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媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗 寃곌낵蹂닿퀬 (2016-2017)
Report on the External Quality Assessment Scheme of Hepatitis Viral Markers in Korea, (2016-2017)
J Lab Med Qual Assur 2018;40:51-69
Published online June 30, 2018
© 2018 Korean Association of External Quality Assessment Service.

議곗젙1, 理쒖븷2, 瑜섏삎2,3, 쑄냼젙2,3, 씠슦李4, 쟾궗씪4, 誘쇱썝湲4, 삤吏2
Eun-Jung Cho1, Ae Ran Choi2, Ji Hyeong Ryu2,3, So Jeong Yun2,3, Woochang Lee4, Sail Chun4, Won-Ki Min4, Eun-Jee Oh2

1媛넧由븰援 쓽怨쇰븰 쓽젙遺꽦紐⑤퀝썝 吏꾨떒寃궗쓽븰怨,
2媛넧由븰援 쓽怨쇰븰 꽌슱꽦紐⑤퀝썝 吏꾨떒寃궗쓽븰怨,
3媛넧由븰援 븰썝 쓽깮紐낃굔媛뺢낵븰怨 遺꾩옄꽭룷깮臾쇳븰,
4슱궛븰援 쓽怨쇰븰 꽌슱븘궛蹂묒썝 吏꾨떒寃궗쓽븰怨

1Department of Laboratory Medicine, Uijeongbu St. Mary셲 Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea
2Department of Laboratory Medicine, Seoul St. Mary셲 Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
3Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea, Seoul, Korea
4Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence to: Eun-Jee Oh Department of Laboratory Medicine, Seoul St. Mary셲 Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea Tel: +82-2-2258-1641 Fax: +82-2-2258-1719 E-mail: ejoh@catholic.ac.kr
援먯떊옄: 삤吏 슦)06591 꽌슱떆 꽌珥덇뎄 諛섑룷濡 222, 媛넧由븰援 쓽怨쇰븰 꽌슱꽦紐⑤퀝썝 吏꾨떒寃궗쓽븰怨 Tel: 02)2258-1641, Fax: 02)2258-1719, E-mail: ejoh@catholic.ac.kr
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

븳엫긽寃궗젙룄愿由ы삊쉶 硫댁뿭삁泥봽濡쒓렇옩쓽 2016뀈 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽 6썡怨 10썡뿉, 2017뀈 떊鍮숇룄議곗궗궗뾽 5썡怨 10썡뿉 2쉶뿉 嫄몄퀜 떆뻾릺뿀떎. 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽 珥 10醫낅ぉ뿉 븯뿬 떎떆븯떎. 옄뱾 2016뀈 1쉶李 2媛, 2쉶李 3媛쒖쓽 샎빀삁泥 寃泥대 媛곴컖 965湲곌, 962湲곌뿉 諛쒖넚븯떎. 李몄뿬湲곌 1쉶李⑥뿉 915湲곌(94.8%), 2쉶李 913湲곌(95.0%)씠뿀떎. 2017뀈룄뿉뒗 留 쉶李 3媛쒖쓽 샎二쇳삁泥 寃泥대 媛곴컖 936湲곌, 1,015湲곌뿉 諛쒖넚븯떎. 李몄뿬湲곌 1쉶李⑥뿉 920湲곌(98.3%), 2쉶李 996湲곌(98.1%)씠뿀떎. Hepatitis B surface antigen뿉 媛옣 留롮 湲곌씠 李몄뿬븯怨, hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus 諛 antibodies to hepatitis B core antigen 닚쑝濡 李몄뿬븯떎. 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗 寃곌낵, matrix effect濡 씤븯뿬 쟾湲고솕븰諛쒓킅硫댁뿭寃궗踰뺤쓣 룷븿븳 솕븰諛쒓킅硫댁뿭寃궗踰뺤뿉꽌 쐞뼇꽦 寃곌낵媛 諛쒖깮븯떎. Anti-hepatitis A virus寃궗뿉꽌 硫댁뿭겕濡쒕쭏넗洹몃옒뵾踰뺤쓽 궙 誘쇨컧룄뒗 쐞쓬꽦 寃곌낵瑜 珥덈옒븯떎. 寃궗떎쓽 媛꾩뿼諛붿씠윭뒪 떊鍮숇룄議곗궗궗뾽쓽 吏냽쟻씤 李몄뿬瑜 넻븳 寃궗쓽 吏 뼢긽씠 븘슂븷 寃껋쑝濡 깮媛곷릺뿀떎.

