원저 Lab Med Online Vol. 3, No. 3: 138-144, July 213 http://dx.doi.org/1.3343/lmo.213.3.3.138 임상화학 LABGEO PT Hepatic Test 9 의수행능평가 Evaluation of the Performance of LABGEO PT Hepatic Test 9 정태동 강현정 김민숙 김소영 이우창 전사일 민원기 Tae-Dong Jeong, M.D., Hyun Jung Kang, M.D., Min Sook Kim, M.D., So Young Kim, M.D., Woochang Lee, M.D., Sail Chun, M.D., Won-Ki Min, M.D. 울산대학교의과대학서울아산병원진단검사의학과 Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea Background: The Samsung LABGEO PT Hepatic Test 9 (Samsung electronics, Korea) was developed as a point-of-care (POC) testing device. The levels of 9 analytes, namely, albumin, AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, glucose, total bilirubin, direct bilirubin, and total protein, could be evaluated simultaneously by using 7 μl of whole blood, plasma, or serum samples. In this study, we assessed the performance of the Samsung LABGEO PT Hepatic Test 9. Methods: The precision and linearity of the test were evaluated according to the CLSI EP5-A2 and CLSI EP6-A guidelines, respectively. Correlational analyses between Samsung LABGEO PT Hepatic Test 9 and Cobas 8 modular analyzer (Roche, Switzerland) were carried out as per the CLSI EP9-A2 guidelines. Additionally, the results between 3 different specimen types, whole blood, plasma, and serum samples obtained from the same individual were compared to evaluate the matrix effect. Results: The total imprecision at both low and high levels of the 9 analytes was within 1% and in the clinically important concentration range for all test items, all obtained results were linear. We compared the above results with those obtained using Cobas 8 and a good correlation was observed with a correlation coefficient of more than.975 for all 9 analytes. Simple linear regression analyses between the 3 different specimen types indicated that there was no statistically significant difference (P <.1). Conclusions: The Samsung LABGEO PT Hepatic Test 9 showed good precision and linearity when compared to established assays for 9 clinical test items and could be useful in cases where the POC testing is required. Key Words: Samsung LABGEO PT Hepatic Test 9, Precision, Linearity, Method comparison, Specimen type 서론 현장검사는검체채취후중앙검사실로의운송이나원심분리 등의검체의전처리과정없이간편하게검사할수있으므로검사 보고시간 (turnaround time, TAT) 을단축시킬수있다 [1]. 의사나간 호사가검사를직접수행하므로검사결과를쉽게확인하여신속 Corresponding author: Won-Ki Min, M.D. Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea Tel: +82-2-31-453, Fax: +82-2-478-884, E-mail: wkmin@amc.seoul.kr Received: November 3, 212 Revision received: November 27, 212 Accepted: January 2, 213 This article is available from http://www.labmedonline.org 213, Laboratory Medicine Online 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./) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 하게환자의진단또는치료에적용할수있는장점이있어현장검사의이용도가점차증가하고있다 [2-4]. 반면, 현장검사는검사항목이제한되어있으며비검사실인력에의해검사가이루어지기에질관리가어려운단점이있다 [5]. 현재까지임신반응검사, 혈당검사, 동맥혈가스및전해질검사등의현장검사가보편화되었고, 그밖에감염성질환, 심혈관질환, 약물중독등다양한분야에활용되고있으며점차그적용범위가확대되고있다. 최근개발된 Samsung LABGEO PT Hepatic Test 9 (Samsung electronics, Korea) 은현장검사용전용장비 Samsung LABGEO PT1 (Samsung electronics) 에서간편하게검사할수있다. 혈청, 혈장뿐아니라전혈검체로알부민 (albumin), 알칼리성포스파타제 (alkaline phosphatase, ALP), 알라닌아미노전달효소 (alanine aminotransferase, ALT), 아스파르테이트아미노전달효소 (aspartate aminotransferase, AST), 총빌리루빈 (total bilirubin), 직접빌리루빈 (direct bilirubin), 혈당 (glucose), 감마글루타밀전이효소 (gamma-glutamyl transferase, γ-gt), 총단백 (total protein) 등 9가지항목을동시에검사할수있다. 138 www.labmedonline.org eissn 293-6338
본연구의목적은 Samsung LABGEO PT Hepatic Test 9를대상으로 9가지검사항목의정밀도 (precision), 직선성 (linearity), 상관성 (method comparison) 등의수행능평가와또한전혈, 혈장, 혈청검체를서로비교함으로서검체종류에따른기질효과 (matrix effect) 를평가하고자하였다. 대상및방법 1. 장비및시약 Samsung LABGEO PT1 장비와 Samsung LABGEO PT Hepatic Test 9 카트리지를사용하였고, 제조사의지침에따라검사를시행하였다. Samsung LABGEO PT1은혈액종류에상관없이 7 µl 의검체량으로임상화학분석검사를간단히수행할수있도록고안된현장검사장비이다. 장비내부에포함된 QC 모드를이용하여정도관리를수행할수있고, 일반적인현장검사장비와같이각각의카트리지 lot에따라제조사에서 calibration 을수행하여사용자가추가적인작업을할필요가없다. 대부분의검사과정이터치스크린방식으로조절할수있도록고안되었다. Samsung LABGEO PT Hepatic Test 9은전혈, 혈장, 혈청검체로일반화학검사 9가지항목을동시에검사할수있다. 제조사의지침에따르면검체채취는전용용기인리튬헤파린관 (lithium heparin tube) 을사용해야한다. 검체를카트리지에주입하여검사를시작하면약 7분후 9가지검사항목의결과를얻을수있다. 검사가끝나면종료음과함께검사결과가화면에표시되며동시에결과지가출력된다. 각검사항목의측정원리는다음과같다. 알부민은 dye bindingbromcresol purple (BCP) 법, AST와 ALT는비색법 (colorimetric method), ALP는 JSCC-EAE법, 총빌리루빈과직접빌리루빈은빌리루빈산화효소법 (enzymatic bilirubin oxidase method), 혈당은포도당탈수효소법 (glucose dehydrogenase method), GGT는 IFCC 법, 총단백은뷰렛법 (Biuret method) 으로측정하였다. 3. 직선성 (Linearity) 직선성은 Validate GC Linearity Test Set (Marine Standard Company, Windham, ME, USA) 를사용하여 CLSI EP6-A의지침에따라평가하였다 [7]. Validate 는 calibration 또는직선성검증을위해개발된액상의물질로미국식품의약국 (Food and Drug Administration) 의허가를받았다. 다섯가지농도의물질로구성되어있으며, 각농도는동일한간격으로이루어져있다. Validate 는검체를희석하거나혼합할필요가없으며, 액상으로이루어졌기때문에검체의전처리과정이없이사용이가능하다. 9가지검사항목각각에대해제조사가제시한측정가능범위 (analytical measurement range) 를고려하여저농도에서고농도까지 5가지농도를 4회반복측정하였다. 