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1 임상검사와정도관리 : 제 28 권제 1 호 2006 J Lab Med Qual Assur 2006:28:1-9 1 임상화학검사신빙도조사결과보고 (2005) 민원기 ( 집필대표 ) 고창하 김경동 김영기 김정호 김진규 김태진박일규 박준석 안광섭 이도훈 이수연 전사일 한태진 홍기숙 대한임상검사정도관리협회임상화학분과위원회 Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2005) Won Ki Min, Changha Ko, Kyung-Dong Kim, Young-Kee Kim, Jeong-Ho Kim, Jin Q Kim, Tae Jin Kim, Ile-Kyu Park, Joonseok Park, Kwang Sup Ahn, Do-Hoon Lee, Soo-Youn Lee, Sail Chun, Tae-Jin Han, and Kisook Hong Clinical Chemistry Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratory, Seoul, Korea Ten trials of external quality assessment for Clinical Chemistry in general chemistry and blood gas were performed in All the control materials were sent in specifically-made boxes at the same time. The response rates were 90.1% in general chemistry and 84.8% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and ph, pco 2 and po 2 in blood gas. Compared with the previous year (2004), the methods of analysis were changed and the coefficient of variation and VIS scores of general chemistry items were increased. Key Words:External quality assessment, Clinical chemistry 교신저자 : 민원기우 ) 서울시송파구풍납동 울산의대서울아산병원진단검사의학과전화 :02) , FAX:02) wkmin@amc.seoul.kr 서 임상화학분과위원회에서는 2005 년도에일반화학검사는 12회, 혈액가스검사는 6회를시행하였다. 정도관리물질의배송은일반화학 12종, 혈액가스 6종을특수제작한용기에넣어발송하였다. 매회차마다측정항목별및 peer group( 측정원리가동일한기관묶음 ) 별로평균, 표준편차, 변이계수및 VIS 와산포도, 장비군별성적등을보고하였다. 재료및방법 일반화학관리물질은 BioRad (Lyphochek L1, L2), 론 Randox (Assayed L2, L3, Precision L2, L3), Roche (Precinorm PNU, Precipath PPU) 사의인혈청기본의제품을사용하였고, 혈액가스관리물질은 BioRad (Liquichek, Level 1, 2, 3) 사의제품을사용하였다 (Table 1). 검사종목은일반화학검사중전해질, 단백, 지방, 효소검사등 19종목과혈액가스검사 ph, pco 2, po 2 등총 22종목으로전년도와동일하였다. 검체의발송은검사실시약한달전에 12회분을일반화학 556 개기관, 혈액가스 313기관에동시에발송하였고, 4월에 2기관, 7월에 20기관추가로발송하였다. 미리정해진검사시행일로부터 1주이내에결과를회송하도록하였다. 결과분석은평균, 표준편차, 변이계수, 항목별 VIS 및동일방법에속한 peer group 별 VIS 등과검사치의도수분포표를보고하였다. VIS 계산에는 ±2 표준편차이상의값들은제외하고재계산하여표준값으로하였다.

