ORIGINAL ARTICLE Development of External Quality Controls for Human Immunodeficiency Virus Antigen/ Antibo

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1 ORIGINAL ARTICLE Development of External Quality Controls for Human Immunodeficiency Virus Antigen/ Antibody Tests in Korea Dong Hee Seo 1,2, Yeo Rin Choi 1, Won Woong Choi 1, Cheol Hee Yoon 3, Byeong Sun Choi 3, Yoon-Seok Chung 3, and Chun Kang 3 1 WON Medical Corporation, Bucheon; 2 LabGenomics Clinical Laboratories, Seongnam; 3 Division of AIDS, Centers for Disease Control & Prevention, Cheongju, Korea Corresponding author: Dong Hee Seo LabGenomics Clinical Laboratories, 700 Daewangpangyo-ro, Bundanggu, Seongnam 13488, Korea Tel: Fax: Background: Quality control is important for accurate diagnosis of human immunodeficiency virus (HIV) infection, and proficiency testing with external quality controls is an important part of quality control. This study intended to develop and supply customized external quality controls for HIV antigen/antibody testing fitted with currently used reagents for standardization of HIV infection diagnosis and evaluation of HIV testing competency of laboratories in Korea. Methods: Serological tests and inactivation were performed on the obtained HIV antibody positive plasma. To manufacture quality controls having the required antibody titers, dilution ratio was searched using VIDAS (biomérieux, France), Architect (Abbott Laboratories, USA), and Cobas 8000 (Roche Diagnostics, Germany) analyzers. Diluted source plasma was divided into aliquots after filtering. Homogeneity and stability of the produced external quality controls were evaluated. Results: The collected HIV antibody positive plasma was confirmed by Western blot. Dilution ratios for source plasma were produced for each analyzer showing signal-to-cutoff 2 3, 5 7, and reactivity. Diluted plasma was made to 1 ml aliquots and total set of 1,500 external quality controls for HIV antigen/antibody were manufactured. Produced controls satisfied the required criteria of homogeneity and showed less than 10% coefficient of variation for stability except negative controls. Conclusions: Customized external quality controls were developed and qualified for HIV