측정된결과로다항회귀분석을시행하여최적의다항식 (best fit polynomial) 을산출하였다. 최적의다항식이일차선형인경우해당범위에서직선성이유지되는것으로판정하고, 일차선형이아닌다항식의경우각농도의상대적비직선성이모두 2.5% 이하를만족하면해당범위에서직선성이있다고판단하였다. 4. 상관성 (Method comparison) 상관성은 CLSI EP9-A2 지침에준하여평가하였다 [8]. 기준장비는기존검사실에서사용중인 Cobas 8 modular analyzer (Roche diagnostics, Switzerland) 로하였다. 각검사항목별로측정가능범위에포함된농도와측정가능범위를벗어난농도가모두포함되도록 6명의환자검체를수집하였다. 각각의장비에서 2회반복측정한값의평균값을사용하여각검사법간의회귀방정식과상관계수 (coefficient of correlation, r) 를산출하였다. 총허용오차 (total allowable error) 는 College of American Pathologists 와 Clinical Laboratory Improvement Amendments (CLIA) 기준을사용하였다. 상관계수가.975 이상인경우상관성이있다고판단하였다. 2. 정밀도 (Precision) 정밀도는 BIO-RAD Liquid Assayed Multiqual Level 1과 Level 3 (Bio-Rad Laboratories Inc., Hercules, CA, USA) 를사용하여 Clinical and Laboratory Standards Institute (CLSI) EP5-A2 지침에따라평가하였다 [6]. 2일간각농도에대해 1일 2회, 1회 2번씩반복측정하였다. 하루 2회검사는 2시간이상의간격을두고오전과오후로나누어실시하였다. 측정된결과로검사내변이계수 (within run coefficient of variation, CV), 검사간변이계수 (between run CV), 검사일간변이계수 (between day CV), 총변이계수 (total CV) 등을계산하였다. 5. 검체종류별상관성검체유형에따른상관성을평가하기위해 CLSI EP14-A2 [9] 를변형하여 4명환자에서동일환자의혈청, 혈장그리고전혈검체를각각 2회반복측정하였다. 동일환자에게얻은혈액의전혈, 혈장, 혈청검체의차이를확인하기위해리튬헤파린관과혈청분리관 (serum separating tube, SST) 두개의관에각각채혈하였다. 준비된카트리지에리튬헤파린관으로채혈한전혈검체 7 μl를분주하여검사를시작하였다. 전혈검체의검사가진행되는동안리튬헤파린관과혈청분리관을 3, g로 1분간원심분리를하였다. 원심분리로얻어진 lithium heparinized 혈장과혈청을준비한후, 전혈을이용한검사가끝나면혈장과혈청검체를차례로검사 http://dx.doi.org/1.3343/lmo.213.3.3.138 www.labmedonline.org 139
하였다. 측정은동일 lot의카트리지를사용하였고, 동일환자의검체는같은장비로검사하였다. 각각의검체로측정된결과는단순선형회귀분석을하여결정계수와 P값을구하였다. 6. 통계분석통계분석은 EP Evaluator Release 1 (David G. Rhoads Assoc., Kennett square, PA, USA), Analyse-it Standard Edition 2.26, SPSS version 13. (SPSS Inc., Chicago, IL, USA) 을사용하였다. 결과 1. 정밀도 검사항목별평균, 표준편차, 검사내변이계수, 검사간변이계 수, 검사일간변이계수, 총변이계수는 Table 1과같다. 정밀도평가결과알부민, AST, 혈당, 총빌리루빈, 총단백등 5가지항목에서 Level 1과 Level 3의총변이계수가모두 5% 이하였다. ALP, GGT, 직접빌리루빈등 3가지항목의총변이계수는 Level 3에서는 5% 이하였고, Level 1에서 5-1% 였다. ALT는 Level 1과 Level 3의총변이계수가각각 5.1%, 5.5% 였다. 2. 직선성 9가지검사항목모두최적의다항식이일차선형이었고결정계수 (coefficient of determination, R 2 ) 는.99 이상이었다 (Table 2, Fig 1). 모든검사항목에서임상적으로중요한농도범위에서직선성을나타내었다. Table 1. Precision profiles of Samsung LABGEO PT Hepatic Test 9 Analytes (unit) Level Mean SD Within-run Between-run Between-day Total CLIA criteria for acceptance performance (%) ALB (g/dl) 1 2.73.9 3. 1.1.4 3.2 1 3 4.89.17 2.9. 1.8 3.4 AST (U/L) 1 46.39 2.25 4.2. 2.4 4.8 2 3 256.3 8.68 2.5.6 2.2 3.4 ALT (U/L) 1 19.27.98 4.4 2.6. 5.1 2 3 151.55 8.3 3.4 4.3. 5.5 ALP (U/L) 1 1.39 7.7 5.3 4.6.6 7. 