2 2 민원기 고창하 김경동 김영기 김정호 김진규외 결과 2005 년도에일반화학의경우총 578 개기관에관리물질을발송하여평균회신율이 90.1% 로 2004 년도의 92.0% 보다감소하였다. 혈액가스의경우는총 319 개기관에관리물질을발송하였는데, 평균회신율이 84.8% 로 2004 년도의 86.0% 보다낮아졌다 (Table 1). 각회차별로각검사항목의회신율은 Table 2에정리하였다. 전회모두응답한기관은일반화학의경우전체의 79.6%, 혈액가스의경우는 78.6% 이었고, 4회이하로응답한기관은일반화학의경우 7.4%, 혈액가스의경우 21.1% 이었다 (Table 3). 각검사항목별로한번이상응답한기관의수는 Table 4에정리하였다. 각검사항목별측정방법의분포를살펴보면 (Table 5), sodium/potassium 에서 flame photometry 방법이전년도의 0.9% 에비해 0.7% 로감소하였고 indirect ISE 방법이전년도의 40.6% 에서 45.4% 로증가하였다. Glucose 의측정방법에서 hexokinase 법이전년도의 66.2% 에서 75.8% 로증가하였고, ALP 측정방법에서 GSCC 법이전년도와같이 39.7% 를차지하였다. LD 측정방법에서는 pyruvate to lactate 법이전년도의 62.0% 에비해 68.4% 로증가하였다. 변이계수는항목별 (Table 6-1) 로표시하였는데전년도의결과와비교할때 sodium, chloride, BUN, glucose, total calcium, phosphorus, uric acid, creatinine, total bilirubin, albumin, total cholesterol, triglyceride, AST는증가하였고나머지는감소하였다 (Table 7). 측정원리별변이계수는 Table 6-2 에정리하였다. VIS 는전년도와달리항목별로분석하였는데측정원리별로분석한전년도와비교해보면 ALP 와 LD 를제외하고모두높아졌다 (Table 9). Peer group VIS 분포에따른기관수는 100 이하가 79.93% 였다 (Table 10). 고찰관리물질의배송에있어서는당해연도초에일괄적으로보내고그후추가로가입하는기관에물질을발송하고있어회차마다물질을보낸기관수가약간씩다르게된다. 그에따라응답율도회차마다달라지므로매회차의응답률을계산하여평균을내었다. 일반화학의경우총 578 개기관에물질을발송하여평균응답률이 90.1% 로전년도의 92.0% 보다감소하였고, 혈액가스의경우는총 319 개기관에물질을발송하여평균 84.8% 의응답률을보여전년도의 86.0% 보다낮아졌다 (Table 1). 연간 10회중한번도보고하지않은기관은일반화학 6.7%(39기관 ), 혈액가스의경우 11.0%(35 기관 ) 로작년에비해일반화학의비율은감소하였고혈액가스는증가하였다 (Table 3). 측정방법에있어서는 sodium 및 potassium 의경우는 indirect ISE 법이작년보다증가하여 45.4% 이었고, chloride 는 ISE법이 98.7% 에이르렀다. 전체적으로전년도와큰차이는없지만, glucose 의측정방법에서 hexokinase 법이증가하였고, LD 측정방법에서 pyruvate to lactate 법이증가하였으며 GGT 측정방법에서 IFCC 법이증가하였다 (Table 5). 측정방법에서한가지원리가전체의 90% 를넘는항목을살펴보면 BUN 은 urease with glutamate dehydrogenase법이 93.4%, calcium은 OCPC 법이 95.8%, uric acid 는 uricase 를이용한 colorimetry 법이 98.8%, protein 은 Biuret 법이 99.6%, albumin 은 BCG 법이 97.3%, cholesterol 은 enzymatic colorimetry 법이 99.4%, AST, ALT 는 UV -P5P 법이 93.1%, 로작년보다다소증가하였다 (Table 5). 각검사항목별로변이계수의추이가전년도에비해증가하여정밀도가다소떨어졌음을보여주었다 (Table 7). 각검사항목별로측정원리에따른변동이적은측정법은전해질은 indirect ISE 법, BUN 은 urease quinolinium dye법, glucose는 GOD, POD, colorimetry법, bilirubin 은 bilirubin oxidase 법, AST는 enzymatic colorimetry 법, alkaline phosphatase는 GSCC 법, LD는 dry chemistry 법등으로작년에비해 glucose, AST 가다른결과를보였다 (Table 6-2). VIS 점수는전년도에비해증가하였는데이는점수산출법이전년도와달라진데일부기인하는것으로판단되었다 (Table 8, 9). Peer group 에의한 VIS 분포를보면 50점이하의기관이 34.4% 로전년도의 34.6% 에비해별변화가없었고, 100 점이하의기관은전체의 79.9% 로전년도의 81.4% 에비해감소되었음이발견되었다 (Table 10). 요약 2005 년에는일반화학 578 개기관및혈액가스 319 개기관을대상으로일반화학 19종목, 혈액가스 3종목에대하여 4월부터 10월까지일반화학 12회, 혈액가스 6회에걸쳐서외부정도관리를시행하여그성적을종합하였다. 4월부터 2기관, 7월부터 20기관이추가되었다. 관리물질은상자속에넣어 1년분을한번에발송하였다. 응답률은일반화학 90.1%, 혈액가스 84.8% 로감소하였으며, 측정방법의분포는전년도와비교할때 glucose 에서 hexokinase 법, LD에서 pyruvate to lactate 법이증가하였다. 대부분검사항목에서측정의변이계수는증가하였고 VIS 치는전년도에비해새로운계산법을적용하여증가된수준이었다. VIS 100 이하가 79.9% 로전년도에비해증가하였다.

