대한진단검사의학회지제 26 권제 6 호 2006 Korean J Lab Med 2006;26:436-41 원저 진단면역학 Bio-Rad Elite Microplate 장비를이용한 HBs 항원, HCV, HIV 항원-항체검사시약평가 황상현 1 오흥범 2 김현숙 3 이은엽 1 부산대학교의학전문대학원진단검사의학교실 1, 울산대학교의과대학서울아산병원진단검사의학과 2, 연세대학교의과대학진단검사의학교실 3 Evaluation of HBs Ag, HCV and HIV Ag-Ab Assays using Bio-Rad Elite Microplate Analyzer Sang-Hyun Hwang, M.D. 1, Heung-Bum Oh, M.D. 2, Hyon-Suk Kim, M.D. 3, and Eun Yup Lee, M.D. 1 Departments of Laboratory Medicine, Pusan National University School of Medicine 1, Busan; University of Ulsan College of Medicine and Asan Medical Center 2, Seoul; Yonsei University College of Medicine 3, Seoul, Korea Background : In this study, we evaluated the performance of Elite microplate analyzer (Bio-Rad Laboratories, France) and the related assays (ULTRA line) for the detection of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Methods : Seroconversion panels, HBsAg positive/hbsag negative (n=99/n=1,422), anti-hcv positive/negative (n=97/n=1,670), and anti-hiv positive/negative (n=112/n=1,704) samples were used to evaluate the performance of Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, and Genscreen ULTRA HIV Ag-Ab, respectively. The agreement of Elite microplate analyzer with CODA analyzer (Bio-Rad Laboratories, CA, USA) was also evaluated. Results : The detection limit of Monolisa HBsAg ULTRA was 0.034 IU/mL. For Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, and Genscreen ULTRA HIV Ag-Ab, diagnostic sensitivities were all 100%, diagnostic specificities were 100%, 99.8% and 99.9%, and total CVs (coefficients of variation) were 13.8-17.5%, 3.4-5.2%, and 7.5-9.5%, respectively. The agreement of Elite microplate analyzer with CODA analyzer was 99.5%. Conclusions : The performance of Elite microplate analyzer and the related assays on analytical sensitivity, precision, early detection, diagnostic sensitivity and specificity was all adequate for a mass screening. However, further large multi-center studies should be performed to validate our results. (Korean J Lab Med 2006;26:436-41) Key Words : Hepatitis B virus, Hepatitis C virus, Human immunodeficiency virus, Evaluation, Sensitivity, Specificity, Elite Microplate Analyzer 서 론 접수 : 2006년 8월 7일접수번호 : KJLM1975 수정본접수 : 2006년 10월 25일게재승인일 : 2006년 11월912일교신저자 : 오흥범우 138-736 서울시송파구풍납동 388-1 서울아산병원진단검사의학과전화 : 02-3010-4505, Fax: 02-478-0884 E-mail : hboh@amc.seoul.kr * 본연구는부산대학교연구비 (2006) 지원으로일부이루어졌음. Hepatitis B virus (HBV) 표면항원 (HBsAg), human immunodeficiency virus (HIV) 항체및 hepatitis C virus (HCV) 항체검사는헌혈혈액의가장중요한선별검사항목이다. 최근국내에서발생한수혈전파성에이즈혹은간염으로인해혈액안전성확보를위한다양한노력을요구되고있다. 헌혈혈액의안정성을확보하기위해서는객관적이고신뢰성있는평가를통하여성능이우수한시약을사용하는것이매우중요하다. 또한대규모검체를처리해야하는혈액사업에서는사무적오류가적으면서대규모검체처리가가능하고, 비용-효율적이며, 검사의편차및무작위적오류가적은자동화장비가필요하다. Bio-Rad Elite microplate 자동화검사장비 (Bio-Rad, Marnes 436
