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1 대한수혈학회지 : 제 27 권제 3 호, 2016 The Korean Journal of Blood Transfusion Vol. 27, No. 3, , December pissn eissn Original Article HCV 및 HIV 선별검사양성헌혈자의헌혈보류해제검사에서의면역블롯검사적용의타당성검토 강재원ㆍ윤경원ㆍ서종현ㆍ서영익ㆍ박수진 대한적십자사혈액수혈연구원 Consideration of Appropriateness of Application of Immunoblot Assay as a Reentry Test for HCV or HIV Screening Reactive Donors Jae-Won Kang, Kyoung Won Youn, Jong-Hyun Seo, Young Ik Seo, Soojin Park Blood Transfusion Research Institute, Korean Red Cross, Wonju, Korea Background: Currently, serological assay, immunoblotting, and nucleic acid amplification test (NAT) are required as reentry tests for deferred donors with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) screening reactive result. However, immunoblotting must be performed even for serological nonreactive donors. In this study, the efficacy of immunoblot applications for serological nonreactive donors in donor reentry procedures was examined. Methods: We analyzed non-qualified donors with immunoblot results from 2011 to 2015 in Korea and investigated reentry procedures related with HCV or HIV in other countries. Results: Percentages of donors who could not be released due to immunoblot results even with serological nonreactive results were 54.2% (1,824/3,367) for HCV and 35.9% (4,300/11,964). In the case of 662 donors, their results were considered to be different using other assay kits or based on other criteria. In other countries, immunoblotting is not required as a donor reentry test. Conclusion: Indeterminate or reactive immunoblotting results in serological nonreactive donors were due to nonspecific reactions. It is not reasonable to apply immunoblotting to serological nonreactive donors. Therefore, we suggest that immunoblot assays be excluded from the reentry test. (Korean J Blood Transfus 2016;27: ) Key words: Reentry, Immunoblot, HCV, HIV 서론 사람면역결핍바이러스 (Human Immunodeficiency Virus, HIV), C형간염바이러스 (Hepatitis C Virus, HCV) 의수혈전파위험방지를위하여대한적십자사에서는 HIV 항체검사 (HIV antibody, anti-hiv), Received on November 11, Revised on December 7, Accepted on December 7, 2016 Correspondence to: Jae-Won Kang Blood Transfusion Research Institute, Korean Red Cross, 50 Hyeoksin-ro, Wonju 26465, Korea Tel: , Fax: , kangjaewon@redcross.or.kr This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright C 2016 The Korean Society of Blood Transfusion

