원저 Lab Med Online Vol. 3, No. 1: 23-28, January 2013 진단면역학 바이러스간염진단을위한혈청학적검사법과 Magicplex HepaTrio Real-time PCR 의비교 The Comparison between Serologic Tests and Magicplex HepaTrio Real-time PCR in the Diagnosis of Viral Hepatitis 김근 김덕언 Keun Kim, M.D., Duck-An Kim, M.D. 한양대학교병원진단검사의학과 Department of Laboratory Medicine, Hanyang University Medical Center, Seoul, Korea Background: Magicplex HepaTrio Real-time PCR (Magicplex, Seegene, Korea) simultaneously detects and distinguishes each type of hepatitis A, hepatitis B, and hepatitis C viruses. We investigated the diagnostic performance of Magicplex in comparison with that of serologic test. Methods: We tested and analyzed 184 serum samples for hepatitis A IgM antibody (IgM anti HAV), hepatitis B virus surface antigen (HBsAg), and anti-hepatitis C virus antibody (anti HCV). Serologic markers including IgM anti HAV, HBsAg, and anti HCV were tested with electrochemiluminescence immunoassay method. We calculated positive rates of the test results and concordance rates between serologic tests and Magicplex. Results: The positive rates of IgM anti HAV, HBsAg, and anti HCV using serologic methods were 15.2% (28/184), 13.6% (25/184), and 8.2% (15/184), respectively. The positive rates of the corresponding viral nucleic acid detection by Magicplex were 18.5% (34/184), 16.3% (30/184), and 4.3% (8/184), respectively. The concordance rates between serologic test and Magicplex were 95.7% (176/184) in hepatitis A, 97.3% (179/ 184) in hepatitis B, and 96.2% (177/184) in hepatitis C. Conclusions: In our study, the concordance rates between Magicplex and traditional serologic tests are over 95%. Magicplex could not yet totally replace traditional serologic tests because there are some possibilities of cross reaction among the hepatitis viruses and false negative results in hepatitis C. If Magicplex resolves these problems, it would be a useful tool for screening test for the diagnosis of viral hepatitis as it provides an automated, easy, and simultaneous detection of the 3 major hepatitis viruses. Key Words: Magicplex, Real-time PCR, Hepatitis, Serologic test 서론 급성바이러스간염의원인은대부분 A 형간염바이러스 (hepatitis A virus, HAV), B 형간염바이러스 (hepatitis B virus, HBV), C 형간 Corresponding author: Duck-An Kim, M.D. Department of Laboratory Medicine, Hanyang University Medical Center, 222 Wangsimni-ro, Seongdong-gu, Seoul 133-792, Korea Tel: +82-2-2290-8977, Fax: +82-2-2298-1735, E-mail: dukim@hanyang.ac.kr Received: May 17, 2012 Revision received: August 20, 2012 Accepted: August 27, 2012 This article is available from http://www.labmedonline.org 2013, 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/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 염바이러스 (hepatitis C virus, HCV), D형간염바이러스 (hepatitis D virus, HDV), E형간염바이러스 (hepatitis E virus, HEV) 이다 [1]. 질병관리본부연간통계에따르면 A형간염은 2007년 2,233명, 2008년 7,895 명, 2009년 15,231 명, 2010년 7,655 명으로교육과예방접종으로인하여최근상승세가한풀꺾였지만수년간발생률이비약적으로증가하고있고, B형간염바이러스는 1998년보건복지부에서시행한실태조사에의하면한국인 10세이상남자의 5.1% 와여자의 4.1% 에서 B형간염표면항원 (hepatitis B surface antigen, HBsAg) 양성으로나타나여전히 B형간염환자가많은것으로나타나고있다 [2]. C형간염바이러스는인구의 1-2% 정도가감염되어있는것으로알려져있으며만성간질환의 15-20% 가만성 C 형간염과관련이있다 [3-5]. 급성바이러스간염은각기다른바이러스가원인이라할지라도임상양상이서로비슷하여혈청학적검사가진단에필수적이며 [1] 현재본원에서는 A형, B형, C형간염을진단하기위하여 IgM anti- eissn 2093-6338 www.labmedonline.org 23
HAV, HBsAg, anti-hcv 검사를증상이의심되는환자에한해각각혈청학적방법으로검사하고있다. 하지만이러한방법에는몇가지문제점이있다. HBsAg은바이러스의증식이나감염성여부를평가하는데도움이되지않고과거에비해검출민감도가증가하였음에도불구하고위음성결과들이보고되고있다 [6, 7]. Anti-HCV 검사는현재감염과과거의감염을구분할수없고자원공혈자나건강한성인집단등의 C형간염저위험군을대상으로연구한결과적지않은위양성 (41%) 과위음성 (32%) 의문제점이있다 [8, 9]. 또한 B형간염바이러스보균자가 A형간염에중복감염시전격간염으로진행할확률과사망률이각각 55%, 25% 에이른다는연구결과 [10] 와 B형간염바이러스보균자에서 A형간염의중복감염시전격간염의발생빈도가약 9 배증가하였다는연구결과 [11] 를고려할때 B형간염의유병률이높은우리나라에서는 A형, B형, C형간염모두를검사하여심각한결과를사전에예방할필요가있다고생각된다. 이에대한보완책으로분자생물학적방법을이용한 PCR ( 중합효소연쇄반응법 ) 이대두되고있으나검사방법의복잡성, 높은위양성의문제점, 과거감염력과급성감염의구별및치료효과판정의어려움이있으며고가이므로선별검사로는이용되지못하고있다 [12]. 하지만위의단점들을보완하고세가지간염바이러스의검출을분자생물학적방법으로한번에시행할수있는단일시험관다중실시간중합효소연쇄반응법 (single tube multiplex real-time polymerase chain reaction) 을이용한 Magicplex HepaTrio Real-time PCR (Magicplex, Seegene, Seoul, Korea) 이개발되어저자들은그성능을평가하고자하였다. 2) Magicplex (1) 검사원리 Magicplex 는실시간중합효소연쇄반응법을바탕으로한검사로통상적인핵산증폭장비를통한다중유전자증폭단계와실시간핵산증폭장비를통한실시간다중검출단계로구성되어있다. 실시간중합효소연쇄반응법에서증폭된 PCR 산물은 PCR 과정중실시간형광강도측정을통해확인할수있다. (2) 핵산추출혈청 500 μl를핵산자동화추출장비인 STARlet (Hamilton corp., Bonaduz, Switzerland) 을이용하여핵산추출을진행했다. (3) 증폭과검출 Magicplex HepaTrio Amplification kit 시약 10X HepaTrio PM 5 μl, 10X OneStep RT-PCR Buffer 5 μl, OneStep RT-PCR Enzyme mix 4 μl와추출한핵산 36 μl를혼합하여제조사매뉴얼에언급된조건으로 96-well GeneAmp PCR System 9700 (ABI, Foster City, CA, USA) 장비를이용하여통상적인다중중합효소연쇄반응법을수행했다. 통상적인다중중합효소연쇄반응법이완료되면증폭된 PCR 산물을 Magicplex HepaTrio Real-time Detection kit 시약 5X HepaTrio DOM 4 μl, RNase free water 4 μl, 2X Detection Mix 10 μl에 PCR 산물 2 μl를혼합하여매뉴얼에언급된조건으로 CFX96 Real-time PCR system (BioRad, Hercules, CA) 을이용하여검출을수행했다. 