 3.0 5.3 2.6 111 3.0 4.6 3.1 137 3.5 2.9 3.2 132 3.6 3.2 3.1
 Cresolphthalein complexone 406 2.3 3.4 2.6 405 1.7 3.0 1.9 416 3.7 3.0 2.5 412 3.7 2.7 2.9
 Mmethylxylenol blue method 18 1.5 3.5 3.3 18 1.4 2.7 1.5 20 2.4 2.0 1.3 19 1.7 2.0 1.4
 NM-BAPTA 109 1.2 1.9 1.5 109 1.5 1.8 1.2 118 0.9 1.3 1.2 119 1.0 1.1 0.7
 Other method 20 2.7 5.6 6.5 18 6.5 7.4 5.2 20 6.4 5.0 3.5 19 4.4 4.7 3.2
Chloride 876 878 986 977
 ISE, diluted (indirect) 506 1.7 3.4 2.4 509 2.4 3.6 1.7 534 3.6 2.8 2.0 534 2.8 2.0 2.2
 ISE, undiluted (direct) 332 2.0 2.6 2.2 331 2.2 2.7 1.8 409 2.4 2.2 2.6 402 2.3 2.7 2.6
 Other method 38 2.4 3.6 2.5 38 2.8 3.0 2.2 43 3.1 1.7 2.1 41 2.5 2.9 2.5
Cholesterol (total) 1,407 1,411 1,572 1,557
 Enzymatic 1,299 2.6 3.1 2.9 1,313 2.7 3.2 2.9 1,473 3.0 2.8 4.9 1,459 2.9 5.2 4.9
 Other method 108 3.5 4.0 3.7 98 3.8 3.1 3.6 99 3.3 3.2 4.5 98 3.9 5.2 4.9
Creatine kinase 622 614 654 652
 Other method 57 9.0 8.8 6.2 52 7.4 8.1 7.2 52 4.5 4.9 4.8 54 6.4 5.9 5.5
 Reverse (CrP→Cr) reaction 257 4.2 5.0 5.4 252 4.4 4.7 4.1 266 4.2 4.1 3.1 265 4.1 3.2 3.1
 Reverse (CrP→Cr) reaction with cofactor 308 6.2 5.8 6.5 310 6.4 6.0 6.2 336 4.3 3.9 5.8 333 4.1 5.9 6.0
Creatinine 1,353 1,358 1,524 1,514
 Compensated kinetic Jaffe method 148 3.8 15.0 5.8 166 4.2 13.2 4.1 315 12.2 10.3 6.7 320 7.9 6.8 6.2
 Enzymatic method 50 3.2 9.0 4.5 57 4.9 7.5 3.9 63 35.3 15.4 5.2 60 12.0 4.9 5.1
 Kinetic Jaffe method 845 5.6 9.2 7.3 833 6.7 6.9 5.9 819 10.1 6.7 7.0 808 6.7 7.1 6.9
 Other method 96 11.5 12.1 12.7 86 9.3 14.6 7.8 87 11.0 11.4 10.8 85 14.0 11.1 12.0
 Rate blanked compensated kinetic Jaffe method 214 3.6 6.9 4.8 216 3.8 5.2 3.5 240 6.2 5.5 3.9 241 5.7 3.8 4.3
Gamma-glutamyl transferase 1,385 1,388 1,540 1,525
 G-glutamyl-carboxy-nitroanilide (IFCC) 872 5.0 9.5 5.4 883 5.3 9.2 5.1 962 7.3 7.3 7.6 959 7.8 8.0 8.1
 G-glutamyl-carboxy-nitroanilide (JSCC) 270 2.9 6.0 3.3 277 3.0 5.1 2.6 320 2.2 1.5 2.1 314 2.6 2.2 2.2
 G-glutamyl-p-nitroanilide 13 1.5 13.8 5.5 11 4.5 5.1 4.7 22 8.4 3.7 6.1 21 8.6 7.2 6.1
 G-glutamyl-p-nitroanilide (dry chemistry) 80 6.2 9.6 6.2 81 5.8 7.7 6.3 97 7.4 7.7 7.1 96 7.1 7.2 6.9
 Other method 150 7.7 11.8 8.0 136 7.2 11.9 6.9 139 8.6 7.4 7.0 135 7.0 6.9 7.1
Glucose 1,399 1,403 1,561 1,544
 Glucose oxidase 323 3.6 4.8 4.1 328 4.7 5.6 4.3 383 5.0 5.0 4.2 379 5.0 4.3 4.4
 Hexokinase 975 2.7 2.1 2.9 983 2.7 2.3 2.5 1,087 3.2 2.8 2.6 1,076 3.1 2.8 2.9
 Other method 101 4.7 6.3 5.0 92 4.7 6.1 4.8 91 4.3 5.0 4.4 89 3.9 3.8 3.8
High density lipoprotein cholesterol 1,308 1,309 1,447 1,432
 Beckman AU HDL direct method 164 3.9 3.2 3.1 165 4.0 3.7 3.9 175 3.6 3.2 5.6 175 3.8 5.6 3.5
 Denka HDL direct method 6 15.5 28.2 4.2 4 5.3 9.4 8.3 4 11.7 9.0 8.9 5 4.9 7.9 6.8
 Direct method (other company) 350 22.9 28.2 15.1 360 16.6 32.4 23.7 424 14.3 12.9 12.6 423 12.6 12.8 11.9
 Kyowa HDL direct method 76 3.3 4.4 4.5 77 5.4 5.4 5.8 76 5.9 4.4 6.6 75 4.1 7.9 6.9
 Other method 107 24.9 29.8 13.3 96 10.2 26.6 22.1 97 14.8 12.6 13.3 94 12.3 13.8 14.5
 Roche HDL direct method 216 5.2 3.4 3.9 216 3.6 2.8 6.0 232 3.8 3.6 3.2 232 3.6 3.5 3.6
 Sekisui HDL direct method 297 4.1 4.0 3.4 302 3.6 4.5 4.3 337 2.8 3.7 2.9 330 4.2 4.5 3.0
 Siemens Advia direct HDL method 38 2.8 4.6 3.3 37 4.3 6.2 5.6 42 4.4 3.2 0.0 42 3.8 3.4 3.4
 Siemens HDL direct method 5 1.7 5.5 5.4 5 7.5 7.3 6.5 5 12.0 12.3 14.8 5 9.1 8.7 8.5
 Wako HDL direct method 48 7.9 6.5 6.7 46 6.9 8.4 9.2 54 9.6 10.5 6.2 50 8.7 7.1 7.8
Iron 388 393 408 406
 Bathophenanthroline without deproteinization 130 2.2 2.0 2.0 136 1.5 1.8 1.2 136 1.2 1.3 2.3 134 1.5 2.2 2.7
 Ferrachrome/ferrozine without deproteinization 139 3.6 2.9 3.4 133 3.0 3.1 3.3 141 2.6 2.2 3.4 138 2.0 2.4 2.7
 Nitroso-PSAP without deproteinization 34 1.8 1.7 2.2 35 2.2 2.2 1.8 36 1.3 0.8 1.3 35 1.2 2.5 1.5
 Other method 12 3.2 5.8 4.4 12 3.9 3.1 4.1 14 6.7 5.5 6.0 16 3.7 6.2 7.6
 Tripyridyltriazine-without prior protein removal 69 1.5 2.0 2.2 73 1.7 2.2 1.5 77 1.2 1.2 2.8 79 1.2 2.2 2.5
Lactate dehydrogenase 830 824 886 878
 Dinitrophenyl hydrazine (DNPH) 4 20.9 11.2 13.9 4 0.9 1.3 1.6 5 3.8 3.8 3.5 5 4.8 4.6 5.0
 Lactate to pyruvate 399 3.9 5.3 4.2 395 6.8 7.3 6.6 446 5.0 5.6 5.6 435 5.1 5.7 5.6
 Other method 47 36.2 36.6 33.0 44 35.2 35.3 34.8 46 30.0 31.3 32.1 49 31.5 34.3 34.5
 Pyruvate to lactate 375 9.1 8.1 7.9 376 7.7 7.0 9.0 383 6.9 6.5 6.7 383 7.1 6.9 6.9
 Pyruvate to lactate (dry chemistry) 5 2.3 3.0 2.0 5 2.5 8.3 1.1 6 2.0 1.3 0.8 6 4.6 2.4 1.8
Lipase 394 392 406 400
 Hydrolysis of 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6’-methylresorufin) ester 271 6.3 11.8 6.0 268 8.7 9.7 9.0 275 7.7 5.1 11.2 266 6.8 10.0 8.7
 Hydrolysis of 1-oleoyl-2,3-diacetyl glycerol 10 3.3 4.2 4.4 10 3.0 3.0 6.4 10 2.5 3.6 3.1 10 3.5 2.7 0.0