testing reagents used in Korea. Continuous external quality control assessment for HIV tests with controls would be required. (J Lab Med Qual Assur 2018;40:92-100) Key Words: HIV, Quality control, Antibody, Proficiency test pissn: eissn: Received December 15, 2017, Revision received April 3, 2018, Accepted April 11, 2018 서론 Human immunodeficiency virus (HIV) 항원 항체검사는 HIV 감염자의조기발견, HIV 감염의진단및치료그리고안전한혈액공급등을목적으로사용되고있다. HIV 감염자의조기발견과 HIV 감염의전파방지를위해서는일선병 의원이나보건소같은 1차검사기관에서실시하는혈청검사의정확성이무엇보다중요하다. 현재 HIV 항원 항체검사법으로는 3세대 HIV enzyme-linked immunosorbent assay (ELISA) 에 p24 항원을결합한 4세대 ELISA 검사법이주로 사용되고있다 [1]. 항레트로바이러스제를이용한치료등으로현재 HIV 감염은치료가불가능한질환이아니라극복가능한질환으로여겨지고있다 [2]. 이러한 HIV 감염의정확한진단을위해서는의료기관또는공공기관의검사실에서시행되고있는검사에대한결과의정확성, 정밀성및재현성이보증되어야한다. 국내 HIV 감염검사는시 도보건환경연구원, 질병관리본부, 보건소, 혈액원, 그리고의료기관등에서시행되고있다. 검사의신뢰성확보를위하여일반적으로검사의내부정도관리와외부정도관리가시행되고있다. 검사의외부정도관리는 92 Copyright 2018 Korean Association of External Quality Assessment Service

2 동일한검체를다수의검사기관이측정하여장비또는측정방법에따라발생하는측정값의바이어스를최소화하여검사의정확도를유지하기위하여실시된다 [3]. 국내의대표적인임상검사외부정도관리기관으로는대한임상검사정도관리협회가있다. HIV검사에대한외부정도관리는 1998년국립보건연구원에서시작하였으며, 외부정도관리평가용물질을매년상반기와하반기에배포하고그결과를분석하여발표하고있다 [4,5]. 수혈로인한 HIV 감염예방을위해헌혈혈액에대한 HIV 항원항체검사는필수적인선별검사이고이러한혈액선별검사에대한품질보증프로그램도필요하다 [6]. 외부정도관리평가에는균질한다량의외부정도관리물질이필요한데, HIV 검사용외부정도관리물질은 HIV 항체양성혈액을이용하여만들어지고있다. 2005년부터는 HIV검사외부정도관리평가용물질제조가, 표준품개발경험과제조에필요한시설을갖춘민간기관에의하여이루어지고있다 [7]. 본연구는체계적인국가 HIV 감염진단표준화와국내 HIV 검사기관의검사능력향상을위하여품질관리가이루어진 HIV 항원 항체검사용맞춤형외부정도관리평가용물질을개발하여공급하는데그목적이있다. 재료및방법 HIV 항원 항체검사용맞춤형외부정도관리물질개발을위한원료물질인 HIV 항체양성혈액은 연구자원자개발및지속적인참여를위한프로그램 을통하여자발적으로참여한적합자를대상으로확보한성분채혈된혈장중, 75 C 이하의초저온냉동고에보관되어있던 12명의혈장을사용하였다. HIV p24 항원양성혈장은국내에서는확보하기가어려워호주국립보건원로부터 20 ml를구입하여확보하였다. HIV 항체음성혈장은대한산업보건협회한마음혈액원을통하여확보하였다. 1. 원료물질의혈청학적검사및불활성화원료물질의혈청학적검사및희석배수확인에는 VIDAS (biomérieux, Marcy-L Etoile, France), Architect plus (Abbott Laboratories, Abbott Park, IL, USA), Cobas 8000 (Roche Diagnostics, Mannheim, Germany) 검사장비를사용하였다. 상 하반기외부정도관리평가용표준품제조에필요한, 양성혈장 12개, 음성혈장 59개, 그리고조기검출능력을보기위한희석한양성혈장으로 signal-to-cut-off (S/ CO) 가 2-3, 5-7 그리고 15 이상의 3개의혈장을포함하여총 74개혈장에대해 rapid법으로는 SD BioLine HIV 1/2 3.0 (Standard Diagnostic Inc., Yongin, Korea), enzyme-linked fluorescence assay (ELFA) 법으로는 VIDAS HIV DUO Ultra (biomérieux), 혈구응집반응법 (particle agglutination) 으로는 Serodia HIV 1/2 (Fujirebio, Tokyo, Japan), CLIA (clinical laboratory improvement amendments) 법으로는 Architect HIV antigen-antibody (Ag/Ab) Combo (Abbott Laboratories), HIV combi PT ARC HIV Ag/Ab (Roche Diagnostics) 를이용하여 HIV 항체검사를진행하였다. HIV항원검사로는 ELFA법을이용한 VIDAS HIV p24 II (biomérieux) 로검사를실시하였다. HIV검사용외부정도관리평가용표준품개발에사용되는모든혈액은잠재적인인체감염가능성을가지고있기때문에사용자의안전을위하여 HIV 항체양성및음성원재료를항온수조에 56 C 에서 60분간가열하여병원체를불활성화하였다. 2. 저, 중, 고농도표준물질제조를위한희석배수산정 HIV검사외부정도관리평가용표준품제조계획에따라저농도 (S/CO 2-3), 중농도 (S/CO 5-7), 고농도 (S/CO 15 이상 ) 표준품제조희석배수를찾기위하여 VIDAS HIV DUO Ultra (biomérieux) 시약, Serodia HIV-1/2 (Fujirebio) 시약, Architect HIV Ag/Ab Combo (Abbott Laboratories) 와 ARC HIV Ag/Ab (Roche Diagnostics) 시약, 그리고 BioLine HIV 1/2 3.0 (Standard Diagnostic Inc.) 시약을사용하여총 3차례에걸쳐희석하여반응도를평가하였다. 도출된희석배수를제3의기관으로의뢰하여희석배수를다시한번확인하였다. 3. 원료의여과와분주희석한원료혈장을제조지시서에따라각농도별로각각 1,200 ml씩멸균된유리용기에분주하였다. 물질보존제로 methyl isothiazolin (Sigma Cat#M6045) 0.1 g, Bromo nitrodioxane (Sigma Cat#B8791) 0.1 g, proclin 300 (supelco Cat#48914-u) 10 μl 를각각그양을칭량하여별도로보관하였다. 칭량이완료된희석혈장을 0.4 μm Miracloth filter와 0.2 μm 멸균된필터로여과하여새로이멸균된용기에분주하고, 보존제를첨가한후라벨을부착하였다. HIV검사외부정도관리평가용표준품분주를위하여공공기관과민간기관용패널별로지정된라벨을부착한튜브를준비하였다. 음성과양성표준품을조합하여공공기관용으로 3 개 (A, B, C) 패널, 민간기관용으로 3개 (D, E, F) 패널을제조하였다. 튜브는장기보관에용이하며, 검체의누출이완전히차단된기능을가진 screw type 의 2 ml cryogenic tube J Lab Med Qual Assur 2018;40:

3 (Sarstedt AG & Co., Nümbrecht, Germany) 를사용하였다. 자동분주기를이용하여불활성화시켜놓은음성혈장을 1 ml 씩먼저분주하여시료물질용기의마개를닫고수량과용량을확인하고냉장상태에보관하였다. 음성혈장의분주가끝난후작업용안전상자내부를알코올로소독하고, 양성혈장을각각 1 ml씩소분하여외부정도관리평가용표준품을제조하였다. 4. 균질성및안정성평가 HIV검사외부정도관리평가용표준품은각검사실에서사용하는시약에맞춤형으로제조하였기때문에질병관리본부에서제시한균질성평가안에따라해당시약에대한균질성평가를진행하였다. 제조된표준품 10 바이얼에대해각시약별로 3회반복검사를시행하였다. 결과분석은 analysis of variance (ANOVA) 분석에의한 95% 신뢰구간에서안정성검증을하여 F비가 F기각치미만이거나 P-value가 0.05 초과면표준품은균질하다고판단하였다. 외부정도관리평가용표준품은제조후검사기관에서의검사까지최대 4주가소요되기때문에운송또는사용기간동안의표준품의안정성을확보하기위하여냉장, 실온두가지조건에서 0일, 5일, 12일, 21일에대해단기안정성평가를진 행하였다. 검체의흡광도를각날짜에측정하여 coefficient of variation (CV) 의변화가 10% 이내일때표준품이안정한것으로분석하였다. 결과 1. 원료혈장의특성 HIV 항체검사결과를이미알고있는결과와비교하였을때, 항체양성 12개의혈장과희석혈장 3개는모두양성으로판정되었으며, 음성혈장 59개는모두음성으로판정되었다 (Table 1). 선별검사에서 HIV 항체양성반응을보인 12 개원료혈장은질병관리본부에이즈종양바이러스과로웨스턴블롯검사를의뢰한결과, 모두최종양성으로판정되었다. 희석혈장은웨스턴블롯검사상저농도 (S/CO 2-3) 검체는 gp160/120 밴드에서 /- 반응을, 중농도검체는 p24 와 gp41에서 /- 반응을보였고 gp160/120 밴드에서는 1 반응을보였다. 