3 3 723.75 24.69 2.6 2.2. 3.4 GGT (U/L) 1 22.85 1.81 6.5 3.9 2.2 7.9 NA 3 132.78 3.6 2.1..8 2.3 GLU (mg/dl) 1 57.69.88 1.2.8.5 1.5 1 3 363.24 6.26 1.3 1.2. 1.7 TBIL (mg/dl) 1.66.2 3.7.8 1.5 4.1 2 3 7.21.1 1.3.4.5 1.4 DBIL (mg/dl) 1.47.3 8.3. 3.3 8.9 2 3 3.74.17 4.1. 1.5 4.4 TP (g/dl) 1 4.58.11 1.9.7 1.1 2.4 1 3 6.28.2 2.8. 1.4 3.2 Abbreviations: SD, standard deviation; CV, coefficient of variation; CLIA, Clinical Laboratory Improvement Amendments; ALB, albumin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, γ-glutamyl transferase; GLU, glucose; TBIL, total bilirubin; DBIL, direct bilirubin; TP, total protein; NA, not applicable. Table 2. Linearity of Samsung LABGEO PT Hepatic Test 9 Analytes (unit) Linear range specified by the manufacture Test range Observed linear range Slope Intercept R 2 ALB (g/dl) 1. 7.8 5.3.8 5.3.9896.269.9999 AST (U/L) 1 5. 398.1. 398.1 1.19-9.9463.9995 ALT (U/L) 1 7. 39.6. 39.6 1.338.5266.9995 ALP (U/L) 2 2. 655.1. 655.1.9962-5.947.9999 GGT (U/L) 1 15. 1161.7. 1161.7 1.74-8.3447.9996 GLU (mg/dl) 1 4 3.5 49.5 3.5 49.5.9826 2.2947.9999 TBIL (mg/dl).1 3.1 29.8.1 29.8 1.28.497.9991 DBIL (mg/dl).1 16.3 24.1.3 24.1 1.6 -.645.9995 TP (g/dl) 2. 11 2.3 11.1 2.3 11.1.9926.138.9995 Abbreviations: R 2, coefficient of determination; ALB, albumin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, γ-glutamyl transferase; GLU, glucose; TBIL, total bilirubin; DBIL, direct bilirubin; TP, total protein. 14 www.labmedonline.org http://dx.doi.org/1.3343/lmo.213.3.3.138
6 ALB 5 AST 5 ALT 5 4 4 Measured ALB (g/dl) 4 3 2 1 y=.9896x+.269 R 2 =.9999 Measured AST (U/L) 3 2 1 y=1.19x-9.9463 R 2 =.9995 Measured ALT (U/L) 3 2 1 y=1.338x+.5266 R 2 =.9995 1 2 3 4 5 6 Assigned ALB (g/dl) A 1 2 3 4 5 Assigned AST (U/L) B 1 2 3 4 5 Assigned ALT (U/L) C 8 ALP 1,5 GGT 5 GLU Measured ALP (U/L) 6 4 2 y=.9962x-5.947 R 2 =.9999 Measured GGT (U/L) 1, 5 y=1.74x-8.3447 R 2 =.9996 Measured GLU (md/dl) 4 3 2 1 y=.9826x+2.2947 R 2 =.9999 2 4 6 8 Assigned ALP (U/L) D 5 1 15 Assigned GGT (U/L) E 1 2 3 4 5 Assigned GLU (md/dl) F 35 TBIL 25 DBIL 15 TP Measured TBIL (md/dl 3 25 2 15 1 5 y=1.28x+.497 R 2 =.9991 Measured DBIL (mg/dl) 2 15 1 5 y=1.6x-.645 R 2 =.9995 Measured TP (g/dl) 12 9 6 3 y=.9926x+.138 R 2 =.9995 5 1 15 2 25 3 35 Assigned TBIL (md/dl) G 5 1 15 2 25 Assigned DBIL (mg/dl) H 5 1 15 Assigned TP (g/dl) I Fig. 1. Linearity of Samsung LABGEO Hepatic Test 9. (A) ALB, albumin; (B) AST, aspartate aminotransferase; (C) ALT, alanine aminotransferase; (D) ALP, alkaline phosphatase; (E) GGT, γ-glutamyl transferase; (F) GLU, glucose; (G) TBIL, total bilirubin; (H) DBIL, direct bilirubin; (I) TP, total protein. 