 Other method 40 15.3 33.5 16.8 42 15.0 22.8 14.5 43 9.4 7.7 12.4 45 12.2 15.9 15.7
 Spectrophotometric method with triglyceride 68 3.6 7.1 3.9 67 4.3 3.9 2.9 74 1.4 2.0 2.0 75 3.5 2.4 2.6
Low density lipoprotein cholesterol 833 829 903 890
 Beckman AU LDL direct method 105 7.1 8.8 6.6 104 6.7 9.7 8.8 111 6.5 6.8 6.8 112 6.7 6.9 7.3
 Direct method (other company) 157 25.9 34.3 14.5 161 14.7 36.2 23.2 190 9.2 9.3 10.9 190 9.7 10.9 10.3
 Kyowa LDL direct method 66 2.7 5.4 3.0 67 2.6 6.2 2.9 65 2.2 1.5 2.9 64 2.2 2.7 2.5
 Other method 49 32.3 50.2 16.9 43 15.3 51.5 26.1 45 11.7 11.5 12.3 40 10.4 13.9 12.2
 Roche LDL direct method 169 4.8 9.7 3.5 168 2.5 8.2 4.3 175 4.2 4.8 4.8 173 5.4 4.7 4.5
 Sekisui LDL direct method 204 4.1 7.6 3.3 207 3.1 8.7 3.5 232 2.6 2.8 3.5 227 2.8 3.2 3.0
 Siemens Advia direct LDL method 38 2.0 4.7 1.7 37 3.7 5.6 3.8 41 2.8 3.2 3.1 41 2.3 3.1 3.9
 Siemens LDL direct method 4 6.9 7.8 4.0 4 2.6 7.7 3.9 4 5.0 3.5 3.5 4 6.7 6.1 4.3
 Wako LDL direct method 38 8.6 6.7 8.6 35 6.3 7.7 6.9 38 5.1 5.0 3.0 36 5.8 6.3 6.9
Magnesium 267 272 283 282
 Colorimetrc test-xylidyl blue 28 2.3 0.0 2.9 27 3.3 4.9 2.1 27 3.4 3.1 2.3 28 3.1 1.7 1.9
 Colorimetric-Vitros Chemistry Systems 4 3.8 4.6 2.5 4 0.0 5.8 2.2 4 7.1 5.9 0.0 4 3.5 2.3 2.3
 Colorimetric (dye-xylidyl blue/magon) 226 2.2 5.2 3.5 232 3.2 4.6 2.3 242 3.9 3.8 3.4 240 4.0 2.2 2.6
 Other method 5 3.6 11.6 1.9 5 2.2 3.6 6.3 6 8.1 8.3 5.8 6 4.3 6.5 7.9
Osmolality 129 135 143 143
 Freezing point depression osmometer 114 1.2 1.5 1.6 120 1.3 1.2 1.4 128 1.6 1.3 1.1 127 1.3 1.3 1.3
 Other method 15 1.2 1.5 1.7 15 0.8 1.2 1.0 15 1.6 1.4 1.1 16 1.8 1.4 1.3
Phosphorus 617 617 664 658
 Other method 20 3.5 5.1 5.9 20 5.1 8.9 4.7 22 4.3 4.3 2.8 22 3.6 3.5 2.9
 Phosphomolybdate with any reduction method 126 3.7 6.0 3.5 128 3.0 5.8 2.7 136 2.3 2.2 2.0 137 2.0 1.8 1.2
 Phosphomolybdate (UV) 470 3.0 5.2 3.0 468 2.0 4.6 2.5 505 2.5 2.3 2.2 498 2.4 2.3 2.3
Potassium 888 891 999 990
 ISE, diluted (indirect) 509 1.7 2.9 1.8 513 1.6 3.1 1.3 537 1.7 1.8 1.5 537 1.8 1.7 1.5
 ISE, undiluted (direct) 341 2.5 5.4 2.2 340 2.1 4.2 2.7 419 2.0 2.2 2.5 412 2.6 2.6 2.2
 Other method 38 3.1 4.2 3.3 38 2.8 6.1 2.5 43 2.0 1.9 2.2 41 2.1 2.8 2.5
 Protein (total) 1,284 1,290 1,447 1,429
 Biuret method 1,195 3.4 3.3 3.1 1,210 2.3 2.2 3.3 1,371 2.8 3.2 3.7 1,355 3.2 4.1 3.7
 Other method 89 5.3 4.2 4.7 80 4.5 3.7 5.9 76 4.9 5.4 5.4 74 5.0 4.9 6.2
Sodium 888 890 999 990
 ISE, diluted (indirect) 455 1.1 1.3 1.2 465 0.7 0.8 1.0 490 1.0 1.0 1.2 492 1.2 1.1 1.2
 ISE, undiluted (direct) 391 1.9 2.0 1.9 384 1.7 2.1 1.8 464 1.4 1.4 1.4 454 1.3 1.7 1.7
 Other method 42 2.3 1.7 1.6 41 1.4 2.0 2.1 45 1.2 1.6 1.7 44 1.6 1.7 2.0
Total CO2 177 185 199 199
 ISE, diluted (indirect) 5 15.0 20.9 16.8 4 22.2 23.7 16.7 2 3.8 2.8 6.4 2 3.3 6.1 1.0
 Other method 13 9.7 13.5 10.1 12 9.9 11.6 7.5 13 9.2 7.4 9.8 13 12.4 12.2 12.7
 Phosphoenolpyruvate carboxylase (PEPC) 159 6.5 8.1 6.7 169 9.1 9.3 7.5 184 5.7 5.3 5.5 184 5.7 5.3 5.2
Total iron-binding capacity 350 356 371 369
 Bathophenanthroline 113 2.3 3.1 2.7 118 2.9 3.5 2.6 122 1.7 1.9 3.0 120 2.1 2.8 2.8
 Chromazural B 20 1.5 2.2 1.9 18 3.5 2.3 2.9 19 4.3 3.7 2.7 19 2.8 4.0 3.9
 Ferrachrome/ferrozine 103 2.8 5.4 3.5 100 2.9 4.3 3.0 105 2.9 2.8 3.8 102 3.2 3.1 3.4
 Nitroso-PSAP 88 1.8 2.6 2.2 93 2.6 3.5 2.3 98 2.4 2.3 2.4 99 2.4 1.8 2.0
 Other method 25 7.5 9.1 8.9 26 6.3 8.9 5.0 25 5.1 4.6 7.7 27 4.2 3.4 4.2
Triglyceride 1,379 1381 1,531 1,516
 Enzymatic (glycerol phosphate oxidase) with glycerol blank 452 4.7 21.8 5.5 454 4.8 23.1 6.8 489 2.9 2.8 3.3 477 3.0 3.2 3.1
 Enzymatic (glycerol phosphate oxidase) without glycerol blank 821 4.6 12.6 4.2 830 4.5 11.6 4.3 947 4.2 4.2 6.4 946 4.5 7.1 6.4
 Other method 106 38.2 47.8 26.4 97 28.2 58.3 47.4 95 5.4 5.7 6.6 93 6.1 7.0 6.6
Urea nitrogen 1,350 1,349 1,511 1,497
 Conductivity rate method 4 3.1 0.9 3.2 3 1.4 9.7 2.3 2 7.9 3.6 0.6 2 6.5 0.5 1.7
 Enzymatic UV test (urease-GLDH) 67 7.8 6.6 5.3 67 5.0 8.6 4.3 74 5.8 6.7 5.5 73 7.2 6.8 6.1
 Other method 95 6.7 11.5 6.2 86 5.2 7.9 7.8 83 6.3 5.9 6.0 82 8.0 7.0 5.7
 Urease quinolinium dye (Vitros) 9 1.3 0.0 4.3 9 2.2 1.9 1.9 9 2.1 2.3 0.5 9 2.9 1.2 2.1
 Urease with GLDH (coupled enzymes) 1,172 5.0 4.1 4.2 1,180 4.0 5.4 5.5 1,336 5.2 4.7 4.2 1,324 5.6 5.5 4.8
 Urease-indophenol (Berthelot) 3 0.5 6.9 1.8 4 1.9 0.7 0.8 7 4.7 6.5 5.6 7 1.1 4.1 4.1
Uric acid 1,103 1,098 1,201 1,191
 Other method 71 5.6 7.2 5.8 67 6.9 7.5 5.5 73 5.5 4.8 4.8 71 4.8 3.0 4.6
 Uricase 1,025 4.5 7.2 4.6 1,024 4.2 5.8 4.4 1,122 3.9 4.0 3.7 1,114 4.0 4.1 3.6
 Uricase (Vitros) 7 1.5 0.0 0.0 7 4.3 2.8 4.6 6 2.0 3.0 2.0 6 2.7 2.9 1.8