고농도검체는 p24와 gp41에서 1 반응을, gp160/120에서 2 양성반응을보였다. 또한원료혈장은다른병원체의위험성을확인하기위하여 hepatitis B surface antigen, anti-hcv검사를 rapid 법 (Standard Diagnostic Table 1. HIV serological test results of primary and diluted source plasma Variable Reagent SD BioLINE HIV 1/2 3.0 VIDAS HIV DUO Ultra Serodia HIV 1/2 Architect HIV Ag/Ab Combo ARC HIV Ag/Ab Plasma /- <1 HIV 1/2 S/CO S/CO Primary / / / / / / / / / / / / Diluted S/CO / S/CO / S/CO > / The instruments used were from the following companies: SD BioLine HIV 1/2 3.0 (Standard Diagnostic Inc., Yongin, Korea), VIDAS HIV DUO Ultra (biomérieux, Marcy-L Etoile, France), Serodia HIV 1/2 (Fujirebio, Tokyo, Japan), Architect HIV Ag/Ab Combo (Abbott Laboratories, Abbott Park, IL, USA), and ARC HIV Ag/Ab (Roche Diagnostics, Mannheim, Germany). Abbreviations: HIV, human immunodeficiency virus; Ag/Ab, antigen-antibody; S/CO, signal-to-cut-off. 94 J Lab Med Qual Assur 2018;40:

4 Inc.)으로 진행한 결과 모두 음성이었다. 값을 고려하여 안정한 것으로 평가하였다(Table 5). 2. 희석배수 및 표준품 제조 HIV검사 외부정도관리 평가용 표준품 제조를 위한 희석 배수 시험결과, VIDAS 시약은 1:2,000 희석에서 저농도(S/ CO 2-3)를, 1:1,000에서 중농도(S/CO 5-7)를, 1:10 희석에 서 고농도(S/CO 15-16)를 보였다. 로슈와 애보트 시약에서 는 1:150, 1:3,500, 1:6,000 희석에서 각각 고농도, 중농도, 저 농도 반응값을 보였다(Table 2). 이 희석배수를 사용하여 표 준품을 만들어 각 기관별로 음성과 양성 검체 구성을 달리하 여 2016년도 상 하반기 공공기관과 민간기관의 숙련도 평가 에 필요한 HIV 항원 항체검사 외부정도관리 평가용 표준품 을 각각 750 set씩 총 1,500 set를 제조하였다. 분주와 라벨링 을 마친 외부정도관리 평가용 표준품이 Fig. 1에 나와 있다. 고찰 전 세계적으로 HIV검사에 대한 정도관리가 매우 중요하게 여겨지고 있으며, 각 국에서는 그 나라에 적합한 물질을 확보 하여 HIV 감염검사의 정도관리에 만전을 기하고 있다[8]. 외 3. 균질성 및 안정성 평가결과 분주된 외부정도관리 평가용 표준품의 균질성을 평가한 결 과 VIDAS, 로슈, 애보트 검사기기에서 모두 균질함을 보였다. Table 3과 Table 4에 HIV 항체 양성과 음성 검체 10 바이얼에 대한 VIDAS 시약의 균질성 평가결과가 나와 있다. ANOVA 분석결과 F비가 F기각치보다 낮아 모두 병간 균질성이 확보 됨을 보였다(Tables 3, 4). 안정성 평가에서는 4 C와 25 C 두 조건 모두에서 21일까지 안정함을 보였다. 다만 음성 검체는 S/CO 값이 매우 낮아서 S/CO 0.02의 변화가 CV 17.6%의 변 화를 유발해서 판정기준 10%를 넘었지만 음성 검체의 S/CO Fig. 1. External quality controls for human immunodeficiency virus antigen/antibody tests. Table 2. Determination of dilution rates of human immunodeficiency virus antibody positive source plasma according to reagents Reagent VIDAS (S/CO) Roche/Abbott (S/CO) Particle agglutination Rapid Dilution rates A institute B institute 1st 2nd 3rd 1st 2nd :1, :2, :3, :6, :1,000 1:8,000 1:10,000 1:10 1:90 1:150 1:10 1:150 Abbreviation: S/CO, signal-to-cut-off. J Lab Med Qual Assur 2018;40:

5 Table 3. Homogeneity evaluation of ten aliquots of candidate external quality controls with human immunodeficiency virus antibody positive reaction by VIDAS reagent Vial trial Analysis of variance: F ratio=1.68, F rejection value=2.39, and P-value=0.15. Table 4. Homogeneity evaluation of ten aliquots of candidate external quality controls with human immunodeficiency virus antibody negative reaction by VIDAS reagent Vial trial Analysis of variance: F ratio=0.77, F rejection value=2.39, P-value=0.63. 부정도관리물질은검사의정도관리에중요하며, 검사의신뢰성을객관적으로평가할수있다 [9]. HIV 검사용외부정도관리평가표준품은 HIV 감염자의조기발견및감염의진단, 안전한혈액공급등을목적으로검사장비나진단시약을사용하는검사의질관리에사용되고있다. 국내 HIV 감염의정확한진단을위해서혈액원과의료기관은다양한형태의검사방법과 HIV 확진검사전략을수립하여검사를수행하고있다. 특히근래에는기존의진단시약보다우수한성능을가진진단시약이널리보급되어사용되고있다 [10]. 국내의료서비스의특성상외국에서개발된진단시약을각실험실및병원검사실에서선별및확인검사용으로도입하여사용함에따라검사결과의정확성, 정밀성및재현성이보장되는검사의품질관리시스템이필요하다. 그러나그동안이루어진연구에서는단순히양성과음성을조합하여평가를진행하고그결과를공유하는수준이었다. 이에국내 HIV검사에대한정확도와정밀도, 그리고재현성이일정하게도출될수있는좀더체계화되고시스템화된국가차원의정도관리사업의필요성이대두되었다. 이에 2005년부터는숙련도평가용물질을더세분화하고체계화시켜다양한기관들이참여할수있도록질병관리본부국립보건연구원에서연구전략을수립하여기존에공공기관에서만시행하던숙련도평가를민간기관까지확대하게되었다. 그러나참여기관의증가로인하여소량제조하던숙련도평가용표준물질로는더이상의진행이어렵게되어원료물질제조용혈액확보와제조및품질평가부분을민간기관으로이관하여진행하게되었다. 이후매년상 하반기 2회의숙련도평가를진행하기위하여양성과음성그리고약양성물질, 항원양성물질등다양한농도의 HIV 숙련도 평가용표준물질을개발하여전국대학병원과종합병원을포함하여시 도보건환경연구원과보건소, 검역소는물론병무청까지참여하는대단위의숙련도평가가이루어지게되었으며그결과국내 HIV검사실의신뢰도를한단계높이고, 정부에서는국내 HIV검사실관리에대한정도관리자료를축적하고있다 [11,12]. 국제적으로 HIV 진단을위한다양한진단시약과장비가개발되고도입됨에따라사용장비와시약별로차이를최대한으로줄이기위하여각각에적합한맞춤형표준물질이필요하게되었고, 본연구를통하여이를개발하기에이르렀다. 공공기관의경우설문을통하여사용장비와시약에대하여전수조사를실시하여분석하였고, 민간기관의경우대한임상검사정도관리협회를통하여사용장비와시약을조사하였다. 조사결과공공기관에서사용하는장비와시약은약 5종으로다양하였으며, 민간기관은로슈와애보트 2종의장비와시약을주로사용하고있었다. 공공기관과민간기관에서사용하는장비와시약은서로상이하여, 각장비와시약에적합하도록질병관리본부표준물질제조권고안과 KS A ISO guide를기준으로표준물질을제조하고균질성과안정성평가를진행하였다. 최종적으로 HIV검사용숙련도평가에필요한한국형맞춤형표준물질을개발하였으며이를통하여더세분화되고다양한숙련도평가용맞춤형표준물질을개발할수있는기초자료를확보하였다 [13,14]. 한국산업규격에서라벨에표시되는정보는생산기관명, 물질명, 생산기관의코드, 배치번호, 안전경고에한정하라고규정하고있으며이는인증서에있는정보를이해하지않고물질을사용하는것을방지하기위한조치이다 [14]. 이에따라본연구의제조물질에도최소한의정보만라벨링하였다 (Fig. 1). 96 J Lab Med Qual Assur 2018;40:

6 Table 5. Stability evaluation of a candidate panel using VIDAS HIV DUO Ultra reagent 0 day 5 day 12 day 21 day Panel* Trial 4 C 25 C Mean CV 4 C 25 C Mean CV 4 C 25 C Mean CV 4 C 25 C Mean CV A A A A A A Abbreviations: HIV, human immunodeficiency virus; CV, coefficient variation. *A1, A4, A5, A6: HIV antibody positive controls; A2, A3: HIV antibody negative controls. Acceptable criteria of stability is CV 10%, exception is allowed to negative controls. J Lab Med Qual Assur 2018;40:

7 본연구과제수행결과로각시약별맞춤형표준물질의제조와품질의확보가가능하게되었으며, 이로인하여우리나라에서도 HIV검사외부정도관리평가용표준품을생산할수있는시스템이마련되었다. 향후에도국내에서제조된표준품을이용한지속적인 HIV검사에대한외부정도관리가필요하다고본다. HIV검사용외부정도관리평가용맞춤형표준물질개발에서제일어려운부분은 HIV 항체양성원료혈장의확보이다. 에이즈환자의치료성적이좋아지면서고역가의항체를가진혈장을구하기어렵게되고있다. 해외에서도이러한자원확보가어려워지고있는상황을극복하는방안들이모색되고있다 [15]. 본연구에서는기존연구에서형성된 HIV 감염자네트워크를이용하여항체양성혈액을확보하였고, 혈액원을통해음성혈액을구입하여연구를수행하였다. 본과제와유사한타연구를위해서도이러한 HIV 감염자및음성혈액의수요는점점증가되고있다. 그러나이러한혈액의확보를위해서는여러절차가필요하며, 이러한절차는일반화되어있지않다. 앞으로생명윤리및안전에관한법률에적합하게다량의원료물질확보가가능하게된다면다양한성능과농도를가진혈청전환패널, 저역가항체패널, 고역가항체패널등다양한패널개발을통해향후 HIV검사수행기관의외부정도관리와진단시약평가등다양한목적으로사용이가능할것으로여겨진다. 감사의글 이논문은질병관리본부의 2016년정책연구용역사업의 HIV 항원 항체검사용표준품개발 연구비지원으로이루어진것이다. REFERENCES 1. Lee SH. Update on laboratory testing for diagnosing HIV infection. Korean J Med 2016;90: Choi JY. Updates on preventing HIV infection. Korean J Med 2016;90: Min WK. Laboratory quality management. In: Korean Society for Laboratory Medicine, editor. Laboratory medicine. 5th ed. Seoul: PanMun, 2014: Lee JS, Park KY, Kim SS, Suh SD, Park HK, Hwang YS, et al. Report on external quality assessment of HIV antibody test (1998). J Clin Pathol Qual Control 1999;21: Kim SS, Suh SD, Kim OJ, Lee MW, Lee JS, Kim HS, et al. External quality assessment in anti-hiv enzyme immunoassay in Korea. J Clin Pathol Qual Control 2000;22: Cha YJ. The results of external proficiency tests to prevent transfusion-transmitted virus infection: there is a need for a quality assurance program for donor screening tests to prevent blood-borne virus infections. Korean J Blood Transfus 2010;21: Kim HS, Wang JS, Kee MK, Park J, Kim YR, Lee YR, et al. The current status of HIV serologic testing in Korean clinical laboratories during the year Korean J Blood Transfus 2008;19: Ferguson M, Holmes H, Sands D. National Institute for Biological Standards and Control/UK Blood Transfusion Service working standards for HBsAg, anti-hcv and anti-hiv-1 ( go/no-go controls). Vox Sang 