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援궡 HIV 빆썝 빆泥닿궗슜 쇅遺젙룄愿由щЪ吏덉쓽 媛쒕컻
Development of External Quality Controls for Human Immunodeficiency Virus Antigen/Antibody Tests in Korea
J Lab Med Qual Assur 2018;40:92-100
Published online June 30, 2018
© 2018 Korean Association of External Quality Assessment Service.

꽌룞씗1,2, 理쒖뿬由1, 理쒖썝썒1, 쑄泥좏씗3, 理쒕퀝꽑3, 젙쑄꽍3, 媛뺤텣3
Dong Hee Seo1,2, Yeo Rin Choi1, Won Woong Choi1, Cheol Hee Yoon3, Byeong Sun Choi3, Yoon-Seok Chung3, Chun Kang3

1닚썝硫붾뵒而 吏꾨떒떆빟뿰援ъ냼,
2옪吏끂誘뱀뒪 쓽븰뿰援ъ냼,
3吏덈퀝愿由щ낯遺 뿉씠利 醫낆뼇諛붿씠윭뒪怨

1WON Medical Corporation, Bucheon, Korea
2LabGenomics Clinical Laboratories, Seongnam, Korea
3Division of AIDS, Centers for Disease Control & Prevention, Cheongju, Korea
Correspondence to: Dong Hee Seo LabGenomics Clinical Laboratories, 700 Daewangpangyo-ro, Bundang-gu, Seongnam 13488, KoreaTel: +82-31-628-0730 Fax: +82-31-628-0701 E-mail: seo2023@nate.com
援먯떊옄: 꽌룞씗 슦)13488 寃쎄린룄 꽦궓떆 遺꾨떦援 솗뙋援먮줈 700, 옪吏끂誘뱀뒪 쓽븰뿰援ъ냼 Tel: 031)628-0730, Fax: 031)628-0701, E-mail: seo2023@nate.com
Received December 15, 2017; Revised March 3, 2018; Accepted March 11, 2018.
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.
 Abstract

諛곌꼍:

Human immunodeficiency virus (HIV) 媛먯뿼쓽 젙솗븳 吏꾨떒쓣 쐞빐 HIV寃궗뿉 븳 젙룄愿由щ뒗 以묒슂븯硫, 쇅遺젙룄愿由щЪ吏덉쓣 씠슜븳 떊猶곕룄 룊媛媛 젙룄愿由ъ뿉 以묒슂븳 遺遺꾩씠떎. 援궡 HIV 媛먯뿼吏꾨떒쓽 몴以솕 援궡 HIV 寃궗湲곌씠 궗슜븯뒗 떆빟뿉 쟻빀븳 HIV 빆썝꺕빆泥닿궗슜 留욎땄삎 쇅遺젙룄愿由щЪ吏덉쓣 媛쒕컻븯뿬 怨듦툒븯뒗 寃껋씠 蹂 뿰援ъ쓽 紐⑹쟻씠뿀떎.

諛⑸쾿:

HIV 빆泥 뼇꽦 삁옣쓣 솗蹂댄븯뿬 삁泥븰쟻 寃궗 遺덊솢꽦솕瑜 떆뻾븯떎. 씪젙 냽룄瑜 媛吏 쇅遺젙룄愿由щЪ吏덉쓣 깮궛븯湲 쐞븯뿬 VIDAS (bioM챕rieux, France), Architect (Abbott Laboratories, USA), Cobas 8000 (Roche Diagnostics, Germany) 寃궗옣鍮꾨 씠슜븯뿬 씗꽍諛곗닔瑜 援ы븯떎. 젣議곕맂 쇅遺젙룄愿由 룊媛 몴以뭹뿉 빐 洹좎쭏꽦 analysis of variance濡 븞젙꽦 蹂씠怨꾩닔濡 룊媛븯떎.

寃곌낵:

HIV 빆泥 뼇꽦 썝猷 삁옣 썾뒪꽩釉붾’ 솗씤寃궗뿉꽌룄 뼇꽦쓣 蹂댁떎. 媛 寃궗옣鍮꾩뿉 빐 씉愿묐룄鍮꾧 2-3, 5-7, 洹몃━怨 15-16쓽 媛믪뿉 빐떦븯뒗 썝猷 삁옣쓽 씗꽍諛곗닔瑜 궛異쒗븯떎. 뿬怨쇰맂 씗꽍 삁옣쓣 1 mL뵫 遺꾩<븯뿬 HIV 빆썝꺕빆泥닿궗슜 쇅遺젙룄愿由щЪ吏덉쓣 怨듦났湲곌슜怨 誘쇨컙湲곌슜쑝濡 媛곴컖 750 set뵫 珥 1,500 set瑜 깮궛븯떎. 젣議곕맂 쇅遺젙룄愿由щЪ吏덉쓽 洹좎쭏꽦 슂援щ릺뒗 湲곗쓣 留뚯”븯怨, 븞젙꽦 쓬꽦 臾쇱쭏쓣 젣쇅븯怨 10% 誘몃쭔쓽 CV瑜 蹂댁떎.

寃곕줎:

援궡뿉꽌 궗슜븯뒗 HIV 吏꾨떒떆빟蹂꾨줈 留욎땄삎 쇅遺젙룄愿由щЪ吏덉쓽 젣議곗 뭹吏덉쓽 솗蹂닿 媛뒫븯寃 릺뿀떎. 뼢썑뿉룄 쇅遺젙룄愿由щЪ吏덉쓣 씠슜븳 HIV寃궗뿉 븳 吏냽쟻씤 젙룄愿由ш 븘슂븯떎怨 蹂몃떎.

Background:

Quality control is important for accurate diagnosis of human immunodefi짯ciency 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 (bioM챕rieux, 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-cut-off 23, 57, and 1516 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.