Bio-Rad HBs 항원, HCV, HIV 항원 - 항체검사시약과장비평가 437 La Coquette, France) 는대용량검체처리에용이하도록설계된개방형 microplate 분석장비로검체분주에서부터검사완료까지모든단계를자동적으로수행할수있다. 또한개방형시스템이기때문에성능이우수한다른회사의시약을비용-효율적으로선택할수있다는장점이있다. 본연구에서는 Elite microplate 자동화장비를이용하여 Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, Genscreen ULTRA HIV Ag-Ab (Bio-Rad, Marnes La Coquette, France) 시약의분석민감도, 정밀도, 조기검출능, 진단민감도, 진단특이도와 Elite microplate 자동화검사장비의개방성을평가하고, 이들시약과자동화검사장비가대규모선별검사에적합한지알아보고자하였다. 재료및방법 1. Monolisa HBsAg ULTRA 분석민감도 WHO 표준물질 (second international standard for HBsAg subtype adw2, genotype A Reference Panel NIBSC code number: 03/262, 33 IU/mL) 을적절히희석하여각농도당 4 개씩분주한후, 두번검사를시행하였고, 각검사당중복측정하여최소검출농도를측정하였다. 2. 정밀도 NCCLS EP5-A[1] 에준하여 Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 검사시약의정밀도를평가하였다. 이미결과를알고있는환자의검체를사용하여, 서로다른농도군으로 pooling한후각각 20개로분주보관하여평가에이용하였다. 각항목마다하루 2회중복검사하여 10일간검사를시행하였으며, 각농도에서의 (signal/cut-off ratio) 의평균, 표준편차를이용하여검사차례내 (within-run) 변이계수 (coefficient of variance; CV), 검사차례간변이계수 (between-run CV), 검사일간변이계수 (between-day CV), 총변이계수 (total CV) 를구하였다. 3. 혈청전환기패널검체를이용한조기검출능평가 Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULT- RA, Genscreen ULTRA HIV Ag-Ab 각시약의혈청전환조기검출능을평가하기위하여, BBI사 (Boston Biomedica Inc., MA, USA) 의 PHM935A, PHV916, PRB931 패널을사용하였고, 첫채혈후며칠째검체부터양성으로검출되는지를측정하였다. 측정된결과를해당 BBI 패널에첨부되어있는 datasheet에서제공되고있는화학발광면역측정법을이용한 Abbott PRISM (Abbott Diagnostics, Wiesbaden, Germany) 및미량입자효소면역측정법을이용한 Abbott AxSYM version 2 (Abbott Diagnostics, Wiesbaden, Germany) 의검사결과와비교하였다. 4. 진단민감도연세대학교병원에서제공된 HBsAg, HCV 항체, HIV 항체양성검체각각 99개, 97개, 112개를대상으로 Genscreen ULT- RA HIV Ag-Ab, Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA 시약을 Elite microplate 자동화검사장비에서시행하였다. HBsAg 양성검체는 Enzygnost HBsAg 5.0 (Dade Behring, Marburg, Germany) 시약에서양성인것으로, HBeAg 또는 anti-hbe 검사중하나가양성인검체들이었고, DiGene Hybrid Capture II (Murex Diagnostics, Dartfold, UK) 를이용한 HBV DNA 정량검사에서는 0.5 pg/ml 이하에서 6,000 pg/ ml 이상까지다양한결과를보였다. HIV 항체양성검체는연세대학교병원에서 HIV 감염으로진단받고추적검사또는치료를위해내원한환자들의검체로서 Architect HIV Ag-Ab Combo (Abbott Diagnostics) 시약에서모두양성을보인검체들이었다. HCV 항체양성검체는연세대학교병원에내원하여 HCV 검사가의뢰된검체중 Genedia HCV ELISA 3.0 (Greencross Life Science, Seoul, Korea) 시약에서양성인검체들이었다. HBsAg, HIV 항체양성, HCV 항체양성검체선정시검사결과의흡광치가저역가, 중간역가, 고역가에골고루분포하도록선정하였다. 5. 진단특이도울산의대서울병원핵의학과에서방사선면역검사법인 HBsAg Kit (North Institute of Biological Technology, Beijing, China) 으로시행한 HBsAg 음성 1,400 검체를선정하여 Monolisa HBs- Ag ULTRA 시약의진단특이도를평가하였다. Monolisa HCV Ag-Ab ULTRA 시약의진단특이도는같은병원진단검사의학과에서건강검진을위해 LG HCV Ab 3.0 EIA (LG Chemicals, Seoul, Korea) 로검사한검체중음성결과를보인 1,670 검체를이용하여평가하였다. Genscreen ULTRA HIV Ag-Ab의진단특이도는 Architect HIV Ag-Ab Combo로검사한검체중음성 1,704 검체로평가하였다. 6. Elite microplate 자동화장비의개방성평가서울아산병원진단검사의학과에의뢰된건강검진용검체 1,532 개를무작위로선정한후, LG HCV Ab 3.0 시약을 CODA 자동화검사장비 (Bio-Rad Laboratories, CA, USA) 와 Elite microplate 자동화검사장비로각각검사를시행하고그결과를비교하였다. 불일치하는검체에대해서는 RIBA HCV 3.0 Immunoblot (Chiron, Emeryville, CA) 로확인하였다.