2001;80: Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57: Lee K, Park HD, Kang ES. Reduction of the HIV seroconversion window period and false positive rate by using ADVIA Centaur HIV antigen/antibody combo assay. Ann Lab Med 2013;33: Korea Centers for Disease Control and Prevention. Development of HIV standard materials serologic external quality assurance program. Cheongju: Korea Centers for Disease Control and Prevention, Kim KC, Sim HJ, Park MN, Choi BS, Kang C. Effect of early HIV diagnosis by introduction of acute HIV confirmatory testing algorithm. Public Health Wkly Rep 2016;9: Korean Standards Association. KS A ISO guide 34: general requirements for the competence of reference material producers. Seoul: Korean Standards Association, Korean Standards Association. KS A ISO guide 31: reference materials-contents of certificates and labels. Seoul: Korean Standards Association, Parekh BS, Anyanwu J, Patel H, Downer M, Kalou M, Gichimu C, et al. Dried tube specimens: a simple and 98 J Lab Med Qual Assur 2018;40:

8 cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings. J Virol Methods 2010;163: J Lab Med Qual Assur 2018;40:

9 국내 HIV 항원 항체검사용외부정도관리물질의개발서동희 1,2 최여린 1 최원웅 1 윤철희 3 최병선 3 정윤석 3 강춘 3 1 원메디컬진단시약연구소, 2 랩지노믹스의학연구소, 3 질병관리본부에이즈 종양바이러스과 배경 : Human immunodeficiency virus (HIV) 감염의정확한진단을위해 HIV 검사에대한정도관리는중요하며, 외부정도관리물질을이용한신뢰도평가가정도관리에중요한부분이다. 국내 HIV 감염진단의표준화와국내 HIV 검사기관이사용하는시약에적합한 HIV 항원 항체검사용맞춤형외부정도관리물질을개발하여공급하는것이본연구의목적이었다. 방법 : HIV 항체양성혈장을확보하여혈청학적검사와불활성화를시행하였다. 일정농도를가진외부정도관리물질을생산하기위하여 VIDAS (biomérieux, France), Architect (Abbott Laboratories, USA), Cobas 8000 (Roche Diagnostics, Germany) 검사장비를이용하여희석배수를구하였다. 제조된외부정도관리평가표준품에대해균질성은 analysis of variance 로안정성은변이계수로평가하였다. 결과 : HIV 항체양성원료혈장은웨스턴블롯확인검사에서도양성을보였다. 각검사장비에대해흡광도비가 2-3, 5-7, 그리고 의값에해당하는원료혈장의희석배수를산출하였다. 여과된희석혈장을 1 ml 씩분주하여 HIV 항원 항체검사용외부정도관리물질을공공기관용과민간기관용으로각각 750 set 씩총 1,500 set 를생산하였다. 제조된외부정도관리물질의균질성은요구되는기준을만족하였고, 안정성은음성물질을제외하고 10% 미만의 CV 를보였다. 결론 : 국내에서사용하는 HIV 진단시약별로맞춤형외부정도관리물질의제조와품질의확보가가능하게되었다. 향후에도외부정도관리물질을이용한 HIV 검사에대한지속적인정도관리가필요하다고본다. (J Lab Med Qual Assur 2018;40:92-100) 교신저자 : 서동희우 )13488 경기도성남시분당구대왕판교로 700, 랩지노믹스의학연구소 Tel: 031) , Fax: 031) , J Lab Med Qual Assur 2018;40:

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