Keywords : HIV, Quality control, Antibody, Proficiency test
꽌 濡

Human immunodeficiency virus (HIV) 빆썝꺕빆泥닿궗뒗 HIV 媛먯뿼옄쓽 議곌린 諛쒓껄, HIV 媛먯뿼쓽 吏꾨떒 諛 移섎즺 洹몃━怨 븞쟾븳 삁븸怨듦툒 벑쓣 紐⑹쟻쑝濡 궗슜릺怨 엳떎. HIV 媛먯뿼옄쓽 議곌린 諛쒓껄怨 HIV 媛먯뿼쓽 쟾뙆 諛⑹瑜 쐞빐꽌뒗 씪꽑 蹂묆꺕쓽썝씠굹 蹂닿굔냼 媛숈 1李 寃궗湲곌뿉꽌 떎떆븯뒗 삁泥寃궗쓽 젙솗꽦씠 臾댁뾿蹂대떎 以묒슂븯떎. 쁽옱 HIV 빆썝꺕빆泥닿궗踰뺤쑝濡쒕뒗 3꽭 HIV enzyme-linked immunosorbent assay (ELISA)뿉 p24 빆썝쓣 寃고빀븳 4꽭 ELISA寃궗踰뺤씠 二쇰줈 궗슜릺怨 엳떎[1]. 빆젅듃濡쒕컮씠윭뒪젣瑜 씠슜븳 移섎즺 벑쑝濡 쁽옱 HIV 媛먯뿼 移섎즺媛 遺덇뒫븳 吏덊솚씠 븘땲씪 洹밸났 媛뒫븳 吏덊솚쑝濡 뿬寃⑥怨 엳떎[2]. 씠윭븳 HIV 媛먯뿼쓽 젙솗븳 吏꾨떒쓣 쐞빐꽌뒗 쓽猷뚭린愿 삉뒗 怨듦났湲곌쓽 寃궗떎뿉꽌 떆뻾릺怨 엳뒗 寃궗뿉 븳 寃곌낵쓽 젙솗꽦, 젙諛꽦 諛 옱쁽꽦씠 蹂댁쬆릺뼱빞 븳떎.

援궡 HIV 媛먯뿼寃궗뒗 떆꺕룄 蹂닿굔솚寃쎌뿰援ъ썝, 吏덈퀝愿由щ낯遺, 蹂닿굔냼, 삁븸썝, 洹몃━怨 쓽猷뚭린愿 벑뿉꽌 떆뻾릺怨 엳떎. 寃궗쓽 떊猶곗꽦 솗蹂대 쐞븯뿬 씪諛섏쟻쑝濡 寃궗쓽 궡遺젙룄愿由ъ 쇅遺젙룄愿由ш 떆뻾릺怨 엳떎. 寃궗쓽 쇅遺젙룄愿由щ뒗 룞씪븳 寃泥대 떎닔쓽 寃궗湲곌씠 痢≪젙븯뿬 옣鍮 삉뒗 痢≪젙諛⑸쾿뿉 뵲씪 諛쒖깮븯뒗 痢≪젙媛믪쓽 諛붿씠뼱뒪瑜 理쒖냼솕븯뿬 寃궗쓽 젙솗룄瑜 쑀吏븯湲 쐞븯뿬 떎떆맂떎[3]. 援궡쓽 몴쟻씤 엫긽寃궗 쇅遺젙룄愿由ш린愿쑝濡쒕뒗 븳엫긽寃궗젙룄愿由ы삊쉶媛 엳떎. HIV寃궗뿉 븳 쇅遺젙룄愿由щ뒗 1998뀈 援由쎈낫嫄댁뿰援ъ썝뿉꽌 떆옉븯쑝硫, 쇅遺젙룄愿由 룊媛슜 臾쇱쭏쓣 留ㅻ뀈 긽諛섍린 븯諛섍린뿉 諛고룷븯怨 洹 寃곌낵瑜 遺꾩꽍븯뿬 諛쒗몴븯怨 엳떎[4,5]. 닔삁濡 씤븳 HIV 媛먯뿼 삁諛⑹쓣 쐞빐 뿄삁 삁븸뿉 븳 HIV 빆썝빆泥닿궗뒗 븘닔쟻씤 꽑蹂꾧궗씠怨 씠윭븳 삁븸꽑蹂꾧궗뿉 븳 뭹吏덈낫利앺봽濡쒓렇옩룄 븘슂븯떎[6]. 쇅遺젙룄愿由 룊媛뿉뒗 洹좎쭏븳 떎웾쓽 쇅遺젙룄愿由щЪ吏덉씠 븘슂븳뜲, HIV寃궗슜 쇅遺젙룄愿由щЪ吏덉 HIV 빆泥 뼇꽦 삁븸쓣 씠슜븯뿬 留뚮뱾뼱吏怨 엳떎. 2005뀈遺꽣뒗 HIV寃궗 쇅遺젙룄愿由 룊媛슜 臾쇱쭏 젣議곌, 몴以뭹 媛쒕컻 寃쏀뿕怨 젣議곗뿉 븘슂븳 떆꽕쓣 媛뽰텣 誘쇨컙湲곌뿉 쓽븯뿬 씠猷⑥뼱吏怨 엳떎[7]. 蹂 뿰援щ뒗 泥닿퀎쟻씤 援媛 HIV 媛먯뿼吏꾨떒 몴以솕 援궡 HIV 寃궗湲곌쓽 寃궗뒫젰 뼢긽쓣 쐞븯뿬 뭹吏덇由ш 씠猷⑥뼱吏 HIV 빆썝꺕빆泥닿궗슜 留욎땄삎 쇅遺젙룄愿由 룊媛슜 臾쇱쭏쓣 媛쒕컻븯뿬 怨듦툒븯뒗 뜲 洹 紐⑹쟻씠 엳떎.