Abbreviations: UV, ultra violet; 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; CNP, C-type natriuretic peptide; DCA, deoxycholic acid; DPD, 2,5-dichlorophenyl diazonium; NM-BAPTA, 5-nitro-5’-methyl-(1,2-bis(o-aminophenoxy)ethan-N,N,N’,N’-tetraacetic acid; ISE, ion-selective electrodes; CrP, creatine phosphate; Cr, creatine; IFCC, International Federation of Clinical Chemistry; JSCC, Japanese Society for Clinical Chemistry; HDL, high-density lipoprotein; nitroso-PSAP, 2-nitroso-5-(N-propyl-N-sulfopropylamino)-phenol; LDL, low-density lipoprotein; GLDH, glutamate dehydrogenase.

Number of laboratories that participated in the Korean External Quality Assessment Service 2017.

요화학검사항목 중 알부민, 포도당, 인(phosphorus)과 단백은 측정법의 분포가 일반화학검사와 차이가 있었다. 알부민의 측정법으로는 immunoturbidimetry법이 주로 이용되었고 단백의 측정법으로 dye binding using pyrogallol red법과 turbidimetry using benzethonium chloride법이 이용되었다. 포도당과 인검사에는 각각 hexokinase법과 phosphomolybdate, UV법이 이용되었다(Table 8).

Table 8

Distribution of analytical methods (principle) participated and coefficients of variation (%) according to urine chemistry principles in 2017

   Items/methods Trials

1st 2nd


Lab * CUC-17-01 CUC-17-02 CUC-17-03 Lab CUC-17-04 CUC-17-05 CUC-17-06
Albumin 123 134
 Immunoturbidimetry 114 34.1 36.6 22.7 123 43.8 21.9 22.1
 Other method 6 50.3 54.7 27.9 7 53.0 35.4 37.8
Calcium 117 130
 Arsenazo III dye 12 3.7 3.7 2.9 16 4.4 3.2 2.7
 Cresolphthalein complexone 66 3.5 3.3 2.5 74 2.1 2.4 2.3
 NM-BAPTA 34 2.2 3.2 1.9 36 2.5 2.1 1.6
Chloride 131 147
 ISE, diluted (indirect) 128 8.1 9.4 3.2 144 8.7 2.7 2.8
 Other method 3 6.5 7.5 1.2 3 0.2 3.3 2.7
Creatinine 142 160
 Compensated kinetic Jaffe method 37 2.7 3.8 3.1 41 3.7 2.8 3.7
 Enzymatic method 7 3.0 2.3 4.2 9 5.1 5.5 3.9
 Kinetic Jaffe method 38 4.7 3.4 5.0 45 5.2 4.6 5.3
 Rate blanked compensated kinetic Jaffe method 59 2.7 3.6 3.4 64 2.9 3.2 2.5
Glucose 111 122
 Hexokinase 109 3.1 3.4 2.4 121 3.7 2.4 2.7
Magnesium 96 100
 Colorimetrc test-xylidyl blue 9 8.1 7.4 7.1 9 3.6 8.4 11.5
 Colorimetric (dye-xylidyl blue/magon) 86 3.4 4.2 6.2 89 3.2 5.1 4.7
Phosphorus 113 121
 Phosphomolybdate (UV) 112 3.0 3.1 3.8 119 2.8 2.7 2.9
Potassium 132 148
 ISE, diluted (indirect) 129 2.3 2.7 4.2 145 2.4 4.0 4.3
Protein 129 143
 Biuret method 6 12.1 10.4 9.2 6 8.9 6.7 4.7
 Dye binding using pyrogallol red 71 16.7 16.5 10.6 80 15.1 9.8 10.9
 Turbidimetry using benzethonium chloride 50 5.7 6.9 5.0 55 5.6 4.0 4.0
Sodium 132 149
 ISE, diluted (indirect) 129 2.5 2.5 1.2 146 2.4 1.2 1.2
Urea nitrogen 121 135
 Enzymatic UV test (urease-GLDH) 7 2.0 2.5 8.0 10 5.8 4.3 3.8
 Urease with GLDH (coupled enzymes) 114 3.4 3.2 3.3 125 3.4 3.3 3.3
Uric acid 116 126
 Uricase 114 4.8 5.6 4.3 125 4.6 3.7 3.6

Abbreviations: NM-BAPTA, 5-nitro-5’-methyl-(1,2-bis(o-aminophenoxy)ethan-N,N,N’,N’-tetraacetic acid; ISE, ion-selective electrodes; UV, ultra violet; GLDH, glutamate dehydrogenase.

Number of laboratories that participated in the Korean External Quality Assessment Service 2017.

2017년 일반화학검사 프로그램과 요화학검사 프로그램의 신빙도조사 결과에 대해 보다 자세한 통계분석 결과는 대한임상검사정도관리협회 신빙도조사사업 홈페이지(http://eqas.keqas.org)에서 조회가 가능하다. 각 기관의 신빙도조사 결과에 대한 해석과 검사법 선택 시 본 통계분석 자료가 유용할 것으로 생각된다.

Article information

Journal of Laboratory Medicine and Quality Assurance.Sep 30, 2018; 40(3): 113-127.
Published online 2018-09-30. doi:  10.15263/jlmqa.2018.40.3.113
순천향대학교 의과대학 순천향대학교부천병원 진단검사의학과
Department of Laboratory Medicine & Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
교신저자: 이용화 우)14584 경기도 부천시 원미구 조마루로 170, 순천향대학교 의과대학 순천향대학교부천병원 진단검사의학과 Tel: 032)621-5943, Fax: 032)621-5944, E-mail: lywmd@schmc.ac.kr
Received January 1, 1970; Accepted January 1, 1970.
Articles from Journal of Laboratory Medicine and Quality Assurance are provided here courtesy of Journal of Laboratory Medicine and Quality Assurance

References

  • Lee YW, Jeon BR, Kim JG, Jun SH, Yun YM, and Chun S. Annual report on the external quality assessment scheme for routine clinical chemistry in Korea (2016). J Lab Med Qual Assur 2017;39:61-75.
  • Jun SH, Song J, Song WH, and Clinical Chemistry Subcommittee Korean Association of External Quality, Assessment Service. Annual report on the external quality assessment scheme for clinical chemistry in Korea (2015). J Lab Med Qual Assur 2016;38:111-9.
  • Jun SH and Song J. Clinical Chemistry Subcommittee, The Korean Association of External Quality Assessment Service. Annual report on the external quality assessment scheme for clinical chemistry in Korea (2014). J Lab Med Qual Assur 2015;37:115-23.