438 황상현 오흥범 김현숙외 1 인 7. 통계분석 SPSS 12.0 (SPSS Inc., Illinois, USA) 통계소프트웨어를이용하여평균및표준편차를계산하였고, 선형회귀분석을통해 HBsAg 항원검사의분석민감도를결정하였다. 또한두기기간일치율은 kappa 값으로평가하였고 [2], 통계적인유의수준은 0.05 이하로정하였다. 결과 roplate 자동화검사장비에서시행할경우, 저농도, 고농도에따라검사차례내변이계수 (within-run CV), 검사차례간변이계수 (between-run CV) 는 Table 2와같고, 총변이계수는 HBsAg 13.8-17.5%, HCV 3.4-5.2%, HIV 7.5-9.5% 의분포를보였다. 3. 혈청전환기혈청검체를이용한조기검출능평가혈청전환기혈청을이용한 Elite microplate 자동화검사장비와시약의조기검출능력을검사한결과, HBV 는 21일에서, HCV 는 19일, HIV는 28일째혈청에서양성결과를보였다 (Table 3). 1. Monolisa HBs Ag ULTRA 검사시약의분석민감도 4. 진단민감도및진단특이도 Monolisa HBsAg ULTRA 검사시약의분석민감도를실험한결과는 Table 1과같았다. WHO 표준물질의희석농도에따른관찰된최소검출한계는 0.05 IU/mL이었다. 이를선형회귀분석을시행한결과, y=0.8204x+1.2079 (R 2 =0.9915) 회귀식을얻을수있었다. 회귀식에서 값이 1일때 (y=1일때의 x 절편 ) 의이론적분석민감도는 0.034 IU/mL이었다. Monolisa HBs Ag ULTRA, Monolisa HCV Ag-Ab ULT- RA, Genscreen ULTRA HIV Ag-Ab 검사시약의진단민감도는모두 100% 이었으며, 진단특이도는각각 100%, 99.8%, 99.9 % 이었다 (Table 4). 5. Elite microplate 자동화검사장비의개방성평가 2. 정밀도평가 Monolisa HBs Ag ULTRA, Monolisa HCV Ag-Ab ULT- RA, Genscreen ULTRA HIV Ag-Ab 검사시약을 Elite mic- Table 1. Low detection limit of Monolisa HBsAg ULTRA test for HBsAg WHO standard material WHO standard (IU/mL) 1st replicate 2nd replicate 3rd replicate Abbreviations: P, positive; N, negative;, signal/cut-off ratio. 4th replicate 3.3 40.9 P 38.9 P 46.3 P 43.8 P 0.33 6.4 P 6.1 P 6.6 P 6.8 P 0.1 2.3 P 2.4 P 2.4 P 2.3 P 0.075 2.2 P 2.2 P 2.6 P 2.4 P 0.05 1.2 P 1.7 P 1.2 P 1.2 P 0.025 0.6 N 0.7 N 0.7 N 0.7 N 0.0125 0.4 N 0.5 N 0.5 N 0.5 N Table 2. Precision performance of Bio-Rad ULTRA line kits on Elite microplate system Item level HBsAg 1 2 HCV Ag-Ab 1 2 3 HIV Ag-Ab 1 2 Mean 1.2 11.6 1.8 2.7 6.2 1.9 5.3 Within-run CV 7.2 5.0 3.8 2.5 1.5 2.0 4.5 Between-run CV 13.7 5.4 0.7 4.2 1.2 3.9 2.2 Between-day CV 8.2 11.7 3.5 2.3 2.8 6.1 8.0 Total CV (%) 17.5 13.8 5.2 5.4 3.4 7.5 9.5 Abbreviations:, signal/cut-off ratio; CV, coefficient of variation. LG HCV Ab 동일시약에대해 CODA 장비와 Elite microplate 자동화검사장비를비교한결과, 일치율은 99.5%, kappa 값은 0.88 Table 3. Comparison of the performance of Elite microplate system, Abbott Prism and Abbott AxSYM version 2 in seroconversion panels Panel serial No. Days since 1st bleed Elite microplate ( ratio) Abbott Prism* ( ratio) Abbott AxSYM version 2* ( ratio) HBV BBI PHM935A-02 2 0.1 0.5 0.4 PHM935A-03 7 0.2 0.7 0.4 PHM935A-04 9 0.2 0.3 0.4 PHM935A-05 14 0.1 0.4 0.4 PHM935A-06 16 0.2 0.6 0.4 PHM935A-07 21 1.5 1.8 0.7 HCV BBI PHV916-02 2 0.6 0.1 0.4 PHV916-03 7 0.1 0.1 0.3 PHV916-04 9 1.0 0.2 0.4 PHV916-05 16 0.8 1.0 0.2 PHV916-06 19 2.2 1.9 4.4 PHV916-07 23 3.4 2.7 15.5 HIV BBI PRB931-02 2 0.4 0.3 0.4 PRB931-03 7 0.4 0.4 0.3 PRB931-04 9 0.5 0.3 0.4 PRB931-05 15 0.9 0.3 0.4 PRB931-06 28 37.8 7.0 7.5 PRB931-07 33 37.8 64.9 14.2 *Information was obtained from seroconversion panel data sheets.