2 강재원외 : 헌혈보류해제검사블롯검사적용타당성 HCV 항체검사 (HCV antibody, anti-hcv), HCV 면역블롯검사 (recombinant immunoblot assay, RIBA) 및 HIV, HCV에대한핵산증폭검사 (nucleic acid amplification test, NAT) 를실시하고있다. HIV의경우 anti-hiv 또는 HIV NAT에서양성결과를보일때, HCV의경우 anti-hcv 검사결과양성이면서면역블롯검사결과에서미결정이나양성결과를보일때또는 HCV NAT에서양성결과를보일때해당헌혈자를헌혈유보군으로관리하면서헌혈을금지하고있다. 이러한선별검사에서양성결과를보였다하더라도위양성결과의가능성이존재하기때문에일정기간이경과한후헌혈유보군에대한해제검사로서안전성검사를실시하여그결과에따라헌혈이가능할수있게되어있다. 1) 현행혈액관리법시행규칙에서는감염성인자의선별검사부적격으로인한헌혈금지대상자에대한안전성검사로 HCV의경우에는 anti-hcv, HCV 면역블롯검사 (recombinant immunoblot assay, RIBA) 와 HCV NAT, HIV의경우에는 anti-hiv( 현재는 HIV Antigen-antibody combo를실시 ), 웨스턴블롯 (Western blot, WB) 과 NAT를실시하도록규정하고있으며, 모두음성일경우에만이후헌혈이가능하게된다. 2) 그러나이러한안전성검사에대한규정은검사항목이순차적으로규정된것이아니기때문에안전성검사시항체검사결과음성이라하더라도 RIBA 또는 WB를실시하여야하며, 이들결과가음성으로나타나지않을경우항체검사와 NAT 모두음성일경우에도해제가불가능하게된다. RIBA 또는 WB의경우본래의목적은항체검사양성결과에대한확인이지만, 현행의안전성검사에서는확인이아닌또하나의선별검사와같은목적으로적용하고있기때문에, 현행의검사체계에서 RIBA 또는 WB의적용은검사시약의 용도와도맞지않을뿐아니라, 이로인하여다수의헌혈자를해제하지못하는경우가발생하게된다. 또한미국및캐나다등외국에서의헌혈보류자에대한해제절차권고사항에서도 3-8) RIBA 또는 WB를현검사체계와같은용도로사용하고있는경우는없기때문에현행의안전성검사체계를재고하여헌혈보류해제검사를재정립하는데도움을주고자하였다. 대상및방법 1. 헌혈유보군안전성검사결과에서의 RIBA 또는 WB 만의결과로인하여해제불가된헌혈자분석 대한적십자사혈액관리본부혈액정보관리시스템에축적된데이터베이스를활용하여 2011년부터 2015년동안본원에의뢰된 HCV 및 HIV 헌혈유보군에대한항체검사와 NAT에서는음성결과를보였으나, RIBA 또는 WB에서미결정 (indeterminate, ID) 또는양성결과를보여해제불가가된혈액의검사결과양상을분석하였다. HCV 헌혈유보군에대한안전성검사에서항체검사로는 Archiect Anti-HCV (Abbott, Wiesbaden, Germany), 면역블롯검사로는 HCV Blot 3.0 (MP Diagnostics, Singapore, Singapore), 핵산증폭검사로는 Cobas Ampliprep/Cobas Taqman HCV Test v2.0 (Roche, Molecular Systems, Inc. Branchburg, USA) 를사용하였다. HIV 헌혈유보군에대한안전성검사에서항체검사로는와 Architect HIV Ag/Ab Combo (Abbott, Wiesbaden, Germany), 면역블롯검사로는 2011년 1월부터 2012년 1월까지 HIV Blot 2.2 (MP Diagnostics, Singapore, Singapore) 를, 2012년 2월부터 2015년 12월까지 New LAV Blot 1 (Biorad, CA,

3 Korean J Blood Transfus Vol. 27, No. 3, , Dec USA) 을이용하였으며, 핵산증폭검사로는 Cobas Ampliprep/Cobas Taqman HIV Test v2.0 (Roche, Molecular Systems, Inc. Branchburg, USA) 를이용하여검사를실시하였다. 2. 외국에서의헌혈보류자에대한해제절차조사 미 FDA와일본적십자사, 캐나다혈액서비스, 일본적십자사사에서의 HCV 및 HIV 선별검사결과로인하여헌혈이보류된자들에대한해제절차를문헌및해당기관질의를통하여조사하였다. 3. 통계분석 HIV WB 결과에서서로다른두시약의결과차이에대한통계적유의성은 chi-square test로분석하였으며, P value의유의기준은 0.01 미만으로 하였다. 결과 1. 최근 5 년간 HCV 헌혈유보군에대한안전성검사에서 RIBA 만의결과로해제불가된헌혈자현황 2011년부터 2015년동안총 3,367건의 HCV 헌혈유보군에대한안전성검사가실시되어이중 1,824건 (54.2%) 은해제가불가능하였으며, 이중 1,230건 (67.4%) 은 anti-hcv와 HCV NAT 모두음성이었으나, RIBA 결과에서양성또는미결정결과를보여해제가불가능하였다 (Table 1). 2. 최근 5 년간 HIV 헌혈유보군에대한안전성검사에서 WB 만의결과로해제불가된헌혈자현황 2011년부터 2015년동안총 11,964건의 HIV 헌혈유보군에대한안전성검사가실시되어이중 4,300건 (35.9%) 은해제가불가능하였다. 이중 3,761 건 (87.5%) 은 HIV Ag/Ab combo 결과는음성이었으나, WB 결과에서양성또는미결정결과를보여해제가불가능하였는데, 이들에대한 NAT는 Table 1. Cases of non-reentered donors with RIBA despite NAT and anti-hcv negative results ( ) N (%) of not reentered donors Year N of test Total Other causes with RIBA negative RIBA ID or positive with NAT and anti-hcv negative (57.5%) 76 (28.7%) 189 (71.3%) (41.0%) 117 (43.8%) 150 (56.2%) (50.7%) 125 (32.1%) 264 (67.9%) (54.3%) 129 (33.2%) 260 (66.8%) (66.7%) 147 (28.6%) 367 (71.4%) Total 3,367 1,824 (54.2%) 594 (32.6%) 1,230 (67.4%) Abbreviations: RIBA, recombinant immunoblot assay; ID, indeterminate; NAT, nucleic acid amplification test; Anti-HCV, hepatitis C virus antibody