3 임상화학검사신빙도조사결과보고 (2005) 3 참고문헌 1. 민원기김경동, 김상섭, 김상철, 김영기, 김정호, 김종원, 김진규, 김태진, 박일규, 안광섭, 이수연, 전사일, 정하승, 한태진, 홍기숙. 임상화학검사신빙도조사결과보고 (20 04). 임상검사와정도관리 2005;27:1-10. Table 1. Chemistry Control Materials distributed and QC schedule in 2005 Trial Product name Maker Lot No. Test date Resp. rate(%) CC Lyphochek L1 BioRad /556(92.6) CC Lyphochek L2 BioRad /556(92.6) CC Precision L3 Randox 187UE/ /556(92.8) CC Lyphochek L1 BioRad /558(91.2) CC Precision L2 Randox 360UN/ /558(91.0) CC Assayed L3 Randox 190UE/ /558(91.0) CC Precinorm PNU Roche /578(90.0) CC Lyphochek L2 BioRad /578(90.1) CC Precipath PPU Roche /578(90.1) CC Lyphochek L1 BioRad /578(86.7) CC Assayed L2 Randox 336UN/ /578(86.7) CC Precipath PPU Roche /578(86.7) CG Liquichek L1 BioRad /313(85.9) CG Liquichek L2 BioRad /313(87.9) CG Liquichek L3 BioRad /313(87.2) CG Liquichek L2 BioRad /319(82.8) CG Liquichek L3 BioRad /319(82.4) CG Liquichek L1 BioRad /319(82.8) Table 2. Number of responded laboratories according to each item in 2005 Item\Trial Sodium Potassium Chloride BUN Glucose T.calcium Phosphorus Uric Acid Creatinine T.bilirubin T.protein Albumin T.cholesterol Triglycerides AST ALT ALP LD GGT PCO PH PO

4 4 민원기 고창하 김경동 김영기 김정호 김진규외 Table 3. Number of Reporting Times in Clinical Chemistry in 2005 Report times General chemistry Blood gas Lab. Rate(%) Lab. Rate(%) Sum Table 4. Number of laboratories responding to more than one trial in 2005 Item No. Item No. Item No. Sodium 399 Potassium 399 Chloride 388 BUN 527 Glucose 509 Calcium 358 Phosphorus 339 Uric Acid 495 Creatinine 517 Bilirubin 514 Protein 520 Albumin 522 Cholesterol 528 Triglyceride 503 AST 538 ALT 538 ALP 509 LD 459 GGT 515 Gas 284

5 임상화학검사신빙도조사결과보고 (2005) 5 Table 5. Changes of analytical methods in Clinical Chemistry (%) Analytical method Analytical method Sodium/potassium T. protein flame photometry Biuret ISE indirect refractometry ISE direct others Colorimetry Albumin other dye binding-bcg Choride dye binding-bcp Coul.-Amperometry others ISE indirect T. cholesterol ISE direct Enzymatic Shales-Shales O2 comsum Merc.Ferricthiocyanated Lieberman Burchard others others BUN Triglycerides urease with GLD Lp,GK,PK,LD-NADH urease-indophenol Lp,GK,GPD,Diaph-colo conductivity rate Lp,GDH,Diaph,fluor o-phthaldehyde Lp,GK,GPO,POD-glyc others Lp,GK,GPO,POD+glyc Glucose others GOD,POD,colorimetry AST GOD,POD,fluorometry UV +P5P GOD-O2 consumption UV - P5P hexokinase,g6pd,uv Enzymatic, colotimetry hexokiniase,g6pd,color NADH depletion glucose dehydrogenase others others ALT Calcium UV +P5P OCPC UV - P5P emission flame Enzymatic, colorimetry ISE NADH depletion others others Phosphorus ALP phosphomolyb/redn P-NPP,DEA(GSCC) phosphomoly date-uv P-NPP,AMP(IFCC) enzymatic method P-NPP,EAE others others Uric acid LD phosphotungstate Lactate to pyruvate uricase,colorimetry Pyruvate to lactate oxygen rate Dry chemistry others others Creatinine GGT Jaffe,endpoint,-abs IFCC(carb.GGPNA) Jaffe,endpoint,+abs Szasz(GGPNA) Jaffe,kinetic Dry chemistry DNBA derivatives others others Gas Bilirubin AVL instrument Evelyn-Malloy +blank BATER instrument Jendrassik-Grof+blank NOVA instrument Evelyn-Malloy -blank RADIOMETER instrument 9.86 Jendrassik-Grof-blank IL instrument 1.06 bilirubin oxidase others spectral shift others

6 6 민원기 고창하 김경동 김영기 김정호 김진규외 Table 6-1. Mean CV of each item in each trial (2005) Item/Trial C01 C02 C03 C04 C05 C06 C07 C08 C09 C10 C11 C12 Mean Sodium Potassium Chloride BUN Glucose T.calcium Phosphorus Uric Acid Creatinine T.bilirubin T.protein Albumin T.cholest Triglyceride AST ALT ALP LD GGT