옱猷 諛 諛⑸쾿

HIV 빆썝꺕빆泥닿궗슜 留욎땄삎 쇅遺젙룄愿由щЪ吏 媛쒕컻쓣 쐞븳 썝猷뚮Ъ吏덉씤 HIV 빆泥 뼇꽦 삁븸 쒖뿰援ъ옄썝옄 媛쒕컻 諛 吏냽쟻씤 李몄뿬瑜 쐞븳 봽濡쒓렇옩앹쓣 넻븯뿬 옄諛쒖쟻쑝濡 李몄뿬븳 쟻빀옄瑜 긽쑝濡 솗蹂댄븳 꽦遺 梨꾪삁맂 삁옣 以, 닋75째C 씠븯쓽 珥덉삩 깋룞怨좎뿉 蹂닿릺뼱엳뜕 12紐낆쓽 삁옣쓣 궗슜븯떎. HIV p24 빆썝 뼇꽦 삁옣 援궡뿉꽌뒗 솗蹂댄븯湲곌 뼱젮썙 샇二 援由쎈낫嫄댁썝濡쒕꽣 20 mL瑜 援ъ엯븯뿬 솗蹂댄븯떎. HIV 빆泥 쓬꽦 삁옣 븳궛뾽蹂닿굔삊쉶 븳留덉쓬삁븸썝쓣 넻븯뿬 솗蹂댄븯떎.

1. 썝猷뚮Ъ吏덉쓽 삁泥븰쟻 寃궗 諛 遺덊솢꽦솕

썝猷뚮Ъ吏덉쓽 삁泥븰쟻 寃궗 諛 씗꽍諛곗닔 솗씤뿉뒗 VIDAS (bioM챕rieux, Marcy-L섷toile, France), Architect plus (Abbott Laboratories, Abbott Park, IL, USA), Cobas 8000 (Roche Diagnostics, Mannheim, Germany) 寃궗옣鍮꾨 궗슜븯떎. 긽꺕븯諛섍린 쇅遺젙룄愿由 룊媛슜 몴以뭹 젣議곗뿉 븘슂븳, 뼇꽦 삁옣 12媛, 쓬꽦 삁옣 59媛, 洹몃━怨 議곌린 寃異쒕뒫젰쓣 蹂닿린 쐞븳 씗꽍븳 뼇꽦 삁옣쑝濡 signal-to-cut-off (S/CO)媛 2-3, 5-7 洹몃━怨 15 씠긽쓽 3媛쒖쓽 삁옣쓣 룷븿븯뿬 珥 74媛 삁옣뿉 빐 rapid踰뺤쑝濡쒕뒗 SD BioLine HIV 1/2 3.0 (Standard Diagnostic Inc., Yongin, Korea), enzyme-linked fluorescence assay (ELFA)踰뺤쑝濡쒕뒗 VIDAS HIV DUO Ultra (bioM챕rieux), 삁援ъ쓳吏묐컲쓳踰(particle agglutination)쑝濡쒕뒗 Serodia HIV 1/2 (Fujirebio, Tokyo, Japan), CLIA (clinical laboratory improvement amendments)踰뺤쑝濡쒕뒗 Architect HIV antigen-antibody (Ag/Ab) Combo (Abbott Laboratories), HIV combi PT ARC HIV Ag/Ab (Roche Diagnostics)瑜 씠슜븯뿬 HIV 빆泥닿궗瑜 吏꾪뻾븯떎. HIV빆썝寃궗濡쒕뒗 ELFA踰뺤쓣 씠슜븳 VIDAS HIV p24 II (bioM챕rieux)濡 寃궗瑜 떎떆븯떎. HIV寃궗슜 쇅遺젙룄愿由 룊媛슜 몴以뭹 媛쒕컻뿉 궗슜릺뒗 紐⑤뱺 삁븸 옞옱쟻씤 씤泥 媛먯뿼 媛뒫꽦쓣 媛吏怨 엳湲 븣臾몄뿉 궗슜옄쓽 븞쟾쓣 쐞븯뿬 HIV 빆泥 뼇꽦 諛 쓬꽦 썝옱猷뚮 빆삩닔議곗뿉 56째C뿉꽌 60遺꾧컙 媛뿴븯뿬 蹂묒썝泥대 遺덊솢꽦솕븯떎.

2. , 以, 怨좊냽룄 몴以臾쇱쭏 젣議곕 쐞븳 씗꽍諛곗닔 궛젙

HIV寃궗 쇅遺젙룄愿由 룊媛슜 몴以뭹 젣議곌퀎쉷뿉 뵲씪 냽룄(S/CO 2-3), 以묐냽룄(S/CO 5-7), 怨좊냽룄(S/CO 15 씠긽) 몴以뭹 젣議 씗꽍諛곗닔瑜 李얘린 쐞븯뿬 VIDAS HIV DUO Ultra (bioM챕rieux) 떆빟, Serodia HIV-1/2 (Fujirebio) 떆빟, Architect HIV Ag/Ab Combo (Abbott Laboratories) ARC HIV Ag/Ab (Roche Diagnostics) 떆빟, 洹몃━怨 BioLine HIV 1/2 3.0 (Standard Diagnostic Inc.) 떆빟쓣 궗슜븯뿬 珥 3李⑤뿉 嫄몄퀜 씗꽍븯뿬 諛섏쓳룄瑜 룊媛븯떎. 룄異쒕맂 씗꽍諛곗닔瑜 젣3쓽 湲곌쑝濡 쓽猶고븯뿬 씗꽍諛곗닔瑜 떎떆 븳踰 솗씤븯떎.