Table 1

Control materials provided for analysis and released dates from the routine chemistry trials in 2017

Trial Material no. Manufacturer    Product name   Lot no. Released date
1st CC-17-01 Randox * Human low serum 5 mL level 1 229ULCM
CC-17-02 Randox Human norm serum 5 mL level 2 1128UN 27 March
CC-17-03 Randox Human Elev serum 5 mL level 3 875UE
2nd CC-17-04 Randox Human low serum 5 mL level 1 256ULCM
CC-17-05 Randox Human norm serum 5 mL level 2 1090UN 27 March
CC-17-06 Randox Human Elev serum 5 mL level 3 845UE
3rd CC-17-07 Bio-Rad Lyphochek assayed & unassayed chemistry control 28811 (level 1)
CC-17-08 Bio-Rad Lyphochek assayed & unassayed chemistry control 26441 (level 2) 16 October
CC-17-09 Bio-Rad Lyphochek assayed & unassayed chemistry control 26442 (level 3)
4th CC-17-10 Bio-Rad Lyphochek assayed & unassayed chemistry control 26431 (level 1)
CC-17-11 Bio-Rad Lyphochek assayed & unassayed chemistry control 26432 (level 2) 16 October
CC-17-12 Bio-Rad Lyphochek assayed & unassayed chemistry control 28812 (level 3)

Table 2

Control materials provided for analysis and released dates from the urine chemistry trials in 2017

Trial Material no. Manufacturer    Product name   Lot no. Released date
1st CUC-17-01 Bio-Rad * Lyphochek quantitative urine control 63371 (level 1)
CUC-17-02 Bio-Rad Lyphochek quantitative urine control 63381 (level 1) 13 June
CUC-17-03 Bio-Rad Lyphochek quantitative urine control 63382 (level 2)
2nd CUC-17-04 Bio-Rad Lyphochek quantitative urine control 63391 (level 1)
CUC-17-05 Bio-Rad Lyphochek quantitative urine control 63392 (level 2) 18 September
CUC-17-06 Bio-Rad Lyphochek quantitative urine control 63372 (level 2)

Table 3

Number of laboratories that participated in each routine chemistry test in 2017

   Test Trial

1st 2nd 3rd 4th
Alanine transaminase 1,416 1,420 1,585 1,569
Albumin 1,302 1,305 1,463 1,447
Alkaline phosphatase 1,241 1,244 1,401 1,389
Amylase 733 733 798 788
Aspartate aminotransferase 1,415 1,419 1,584 1,568
Bilirubin, direct 728 725 783 774
Bilirubin, total 1,305 1,308 1,468 1,452
Calcium 662 664 712 702
Chloride 876 878 986 977
Cholesterol, total 1,407 1,411 1,572 1,557
Creatine kinase 622 614 654 652
Creatinine 1,356 1,358 1,524 1,514
Gamma-glutamyl transferase 1,385 1,388 1,540 1,525
Glucose 1,400 1,403 1,561 1,544
High density lipoprotein cholesterol 1,308 1,309 1,447 1,432
Iron 388 393 408 406
Lactate dehydrogenase 831 824 886 878
Lipase 394 392 406 400
Low density lipoprotein cholesterol 834 829 903 890
Magnesium 269 273 284 283
Osmolality 129 135 143 143
Phosphorus 617 617 664 658
Potassium 888 891 999 990
Protein, total 1,284 1,290 1,447 1,429
Sodium 888 890 999 990
Total CO2 177 185 199 199
Total iron-binding capacity 350 356 371 369
Triglyceride 1,379 1,381 1,531 1,516
Urea nitrogen 1,351 1,350 1,512 1,498
Uric acid 1,103 1,098 1,201 1,191
Estimated glomerular filtration rate (adult) 280 270
Estimated glomerular filtration rate (child) 181 166

Table 4

Number of laboratories that participated in each urine chemistry test in 2017

   Test Trial

1st 2nd
Albumin 123 135
Calcium 117 131
Chloride 131 148
Creatinine 142 161
Glucose 112 123
Magnesium 97 101
Phosphorus 114 122
Potassium 132 149
Protein 129 144
Sodium 132 150
Urea nitrogen 123 136
Uric acid 116 127

Table 5

Peer-group coefficients of variation (%) according to the test and trials of routine chemistry in 2017

   Test Trial

CC-17-01 CC-17-02 CC-17-03 CC-17-04 CC-17-05 CC-17-06 CC-17-07 CC-17-08 CC-17-09 CC-17-10 CC-17-11 CC-17-12
Alanine aminotransferase 5.9 10.6 7.1 6.6 13.1 5.8 6.5 6.4 5.8 6.7 6.2 6.2
Albumin 5.2 5.4 3.9 3.9 5.7 5.2 4.9 4.9 5.1 4.9 5.8 5.2
Alkaline phosphatase 46.1 61.2 48.2 43.7 65.2 40.4 44.5 44.2 37.7 45.1 38.7 36.5
Amylase 18.2 17.5 15.7 15.8 15.6 18.0 13.0 13.1 19.1 13.3 19.0 19.2
Aspartate aminotransferase 5.2 5.5 6.7 6.4 9.3 5.4 5.4 5.2 4.4 6.1 4.7 4.6
Bilirubin, direct 15.3 20.4 15.0 13.6 16.6 16.4 20.3 18.7 20.1 9.0 21.3 15.2
Bilirubin, total 6.9 8.3 8.8 7.6 9.4 6.4 9.4 9.9 6.7 11.1 6.5 6.6
Calcium 2.3 3.6 2.8 2.6 4.3 2.3 4.2 3.6 2.7 4.4 2.9 2.5
Chloride 2.0 3.1 2.6 2.9 3.4 1.9 3.3 2.8 2.5 3.0 2.6 2.5
Cholesterol (total) 2.6 3.1 2.9 2.7 3.2 2.9 3.0 3.0 4.9 2.9 5.2 4.8
Creatine kinase 5.5 5.7 6.2 5.7 5.3 5.2 4.3 3.9 4.7 4.3 5.0 5.0
Creatinine 5.0 12.9 6.9 5.7 10.5 5.2 14.0 11.5 7.9 12.3 7.7 8.0
Gamma-glutamyl transferase 5.5 9.4 5.8 5.9 9.1 5.4 7.8 7.2 7.3 7.6 7.5 7.7
Glucose 3.1 3.5 3.3 3.0 4.0 3.1 3.8 3.7 3.1 3.9 3.3 3.2
High density lipoprotein cholesterol 21.6 27.4 7.5 7.0 31.4 12.6 14.2 10.8 13.3 12.6 14.5 13.6
Iron 3.7 3.4 3.6 3.2 3.6 3.5 3.5 3.3 4.0 3.2 3.8 3.5
Lactate dehydrogenase 37.9 37.9 37.0 37.8 36.6 38.3 36.0 37.7 40.0 36.1 40.3 40.3
Lipase 12.0 15.6 11.8 11.2 11.2 11.4 7.5 4.9 14.0 7.0 15.3 16.2
Low density lipoprotein cholesterol 29.3 39.2 15.1 15.2 41.1 22.5 8.0 8.4 8.9 8.0 8.2 7.2
Magnesium 2.3 5.2 3.5 3.2 4.7 3.4 3.9 3.8 3.4 4.0 2.2 2.7
Osmolality 1.2 1.6 1.6 1.3 1.2 1.4 1.6 1.3 1.1 1.4 1.3 1.3
Phosphorus 3.3 5.4 3.2 2.0 4.9 3.2 2.5 3.5 2.3 2.3 2.4 2.7
Potassium 1.6 3.8 1.9 1.9 4.7 1.5 1.9 1.9 2.2 1.9 1.6 1.5
Protein, total 3.5 3.3 3.1 2.3 2.3 3.3 2.8 3.3 3.7 3.3 4.1 4.2
Sodium 1.7 1.8 1.5 1.5 1.5 1.4 1.3 1.2 1.3 1.3 1.3 1.4
Total CO2 6.7 8.9 7.0 9.2 9.5 7.4 6.1 5.5 5.6 6.0 5.5 5.5
Total iron-binding capacity 2.7 4.7 4.8 4.3 4.3 3.3 3.2 2.8 3.7 3.6 3.2 3.2
Triglyceride 42.8 51.1 29.2 28.7 60.7 50.8 3.6 3.6 5.3 4.0 5.7 5.3
Urea nitrogen 5.2 4.8 4.5 4.2 5.5 5.8 5.3 4.8 4.4 5.7 5.7 4.9
Uric acid 4.3 7.2 4.7 4.3 5.9 4.4 4.1 4.1 3.7 4.1 4.1 3.7
Estimated glomerular filtration rate (adult) NA 16.0 14.2 17.6 13.2 13.4
Estimated glomerular filtration rate (child) 55.2 NA NA NA NA NA

Abbreviation: NA, not applicable.