7 임상화학검사신빙도조사결과보고 (2005) 7 Table 6-2. Coefficient of variation in each items by test principle (%, 2005) Test Principle *CV Test Principle CV Sodium Flame photometry 2.96 ISE, diluted (indirect) 1.53 ISE, undiluted (direct) 1.90 Other methods Potassium Flame photometry 3.22 ISE, diluted (indirect) 2.44 ISE, undiluted (direct) 3.40 Other methods 6.42 Chloride ISE, diluted (indirect) 2.58 ISE, undiluted (direct) 3.55 Other methods 6.50 BUN Urease with GLDH 6.55 Urease-Indophenol 5.62 Urease quinolinium dye 3.31 Other methods Glucose GOD,POD,dye(colorimetry) 4.15 Glucose dehydrogenase 5.66 HK, G6PD, UV 4.16 Total Calcium Alizarin 5.12 Arsenazo III dye 7.41 Cresolphthalein complexone 4.82 ISE, diluted (indirect) 5.98 Phosphorus Phosphomolybdate,Reduction,Indirect 6.28 Phosphomolybdate,UV,Direct 4.56 Uric acid Oxygen rate method 8.13 Uricase 4.67 Other methods Creatinine Jaffe, endpoint, - absorbant Jaffe, endpoint, + absorbant Jaffe, kinetic 9.01 Total Bilirubin Evelyn-Malloy +serum blank(azo) Jendrassik-Grof+serum blank(alk.azo) 9.47 Evelyn-Malloy -serum blank(azo) 9.46 Jendrassik-Grof-serum blank(alk.azo) Bilirubin oxidase 7.53 Total Protein Biuret method 3.16 Other methods 3.15 Albumin Dye Binding-BCG 5.00 Dye Binding-BCP 4.49 Total Cholesterol Enzymatic 3.92 Other methods 8.51 Triglycerides Lipase,GK,PK,LDH-NADH consump 8.14 Lipase,GK,GPD,Diaph-Formazan color 5.24 Lipase,GK,GPO,POD - Glycerol blank 6.93 Lipase,GK,GPO,POD + Glycerol blank AST UV,- P-5'-P 6.36 UV,+ P-5'-P 9.89 Enzymatic, colorimetric 4.50 NADH depletion Other methods ALT UV,- P-5'-P 6.83 UV,+ P-5'-P Enzymatic, colorimetric 5.46 NADH depletion 8.56 Other methods ALP P-NPP, DEA (GSCC,Bessey-Lowry) P-NPP, AMP (IFCC,Bower-McComb) P-NPP, EAE aminoantipyrine LD LD, lactate to pyruvate 9.44 LD, pyruvate to lactate 7.36 Colorimetry, Dry chemistry 3.41 Other methods GGT Szas-z (GGPNA),incl. modified IFCC (carboxylated-ggpna) *CV: coefficient of variation

8 8 민원기 고창하 김경동 김영기 김정호 김진규외 Table 7. Annual changes of CV of each item (%) Item CCV Sodium Potassium Chloride BUN Glucose T. calcium Phosphorus Uric acid Creatinine T.bilirubin T.protein Albumin T.cholesterol Triglyceride AST ALT ALP LD GGT Table 8. Mean VIS of each item in each trial (2005) Item/Trial Mean Sodium Potassium Chloride BUN Glucose T.calcium Phosphorus Uric Acid Creatinine T.bilirubin T.protein Albumin T.cholest Triglyceride AST ALT ALP LD GGT PCO PH PO

9 임상화학검사신빙도조사결과보고 (2005) 9 Table 9. Annual changes of mean VIS Item *2003 *2004 **2005 Sodium Potassium Chloride BUN Glucose T. calcium Phosphorus Uric acid Creatinine T.bilirubin T. protein Albumin T.cholest Triglyceride AST ALT ALP LD GGT *VIS score was calculated among groups of laboratories with same test method. **VIS score was calculated with groups of same test items. Table 10. Distribution of VIS Score VIS block 1992 *2003 *2004 ** No. of Lab *Proportions were estimated with numbers of laboratories and mean VIS of each laboratory. **Proportions were estimated with VIS score of each test.

<333520B1E8C7FDC1A42D20C1DFBCD2C0C7B7E1B1E2B0FCC0C720BFDCBACEC1A4B5B5B0FCB8AE2E687770>

<333520B1E8C7FDC1A42D20C1DFBCD2C0C7B7E1B1E2B0FCC0C720BFDCBACEC1A4B5B5B0FCB8AE2E687770> Journal of the Korea Academia-Industrial cooperation Society Vol. 20, No. 2 pp. 294-299, 2019 https://doi.org/10.5762/kais.2019.20.2.294 ISSN 1975-4701 / eissn 2288-4688 김혜정경운대학교임상병리학과 Analysis of Relevant