3. 썝猷뚯쓽 뿬怨쇱 遺꾩<

씗꽍븳 썝猷 삁옣쓣 젣議곗떆꽌뿉 뵲씪 媛 냽룄蹂꾨줈 媛곴컖 1,200 mL뵫 硫멸퇏맂 쑀由ъ슜湲곗뿉 遺꾩<븯떎. 臾쇱쭏 蹂댁〈젣濡 methyl isothiazolin (Sigma Cat竊긎6045) 0.1 g, Bromo nitrodioxane (Sigma Cat竊귻8791) 0.1 g, proclin 300 (supelco Cat竊48914-u) 10 關L瑜 媛곴컖 洹 뼇쓣 移웾븯뿬 蹂꾨룄濡 蹂닿븯떎. 移웾씠 셿猷뚮맂 씗꽍 삁옣쓣 0.4 關m Miracloth filter 0.2 關m 硫멸퇏맂 븘꽣濡 뿬怨쇳븯뿬 깉濡쒖씠 硫멸퇏맂 슜湲곗뿉 遺꾩<븯怨, 蹂댁〈젣瑜 泥④븳 썑 씪踰⑥쓣 遺李⑺븯떎.

HIV寃궗 쇅遺젙룄愿由 룊媛슜 몴以뭹 遺꾩<瑜 쐞븯뿬 怨듦났湲곌怨 誘쇨컙湲곌슜 뙣꼸蹂꾨줈 吏젙맂 씪踰⑥쓣 遺李⑺븳 뒠釉뚮 以鍮꾪븯떎. 쓬꽦怨 뼇꽦 몴以뭹쓣 議고빀븯뿬 怨듦났湲곌슜쑝濡 3媛(A, B, C) 뙣꼸, 誘쇨컙湲곌슜쑝濡 3媛(D, E, F) 뙣꼸쓣 젣議고븯떎. 뒠釉뚮뒗 옣湲곕낫愿뿉 슜씠븯硫, 寃泥댁쓽 늻異쒖씠 셿쟾엳 李⑤떒맂 湲곕뒫쓣 媛吏 screw type쓽 2 mL cryogenic tube (Sarstedt AG & Co., N체mbrecht, Germany)瑜 궗슜븯떎. 옄룞遺꾩<湲곕 씠슜븯뿬 遺덊솢꽦솕 떆耳쒕넃 쓬꽦 삁옣쓣 1 mL뵫 癒쇱 遺꾩<븯뿬 떆猷뚮Ъ吏 슜湲곗쓽 留덇컻瑜 떕怨 닔웾怨 슜웾쓣 솗씤븯怨 깋옣긽깭뿉 蹂닿븯떎. 쓬꽦 삁옣쓽 遺꾩<媛 걹궃 썑 옉뾽슜 븞쟾긽옄 궡遺瑜 븣肄붿삱濡 냼룆븯怨, 뼇꽦 삁옣쓣 媛곴컖 1 mL뵫 냼遺꾪븯뿬 쇅遺젙룄愿由 룊媛슜 몴以뭹쓣 젣議고븯떎.

4. 洹좎쭏꽦 諛 븞젙꽦 룊媛

HIV寃궗 쇅遺젙룄愿由 룊媛슜 몴以뭹 媛 寃궗떎뿉꽌 궗슜븯뒗 떆빟뿉 留욎땄삎쑝濡 젣議고븯湲 븣臾몄뿉 吏덈퀝愿由щ낯遺뿉꽌 젣떆븳 洹좎쭏꽦 룊媛븞뿉 뵲씪 빐떦 떆빟뿉 븳 洹좎쭏꽦 룊媛瑜 吏꾪뻾븯떎. 젣議곕맂 몴以뭹 10 諛붿씠뼹뿉 빐 媛 떆빟蹂꾨줈 3쉶 諛섎났 寃궗瑜 떆뻾븯떎. 寃곌낵遺꾩꽍 analysis of variance (ANOVA) 遺꾩꽍뿉 쓽븳 95% 떊猶곌뎄媛꾩뿉꽌 븞젙꽦 寃利앹쓣 븯뿬 F鍮꾧 F湲곌컖移 誘몃쭔씠嫄곕굹 P-value媛 0.05 珥덇낵硫 몴以뭹 洹좎쭏븯떎怨 뙋떒븯떎.

쇅遺젙룄愿由 룊媛슜 몴以뭹 젣議 썑 寃궗湲곌뿉꽌쓽 寃궗源뚯 理쒕 4二쇨 냼슂릺湲 븣臾몄뿉 슫넚 삉뒗 궗슜湲곌컙 룞븞쓽 몴以뭹쓽 븞젙꽦쓣 솗蹂댄븯湲 쐞븯뿬 깋옣, 떎삩 몢 媛吏 議곌굔뿉꽌 0씪, 5씪, 12씪, 21씪뿉 빐 떒湲 븞젙꽦 룊媛瑜 吏꾪뻾븯떎. 寃泥댁쓽 씉愿묐룄瑜 媛 궇吏쒖뿉 痢≪젙븯뿬 coefficient of variation (CV)쓽 蹂솕媛 10% 씠궡씪 븣 몴以뭹씠 븞젙븳 寃껋쑝濡 遺꾩꽍븯떎.