Table 6

Peer-group coefficients of variation (%) according to the test and trials of urine chemistry in 2017

   Test Trials

CUC-17-01 CUC-17-02 CUC-17-03 CUC-17-04 CUC-17-05 CUC-17-06
Albumin 36.1 38.0 23.6 49.6 22.9 23.3
Calcium 3.6 3.1 3.0 3.5 2.5 2.4
Chloride 8.1 9.3 3.1 8.6 2.7 2.8
Creatinine 5.3 5.7 5.5 4.8 4.5 4.7
Glucose 3.3 3.4 2.4 3.7 2.4 2.7
Magnesium 3.5 4.5 6.3 3.4 4.1 4.9
Phosphorus 3.0 3.1 3.3 2.8 2.7 2.9
Potassium 2.2 2.5 4.0 2.4 4.0 4.3
Protein 14.3 14.6 9.4 13.5 8.8 9.6
Sodium 2.5 2.5 1.2 2.4 1.2 1.2
Urea nitrogen 3.8 3.7 3.3 3.5 3.4 3.0
Uric acid 4.8 5.6 4.3 4.6 3.7 3.6

Table 7

Distribution of analytical methods (principle) participated and coefficients of variation (%) according to routine chemistry principles in 2017

   Items/methods Trials

1st 2nd 3rd 4th




Lab * CC-17-01 CC-17-02 CC-17-03 Lab CC-17-04 CC-17-05 CC-17-06 Lab CC-17-07 CC-17-08 CC-17-09 Lab CC-17-10 CC-17-11 CC-17-12
Alanine aminotransferase 1,415 1,420 1,585 1,569
 Enzymatic, colorimetric (Vitros) 10 7.3 7.4 13.7 10 7.1 10.4 1.3 11 18.0 11.6 0.5 11 7.5 1.0 1.0
 Other method 104 7.9 12.8 8.6 96 9.5 19.4 7.0 96 6.7 6.8 6.9 95 7.4 7.1 7.2
 UV with P5P 11 5.4 18.1 10.4 12 10.5 27.2 8.6 15 14.9 12.3 3.3 15 12.0 4.0 3.9
 UV without P5P 1,290 5.8 10.3 6.9 1,302 6.6 12.8 5.7 1,463 6.5 6.4 5.7 1,448 6.7 6.1 6.1
Albumin 1,302 1,305 1,463 1,447
 Dye binding (BCG) 1,206 5.2 5.4 3.9 1,218 3.8 5.6 5.2 1,382 5.0 4.9 5.1 1,366 4.9 5.7 5.1
 Dye binding (BCP) 11 7.9 7.3 2.6 10 2.1 5.5 5.3 9 2.9 4.7 6.9 10 5.1 3.1 5.0
 Other method 85 4.5 5.5 3.9 77 3.8 6.1 5.2 72 4.7 4.8 6.4 71 5.0 6.0 6.7
Alkaline phosphatase 1,240 1,244 1,401 1,389
 Other method 111 51.2 57.2 52.8 109 45.1 61.9 40.9 119 43.9 43.6 38.8 116 44.8 40.9 38.4
 PNPP (AMP buffer) 658 23.1 17.2 21.7 660 16.7 23.2 18.1 756 14.2 14.2 17.2 755 14.9 17.5 17.0
 PNPP (DEA buffer) 140 11.4 18.8 10.5 143 12.1 20.5 12.2 147 12.2 12.0 9.6 149 14.5 11.6 12.4
 PNPP (EAE buffer) 331 6.4 8.4 6.0 332 5.4 15.6 5.6 379 5.8 5.8 4.9 369 6.7 5.3 4.8
Amylase 733 733 798 788
 Hydrolysis of 2-chloro-p-nitrophenyl-α-D-maltotrioside (CNP-G3) 227 4.4 5.7 4.3 227 8.1 9.7 8.3 241 5.5 6.7 4.3 241 5.0 5.1 4.7
 Hydrolysis of 4,6-ethylidene-4-nitrophenyl (4-NP)-maltohetaose (G7) substrate 264 3.2 12.6 3.3 264 2.5 7.5 3.5 283 3.1 2.1 3.3 273 2.5 3.6 3.2
 Hydrolysis of 4-nitrophenyl (4-NP)-maltohetaose (G7) substrate 4 7.4 11.3 4.0 3 1.0 7.7 1.1 5 2.0 2.5 1.9 6 5.9 4.9 1.0
 Other method 238 21.9 13.7 18.0 239 17.6 12.2 22.5 269 13.0 13.6 20.0 268 13.2 20.2 20.1
Aspartate aminotransferase 1,414 1,419 1,584 1,568
 Enzymatic, colorimetric (Vitros) 10 9.3 4.4 5.9 10 4.7 6.0 2.9 11 2.5 3.6 0.7 11 4.2 2.7 2.7
 Other method 100 6.8 12.7 8.6 92 8.3 13.3 6.7 91 4.9 5.4 5.0 90 6.9 5.6 6.2
 UV with P5P 11 11.3 21.8 18.2 12 18.7 24.8 6.4 15 5.0 3.1 2.5 15 3.3 5.5 5.1
 UV without P5P 1,293 5.2 5.5 6.6 1,305 6.4 9.1 5.3 1,467 5.4 5.2 4.3 1,452 5.5 4.7 4.5
Bilirubin (direct) 723 723 783 773
 Colorimetric test (DCA/DPD) 18 11.4 10.6 10.0 17 12.6 3.7 9.5 14 12.3 12.9 12.1 15 4.5 13.3 13.7
 Diazonium salt/diazonium ion with blank 248 12.1 9.2 4.7 251 4.3 9.4 14.3 278 22.7 19.5 3.8 278 18.3 5.0 6.3
 Enzymatic bilirubin oxidase 14 10.4 15.7 16.2 15 9.6 2.2 15.7 17 18.5 18.2 14.1 17 2.7 15.1 13.3
 Evelyn-Malloy method with blank 19 34.6 32.5 15.9 18 13.4 27.5 17.5 24 32.5 35.8 17.5 22 28.9 14.6 14.5
 Evelyn-Malloy method without blank 11 21.3 13.4 26.3 9 22.2 30.1 33.4 10 16.4 14.9 24.4 10 16.6 14.6 16.3
 Jendrassik-Grof method with blank 3 13.4 11.2 17.3 3 20.8 28.7 18.7 3 22.8 27.3 17.7 3 27.5 14.5 19.4
 Other method 93 27.8 31.3 20.2 87 14.1 21.7 25.6 80 23.8 21.1 36.7 76 5.7 38.0 35.4
 Other method (modified Jendrassik-Groff using surfactant as an accelerator) 4 49.9 72.1 69.2 5 25.7 33.7 31.5 8 21.3 36.1 34.7 10 19.3 28.6 14.4
 Oxidation 23 9.0 12.2 0.7 24 7.0 0.0 3.2 26 0.0 2.5 4.2 26 19.8 5.4 6.9
 Oxidation direct bilirubin 5 6.1 22.2 8.9 3 17.3 15.7 14.4 5 39.1 39.1 0.0 5 22.8 6.7 6.7
 Vanadate oxidation 285 11.9 14.0 10.9 291 8.9 4.3 7.0 318 14.3 12.7 13.1 311 3.5 11.2 13.2
Bilirubin (total) 1,305 1,308 1,467 1,451
 Colorimetric test (DCA/DPD) 37 8.1 11.2 9.9 39 6.8 5.9 6.9 42 6.7 5.7 6.2 42 7.5 6.7 5.7
 Diazo-dimethyl sulfoxide with blank 57 8.1 15.5 18.8 62 14.3 15.3 6.1 72 6.3 7.9 5.1 76 10.7 4.8 5.3
 Diazonium salt/diazonium ion with blank 374 5.7 7.7 8.2 374 6.8 9.8 5.5 405 10.1 11.4 6.3 404 12.8 6.0 6.3
 Diazonium salt/diazonium ion without blank 29 8.9 10.0 11.3 33 7.4 11.8 8.1 38 13.8 18.0 13.8 38 14.4 10.8 10.6
 Diazonium salt-dyphylline (Vitros) 10 3.0 12.9 12.0 9 7.1 21.4 2.9 11 10.6 13.6 6.0 11 10.2 5.2 5.6
 Enzymatic bilirubin oxidase 25 4.6 6.3 4.3 27 5.5 1.7 5.2 30 9.6 8.0 5.9 30 11.1 5.4 5.5
 Evelyn-Malloy method with blank 53 8.6 11.3 9.4 50 8.2 8.7 9.8 61 10.7 9.5 6.6 57 9.6 7.6 7.5
 Evelyn-Malloy method without blank 74 7.8 15.5 14.3 72 12.1 13.9 8.5 97 12.5 17.7 6.8 94 16.6 5.5 6.3