Bio-Rad HBs 항원, HCV, HIV 항원 - 항체검사시약과장비평가 439 Table 4. Summary of the diagnostic sensitivity and specificity of Bio-Rad Monolisa HBsAg, HCV Ag-Ab, and Genscreen HIV Ag-Ab ULTRA kits on Elite microplate system Performance item Test item Test sample number (95% 신뢰구간 ; 0.797-0.962) 로우수한일치율을보였다 (Table 5). 불일치결과를보인 8 검체에대해 RIBA HCV 3.0 Immunoblot로확인한결과모두음성이었다. Elite microplate 자동화장비에서는위양성결과가 2개이었던반면 CODA 자동화장비에서는 6개로 Elite microplate 자동화장비의위양성이다소낮은경향을보였다 (Table 5). 고 수혈을통한바이러스감염은선별검사의성능이향상되었음에도불구하고국내외에서여전히보고되고있는실정이다 [3-6]. 국내에서는과거선별검사상양성반응을보였던헌혈자들중에서헌혈당시음성결과를보여출고된혈액 2,550 건에대해추적조사한결과, 수혈을통한 B형간염이 3건, C형간염이 5건확인되었다는보고가있었고, 수혈을통한 HIV 감염의경우도국내에서지금까지 10여건에이르고있다 [7]. 따라서헌혈혈액의안전성은아직까지완전히담보할수없는실정이기때문에, 보다우수한시약및검사시스템도입이필요하다. HBsAg 검사는측정한계이하인경우나변이형항원에 [8, 9] 의한위음성이문제가된다. 따라서우리나라처럼 HBV 유병률이높은지역에서는 HBsAg 성능평가시분석민감도를평가하는것이필요한데, Monolisa HBsAg ULTRA 검사의최소검출농도는 0.05 IU/mL로분석되었다. 이는 IMMULITE 2000 HBsAg assays (Diagnostics Products Corporation, LA, USA) 의분석민감도 0.1 IU/mL[10], AxSYM HBsAg version 2의분석민감도 0.03-0.17 IU/mL[11], Elecsys HBsAg (Roche Diagnostics, Penzberg, Germany) 의 0.033-0.055 IU/mL[12], Architect HBsAg의 0.05 IU/mL[13] 등과비교하여볼때, 비슷한성능으로판단된다. 찰 Elite microplate Positive Negative Performance (95%CI) Diagnostic HBsAg 99 99 0 100% sensitivity (96.3-100%) HCV Ab 97 97 0 100% (96.2-100%) HIV Ab 112 112 0 100% (96.7-100%) Diagnostic HBsAg 1,400 0 1,400 100% specificity (99.7-100%) HCV Ab 1,670 4 1,666 99.8% (99.4-99.9%) HIV Ab 1,704 1 1,703 99.9% (99.7-99.9%) Abbreviation: CI, confidence interva. Table 5. Comparison of anti-hcv results of LG HCV Ab 3.0 EIA test kit (LG chemicals, Seoul, Korea) performed on the different automatic analyzers, CODA system and Elite microplate system LG HCV Ab test on Elite system Positive Negative Total Kappa LG HCV Ab Positive 30 6* 36 0.88 test on CODA Negative 2* 1,494 1,496 system Total 32 1,500 1,532 *Eight discrepant results were confirmed as all negative by RIBA test. Standards for strength of agreement for the kappa coefficient: 0= poor, 0.01-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80= substantial, and 0.81-1.0=almost perfect[29]. HBsAg의항원결정기 ( a 결정기 ) 의 [14] 돌연변이는 HBsAg 효소면역검사에서위음성을일으키는원인의하나이며 [15, 16], 헌혈을통한감염을일으킨다 [17]. 