寃 怨

1. 썝猷 삁옣쓽 듅꽦

HIV 빆泥닿궗 寃곌낵瑜 씠誘 븣怨 엳뒗 寃곌낵 鍮꾧탳븯쓣 븣, 빆泥 뼇꽦 12媛쒖쓽 삁옣怨 씗꽍 삁옣 3媛쒕뒗 紐⑤몢 뼇꽦쑝濡 뙋젙릺뿀쑝硫, 쓬꽦 삁옣 59媛쒕뒗 紐⑤몢 쓬꽦쑝濡 뙋젙릺뿀떎(Table 1). 꽑蹂꾧궗뿉꽌 HIV 빆泥 뼇꽦 諛섏쓳쓣 蹂댁씤 12媛 썝猷 삁옣 吏덈퀝愿由щ낯遺 뿉씠利 醫낆뼇 諛붿씠윭뒪怨쇰줈 썾뒪꽩釉붾’寃궗瑜 쓽猶고븳 寃곌낵, 紐⑤몢 理쒖쥌 뼇꽦쑝濡 뙋젙릺뿀떎. 씗꽍 삁옣 썾뒪꽩釉붾’寃궗긽 냽룄(S/CO 2-3) 寃泥대뒗 gp160/120 諛대뱶뿉꽌 +/- 諛섏쓳쓣, 以묐냽룄 寃泥대뒗 p24 gp41뿉꽌 +/- 諛섏쓳쓣 蹂댁怨 gp160/120 諛대뱶뿉꽌뒗 1+ 諛섏쓳쓣 蹂댁떎. 怨좊냽룄 寃泥대뒗 p24 gp41뿉꽌 1+ 諛섏쓳쓣, gp160/120뿉꽌 2+ 뼇꽦 諛섏쓳쓣 蹂댁떎. 삉븳 썝猷 삁옣 떎瑜 蹂묒썝泥댁쓽 쐞뿕꽦쓣 솗씤븯湲 쐞븯뿬 hepatitis B surface antigen, anti-HCV寃궗瑜 rapid 踰(Standard Diagnostic Inc.)쑝濡 吏꾪뻾븳 寃곌낵 紐⑤몢 쓬꽦씠뿀떎.

Table 1 . HIV serological test results of primary and diluted source plasma.

꺿꺿긘ariableReagentSD BioLINE HIV 1/2 3.0VIDAS HIV DUO UltraSerodia HIV 1/2Architect HIV Ag/Ab ComboARC HIV Ag/Ab
Plasma+/-<1HIV 1/2S/COS/CO
Primary1+18.65+++/-507.08511.31
2+20.82+++/-849.17848.61
3+17.69++/-178.87172.25
4+20.91+++/-881.23894.14
5+12.05+/-124.97125.72
6+18.97+++/-164.88163.02
7+16.78++/-148.81149.50
8+19.87++/-194.48184.93
9+19.38+/-271.08266.57
10+20.94+++/-425.45427.95
11+20.70+++/-552.53531.20
12+20.82+++/-760.11787.02
DilutedS/CO 23+2.35+/-3.633.76
S/CO 57+6.73+/-6.266.73
S/CO >15+15.06++/-15.7117.45

The instruments used were from the following companies: SD BioLine HIV 1/2 3.0 (Standard Diagnostic Inc., Yongin, Korea), VIDAS HIV DUO Ultra (bioM챕rieux, Marcy-L섷toile, 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.


2. 씗꽍諛곗닔 諛 몴以뭹 젣議

HIV寃궗 쇅遺젙룄愿由 룊媛슜 몴以뭹 젣議곕 쐞븳 씗꽍諛곗닔 떆뿕寃곌낵, VIDAS 떆빟 1:2,000 씗꽍뿉꽌 냽룄(S/CO 2-3)瑜, 1:1,000뿉꽌 以묐냽룄(S/CO 5-7)瑜, 1:10 씗꽍뿉꽌 怨좊냽룄(S/CO 15-16)瑜 蹂댁떎. 濡쒖뒋 븷蹂댄듃 떆빟뿉꽌뒗 1:150, 1:3,500, 1:6,000 씗꽍뿉꽌 媛곴컖 怨좊냽룄, 以묐냽룄, 냽룄 諛섏쓳媛믪쓣 蹂댁떎(Table 2). 씠 씗꽍諛곗닔瑜 궗슜븯뿬 몴以뭹쓣 留뚮뱾뼱 媛 湲곌蹂꾨줈 쓬꽦怨 뼇꽦 寃泥 援ъ꽦쓣 떖由ы븯뿬 2016뀈룄 긽꺕븯諛섍린 怨듦났湲곌怨 誘쇨컙湲곌쓽 닕젴룄 룊媛뿉 븘슂븳 HIV 빆썝꺕빆泥닿궗 쇅遺젙룄愿由 룊媛슜 몴以뭹쓣 媛곴컖 750 set뵫 珥 1,500 set瑜 젣議고븯떎. 遺꾩< 씪踰⑤쭅쓣 留덉튇 쇅遺젙룄愿由 룊媛슜 몴以뭹씠 Fig. 1뿉 굹 엳떎.

Table 2 . Determination of dilution rates of human immunodeficiency virus antibody positive source plasma according to reagents.

꺿꺿긓eagentDilution ratesA instituteB institute


1st2nd3rd1st2nd
VIDAS (S/CO)1:1015.5415.3615.4416.1216.24
1:1,0005.225.265.285.915.79
1:2,0002.822.912.903.043.18
Roche/Abbott (S/CO)1:150314.14315.20315.90319.80321.40
1:3,5006.706.786.696.846.83
1:6,0003.113.163.103.213.13
Particle agglutination1:1,000++++++++++++++++++++
1:8,000++++++++++
1:10,000+++++
Rapid1:10+++++
1:90+++++
1:150+++++

Abbreviation: S/CO, signal-to-cut-off.


Figure 1.

External quality controls for human immunodeficiency virus antigen/antibody tests.