 Jendrassik-Grof method with blank 7 2.3 13.6 0.0 7 2.0 12.5 8.2 9 3.2 6.8 10.4 9 14.8 10.6 11.9
 Other method 88 10.3 9.8 12.2 81 10.0 12.3 7.4 78 16.7 14.3 8.6 77 17.3 9.6 8.7
 Oxidation 89 4.8 4.3 4.5 86 4.7 1.1 4.5 76 10.6 10.7 6.7 77 12.3 7.2 7.0
 Vanadate oxidation 459 5.7 6.1 7.6 465 5.7 4.8 5.3 546 5.5 4.3 4.8 534 5.8 4.8 4.4
Calcium 661 663 712 702
 Arsenazo III dye 106 3.0 5.3 2.6 111 3.0 4.6 3.1 137 3.5 2.9 3.2 132 3.6 3.2 3.1
 Cresolphthalein complexone 406 2.3 3.4 2.6 405 1.7 3.0 1.9 416 3.7 3.0 2.5 412 3.7 2.7 2.9
 Mmethylxylenol blue method 18 1.5 3.5 3.3 18 1.4 2.7 1.5 20 2.4 2.0 1.3 19 1.7 2.0 1.4
 NM-BAPTA 109 1.2 1.9 1.5 109 1.5 1.8 1.2 118 0.9 1.3 1.2 119 1.0 1.1 0.7
 Other method 20 2.7 5.6 6.5 18 6.5 7.4 5.2 20 6.4 5.0 3.5 19 4.4 4.7 3.2
Chloride 876 878 986 977
 ISE, diluted (indirect) 506 1.7 3.4 2.4 509 2.4 3.6 1.7 534 3.6 2.8 2.0 534 2.8 2.0 2.2
 ISE, undiluted (direct) 332 2.0 2.6 2.2 331 2.2 2.7 1.8 409 2.4 2.2 2.6 402 2.3 2.7 2.6
 Other method 38 2.4 3.6 2.5 38 2.8 3.0 2.2 43 3.1 1.7 2.1 41 2.5 2.9 2.5
Cholesterol (total) 1,407 1,411 1,572 1,557
 Enzymatic 1,299 2.6 3.1 2.9 1,313 2.7 3.2 2.9 1,473 3.0 2.8 4.9 1,459 2.9 5.2 4.9
 Other method 108 3.5 4.0 3.7 98 3.8 3.1 3.6 99 3.3 3.2 4.5 98 3.9 5.2 4.9
Creatine kinase 622 614 654 652
 Other method 57 9.0 8.8 6.2 52 7.4 8.1 7.2 52 4.5 4.9 4.8 54 6.4 5.9 5.5
 Reverse (CrP→Cr) reaction 257 4.2 5.0 5.4 252 4.4 4.7 4.1 266 4.2 4.1 3.1 265 4.1 3.2 3.1
 Reverse (CrP→Cr) reaction with cofactor 308 6.2 5.8 6.5 310 6.4 6.0 6.2 336 4.3 3.9 5.8 333 4.1 5.9 6.0
Creatinine 1,353 1,358 1,524 1,514
 Compensated kinetic Jaffe method 148 3.8 15.0 5.8 166 4.2 13.2 4.1 315 12.2 10.3 6.7 320 7.9 6.8 6.2
 Enzymatic method 50 3.2 9.0 4.5 57 4.9 7.5 3.9 63 35.3 15.4 5.2 60 12.0 4.9 5.1
 Kinetic Jaffe method 845 5.6 9.2 7.3 833 6.7 6.9 5.9 819 10.1 6.7 7.0 808 6.7 7.1 6.9
 Other method 96 11.5 12.1 12.7 86 9.3 14.6 7.8 87 11.0 11.4 10.8 85 14.0 11.1 12.0
 Rate blanked compensated kinetic Jaffe method 214 3.6 6.9 4.8 216 3.8 5.2 3.5 240 6.2 5.5 3.9 241 5.7 3.8 4.3
Gamma-glutamyl transferase 1,385 1,388 1,540 1,525
 G-glutamyl-carboxy-nitroanilide (IFCC) 872 5.0 9.5 5.4 883 5.3 9.2 5.1 962 7.3 7.3 7.6 959 7.8 8.0 8.1
 G-glutamyl-carboxy-nitroanilide (JSCC) 270 2.9 6.0 3.3 277 3.0 5.1 2.6 320 2.2 1.5 2.1 314 2.6 2.2 2.2
 G-glutamyl-p-nitroanilide 13 1.5 13.8 5.5 11 4.5 5.1 4.7 22 8.4 3.7 6.1 21 8.6 7.2 6.1
 G-glutamyl-p-nitroanilide (dry chemistry) 80 6.2 9.6 6.2 81 5.8 7.7 6.3 97 7.4 7.7 7.1 96 7.1 7.2 6.9
 Other method 150 7.7 11.8 8.0 136 7.2 11.9 6.9 139 8.6 7.4 7.0 135 7.0 6.9 7.1
Glucose 1,399 1,403 1,561 1,544
 Glucose oxidase 323 3.6 4.8 4.1 328 4.7 5.6 4.3 383 5.0 5.0 4.2 379 5.0 4.3 4.4
 Hexokinase 975 2.7 2.1 2.9 983 2.7 2.3 2.5 1,087 3.2 2.8 2.6 1,076 3.1 2.8 2.9
 Other method 101 4.7 6.3 5.0 92 4.7 6.1 4.8 91 4.3 5.0 4.4 89 3.9 3.8 3.8
High density lipoprotein cholesterol 1,308 1,309 1,447 1,432
 Beckman AU HDL direct method 164 3.9 3.2 3.1 165 4.0 3.7 3.9 175 3.6 3.2 5.6 175 3.8 5.6 3.5
 Denka HDL direct method 6 15.5 28.2 4.2 4 5.3 9.4 8.3 4 11.7 9.0 8.9 5 4.9 7.9 6.8
 Direct method (other company) 350 22.9 28.2 15.1 360 16.6 32.4 23.7 424 14.3 12.9 12.6 423 12.6 12.8 11.9
 Kyowa HDL direct method 76 3.3 4.4 4.5 77 5.4 5.4 5.8 76 5.9 4.4 6.6 75 4.1 7.9 6.9
 Other method 107 24.9 29.8 13.3 96 10.2 26.6 22.1 97 14.8 12.6 13.3 94 12.3 13.8 14.5
 Roche HDL direct method 216 5.2 3.4 3.9 216 3.6 2.8 6.0 232 3.8 3.6 3.2 232 3.6 3.5 3.6
 Sekisui HDL direct method 297 4.1 4.0 3.4 302 3.6 4.5 4.3 337 2.8 3.7 2.9 330 4.2 4.5 3.0
 Siemens Advia direct HDL method 38 2.8 4.6 3.3 37 4.3 6.2 5.6 42 4.4 3.2 0.0 42 3.8 3.4 3.4
 Siemens HDL direct method 5 1.7 5.5 5.4 5 7.5 7.3 6.5 5 12.0 12.3 14.8 5 9.1 8.7 8.5
 Wako HDL direct method 48 7.9 6.5 6.7 46 6.9 8.4 9.2 54 9.6 10.5 6.2 50 8.7 7.1 7.8
Iron 388 393 408 406
 Bathophenanthroline without deproteinization 130 2.2 2.0 2.0 136 1.5 1.8 1.2 136 1.2 1.3 2.3 134 1.5 2.2 2.7
 Ferrachrome/ferrozine without deproteinization 139 3.6 2.9 3.4 133 3.0 3.1 3.3 141 2.6 2.2 3.4 138 2.0 2.4 2.7
 Nitroso-PSAP without deproteinization 34 1.8 1.7 2.2 35 2.2 2.2 1.8 36 1.3 0.8 1.3 35 1.2 2.5 1.5
 Other method 12 3.2 5.8 4.4 12 3.9 3.1 4.1 14 6.7 5.5 6.0 16 3.7 6.2 7.6
 Tripyridyltriazine-without prior protein removal 69 1.5 2.0 2.2 73 1.7 2.2 1.5 77 1.2 1.2 2.8 79 1.2 2.2 2.5
Lactate dehydrogenase 830 824 886 878
 Dinitrophenyl hydrazine (DNPH) 4 20.9 11.2 13.9 4 0.9 1.3 1.6 5 3.8 3.8 3.5 5 4.8 4.6 5.0
 Lactate to pyruvate 399 3.9 5.3 4.2 395 6.8 7.3 6.6 446 5.0 5.6 5.6 435 5.1 5.7 5.6
 Other method 47 36.2 36.6 33.0 44 35.2 35.3 34.8 46 30.0 31.3 32.1 49 31.5 34.3 34.5
 Pyruvate to lactate 375 9.1 8.1 7.9 376 7.7 7.0 9.0 383 6.9 6.5 6.7 383 7.1 6.9 6.9
 Pyruvate to lactate (dry chemistry) 5 2.3 3.0 2.0 5 2.5 8.3 1.1 6 2.0 1.3 0.8 6 4.6 2.4 1.8
Lipase 394 392 406 400