증폭된 HAV, HBV, HCV와 Internal control은 4개의다른형광프로브에의해검출되고 Seegene viewer 프로그램을이용하여결과를판독했다. 대상및방법 1. 대상 본원에서 IgM anti-hav, HBsAg, anti-hcv 검사를동시에시행한총 184명의환자 (2010 년 6월 7일부터 23일까지 98명, 2011년 2월 1일부터 5월 13일까지 86명 ) 를후향적으로조사하였다. 혈청은측정하기전까지 -70 에서냉동보관하였다. 2. 방법 1) 혈청학적검사 IgM anti-hav, HBsAg, Anti-HCV 측정은모두전기화학적발광면역측정법 (electrochemiluminescence immunoassay) 을이용한 Roche Modular Analytics E170 (Roche Diagnostics, Mannheim, Germany) 을사용하여검사하였으며모든검사는제조사의지침대로시행하였다. (4) 검출한계각바이러스의검출한계는 HAV 10 IU/mL, HBV 5 IU/mL, HCV 35 IU/mL 이다. 3) 통계분석총 184명의혈청을대상으로기존의혈청학적방법과 Magicplex 의양성률과일치율을분석하였다. 검사결과에대한통계학적분석은 SPSS (version 18.0, SPSS Inc., Chicago, IL, USA) 를이용하였고, kappa 값을구해일치도검정을시행하였다. 결과 혈청학적방법으로 IgM anti-hav, HBsAg, anti-hcv 검사를동시에시행한총 184명을대상으로결과를분석하였다. 검사대상환자들의나이분포는 2세부터 93세까지로다양했고 24 www.labmedonline.org
Table 1. Characteristics of patients 남자는 93 명 (50.5%), 여자는 91 명 (49.5%) 참여하였다. 대상들의평 균 AST 는 483.81±94.30 (IU/L), ALT 는 417.5±90.0 (IU/L), 총빌리 루빈은 1.88±0.27 (mg/dl), 직접빌리루빈은 1.26±0.20 (mg/dl) 이 었다 (Table 1). 진료과를살펴보면소화기내과가가장많았고류마 티스내과, 신경과, 응급의학과순으로나타났다. 혈청학적방법으로검사한결과각검사의양성률은 IgM anti- HAV 15.2% (28/184), HBsAg 13.6% (25/184), anti-hcv 8.2% (15/184) 로나타났다. Total (N=184) 같은환자의검체를 Magicplex 로검사한결과각검사의양성률 은 HAV 18.5% (34/184), HBV 16.3% (30/184), HCV 4.3% (8/184) 로 나타났다 (Tables 2-4). 두방법간의일치율은 A 형간염의경우 95.7% (176/184), 결과 판정의일치측도 κ 는 0.845 (P <0.01) 로나타났으며 B 형간염의일 치율은 97.3% (179/184), 결과판정의일치측도 κ 는 0.893 (P <0.01) 이었다. C 형간염의일치율은 96.2% (177/184), 결과판정의일치 측도 κ 는 0.677 (P <0.01) 이었다. IgM anti-hav (+) (N=28) HBsAg (+) (N=25) 기존의혈청학적검사들과불일치한경우는총 20 건이었다. A 형 간염은혈청학적검사양성, Magicplex 음성인경우가 1 예였으며 Magicplex 양성, 혈청학적검사음성인경우는 7 예였다. B 형간염 은혈청학적검사양성, Magicplex 음성인경우는없었고 Magicplex 양성, 혈청학적검사음성인경우가 5 예였다. C 형간염은 Magicplex 양성, 혈청학적검사음성인예는없었고혈청학적검사 양성, Magicplex 음성인경우가 7 예였다 (Table 5). Anti-HCV (+) (N=15) Age (yr) 46.17±17.80 33.43±9.64 48.04±14.39 55.73±15.22 Sex (M/F) 93/91 17/11 14/11 10/5 AST (IU/L) 483.81±94.30 2,426.07±445.59 188.56±58.31 108.53±52.22 ALT (IU/L) 417.52±89.96 1,929.79±443.71 110.56±23.30 74.47±22.50 TB (mg/dl) 1.88±0.27 7.26±1.22 2.18±0.77 0.98±0.28 DB (mg/dl) 1.26±0.20 5.47±0.88 1.33±0.50 0.55±0.20 Abbreviations: TB, total bilirubin; DB, direct bilirubin. Table 2. Comparison of serum IgM anti-av and Magicplex RT-PCR results of HAV in 184 patients HAV Magicplex RT-PCR Positive Negative Total IgM anti-hav Positive 27 1 28 Negative 7 149 156 Total 34 150 184 Kappa value: 0.845, P <0.01. Abbreviations: HAV, hepatitis A virus; RT-PCR, real-time PCR. Table 3. Comparison of serum HBsAg and Magicplex RT-PCR results of HBV in 184 patients HBV 고찰 현재대부분의병원에서간염바이러스검사를일상적인선별검 사로사용하고있지않으며증상이있고질환이의심되는환자에 한정하여시행하고있다. A 형, B 형, C 형간염모두유병률이높고 심각한결과를초래할수있음에도불구하고선택적으로검사를 시행하므로잠복감염이나무증상감염을발견하지못하는경우가 있다. 