3. 洹좎쭏꽦 諛 븞젙꽦 룊媛寃곌낵

遺꾩<맂 쇅遺젙룄愿由 룊媛슜 몴以뭹쓽 洹좎쭏꽦쓣 룊媛븳 寃곌낵 VIDAS, 濡쒖뒋, 븷蹂댄듃 寃궗湲곌린뿉꽌 紐⑤몢 洹좎쭏븿쓣 蹂댁떎. Table 3Table 4뿉 HIV 빆泥 뼇꽦怨 쓬꽦 寃泥 10 諛붿씠뼹뿉 븳 VIDAS 떆빟쓽 洹좎쭏꽦 룊媛寃곌낵媛 굹 엳떎. ANOVA 遺꾩꽍寃곌낵 F鍮꾧 F湲곌컖移섎낫떎 궙븘 紐⑤몢 蹂묎컙 洹좎쭏꽦씠 솗蹂대맖쓣 蹂댁떎(Tables 3, 4). 븞젙꽦 룊媛뿉꽌뒗 4째C 25째C 몢 議곌굔 紐⑤몢뿉꽌 21씪源뚯 븞젙븿쓣 蹂댁떎. 떎留 쓬꽦 寃泥대뒗 S/CO 媛믪씠 留ㅼ슦 궙븘꽌 S/CO 0.02쓽 蹂솕媛 CV 17.6%쓽 蹂솕瑜 쑀諛쒗빐꽌 뙋젙湲곗 10%瑜 꽆뿀吏留 쓬꽦 寃泥댁쓽 S/CO 媛믪쓣 怨좊젮븯뿬 븞젙븳 寃껋쑝濡 룊媛븯떎(Table 5).

Table 3 . Homogeneity evaluation of ten aliquots of candidate external quality controls with human immunodeficiency virus antibody positive reaction by VIDAS reagent.

Vial trial12345678910
118.6518.6518.6418.6818.5918.6418.6118.6318.6518.61
218.6618.6518.6518.6518.6218.6518.6518.6418.6518.65
318.6618.6718.6418.6518.6418.6718.6218.6618.5818.64

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 trial12345678910
10.080.080.080.080.080.080.080.080.080.08
20.080.080.080.080.080.080.080.080.080.08
30.070.080.070.080.080.080.080.080.070.08

Analysis of variance: F ratio=0.77, F rejection value=2.39, P-value=0.63.


Table 5 . Stability evaluation of a candidate panel using VIDAS HIV DUO Ultra reagent.

Panel*Trial0 day5 day12 day21 day




4째C25째CMeanCV4째C25째CMeanCV4째C25째CMeanCV4째C25째CMeanCV
A1118.6518.6618.650.03818.6618.9218.790.97818.9918.8618.920.48618.9618.9518.950.037
218.6618.6818.670.07618.6918.8218.750.49018.6718.7918.730.45318.8818.6518.760.867
318.6618.6618.600.00018.6918.8818.780.71518.6718.8818.770.79118.9418.7918.860.562
A210.080.080.0800.0000.080.090.0858.3190.070.090.08017.680.080.090.0858.319
20.080.080.0800.0000.090.080.0858.3190.080.080.0800.0000.070.090.08017.68
30.090.080.0858.3190.080.090.0858.3190.080.090.0858.3190.070.090.08017.68
A310.080.090.0858.3190.080.080.0800.0000.080.070.0759.4280.080.080.0800.000
20.080.090.0858.3190.080.070.0759.4280.080.090.0858.3190.090.080.0858.319
30.080.080.0800.0000.080.080.0800.0000.090.090.0900.0000.090.080.0858.319
A4116.6916.6916.690.00016.7216.6816.700.16916.7816.9216.850.58816.8716.5516.711.354
216.6516.6716.660.08516.7116.7016.700.04216.4216.7516.581.40716.7516.8116.780.253
316.6616.6816.670.08516.6916.6816.650.04216.9417.1617.050.91216.5916.7516.670.679
A516.736.756.7400.2106.766.816.7850.5216.786.826.8000.4166.886.826.8500.619
26.756.756.7500.0006.776.796.7800.2096.696.886.7851.9806.646.596.6150.534
36.756.736.7400.2106.736.786.7550.5236.756.836.7900.8336.816.666.7351.575
A612.352.342.3450.3022.362.392.3750.8932.412.362.3851.4822.442.462.4500.577
22.332.352.3400.6042.382.362.3700.5972.432.332.3802.9712.462.482.4700.573
32.352.352.3500.0002.292.322.3050.9202.422.452.4350.8712.392.452.4201.753

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.


怨 李

쟾 꽭怨꾩쟻쑝濡 HIV寃궗뿉 븳 젙룄愿由ш 留ㅼ슦 以묒슂븯寃 뿬寃⑥怨 엳쑝硫, 媛 援뿉꽌뒗 洹 굹씪뿉 쟻빀븳 臾쇱쭏쓣 솗蹂댄븯뿬 HIV 媛먯뿼寃궗쓽 젙룄愿由ъ뿉 留뚯쟾쓣 湲고븯怨 엳떎[8]. 쇅遺젙룄愿由щЪ吏덉 寃궗쓽 젙룄愿由ъ뿉 以묒슂븯硫, 寃궗쓽 떊猶곗꽦쓣 媛앷쟻쑝濡 룊媛븷 닔 엳떎[9]. HIV寃궗슜 쇅遺젙룄愿由 룊媛 몴以뭹 HIV 媛먯뿼옄쓽 議곌린 諛쒓껄 諛 媛먯뿼쓽 吏꾨떒, 븞쟾븳 삁븸怨듦툒 벑쓣 紐⑹쟻쑝濡 寃궗옣鍮꾨굹 吏꾨떒떆빟쓣 궗슜븯뒗 寃궗쓽 吏 愿由ъ뿉 궗슜릺怨 엳떎.