3. 상관성기준장비와의상관방정식기울기는.958-1.24 범위에있었고, 9가지검사항목모두상관계수가허용범위.975 이상으로밀접한상관관계를갖는것으로관찰되었다 (Fig 2). 4. 검체종류별상관성알부민을제외한 8가지검사항목의전혈과혈장, 전혈과혈청, 그리고혈장과혈청검체간비교에서결정계수가.95 이상이었고, 모두통계적으로의미가있었다 (Table 3 ). 알부민은전혈과혈 장검체간비교에서결정계수가.8986 이었고, 전혈과혈청검체간비교에서는상관기울기가.897로다소낮았으나모두통계적으로의미있는결과였다. 고찰 본연구는 Samsung LABGEO PT Hepatic Test 9의수행능에대해검사의정밀도, 직선성, 기존장비와의상관성등을평가하였고, 검체종류에따른기질효과 (matrix effect) 를평가하기위해전혈, http://dx.doi.org/1.3343/lmo.213.3.3.138 www.labmedonline.org 141
A B C D E F G H I 혈장, 혈청검체간의상관성을분석하였다. 정밀도평가에서 9가지검사항목모두총변이계수가 CLIA에서제시하는일반화학검사항목의정밀도기준을만족하였다 [1]. 고농도물질에서는 ALT를제외한 8가지항목이모두총변이계수가 5% 미만이었고, 저농도물질에서는 ALP, GGT, 직접빌리루빈의총변이계수가 5-1% 였다. Samsung LABGEO PT Hepatic Test 9이현 Fig. 2. Linear regression plots and Bland Altman bias plots of the results between Samsung LABGEO PT1 and Cobas 8 modular analyzer for 9 analytes. (A) ALB, albumin; (B) AST, aspartate aminotransferase; (C) ALT, alanine aminotransferase; (D) ALP, alkaline phosphatase; (E) GGT, γ-glutamyl transferase; (F) GLU, glucose; (G) TBIL, total bilirubin; (H) DBIL, direct bilirubin; and (I) TP, total protein. The blue line represents the linear regression, and the gray line depicts a theoretical line with a slope of 1. and a Y intercept of. 장검사용시스템인것을고려하면 9 가지검사항목모두우수한 정밀도를보인다고판단할수있었다. 직선성평가에서모든항목이임상적으로중요한농도범위에서 우수한직선성이확인되었다. 혈당, 총빌리루빈, 직접빌리루빈, 총 단백은제조사가제시하는직선성의범위또는더높은농도까지 의직선성이검증되었다. 그러나알부민, AST, ALT, ALP, GGT 는직 142 www.labmedonline.org http://dx.doi.org/1.3343/lmo.213.3.3.138
Table 3. Simple linear regression analysis of 3 different specimen types by using Samsung LABGEO PT Hepatic Test 9 Analytes Slope (95% CI) ALB.959 (.961 1.56) AST 1.5 (.975 1.36) ALT 1.49 (1.2 1.79) ALP 1.1 (.987 1.16) GGT 1.7 (.996 1.18) GLU.998 (.979 1.14) TBIL.991 (.985.997) DBIL 1 (.989 1.1) TP 1.7 (1.13 1.128) Whole Blood vs. Plasma Plasma vs. Serum Plasma vs. Serum R 2 P Slope (95% CI).8986 <.1.897 (.815.979).9913 <.1 1.38 (.999 1.78).9925 <.1 1.14 (.989 1.39).9982 <.1 1.29 (1.4 1.53).9991 <.1 1.17 (1.7 1.27).9971 <.1 1.5 (.977 1.32).9996 <.1 1.2 (.994 1.1).9991 <.1 1.7 (.992 1.21).9729 <.1 1.23 (.962 1.84) R 2 P Slope (95% CI).918 <.1.929 (.856 1.2).986 <.1 1.33 (.998 1.69).9944 <.1.966 (.937.996).9953 <.1 1.28 (1.14 1.42).9992 <.1 1.1 (1.2 1.18).9927 <.1 1.3 (.978 1.28).9994 <.1 1.11 (1.3 1.19).9984 <.1 1.7 (.998 1.17).966 <.1.952 (.95.998) R 2 P.941 <.1.9887 <.1.9911 <.1.9984 <.1.9995 <.1.9941 <.1.9995 <.1.9993 <.1.9767 <.1 Abbreviations: CI, confidence interval; R 2, coefficient of determination; ALB, albumin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, γ-glutamyl transferase; GLU, glucose; TBIL, total bilirubin; DBIL, direct bilirubin; TP, total protein. 선성평가에사용하였던상품화된물질의농도가제조사에서제시한범위를모두포함하지못하여제한된범위에서만직선성을확인하였다. 총단백이외의검사항목들은 Samsung LABGEO PT Hepatic Test 9와 Cobas 8의검사방법이차이가있었지만상관성평가에서모든검사항목의상관계수가허용범위.975 이상으로우수한상관성이관찰되었다. 알부민은상관계수가.9768로다른검사항목에비해다소낮았는데이는검사방법의차이로해석할수있었다. 알부민의측정원리가 Samsung LABGEO PT Hepatic Test 9 은 dye binding-bcp 법인반면, Cobas 8은 dye binding-bromcresol green (BCG) 법이었다. 알부민은 BCP와 BCG에모두높은친화도 (affinity) 로결합한다. 하지만 BCG가알부민이외에 α1- globulin과 α2-globulin 에결합하기때문에 BCP 보다알부민농도가높게측정되는경향이있다고알려져있다 [11, 12]. 본연구의상관성평가에서도 BCG를사용하는 Cobas 8의알부민값이 BCP를사용하는 Samsung LABGEO PT Hepatic Test 9 보다평균적으로.11 g/dl 높게측정되었으며이는방법의차이로설명할수있었다. 빌리루빈, 콜레스테롤, 크레아티닌등은혈청과혈장농도의차이가없지만일부검사항목들은검체종류에따라측정하고자하는물질의농도가달라질수있다 [13]. 혈장농도가혈청농도보다높은항목은칼슘, 염소 (chloride), 젖산탈수소효소 (lactate dehydrogenase), 총단백등이있으며, 총단백은혈장이혈청보다 4% 가량높다고알려져있다 [13]. 이와반대로알부민, ALP, AST, 혈당 은혈청농도가각각 1.3%, 1.6%,.9%, 5.1% 가량혈장농도보다높다 [13]. 본연구의전혈, 혈장, 혈청검체간비교에서총빌리루빈과직접빌리루빈은검체의종류에상관없이결과가거의일치하였고, 총단백은혈청 (y축) 과혈장 (x축) 검체의비교에서상관기울기.952 로혈장농도가혈청보다높았다. 그리고 AST와혈당은혈장과혈청검체간비교에서상관기울기가각각 1.33, 1.3으로평균적으로혈청농도가혈장보다높았다. 이는기존에알려진바와일치하는소견이다. 알부민은전혈검체에서농도가가장높고그다음이혈장, 혈청순의경향을보였다. 혈장에서피브리노겐을제외한것이혈청이므로이론적으로는혈청알부민농도가혈장보다높아야한다. 본연구에서혈장알부민농도가혈청보다평균.1 g/dl 높았다. 그러나이는측정시발생할수있는오차를감안하면의미있는차이라고보기어려웠다. 따라서저자들은 Samsung LABGEO PT Hepatic Test 9의전혈, 혈장, 혈청검체간비교에서우수한상관성을보인다고판단하였다. 결론적으로 Samsung LABGEO PT Hepatic Test 9의수행능평가결과정밀도와장비간상관성이우수하였고, 임상적으로유용한범위내에서직선성을나타내었다. Samsung LABGEO PT Hepatic Test 9 카트리지는현장검사전용장비 Samsung LABGEO PT1으로검사할수있도록개발되었다. 전혈검체로검사가가능하여원심분리등의검체전처리과정이없이쉽게검사할수있으며, 터치스크린방식으로검체의장착후조작이간편하다. 또한 7 분이내에 9가지검사항목의결과를얻을수있으므로 1차의료기관, 응급실, 중환자실, 외래진료실등다양한곳에서환자의진료 http://dx.doi.org/1.3343/lmo.213.3.3.138 www.labmedonline.org 143
에사용될수있을것으로생각되었다. 감사의글 본연구는 212년도울산대학교산학협력단의지원을받아수행되었습니다. 요약 배경 : Samsung LABGEO PT Hepatic Test 9 (Samsung electronics, Korea) 은현장검사용으로개발되어혈청, 혈장검체뿐아니라전혈에서알부민, AST, ALT, ALP, GGT, 혈당, 총빌리루빈, 직접빌리루빈, 총단백등 9가지항목을동시에측정할수있다. 본연구는 Samsung LABGEO PT Hepatic Test 9의수행능을평가하고자하였다. 방법 : CLSI 지침에따라 9가지일반화학검사항목에대해정밀도, 직선성, 기존장비와의상관성을평가하였다. 또한검체종류에따른기질효과를평가하기위해동일환자의전혈, 혈장, 혈청검체로 9가지항목을측정하여비교하였다. 