또한요즘증가하고있는중복감염을놓칠가능성도있다. 중복감염은발생시단독감염에비해심각한간질환과간암을유 도하고, 예후가좋지않다는연구결과들 [13-15] 이발표된바있다. 따라서무증상환자를조기에발견할수있는진단법이필요한시 점이므로분자생물학적방법으로 A 형간염, B 형간염, C 형간염 검사를한번에시행할수있는 Magicplex 의평가는시의적절했다 고생각된다. 본연구결과에서기존의혈청학적검사와 Magicplex 일치율은 모두 95% 이상으로비교적높게나타났다. 기존의혈청학적검사 들과불일치한경우를상세히살펴보면 A 형간염의경우혈청학적 검사양성, Magicplex 음성인경우가 1 예, Magicplex 양성, 혈청학 적방법음성인경우가 7 예였다. Magicplex RT-PCR Positive Negative Total HBsAg Positive 25 0 25 Negative 5 154 159 Total 30 154 184 Kappa value: 0.893, P <0.01 Abbreviations: HBV, hepatitis B virus; RT-PCR, real-time PCR. Table 4. Comparison of serum anti-hcv and Magicplex RT-PCR results of HCV in 184 patients HCV Magicplex RT-PCR Positive Negative Total Anti-HCV Positive 8 7 15 Negative 0 169 169 Total 8 176 184 Kappa value: 0.677, P <0.01 Abbreviations: HCV, hepatitis C virus; RT-PCR, real-time PCR. 혈청학적검사양성, Magicplex 음성인경우는처음방문한병 원에서급성 A 형간염으로진단받고치료를받던중증세가호전 되지않아내원한환자로지속적으로약물을투여하고있는상태 였다 ( 환자 1). 처음진단당시 AST/ALT 가 3,615/3,000 이었으나내 원당시 AST/ALT 는 182/827 로감소되어있었다. 위와같은결과는 Anti-HAV 의경우약 4-6 주가량지속되어혈청학적방법으로검출 www.labmedonline.org 25
Table 5. Discrepant results between serologic test and Magicplex RT-PCR Pt. Serologic test Magicplex RT-PCR Clinical information IgM anti-hav HBsAg Anti-HCV HAV HBV HCV Final diagnosis Others 1 (+) (+) (-) (-) (+) (-) Acute hepatitis A Hepatitis medication 2 (-) (-) (-) (+) (-) (-) Acute hepatitis A IgM anti-hav(+) on repeat serologic test 3 (-) (-) (-) (+) (-) (-) Acute hepatitis A IgM anti-hav(+) on repeat serologic test 4 (-) (-) (-) (+) (-) (-) Acute hepatitis A IgM anti-hav(+) on repeat serologic test 5 (-) (-) (-) (+) (-) (-) Acute hepatitis A IgM anti-hav(+) on repeat serologic test 6 (-) (+) (-) (+) (+) (-) HCC due to hepatitis B Radiation therapy 7 (-) (-) (+) (+) (-) (+) Known chronic hepatitis C HCV genotype: Type 1b in 2010 8 (-) (-) (-) (+) (-) (-) R/O) Acute hepatitis A Further evaluation was impossible 9 (-) (-) (-) (-) (+) (-) Operation for paravalvular leakage HBsAb: 210.5 miu, AST/ALT (35/14) 10 (-) (-) (-) (-) (+) (-) Acute laryngitis HBsAb: 10.4 miu, AST/ALT (27/34) 11 (-) (-) (-) (-) (+) (-) Traumatic pneumothorax HBsAb: > 1,000.0 