 Hydrolysis of 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6’-methylresorufin) ester 271 6.3 11.8 6.0 268 8.7 9.7 9.0 275 7.7 5.1 11.2 266 6.8 10.0 8.7
 Hydrolysis of 1-oleoyl-2,3-diacetyl glycerol 10 3.3 4.2 4.4 10 3.0 3.0 6.4 10 2.5 3.6 3.1 10 3.5 2.7 0.0
 Other method 40 15.3 33.5 16.8 42 15.0 22.8 14.5 43 9.4 7.7 12.4 45 12.2 15.9 15.7
 Spectrophotometric method with triglyceride 68 3.6 7.1 3.9 67 4.3 3.9 2.9 74 1.4 2.0 2.0 75 3.5 2.4 2.6
Low density lipoprotein cholesterol 833 829 903 890
 Beckman AU LDL direct method 105 7.1 8.8 6.6 104 6.7 9.7 8.8 111 6.5 6.8 6.8 112 6.7 6.9 7.3
 Direct method (other company) 157 25.9 34.3 14.5 161 14.7 36.2 23.2 190 9.2 9.3 10.9 190 9.7 10.9 10.3
 Kyowa LDL direct method 66 2.7 5.4 3.0 67 2.6 6.2 2.9 65 2.2 1.5 2.9 64 2.2 2.7 2.5
 Other method 49 32.3 50.2 16.9 43 15.3 51.5 26.1 45 11.7 11.5 12.3 40 10.4 13.9 12.2
 Roche LDL direct method 169 4.8 9.7 3.5 168 2.5 8.2 4.3 175 4.2 4.8 4.8 173 5.4 4.7 4.5
 Sekisui LDL direct method 204 4.1 7.6 3.3 207 3.1 8.7 3.5 232 2.6 2.8 3.5 227 2.8 3.2 3.0
 Siemens Advia direct LDL method 38 2.0 4.7 1.7 37 3.7 5.6 3.8 41 2.8 3.2 3.1 41 2.3 3.1 3.9
 Siemens LDL direct method 4 6.9 7.8 4.0 4 2.6 7.7 3.9 4 5.0 3.5 3.5 4 6.7 6.1 4.3
 Wako LDL direct method 38 8.6 6.7 8.6 35 6.3 7.7 6.9 38 5.1 5.0 3.0 36 5.8 6.3 6.9
Magnesium 267 272 283 282
 Colorimetrc test-xylidyl blue 28 2.3 0.0 2.9 27 3.3 4.9 2.1 27 3.4 3.1 2.3 28 3.1 1.7 1.9
 Colorimetric-Vitros Chemistry Systems 4 3.8 4.6 2.5 4 0.0 5.8 2.2 4 7.1 5.9 0.0 4 3.5 2.3 2.3
 Colorimetric (dye-xylidyl blue/magon) 226 2.2 5.2 3.5 232 3.2 4.6 2.3 242 3.9 3.8 3.4 240 4.0 2.2 2.6
 Other method 5 3.6 11.6 1.9 5 2.2 3.6 6.3 6 8.1 8.3 5.8 6 4.3 6.5 7.9
Osmolality 129 135 143 143
 Freezing point depression osmometer 114 1.2 1.5 1.6 120 1.3 1.2 1.4 128 1.6 1.3 1.1 127 1.3 1.3 1.3
 Other method 15 1.2 1.5 1.7 15 0.8 1.2 1.0 15 1.6 1.4 1.1 16 1.8 1.4 1.3
Phosphorus 617 617 664 658
 Other method 20 3.5 5.1 5.9 20 5.1 8.9 4.7 22 4.3 4.3 2.8 22 3.6 3.5 2.9
 Phosphomolybdate with any reduction method 126 3.7 6.0 3.5 128 3.0 5.8 2.7 136 2.3 2.2 2.0 137 2.0 1.8 1.2
 Phosphomolybdate (UV) 470 3.0 5.2 3.0 468 2.0 4.6 2.5 505 2.5 2.3 2.2 498 2.4 2.3 2.3
Potassium 888 891 999 990
 ISE, diluted (indirect) 509 1.7 2.9 1.8 513 1.6 3.1 1.3 537 1.7 1.8 1.5 537 1.8 1.7 1.5
 ISE, undiluted (direct) 341 2.5 5.4 2.2 340 2.1 4.2 2.7 419 2.0 2.2 2.5 412 2.6 2.6 2.2
 Other method 38 3.1 4.2 3.3 38 2.8 6.1 2.5 43 2.0 1.9 2.2 41 2.1 2.8 2.5
 Protein (total) 1,284 1,290 1,447 1,429
 Biuret method 1,195 3.4 3.3 3.1 1,210 2.3 2.2 3.3 1,371 2.8 3.2 3.7 1,355 3.2 4.1 3.7
 Other method 89 5.3 4.2 4.7 80 4.5 3.7 5.9 76 4.9 5.4 5.4 74 5.0 4.9 6.2
Sodium 888 890 999 990
 ISE, diluted (indirect) 455 1.1 1.3 1.2 465 0.7 0.8 1.0 490 1.0 1.0 1.2 492 1.2 1.1 1.2
 ISE, undiluted (direct) 391 1.9 2.0 1.9 384 1.7 2.1 1.8 464 1.4 1.4 1.4 454 1.3 1.7 1.7
 Other method 42 2.3 1.7 1.6 41 1.4 2.0 2.1 45 1.2 1.6 1.7 44 1.6 1.7 2.0
Total CO2 177 185 199 199
 ISE, diluted (indirect) 5 15.0 20.9 16.8 4 22.2 23.7 16.7 2 3.8 2.8 6.4 2 3.3 6.1 1.0
 Other method 13 9.7 13.5 10.1 12 9.9 11.6 7.5 13 9.2 7.4 9.8 13 12.4 12.2 12.7
 Phosphoenolpyruvate carboxylase (PEPC) 159 6.5 8.1 6.7 169 9.1 9.3 7.5 184 5.7 5.3 5.5 184 5.7 5.3 5.2
Total iron-binding capacity 350 356 371 369
 Bathophenanthroline 113 2.3 3.1 2.7 118 2.9 3.5 2.6 122 1.7 1.9 3.0 120 2.1 2.8 2.8
 Chromazural B 20 1.5 2.2 1.9 18 3.5 2.3 2.9 19 4.3 3.7 2.7 19 2.8 4.0 3.9
 Ferrachrome/ferrozine 103 2.8 5.4 3.5 100 2.9 4.3 3.0 105 2.9 2.8 3.8 102 3.2 3.1 3.4
 Nitroso-PSAP 88 1.8 2.6 2.2 93 2.6 3.5 2.3 98 2.4 2.3 2.4 99 2.4 1.8 2.0
 Other method 25 7.5 9.1 8.9 26 6.3 8.9 5.0 25 5.1 4.6 7.7 27 4.2 3.4 4.2
Triglyceride 1,379 1381 1,531 1,516
 Enzymatic (glycerol phosphate oxidase) with glycerol blank 452 4.7 21.8 5.5 454 4.8 23.1 6.8 489 2.9 2.8 3.3 477 3.0 3.2 3.1
 Enzymatic (glycerol phosphate oxidase) without glycerol blank 821 4.6 12.6 4.2 830 4.5 11.6 4.3 947 4.2 4.2 6.4 946 4.5 7.1 6.4
 Other method 106 38.2 47.8 26.4 97 28.2 58.3 47.4 95 5.4 5.7 6.6 93 6.1 7.0 6.6
Urea nitrogen 1,350 1,349 1,511 1,497
 Conductivity rate method 4 3.1 0.9 3.2 3 1.4 9.7 2.3 2 7.9 3.6 0.6 2 6.5 0.5 1.7
 Enzymatic UV test (urease-GLDH) 67 7.8 6.6 5.3 67 5.0 8.6 4.3 74 5.8 6.7 5.5 73 7.2 6.8 6.1
 Other method 95 6.7 11.5 6.2 86 5.2 7.9 7.8 83 6.3 5.9 6.0 82 8.0 7.0 5.7
 Urease quinolinium dye (Vitros) 9 1.3 0.0 4.3 9 2.2 1.9 1.9 9 2.1 2.3 0.5 9 2.9 1.2 2.1
 Urease with GLDH (coupled enzymes) 1,172 5.0 4.1 4.2 1,180 4.0 5.4 5.5 1,336 5.2 4.7 4.2 1,324 5.6 5.5 4.8
 Urease-indophenol (Berthelot) 3 0.5 6.9 1.8 4 1.9 0.7 0.8 7 4.7 6.5 5.6 7 1.1 4.1 4.1
Uric acid 1,103 1,098 1,201 1,191
 Other method 71 5.6 7.2 5.8 67 6.9 7.5 5.5 73 5.5 4.8 4.8 71 4.8 3.0 4.6
 Uricase 1,025 4.5 7.2 4.6 1,024 4.2 5.8 4.4 1,122 3.9 4.0 3.7 1,114 4.0 4.1 3.6
 Uricase (Vitros) 7 1.5 0.0 0.0 7 4.3 2.8 4.6 6 2.0 3.0 2.0 6 2.7 2.9 1.8