4 강재원외 : 헌혈보류해제검사블롯검사적용타당성 실시되지않았다 (Table 2). 3. HCV RIBA 결과로인한해제불가자의 RIBA 양상 HCV RIBA는안전성검사가의뢰된모든헌혈자의검체를대상으로실시하였기때문에, anti-hcv 및 NAT 결과에따라각기다른양상을관찰할수있었다. Anti-HCV와 HCV NAT 모두양성결과를보이면서 RIBA가양성인경우 core 밴드를비롯한대부분의밴드에서 정도의강한발색반응을보였다. 그러나 NAT가음성인경우에는 RIBA 양성이라하더라도 1, 2개의밴드에서만반응을보이는양상을나타냈다. 또한 anti-hcv가음성일경우 RIBA에서의밴드의강도는 anti-hcv가양성일경우에비하여상대적으로약한양상을보였다 (Fig. 1). Anti-HCV와 HCV NAT 모두음성이면서 RIBA 결과가양성또는미결정으로해제불가된 1,230명중 367명 (29.8%) 은이후해제검사를다시의뢰하였으며, 이중 107명은 (29.2%) 음성결과를보여해제되었으며, 260명 (70.8%) 은 ID 결과를보여해제불가되었다. 4. 안전성검사로서의 HIV WB 결과 년동안 HIV 헌혈유보군에대한안전성검사에서의 HIV WB은 HIV Ag-Ab combo 결과음성결과를보인 11,425건의검체에대해서만실시되었으며, 이중 2,391건은 HIV Blot 2.2 (MP Diagnostics), 9,034건은 New LAV Blot 1 (Biorad, CA, USA) 을이용하여검사가실시되었다. HIV Blot 2.2에의하여검사가실시된 2,391건중 533건 (22.3%) 은 ID 결과를보였으며, 1,858건 (77.7%) 은음성결과를보였다 (Table 3). 반면, New LAV Blot 1을이용하여검사가실시된 9,034건중 13건 (0.1%) 은양성으로, 3,215건 (35.6%) 은 ID 로, 5,806건 (64.3%) 은음성으로판정되어두시약간의결과에유의한차이가있었다 (P<0.001). 판정기준은사용시약의제조사및기준제시기관에따라달라 (Fig. 2), HIV Blot 2.2의경우 p17에서만반응을보일경우음성으로판정하지만, New LAV Blot 1에의한검사에서는 p18/17의경우 ID로판정하기때문에 New LAV Blot에서 p18/17에서만반응을보인 649건은 HIV Blot 2.2 로검사할경우음성으로판정될수있는것으로판단되었다. 또한 New LAV Blot에서양성으로판정된 13건은모두하나의 ENV 밴드에서반응 Table 2. Cases of non-reentered donors with HIV WB despite HIV Ag-Ab negative results ( ) Year N of test N (%) of not reentered donors Total Other causes with RIBA negative WB ID or positive with HIV Ag/Ab negative , (26.5%) 110 (18.5%) 484 (81.5%) , (25.2%) 57 (9.7%) 533 (90.3%) , (38.8%) 79 (8.4%) 860 (91.6%) , (37.7%) 76 (7.7%) 916 (92.3%) ,278 1,135 (49.8%) 267 (23.5%) 868 (76.5%) Total 11,964 4,300 (35.9%) 539 (12.5%) 3,761 (87.5%) Abbreviations: WB, Wstern blot; ID, indeterminate; HIV Ag/Ab, human immunodeficiency virus antigen and antibody

5 Korean J Blood Transfus Vol. 27, No. 3, , Dec Fig. 1. HCV RIBA patterns according to the results of anti-hcv and HCV NAT. (A) RIBA positive with reactive results for anti-hcv and HCV NAT. (B) RIBA positive with reactive result for anti-hcv and non-reactive result for HCV NAT. (C) RIBA positive with non-reactive results for anti-hcv and HCV NAT. (D) RIBA ID with reactive result for anti-hcv and non-reactive result for HCV NAT. (E) RIBA ID with non-reactive results for anti-hcv and HCV NAT. 을보인것으로이는 Consortium for Retrovirus serology standardization (CRSS) 의기준을근거한것이지만, 세계보건기구 (World Health Organization, WHO) 의기준을적용할경우에는 ID로판정될수있는대상이었다. 9) HIV WB이실시된대부분의검체의경우하나