援궡 HIV 媛먯뿼쓽 젙솗븳 吏꾨떒쓣 쐞빐꽌 삁븸썝怨 쓽猷뚭린愿 떎뼇븳 삎깭쓽 寃궗諛⑸쾿怨 HIV 솗吏꾧궗 쟾왂쓣 닔由쏀븯뿬 寃궗瑜 닔뻾븯怨 엳떎. 듅엳 洹쇰옒뿉뒗 湲곗〈쓽 吏꾨떒떆빟蹂대떎 슦닔븳 꽦뒫쓣 媛吏 吏꾨떒떆빟씠 꼸由 蹂닿툒릺뼱 궗슜릺怨 엳떎[10]. 援궡 쓽猷뚯꽌鍮꾩뒪쓽 듅꽦긽 쇅援뿉꽌 媛쒕컻맂 吏꾨떒떆빟쓣 媛 떎뿕떎 諛 蹂묒썝 寃궗떎뿉꽌 꽑蹂 諛 솗씤寃궗슜쑝濡 룄엯븯뿬 궗슜븿뿉 뵲씪 寃궗寃곌낵쓽 젙솗꽦, 젙諛꽦 諛 옱쁽꽦씠 蹂댁옣릺뒗 寃궗쓽 뭹吏덇由ъ떆뒪뀥씠 븘슂븯떎. 洹몃윭굹 洹몃룞븞 씠猷⑥뼱吏 뿰援ъ뿉꽌뒗 떒닚엳 뼇꽦怨 쓬꽦쓣 議고빀븯뿬 룊媛瑜 吏꾪뻾븯怨 洹 寃곌낵瑜 怨듭쑀븯뒗 닔以씠뿀떎. 씠뿉 援궡 HIV寃궗뿉 븳 젙솗룄 젙諛룄, 洹몃━怨 옱쁽꽦씠 씪젙븯寃 룄異쒕맆 닔 엳뒗 醫 뜑 泥닿퀎솕릺怨 떆뒪뀥솕맂 援媛 李⑥썝쓽 젙룄愿由ъ궗뾽쓽 븘슂꽦씠 몢릺뿀떎. 씠뿉 2005뀈遺꽣뒗 닕젴룄 룊媛슜 臾쇱쭏쓣 뜑 꽭遺꾪솕븯怨 泥닿퀎솕떆耳 떎뼇븳 湲곌뱾씠 李몄뿬븷 닔 엳룄濡 吏덈퀝愿由щ낯遺 援由쎈낫嫄댁뿰援ъ썝뿉꽌 뿰援ъ쟾왂쓣 닔由쏀븯뿬 湲곗〈뿉 怨듦났湲곌뿉꽌留 떆뻾븯뜕 닕젴룄 룊媛瑜 誘쇨컙湲곌源뚯 솗븯寃 릺뿀떎. 洹몃윭굹 李몄뿬湲곌쓽 利앷濡 씤븯뿬 냼웾 젣議고븯뜕 닕젴룄 룊媛슜 몴以臾쇱쭏濡쒕뒗 뜑 씠긽쓽 吏꾪뻾씠 뼱졄寃 릺뼱 썝猷뚮Ъ吏 젣議곗슜 삁븸솗蹂댁 젣議 諛 뭹吏 룊媛 遺遺꾩쓣 誘쇨컙湲곌쑝濡 씠愿븯뿬 吏꾪뻾븯寃 릺뿀떎. 씠썑 留ㅻ뀈 긽꺕븯諛섍린 2쉶쓽 닕젴룄 룊媛瑜 吏꾪뻾븯湲 쐞븯뿬 뼇꽦怨 쓬꽦 洹몃━怨 빟뼇꽦 臾쇱쭏, 빆썝뼇꽦 臾쇱쭏 벑 떎뼇븳 냽룄쓽 HIV 닕젴룄 룊媛슜 몴以臾쇱쭏쓣 媛쒕컻븯뿬 쟾援 븰蹂묒썝怨 醫낇빀蹂묒썝쓣 룷븿븯뿬 떆꺕룄 蹂닿굔솚寃쎌뿰援ъ썝怨 蹂닿굔냼, 寃뿭냼뒗 臾쇰줎 蹂묐Т泥源뚯 李몄뿬븯뒗 떒쐞쓽 닕젴룄 룊媛媛 씠猷⑥뼱吏寃 릺뿀쑝硫 洹 寃곌낵 援궡 HIV寃궗떎쓽 떊猶곕룄瑜 븳 떒怨 넂씠怨, 젙遺뿉꽌뒗 援궡 HIV寃궗떎 愿由ъ뿉 븳 젙룄愿由ъ옄猷뚮 異뺤쟻븯怨 엳떎[11,12].