따라서, 이러한돌연변이를검출할수있는성능이중요한데, HBsAg epitope을포획하는항체와신호증폭항체 ( 또는검출항체 ) 의특성에따라돌연변이검출에서차이가발생하는것으로알려져있다 [18, 19]. 본연구에서는변이형 HBsAg에대한시약의검출능을평가하지는않았지만 Monolisa HBsAg ULTRA 시약은세개의단클론성포획항체와신호증폭항체로다클론성항체와한개의단클론성항체를이용하는것이특징이므로, 단클론성포획항체 / 단클론성신호증폭항체를이용하는검사시약에비해주요한돌연변이형인 G145R을포함한다른변이형검출에서더나을것으로판단된다 [20]. Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 검사시약의정밀도는농도분포에따라총변이계수가각각 13.8-17.5%, 3.4-5.2%, 7.5-9.5% 의성능을보였다. 이는기존에문헌을통해보고되었던 ADVIA Centaur HBsAg의총변이계수 <15%[21], AxSYM HCV version 3.0의총변이계수 6.63-7.71%[22], ADVIA Centaur anti- HIV의총변이계수 8.4-13.65%[23], AxSYM HIV Ag/Ab Combo의총변이계수 <10%[24], Architect HIV Ag/Ab Combo의총변이계수 3.6-15.7%[25] 와비교할때, 유사한수준의정밀도를보이는것으로판단된다. BBI 혈청전환기패널을이용한조기검출능평가에서 Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 검사시약은 Abbott PRISM, Abbott AxSYM version 2와거의동등한윈도우기간을보여주어, 이들키트와유사한성능을가지고있음을확인할수있었다. HCV Ag-Ab ULTRA 시약은항체단독검사인 anti-hcv Ab UL- TRA 시약보다 21.6-30.1일정도조기검출이가능하다고알려져있지만 [26], 본연구결과로는항체와항원을동시에검출하는 Monolisa HCV Ag-Ab ULTRA 검사시약이항체만을검출하는기존의두비교검사키트에비해조기검출능이더우수하지는않았다. 뿐만아니라, HCV 핵산증폭검사를이미시행하고있는
440 황상현 오흥범 김현숙외 1 인 국내혈액사업에서는항원-항체동시검출시약이큰이점을가져다주지는못할것으로판단된다. Monolisa HBsAg ULTRA test의진단민감도와진단특이도는 100% (95% 신뢰구간 : 96.3-100%), 100% (95% 신뢰구간 : 99.7-100%) 으로매우우수하였다. 이는화학발광면역측정법인 ADVIA Centaur HBsAg assay (Bayer, Marburg, Germany) 의진단민감도 (100%, 538/538) 및진단특이도 (99.94%, 5259/ 5262) 와비슷한수준으로판단되었다 [21]. Monolisa HCV Ag- Ab ULTRA test의진단민감도와진단특이도는 100% (95% 신뢰구간 : 96.2-100%), 99.8% (95% 신뢰구간 : 99.4-99.9%) 이었다. 이는 Architect Anti-HCV assay의진단특이도 99.92% (3808/ 3811)[27], ADVIA Centaur anti-hcv의진단민감도 (99.6%, 449/451), 진단특이도 (99.90%, 5182/5187)[21] 와유사한수준의성능인것으로판단된다. Genescreen ULTRA HIV Ag-Ab 시약의경우, 본연구에서진단민감도 100% (95% 신뢰구간 ; 96.7-100%), 진단특이도 99.9 % (95% 신뢰구간 ; 99.7-99.9%) 로매우우수한성적으로보였다. 항원-항체동시검사법을평가한 Kwon 등의연구에서 Architect HIV Ag/Ab combo, Elecsys 2010 HIV Combi, AxSYM HIV Ag/Ab Combo 키트의진단민감도는 100% 이었던반면, 진단특이도에있어서는각각 99.6% (Architect assay), 98.8% (Elecsys assay) 98% (AxSYM assay) 를보였다고하였는데 [28], 이연구와비교하면 Genescreen ULTRA HIV Ag-Ab 시약은다른항원-항체동시검사에비해진단특이도가다소우수한것으로판단되었다. HIV 유병률이비교적낮은국내현실을고려해볼때, 진단특이도가높은 Genescreen HIV Ag-Ab combo Ultra 는위양성의빈도가다소낮을것으로예상된다. LG HCV Ab 3.0 시약을이용하여 Elite microplate 자동화검사장비와 CODA microplate 자동화검사장비를비교한결과, Kappa 결과가 0.88로우수한일치율을보여주었다 [29]. Elite 장비의분주기는최대 792개의검체와 27장의 plate를동시에처리할수있으며완전자동화가가능한 microplate 기반의자동화장비이다. 