기존장비와의평가에는 Cobas 8 modular analyzer (Roche, Switzerland) 를사용하였다. 결과 : 9가지검사항목의저농도와고농도에서총정밀도는모두 1% 이내였고, 모든검사항목은임상적으로중요한범위에서직선성을나타내었다. 기존장비와의상관성평가에서 9가지항목모두상관계수.975 이상으로우수한상관성을나타내었다. 전혈, 혈장, 혈청검체간단순선형회귀분석에서 9가지항목모두통계적으로유의한상관성이있었다. 결론 : Samsung LABGEO PT Hepatic Test 9은 9가지일반화학검사항목측정에있어정밀도, 직선성및기존장비와의상관성이우수하여현장검사가필요한곳에서유용하게사용될수있을것으로사료된다. REFERENCES 1. Salem M, Chernow B, Burke R, Stacey JA, Slogoff M, Sood S. Bedside diagnostic blood testing. Its accuracy, rapidity, and utility in blood conservation. JAMA 1991;266:382-9. 2. Sands VM, Auerbach PS, Birnbaum J, Green M. Evaluation of a portable clinical blood analyzer in the emergency department. Acad Emerg Med 1995;2:172-8. 3. Aduen J, Bernstein WK, Khastgir T, Miller J, Kerzner R, Bhatiani A, et al. The use and clinical importance of a substrate-specific electrode for rapid determination of blood lactate concentrations. JAMA 1994;272:1678-85. 4. Price CP, John AS, eds. Point-of-care testing making innovation work for patient-centered care. Washington DC: AACCPress, 212:1-26. 5. Nichols JH. Point of care testing. Clin Lab Med 27;27:893-98. 6. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods; Approved guideline. 2nd ed. EP5-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 24. 7. Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline. EP6-A. Wayne, PA: Clinical and Laboratory Standards Institute; 23. 8. Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples; Approved guideline. 2nd ed. EP9-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 22. 9. Clinical and Laboratory Standards Institute. Evaluation of matrix effects; Approved guideline 2nd ed. EP14-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 25. 1. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period. Fed Regist 1992;57:72-186. 11. Xu Y, Wang L, Wang J, Liang H, Jiang X. Serum globulins contribute to the discrepancies observed between the bromocresol green and bromocresol purple assays of serum albumin concentration. Br J Biomed Sci 211;68:12-5. 12. Duly EB, Grimason S, Grimason P, Barnes G, Trinick TR. Measurement of serum albumin by capillary zone electrophoresis, bromocresol green, bromocresol purple, and immunoassay methods. J Clin Pathol 23;56:78-1. 13. Burtis CA, Ashwood ER, Burns DE. eds. Tietz textbook of clinical chemistry and molecular diagnotics. 5th ed. St. Louis: Elsevier Saunders, 211:142-62. 144 www.labmedonline.org http://dx.doi.org/1.3343/lmo.213.3.3.138