援젣쟻쑝濡 HIV 吏꾨떒쓣 쐞븳 떎뼇븳 吏꾨떒떆빟怨 옣鍮꾧 媛쒕컻릺怨 룄엯맖뿉 뵲씪 궗슜옣鍮꾩 떆빟蹂꾨줈 李⑥씠瑜 理쒕븳쑝濡 以꾩씠湲 쐞븯뿬 媛곴컖뿉 쟻빀븳 留욎땄삎 몴以臾쇱쭏씠 븘슂븯寃 릺뿀怨, 蹂 뿰援щ 넻븯뿬 씠瑜 媛쒕컻븯湲곗뿉 씠瑜대떎. 怨듦났湲곌쓽 寃쎌슦 꽕臾몄쓣 넻븯뿬 궗슜옣鍮꾩 떆빟뿉 븯뿬 쟾닔議곗궗瑜 떎떆븯뿬 遺꾩꽍븯怨, 誘쇨컙湲곌쓽 寃쎌슦 븳엫긽寃궗젙룄愿由ы삊쉶瑜 넻븯뿬 궗슜옣鍮꾩 떆빟쓣 議곗궗븯떎. 議곗궗寃곌낵 怨듦났湲곌뿉꽌 궗슜븯뒗 옣鍮꾩 떆빟 빟 5醫낆쑝濡 떎뼇븯쑝硫, 誘쇨컙湲곌 濡쒖뒋 븷蹂댄듃 2醫낆쓽 옣鍮꾩 떆빟쓣 二쇰줈 궗슜븯怨 엳뿀떎. 怨듦났湲곌怨 誘쇨컙湲곌뿉꽌 궗슜븯뒗 옣鍮꾩 떆빟 꽌濡 긽씠븯뿬, 媛 옣鍮꾩 떆빟뿉 쟻빀븯룄濡 吏덈퀝愿由щ낯遺 몴以臾쇱쭏 젣議 沅뚭퀬븞怨 KS A ISO guide瑜 湲곗쑝濡 몴以臾쇱쭏쓣 젣議고븯怨 洹좎쭏꽦怨 븞젙꽦 룊媛瑜 吏꾪뻾븯떎. 理쒖쥌쟻쑝濡 HIV寃궗슜 닕젴룄 룊媛뿉 븘슂븳 븳援삎 留욎땄삎 몴以臾쇱쭏쓣 媛쒕컻븯쑝硫 씠瑜 넻븯뿬 뜑 꽭遺꾪솕릺怨 떎뼇븳 닕젴룄 룊媛슜 留욎땄삎 몴以臾쇱쭏쓣 媛쒕컻븷 닔 엳뒗 湲곗큹옄猷뚮 솗蹂댄븯떎[13,14]. 븳援궛뾽洹쒓꺽뿉꽌 씪踰⑥뿉 몴떆릺뒗 젙蹂대뒗 깮궛湲곌紐, 臾쇱쭏紐, 깮궛湲곌쓽 肄붾뱶, 諛곗튂踰덊샇, 븞쟾 寃쎄퀬뿉 븳젙븯씪怨 洹쒖젙븯怨 엳쑝硫 씠뒗 씤利앹꽌뿉 엳뒗 젙蹂대 씠빐븯吏 븡怨 臾쇱쭏쓣 궗슜븯뒗 寃껋쓣 諛⑹븯湲 쐞븳 議곗튂씠떎[14]. 씠뿉 뵲씪 蹂 뿰援ъ쓽 젣議곕Ъ吏덉뿉룄 理쒖냼븳쓽 젙蹂대쭔 씪踰⑤쭅븯떎(Fig. 1).

蹂 뿰援ш낵젣 닔뻾寃곌낵濡 媛 떆빟蹂 留욎땄삎 몴以臾쇱쭏쓽 젣議곗 뭹吏덉쓽 솗蹂닿 媛뒫븯寃 릺뿀쑝硫, 씠濡 씤븯뿬 슦由щ굹씪뿉꽌룄 HIV寃궗 쇅遺젙룄愿由 룊媛슜 몴以뭹쓣 깮궛븷 닔 엳뒗 떆뒪뀥씠 留덈젴릺뿀떎. 뼢썑뿉룄 援궡뿉꽌 젣議곕맂 몴以뭹쓣 씠슜븳 吏냽쟻씤 HIV寃궗뿉 븳 쇅遺젙룄愿由ш 븘슂븯떎怨 蹂몃떎.

HIV寃궗슜 쇅遺젙룄愿由 룊媛슜 留욎땄삎 몴以臾쇱쭏 媛쒕컻뿉꽌 젣씪 뼱젮슫 遺遺꾩 HIV 빆泥 뼇꽦 썝猷 삁옣쓽 솗蹂댁씠떎. 뿉씠利 솚옄쓽 移섎즺 꽦쟻씠 醫뗭븘吏硫댁꽌 怨좎뿭媛쓽 빆泥대 媛吏 삁옣쓣 援ы븯湲 뼱졄寃 릺怨 엳떎. 빐쇅뿉꽌룄 씠윭븳 옄썝 솗蹂닿 뼱젮썙吏怨 엳뒗 긽솴쓣 洹밸났븯뒗 諛⑹븞뱾씠 紐⑥깋릺怨 엳떎[15]. 蹂 뿰援ъ뿉꽌뒗 湲곗〈 뿰援ъ뿉꽌 삎꽦맂 HIV 媛먯뿼옄 꽕듃썙겕瑜 씠슜븯뿬 빆泥 뼇꽦 삁븸쓣 솗蹂댄븯怨, 삁븸썝쓣 넻빐 쓬꽦 삁븸쓣 援ъ엯븯뿬 뿰援щ 닔뻾븯떎. 蹂 怨쇱젣 쑀궗븳 뿰援щ 쐞빐꽌룄 씠윭븳 HIV 媛먯뿼옄 諛 쓬꽦 삁븸쓽 닔슂뒗 젏젏 利앷릺怨 엳떎. 洹몃윭굹 씠윭븳 삁븸쓽 솗蹂대 쐞빐꽌뒗 뿬윭 젅李④ 븘슂븯硫, 씠윭븳 젅李⑤뒗 씪諛섑솕릺뼱엳吏 븡떎. 븵쑝濡 깮紐낆쑄由 諛 븞쟾뿉 愿븳 踰뺣쪧뿉 쟻빀븯寃 떎웾쓽 썝猷뚮Ъ吏 솗蹂닿 媛뒫븯寃 맂떎硫 떎뼇븳 꽦뒫怨 냽룄瑜 媛吏 삁泥쟾솚뙣꼸, 뿭媛 빆泥 뙣꼸, 怨좎뿭媛 빆泥 뙣꼸 벑 떎뼇븳 뙣꼸 媛쒕컻쓣 넻빐 뼢썑 HIV寃궗 닔뻾湲곌쓽 쇅遺젙룄愿由ъ 吏꾨떒떆빟 룊媛 벑 떎뼇븳 紐⑹쟻쑝濡 궗슜씠 媛뒫븷 寃껋쑝濡 뿬寃⑥쭊떎.

媛먯궗쓽 湲

씠 끉臾몄 吏덈퀝愿由щ낯遺쓽 2016뀈 젙梨낆뿰援ъ슜뿭궗뾽쓽 쏦IV 빆썝꺕빆泥닿궗슜 몴以뭹 媛쒕컻 뿰援щ퉬 吏썝쑝濡 씠猷⑥뼱吏 寃껋씠떎.

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