miu, AST/ALT (14/11) 12 (+) (-) (-) (+) (+) (-) Acute hepatitis A HBsAb: 851 miu, AST/ALT (506/2910) 13 (-) (-) (-) (-) (+) (-) R/O) Toxic hepatitis HBsAb: < 2.0 miu, AST/ALT (723/745) 14 (-) (-) (+) (-) (-) (-) HCC due to hepatitis C HCV genotype: Type 2a in 2011 15 (-) (-) (+) (-) (-) (-) Hepatic encephalopathy d/t hepatitis C HCV genotype: Type 2a in 2009 16 (-) (-) (+) (-) (-) (-) End-stage renal disease Anti-HCV(+) in 2010 17 (-) (-) (+) (-) (-) (-) End-stage renal disease Anti-HCV(+) in 2004 18 (-) (-) (+) (-) (-) (-) End-stage renal disease Anti-HCV(-) in 2007 19 (-) (-) (+) (-) (-) (-) Unstable angina Anti-HCV(+) in 2010 20 (-) (-) (+) (-) (-) (-) For medical examination Anti-HCV(+) in 2010 Abbreviations: RT-PCR, real-time PCR; Pt, patient; HAV, heaptitis A virus; HBV, heaptitis B virus; HCV, heaptitis C virus; HCC, hepatocellular carcinoma. 이되었으나 HAV의경우치료약제의복용으로인해사멸하여 Magicplex 로검사시음성으로나온것으로추측된다. Magicplex 에서 HAV가검출되었으나혈청학적검사음성인 7예중 4예는임상적으로 A형간염이강력히의심되었던환자로혈청학적검사에서음성이나온후시행한추가검사에서양성으로확인되었다 ( 환자 2-5). Lee 등 [16] 은 2008년시행한연구에서내원당시 IgM anti-hav 가음성이었으나추적검사에서양성으로판정되어 A형간염으로진단된경우가 6.7% 있었다고보고했고, Hirata 등 [17] 도임상적으로 A형간염이강력히의심될경우 1-2주후재검하면대부분에서혈청전환을확인할수있었다는보고를한것으로보아위의 4예의경우는실질적으로두검사간의결과가일치했다고판단된다. 나머지 3예중 2예는다른종류의간염으로진단받은과거력이있는환자로 1예는 B형간염으로인한간세포암환자였고 ( 환자 6), 1예는 C형간염으로치료받은환자였다 ( 환자 7). 불일치를보인 2예의경우중복감염을 Magicplex 가민감하게검출했을가능성도있지만 primer가다른종류의간염바이러스와반응하여위양성을보였을가능성을배제할수없다. 이에대하여이번연구를통해서는밝힐수없었으며추가연구가필요한부분이라고판단된다. 나머지 1예는임상양상으로급성간염이강력히의심되었으나추가진료를받지않아재검이불가능하였다 ( 환자 8). B형간염은혈청학적검사양성, Magicplex 음성인예는없었고 Magicplex 양성, 혈청학적검사음성인경우가 5예였다. 5예중 3예 는급성간염에해당하는증상없이다른주소로내원하여치료받던환자로 HBsAg 음성이었으나 Magicplex 에서 HBV가검출되었다 ( 환자 9-11). 간염을의심할만한임상증상이없었고다른검사결과도간염을의심하기힘들어 Magicplex 의위양성가능성이높으나환자 10의경우 anti-hbs가낮은것으로보아잠복감염을배제할수없다. 급성간염의증상을보인 2예중 1예는 IgM anti-hav 가검출되어급성 A형간염진단하에치료받은환자로다른종류의간염바이러스와교차반응하여위양성을보였을가능성이있다 ( 환자 12). 마지막 1예는급성간염의혈청학적지표들이모두음성으로판명되어독성간염의심하에치료받았다 ( 환자 13). 독성간염의심하에치료받은환자가연구기간내추가로혈청학적검사를시행하지않아 Magicplex 의위양성여부는확인할수없었다. 우리나라를포함한 B형간염만연지역과감염의예방을위해예방접종을시행하는지역에서는 vaccine escape mutant가증가할가능성이높다는연구결과와 [18] 혈청학적방법은사용시약에따라돌연변이를검출하지못한다는연구결과 [19] 가보고된적이있고 B형간염보균자의혈중에검사법의검출한계보다낮은농도로표면항원이존재할경우역시검출하지못한다는연구결과들 [20, 21] 을종합해보면전반적으로 Magicplex 의위양성가능성이높다고생각되나 Magicplex 의민감도가높아미량의바이러스를검출했을가능성을배제할수없다고판단된다. C형간염은 Magicplex 양성, 혈청학적검사음성인예는없었고 26 www.labmedonline.org