6 강재원외 : 헌혈보류해제검사블롯검사적용타당성 Table 3. Number of donors with HIV Ag/Ab sero-negativity according to results of HIV Western blotting in the reentry test ( ) Criteria Results New LAV Blot 1 New LAV Blot 1 HIV Blot WHO CRSS 2.2* Interpretation HIV Blot 2.2* 0 13 (0.1%) 2ENV±GAG±POL 1ENV+(1 GAG or 1POL) Positive ENV (gp160/gp41/gp120) and GAG (p17/p24/p55) or POL (p31/p51/p66) 533 (22.3%) 3,215 (35.6%) GAG+POL, GAG, POL, ENV 1 ENV±GAG±POL, GAG+POL, GAG, POL Indeterminate Viral specific band reactivity but does not meet criteria for positive 1,858 (77.7%) 5,806 (64.3%) Negative No Band or p17 only No band Non-classified bands Total 9,034 (100.0%) 9,034 (100.0%) HIV Blot 2.2 (MP Diagnostics, Singapore, Singapore) was used between January, 2011 and January, 2012; New LAV Blot 1 (Biorad, CA, USA) was used between February 2012 and December *P<0.001 vs LAV Blot 1 by chi-square test; New LAV Blot 1 with CRSS criteria. Abbreviations: WHO, World Health Organization; CRSS, Consortium for Retrovirus serology standardization. 의밴드에서만반응을보이거나두개이상의밴드에서반응을보이더라도약한반응으로비특이반응에의한것으로여겨졌다. 그리고항체검사결과음성이면서 HIV WB가양성또는미결정결과로인한해제불가자 3,761명중 1,209명 (32.1%) 은이후해제검사가다시의뢰되어이중 383명은 (31.7%) 음성결과를보여해제되었고 826명 (68.3%) 은여전히 ID 결과를보였다. 6. HCV 및 HIV 헌혈보류자해제관련해외현황 미국, 캐나다, 일본및영국의헌혈자보류해제검사항목의비교는 Table 4에명시하였다. 1) 미국식품의약품안전국가이드라인미국식품의약품안전국 (Food and Drug administration, FDA) 에서는 2010년 5월 HCV와 HIV 선별검사로인하여헌혈이보류된자들에대하여해제검사가가능한대상과해제절차를명시한가이드라인을발표하였다. 3) 이가이드라인에서는 HCV의경우과거헌혈혈액선별검사결과 anti-hcv에서양성결과를보이면서 RIBA와 NAT 가음성이거나실시하지않는경우, 또는 RIBA ID인경우와 anti-hcv가음성이면서 HCV NAT 가양성인경우 6개월이경과되면 anti-hcv와개별검체에대한 HCV NAT를실시하여모두음성인경우에는이후헌혈이가능하도록되어있다. 이검사에서 HCV NAT가양성일경우에는영구적으로헌혈이보류되며, anti-hcv가양성이면서 HCV NAT가음성일경우에는이후추가 6개월경과후다시해제가능여부를위한검사를실시할수있도록되어있다. HIV의경우과거헌혈혈액선별검사결과 anti-hiv-1/2 양성이면서 p24 음성, WB 또는간접형광검사법 (immunofluorescence assay, IFA) 에서 ID 또는음성, HIV NAT 음성또는미실시인경우, anti-hiv-1/2와 p24가음성이면

7 Korean J Blood Transfus Vol. 27, No. 3, , Dec Fig. 2. Proposal of Reentry for Donors Deferred due to Reactive HCV Test Results. *Reentry can be considered by conducting follow-up testing after a waiting period of 6 months. Abbreviation: RIBA, Recombinant immunoblot assay. Table 4. Items of donor reentry test in other countries Country Institute HCV Test items for donor reentry United States Food and Drug Administration Anti-HCV HCV NAT Anti-HIV HIV NAT Canada Canada Blood Services All test for blood donor screening All test for blood donor