따라서대규모검사실에서사용하기에적절한장비라여겨진다. 또한 Elite microplate 자동화장비는타사의제품을사용하지못하는폐쇄적인자동화장비들에비해비용효율적으로시약을운용할수있다는장점이있다. 시약의성능은우수하지만전용장비를생산할만한시장을확보하지못하는국내시약산업의지속적인성장을위해서는 Elite microplate 자동화장비와같이개방적인장비의도입이고려되어야할것이다. 결론적으로, 본연구에서 Bio-Rad Elite 장비와 ULTRA line HBsAg, HCV Ag-Ab, HIV Ag-Ab 시약은분석민감도, 정밀도, 조기검출능, 진단민감도, 진단특이도, 개방성등의성능평가에서우수한결과를보여, 대규모선별검사로사용하기에적절한검사장비로판단되지만, 추가적인대규모다기관연구를통해검증되어야할것이다. 요약배경 : 본연구에서는 Bio-Rad Elite microplate 자동화장비 (Bio-Rad Laboratories, France) 와 hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) 관련시약 (ULTRA line, Bio-Rad Laboratories, France) 의성능을평가하였다. 방법 : 혈청전환패널, HBsAg 양성 99 검체, 음성 1,422 검체, HCV 항체양성 97 검체, 음성 1,670 검체, HIV 항체양성 112 검체, 음성 1,704 검체를이용하여 Bio-Rad Elite Microplate 자동화장비와 Monolisa HBsAg ULTRA, Monolisa HCV Ag- Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 시약에대하여분석민감도, 정밀도, 조기검출능, 진단민감도, 진단특이도및 Elite Microplate 검사장비의일치율을분석하였다. 결과 : Monolisa HBsAg ULTRA의검출한계는 0.034 IU/ ml이었고, Monolisa HBs Ag ULTRA, Monolisa HCV Ag- Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 검사시약의진단민감도는모두 100% 이었으며진단특이도는각각 100%, 99.8 %, 99.9% 이었다. Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, Genscreen ULTRA HIV Ag-Ab 검사시약의총변이계수는각각 13.8-17.5%, 3.4-5.2%, 7.5-9.5% 이었다. 동일시약 (LG HCV Ab 시약 ) 을이용하여 CODA 자동화장비와 Elite Microplate 자동화장비를비교한결과일치율은 99.5% 이었다. 결론 : 본연구에서평가한분석민감도, 정밀도, 조기검출능, 진단민감도, 진단특이도, 개방성등검사성능은대규모선별검사로사용하기에적절한검사장비라판단되지만, 추가적인대규모다기관연구를통한검증이필요할것이다. 참고문헌 1. National Committee for Clinical Laboratory Standards. Evaluation of precision performance of clinical chemistry devices; Approved guideline. Document EP5-A. Vilanova, PA: National Committee for Clinical Laboratory Standards, 1999. 2. Landis JR and Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159-74. 3. Hoofnagle JH. Posttransfusion hepatitis B. Transfusion 1990;30:384-6. 4. Weber B, Muhlbacher A, Melchior W. Detection of an acute asymptomatic HBsAg negative hepatitis B virus infection in a blood donor by HBV DNA testing. J Clin Virol 2005;32:67-70. 5. Matsumoto C, Tadokoro K, Fujimura K, Hirakawa S, Mitsunaga S, Juji T. Analysis of HBV infection after blood transfusion in Japan through investigation of a comprehensive donor specimen repository. Transfusion 2001;41:878-84.
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