혈청학적검사양성, Magicplex 음성인경우가 7예이다. 각각살펴보면 7예중 2예는간질환과연관이있었는데 1예는간세포암종파열로수술을받은환자 ( 환자 14) 였고나머지 1예는간경화로인한간성뇌증으로입원한환자였다 ( 환자 15). 간세포암종으로진단받은환자는동시에실시한 HCV 정량검사에서 256 IU/mL, 유전형은 2a로밝혀져 Magicplex 의위음성으로판정했고간성뇌증으로입원한환자는 1년전시행한 HCV 정량검사결과가 218 IU/mL, 유전형 2a로나타나위음성의가능성이높은것으로판단되지만추가검사를시행하지않아정확한판단은어렵다. 나머지 5예는간질환과무관한증상으로내원한환자로그중 3예는투석환자 ( 환자 16-18) 이고 1예는심장질환 ( 환자 19), 1예는건강검진으로내원한경우였다 ( 환자 20). 이러한결과들의원인은크게세가지로추측된다. 첫째로 Magicplex 의위음성가능성을생각할수있다. 혈청학적검사는바이러스자체나그항원을검출하는것이아니고 anti-hcv 항체를탐지하는방법이므로현재체내에서증식이일어나지않는과거감염일경우 C형간염바이러스의활동상태가아니므로 HCV RNA가검출되지않을가능성 [22] 이있다. 2007년시행된한연구 [1] 에서는심지어급성 C형간염조차 40% 는진단당시 HCV RNA를검출할수없었다고보고한바있다. 두번째혈청학적검사로측정한 anti-hcv의위양성가능성을생각해볼수있다. 위양성의원인으로항원제조과정에서발생한오염원과재조합항원이비특이적부위에결합하는혈청내비특이항체등을고려할수있다 [23]. 기존의다른연구들 [7, 24] 에서도이번실험결과와비슷한수준의위양성률을보이는것으로보아근본적으로존재하는혈청학적검사의위양성이이번실험에서도영향을미쳤을가능성이있다고추측된다. 마지막으로생각할수있는원인은한랭글로불린의영향이다. Thiel 등 [25] 은 C형간염바이러스양성간질환자에서한랭글로불린에의해 PCR 결과가위음성으로나오는경우에대한보고를한바있다. 이번실험에서혈청학적검사는검체채취후바로시행되었으나 Magicplex 로검사하기까지최장 4개월간 -70 에서보관하는과정에서한랭글로불린의영향을받아검사시위음성을보였을가능성이있다고생각된다. 본논문은후향적논문이므로재검이나추가검사가불가능하다는제한점이있다. 또한혈청학적검사와 Magicplex 를이용한검사를동시에진행하지못하고시간차를두고검사하여완벽하게동일한조건을유지하지못한점도이번연구의한계점이라할수있다. 결론적으로 Magicplex 는기존의검사와일치율이비교적높으나각종간염바이러스간의교차반응가능성과 C형간염바이러스검출의위음성가능성이명확히규명되지않아아직까지기존의혈청학적방법을완전히대체하기는힘들다고판단된다. 하지만 분자생물학적검사법의단점인검체처리및검사방법의어려움이자동화로인해편리해졌고무엇보다세가지형태의간염바이러스를한번에검출할수있는장점이있기때문에대규모연구를시행해명확하지않은부분에대해규명한다면 Magicplex 를선별검사로사용할수있을것이라생각된다. 요약 배경 : 간염은여러가지원인으로생길수있지만가장중요한원인은만성간질환을유발할수있는간염바이러스이다. 지금까지간염을진단하기위해서 A형간염바이러스 IgM 항체 (IgM anti- HAV), B형간염표면항원검사 (HBsAg), 항-C형간염바이러스항체 (anti-hcv) 를각각혈청학적방법으로검사해야했으나분자생물학적방법으로세가지검사를한번에시행할수있는 Magicplex HepaTrio Real-time PCR (Seegene, Seoul, Korea, 이하 Magicplex) 이개발되어저자는그성능을평가하고자하였다. 방법 : 본원에서 IgM anti-hav, HBsAg, anti-hcv 검사를동시에시행한총 184명의환자를후향적으로조사하였다. IgM anti-hav, HBsAg, Anti-HCV 측정은모두전기화학적발광면역측정법 (electrochemiluminescence immunoassay) 을이용한 Roche Modular Analytics E170 (Roche Diagnostics, Mannheim, Germany) 을사용했으며기존의혈청학적방법과 Magicplex 의양성률과일치율을분석하였다. 결과 : 총 184개의검체를분석한결과 IgM anti-hav, HBsAg, anti- HCV의양성률은각각 15.2% (28/184), 13.6% (25/184), 8.2% (15/184) 로나타났다. Magicplex로검사한결과 HAV 양성률은 18.5% (34/184), HBV 양성률은 16.3% (30/184), HCV 양성률은 4.3% (8/184) 로나타났고두방법간의일치율은 A형간염 95.7% (176/184), B형간염 97.3% (179/184), C형간염 96.2% (177/184) 로나타났다. 결론 : 새로이개발된 Magicplex 는기존의혈청학적검사법과 95% 이상의일치율을보였다. 그러나각종간염바이러스간의교차반응가능성과 C형간염바이러스검출의위음성가능성이명확히규명되지않아아직까지혈청학적방법을완전히대체하기는힘들다고판단된다. 그럼에도불구하고기존의분자생물학적검사법의단점인검체처리및검사방법의어려움이자동화로인해편리해졌음으로위의문제점을보완한다면 Magicplex 를선별검사로사용해도좋을것이라생각된다. 감사의글 연구를위하여도움을주신 씨젠측에감사드립니다. www.labmedonline.org 27
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