screening Japan Japanese Red Cross Anti-HCV HCV NAT Anti-HIV HIV NAT United Kingdom JPAC* Anti-HCV HCV NAT Anti-HIV HIV NAT *Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee; Human immunodeficiency virus antibody and nucleic acid test, hepatitis B virus antigen and nucleic acid test, hepatitis C virus antibody and nucleic acid test, human T-cell lymphotropic virus antibody test, West Nile virus nucleic acid test, and syphilis antibody test. Abbreviations: HCV, hepatitis C virus; HIV, human immunodeficiency virus; NAT, nucleic acid amplification test. HIV 서 HIV NAT 양성인경우, anti-hiv-1/2 음성, p24 양성이면서 HIV NAT 음성또는미실시인경우 8 주가경과되면 anti-hiv-1/2 와개별검체에대한 HIV NAT를실시하여모두음성인경우에는이후헌혈이가능하도록되어있다. 이검사에서 HIV NAT가양성일경우에는헌혈이보류되며,

8 강재원외 : 헌혈보류해제검사블롯검사적용타당성 anti-hiv-1/2가양성이면서 HIV NAT가음성일경우에는이후추가 8주경과후다시해제가능여부를위한검사를실시할수있도록되어있다. 2) 그밖의국가에서의헌혈보류자해제절차 캐나다혈액서비스 (Canadian Blood Services, CBS) 에서는 HIV 및 HCV 항체검사양성이면서확인검사및 NAT에서는음성또는미결정을보인자, HIV p24 양성이면서 HIV 항체검사및 NAT에서는음성결과를보이거나미실시인경우이후헌혈시검체만을채취하고, 모든선별검사항목에서이상이발견되지않을경우이후헌혈이가능하도록하고있다. 4) 일본적십자사의경우도혈액사업관련기관담당자에따르면 HIV 및 HCV 항체검사양성이면서과거확인검사및 NAT의양성인이력이없는헌혈자는이후헌혈시혈액은사용하지않고선별검사결과항체검사와 NAT가모두음성일경우그다음헌혈부터혈액을사용할수있도록하고있다고한다. 영국수혈및조직이식자문위원회 (Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee, JPAC) 에서발간한 Red book: Guidelines for the Blood Transfusion Services in the UK, 8th edition, 2013 에따르면, 선별검사에서양성결과를보인경우이후확인검사를위하여 reference laboratory로보내지게되며, 확인검사결과가나올때까지는헌혈이금지된다. 확인검사결과음성시, 이후헌혈에서의일상적인선별검사결과와선별검사와같은성능의다른검사시약을이용한검사결과를확인하여야하며, 모두음성을보이면이후헌혈을가능하게된다. 8) 고찰현재헌혈자선별검사양성결과로인하여헌혈이보류된헌혈유보군에대한안전성검사는혈액관리법시행규칙에근거하여실시하고있으나, 실시검사항목이절차로규정되어있지않고항목으로나열되어있어, HCV와 HIV의경우혈청학적검사결과음성을보인경우에도면역블롯검사를실시하도록되어있다. 그결과혈청학적검사와 NAT에서모두음성결과임에도불구하고면역블롯검사결과로인해헌혈유보군으로부터해제되지못하는경우가다수존재하고있다. 본연구결과에서도 HCV 헌혈유보군에대하여실시한안전성검사대상 3,367명중 1,230명 (36.5%) 은 anti-hcv와 HCV NAT 검사결과가모두음성임에도불구하고 HCV RIBA 검사결과로인하여해제되지못한경우이며, HIV 헌혈유보군의경우에는안전성검사대상 11,964명중 3,761명 (31.4%) 가 HIV Ag-Ab combo 검사결과음성이지만 WB 결과로인하여해제되지못하였다. HIV WB의경우기간에따라사용시약이다르며, 두시약간의양성및 ID의비율의차이가나타났으나, 이는두시약의판정및적용기준에따른것이주요원인으로판단되었는데, New LAV Blot 1으로검사하여 ID 결과를보인검체중 649건은 p18/17에서만반응을보였다. 이러한소견은비록동일검체로두가지시약을비교하지는못하였으나 HIV Blot 2.2로검사할경우음성으로판정될가능성이컸으며, 양성결과를보인 13건은 CRSS가아닌 WHO의기준을적용할경우 ID로판정되기때문에만일 New LAV Blot 1으로검사한모든검체를 HIV Blot 2.2으로검사할경우결과는 ID 2,579건 (28.5%), 음성 6,455건 (71.5%) 로두기간에서의결과의비율은유사하게나타날것으로추정되었다