Abbreviations: UV, ultra violet; 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; CNP, C-type natriuretic peptide; DCA, deoxycholic acid; DPD, 2,5-dichlorophenyl diazonium; NM-BAPTA, 5-nitro-5’-methyl-(1,2-bis(o-aminophenoxy)ethan-N,N,N’,N’-tetraacetic acid; ISE, ion-selective electrodes; CrP, creatine phosphate; Cr, creatine; IFCC, International Federation of Clinical Chemistry; JSCC, Japanese Society for Clinical Chemistry; HDL, high-density lipoprotein; nitroso-PSAP, 2-nitroso-5-(N-propyl-N-sulfopropylamino)-phenol; LDL, low-density lipoprotein; GLDH, glutamate dehydrogenase.

Table 8

Distribution of analytical methods (principle) participated and coefficients of variation (%) according to urine chemistry principles in 2017

   Items/methods Trials

1st 2nd


Lab * CUC-17-01 CUC-17-02 CUC-17-03 Lab CUC-17-04 CUC-17-05 CUC-17-06
Albumin 123 134
 Immunoturbidimetry 114 34.1 36.6 22.7 123 43.8 21.9 22.1
 Other method 6 50.3 54.7 27.9 7 53.0 35.4 37.8
Calcium 117 130
 Arsenazo III dye 12 3.7 3.7 2.9 16 4.4 3.2 2.7
 Cresolphthalein complexone 66 3.5 3.3 2.5 74 2.1 2.4 2.3
 NM-BAPTA 34 2.2 3.2 1.9 36 2.5 2.1 1.6
Chloride 131 147
 ISE, diluted (indirect) 128 8.1 9.4 3.2 144 8.7 2.7 2.8
 Other method 3 6.5 7.5 1.2 3 0.2 3.3 2.7
Creatinine 142 160
 Compensated kinetic Jaffe method 37 2.7 3.8 3.1 41 3.7 2.8 3.7
 Enzymatic method 7 3.0 2.3 4.2 9 5.1 5.5 3.9
 Kinetic Jaffe method 38 4.7 3.4 5.0 45 5.2 4.6 5.3
 Rate blanked compensated kinetic Jaffe method 59 2.7 3.6 3.4 64 2.9 3.2 2.5
Glucose 111 122
 Hexokinase 109 3.1 3.4 2.4 121 3.7 2.4 2.7
Magnesium 96 100
 Colorimetrc test-xylidyl blue 9 8.1 7.4 7.1 9 3.6 8.4 11.5
 Colorimetric (dye-xylidyl blue/magon) 86 3.4 4.2 6.2 89 3.2 5.1 4.7
Phosphorus 113 121
 Phosphomolybdate (UV) 112 3.0 3.1 3.8 119 2.8 2.7 2.9
Potassium 132 148
 ISE, diluted (indirect) 129 2.3 2.7 4.2 145 2.4 4.0 4.3
Protein 129 143
 Biuret method 6 12.1 10.4 9.2 6 8.9 6.7 4.7
 Dye binding using pyrogallol red 71 16.7 16.5 10.6 80 15.1 9.8 10.9
 Turbidimetry using benzethonium chloride 50 5.7 6.9 5.0 55 5.6 4.0 4.0
Sodium 132 149
 ISE, diluted (indirect) 129 2.5 2.5 1.2 146 2.4 1.2 1.2
Urea nitrogen 121 135
 Enzymatic UV test (urease-GLDH) 7 2.0 2.5 8.0 10 5.8 4.3 3.8
 Urease with GLDH (coupled enzymes) 114 3.4 3.2 3.3 125 3.4 3.3 3.3
Uric acid 116 126
 Uricase 114 4.8 5.6 4.3 125 4.6 3.7 3.6

Abbreviations: NM-BAPTA, 5-nitro-5’-methyl-(1,2-bis(o-aminophenoxy)ethan-N,N,N’,N’-tetraacetic acid; ISE, ion-selective electrodes; UV, ultra violet; GLDH, glutamate dehydrogenase.