9 Korean J Blood Transfus Vol. 27, No. 3, , Dec 헌혈유보군에대한안전성검사는과거선별검사에서위양성결과의가능성을고려한차원에서실시하는것이지만, RIBA와 WB에서도비특이반응에의한위양성결과의가능성이존재하며, 시약제조사에따라판정기준이다르고밴드의반응강도판정은검사자의감각및주관에따라달라질수있기때문에동일검체에서도판정이달라질수있는요소가존재한다. 10) 또한면역블롯검사로인하여해제불가된자들중일부는이후다시의뢰된안전성검사에서같은양상을보이는경우도있었으나, 음성결과를보여해제되는사례도존재하였다. 미 FDA의가이드라인에서는 HCV 및 HIV로인한헌혈보류자에대한헌혈보류해제검사를 HIV는 8주후, HCV는 6개월후로설정하고있고, 11-13) HIV의경우 anti-hiv와 HIV NAT가모두음성일때, HCV의경우 anti-hcv와 HCV NAT 모두음성일때해제가가능하며, 모든해제검사 에 RIBA 및 WB에대한요구는없다. 이처럼항체검사와 NAT만을요구하고있으며, 캐나다와일본의경우도항체검사결과음성인검체에대한면역블롯검사는실시하고있지않다. 이와같이항체검사결과가음성인검체에대한면역블롯검사의실시는검사시약의용도에도맞지않을뿐만아니라다수의헌혈자로부터헌혈을보류시키게되는결과를초래하여혈액수급에영향을미칠수있는가능성이있으므로운영상비합리적이고비효율적인면을지니고있다. 따라서국내에서도미 FDA의가이드라인에맞추어혈청학적검사와핵산증폭검사만을안전성검사에적용하는것이바람직할것으로여겨졌으며, 이에다음과같이 HCV 및 HIV 헌혈유보군안전성검사체계개선안을제시하고자한다. HCV 헌혈유보군의경우 anti-hcv와 NAT를모두실시하여모두음성일경우에는해제가가능하며, NAT 양성일경우에는 anti-hcv 결과에관계없이 Fig. 3. Proposal of Reentry for Donors Deferred due to Reactive HIV Test Results. *Reentry can be considered by conducting follow-up testing after a waiting period of 8 weeks. Abbreviation: WB, western blot

10 강재원외 : 헌혈보류해제검사블롯검사적용타당성 헌혈을영구적으로보류한다. NAT가음성이면서 anti-hcv만양성일경우에는 RIBA를실시하여양성일경우에는영구보류, 음성또는 ID일경우에는해제는불가능하지만, 이후 6개월경과후안전성검사를실시할수있도록하는것이바람직할것으로여겨졌다 (Fig. 2). HIV 헌혈유보군의경우현행 6개월로되어있는안전성검사의뢰가능기간을 8주로단축하며, 안전성검사로는 anti-hiv( 또는 HIV Ag/Ab combo) 와 NAT를모두실시하여마찬가지로모두음성일경우에만해제가가능하며, NAT가양성일경우에는영구보류, anti-hiv가양성이면서 NAT가음성일경우에는 WB을실시하도록하며, 그결과양성또는 ID일경우에는영구보류, 음성일경우에는 8주경과뒤다시안전성검사를실시할수있도록일시유보군상태를유지하도록하는것이바람직할것으로여겨졌다 (Fig. 3). 이와같은검사체계의효율적인개선은연간약 1,000명의헌혈자를추가확보할수있을것으로여겨지며, 불필요한면역블롯검사를실시하지않음으로써인력및경제적인절감의효과를가져올수있을것으로사료되었다. 또한현재혈청학적검사음성으로면역블롯검사에서 ID 또는양성결과를보이는사례에대하여도이들에대한위양성여부를명확히판단할수있도록향후추적조사시스템의보완및향후혈청학적검사시약의성능에대하여면밀히검토등의보완이필요할것으로여겨졌다. 요약배경 : 현행규정에서는 C형간염바이러스 (hepatitis C virus, HCV) 및사람면역결핍바이러스 (human immunodeficiency virus, HIV) 선별검사양성헌혈자의헌혈보류해제검사로는혈청학적 검사, 면역블롯검사와핵산증폭검사를실시하여야한다. 그러나이규정에따르면혈청학적검사음성인헌혈자에대해서도면역블롯검사를실시하여야한다. 본연구에서는헌혈보류해제검사에서혈청학적검사음성헌혈자에대한면역블롯검사적용의타당성을검토하였다. 방법 : 2011년부터 2015년동안면역블롯검사결과로인하여해제불가된헌혈자의사례를분석하였으며, 다른국가에서의 HCV 및 HIV 선별검사양성헌혈자의헌혈보류해제절차를조사하였다. 결과 : 헌혈보류해제검사의뢰자중혈청학적검사결과음성이지만면역블롯검사결과로헌혈보류해제가불가된백분율은 HCV 54.2% (1,824/ 3,367) 과 HIV 35.9% (4,300/11,964) 였다. HIV 헌혈보류해제불가중 662건은제조사가다른검사시약을사용하거나결과판정기준을달리적용할경우에는판정결과가달라질수있을것으로여겨졌다. 외국의경우 HCV 및 HIV 헌혈보류해제검사면역블롯검사를적용하지않고있었다. 결론 : 혈청학적검사음성헌혈혈액에서의면역블롯검사양성또는미결정결과는비특이반응에기인한것으로혈청학적검사음성혈액에대한면역블롯검사의적용은합리적이않은것으로판단되었다. 따라서헌혈보류해제검사에서는면역블롯검사는생략되어야할것으로사료되었다. References 1. Mac Kenzie WR, Davis JP, Peterson DE, Hibbard AJ, Becker G, Zarvan BS. Multiple falsepositive serologic tests for HIV, HTLV-1, and hepatitis C following influenza vaccination, JAMA 1992;268: Ministry of Health and Welfare. Blood mana

11 Korean J Blood Transfus Vol. 27, No. 3, , Dec gement act enforcement regulation. law.go.kr/lsinfop.do?lsiseq=167324&efyd= #0000 [Online] (last visited on 5 October 2016). 3. U.S. Food and Drug Administration. Guidance for industry: nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry. odvaccines/guidancecomplianceregulatoryi nformation/guidances/blood/ucm pdf [Online] (last visited on 5 October 2016). 4. Canadian Blood Services. Donor reentry at Canadian Blood Services. files/events/donor%20re-entry%20slides% pdf [Online] (last visited on 21 January 2016). 5. U.S. Food and Drug Administration. FDA memorandum to all registered blood establishments: revised recommendations for the prevention of Human Immunodeficiency Virus (HIV-1) transmission by blood and blood products. BiologicsBloodVaccines/Guidance [Online] (last visited on 19 September 2016). 6. U.S. Food and Drug Administration. FDA memorandum to all registered blood and plasma establishments: recommendations for donor screening with a licensed test for HIV-1 antigen, odvaccines/guidancecomplianceregulatoryi nformation/otherrecommendationsformanuf acturers/memorandumtobloodestablishments /UCM pdf [Online] (last visited on 19 September 2016). 7. U.S. Food and Drug Administration. FDA memorandum to all registered blood establishments: revised recommendations for testing whole blood, blood components, source plasma and source leukocytes for antibody to hepatitis C virus encoded antigen(anti-hcv), ines/guidancecomplianceregulatoryinformat ion/otherrecommendationsformanufacturers /MemorandumtoBloodEstablishments/UCM pdf [Online] (last visited on 19 September 2016). 8. Guidelines for the Blood Transfusion Services. Joint United Kingdom (UK) blood transfusion and tissue transplantation services professional a- dvisory committee. logy-tests-for-donors-and-donations-general-sp ecifications-for-laboratory-test-procedures/9-4- reinstatement-of-blood-donors [Online] (last visited on 5 October 2016). 9. Bio-Rad. The manual of NEW LAV BLOT I. Hercules: Bio-Rad, Oh DJ, Kang JW, Park YM. Analysis of the effectiveness of blotting assays for donor blood screening. Korean J Blood Transfus 2011;22: Blood Products Advisory Committee. Reentry for donors deferred because of HIV or HCV NAT or serological test results. fda.gov/ohrms/dockets/ac/01/briefing/3760 b1_01_mied.pdf [Online] (last visited on 5 October 2016). 12. Alter HJ. To C or not to C: these are the questions. Blood 1995;85: Centers for Disease Control. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. RR4719.pdf [Online] (last visited on 5 October 2016)

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untitled 대한수혈학회지 : 제 20 권제 2 호, 2009 B 형간염표면항원양성헌혈유보군의해제검사결과분석 강재원ㆍ전성욱ㆍ권소영ㆍ오덕자 = Abstract = 대한적십자사혈액수혈연구원 Analysis of the Reentry Test Results of the Deferred Donors with Hepatitis B Surface Antigen Reactivity