As part of the immunoserology program of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of hepatitis viral markers in 2016 and 2017. The hepatitis viral antigens and antibodies program consisted of 10 test items. We delivered two and three types of pooled sera specimens to 965 and 965 institutions for the first and second trials of external proficiency testing in 2016, respectively. The number of participating laboratories was 915 (94.8%) and 913 (95.0%) in the first and second trials in 2016, respectively. We also delivered three kinds of pooled sera specimens to 936 and 1,015 institutions for the first and second trials of external proficiency testing in 2017, respectively. The number of participating laboratories was 920 (98.3%) and 996 (98.1%) in the first and second trials in 2017, respectively. The most commonly tested items were hepatitis B surface antigen, followed by the antibodies to hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus and antibodies to hepatitis B core antigen. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay and the electrochemiluminescence immunoassay, but they yielded a few-false positive results due to the matrix effect. The immunochromatographic assay yielded false-negative results for anti-hepatitis A virus due to low sensitivity. Continuous improvement in the quality of viral hepatitis testing through participation in the survey seems necessary.

Keywords : External quality assessment, Hepatitis A, Hepatitis B, Hepatitis C, Immuno짯assay, Laboratory proficiency testing, Pooled serum
꽌 濡

븳엫긽寃궗젙룄愿由ы삊쉶 硫댁뿭삁泥遺꾧낵쐞썝쉶뒗 1982뀈 B삎媛꾩뿼몴硫댄빆썝(hepatitis B surface antigen, HBsAg) 寃궗 留ㅻ룆삁泥寃궗(serologic test for syphilis)뿉 븳 떊鍮숇룄議곗궗瑜 떆옉쑝濡[1], 1983뀈遺꽣 빆-뒪듃젟넗씪씠떊 O (anti-streptolysin O) 쐞떖(Widal) [2], 1986뀈遺꽣 C-諛섏쓳떒諛(C-reactive protein), 瑜섎쭏넗씠뱶씤옄(rheumatoid factor), B삎媛꾩뿼몴硫댄빆泥(antibody to hepatitis B surface antigen, anti-HBs) [3], 1992뀈遺꽣 뿉씠利덊빆泥(anti-human immunodeficiency virus), 1993뀈遺꽣 C삎媛꾩뿼빆泥(anti-hepatitis C virus, anti-HCV) [4], 2004뀈遺꽣 B삎媛꾩뿼以묒떖빆泥(antibody to hepatitis B core antigen, anti-HBc) 寃궗瑜 떊鍮숇룄議곗궗뿉 異붽븯떎[5]. 2016뀈遺꽣뒗 B삎媛꾩뿼쇅뵾빆썝(hepatitis B envelope antigen, HBeAg), B삎媛꾩뿼쇅뵾빆泥(antibody to hepatitis envelope antigen, anti-HBe) 諛 A삎媛꾩뿼빆泥(anti-hepatitis A virus, anti-HAV) 寃궗媛 異붽릺뿀쑝硫, 李⑥꽭 떊鍮숇룄議곗궗궗뾽 떆뻾뿉 뵲씪 遺꾧낵쐞썝쉶媛 뾾뼱吏怨 湲곗〈쓽 諛붿씠윭뒪 빆썝/빆泥 諛 留ㅻ룆빆泥닿궗 떊鍮숇룄議곗궗궗뾽 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽쑝濡 遺꾨━븯뿬 떆뻾릺怨 엳떎. 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽 HBsAg, anti-HBs, anti-HBc total, anti-HBc immunoglobulin M (IgM), HBeAg, anti-HBe, anti-HCV, anti-HAV total, anti-HAV immunoglobulin G (IgG), anti-HAV IgM 벑 珥 10醫낅ぉ뿉 븯뿬 뿰 2쉶 떎떆릺뿀쑝硫, 옄뱾 2016뀈怨 2017뀈뿉 떎떆븳 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗쓽 떊鍮숇룄議곗궗寃곌낵瑜 遺꾩꽍븯뿬 蹂닿퀬븯怨좎옄 븳떎.

옱猷 諛 諛⑸쾿

1. 떊鍮숇룄議곗궗 寃泥 諛 긽湲곌

뿰 2쉶뿉 嫄몄퀜 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗뿉 븳 떊鍮숇룄議곗궗瑜 떎떆븯떎. 2016뀈룄 1쉶李 떊鍮숇룄議곗궗 寃泥대뒗 珥 2媛(IL-16-01, IL-16-02)쓽 寃泥대 965媛 湲곌뿉, 2쉶李⑥뿉뒗 珥3媛쒖쓽 寃泥(IL-16-03, IL-16-04, IL-16-05)瑜 962媛 湲곌뿉 媛곴컖 2016뀈 6썡怨 10썡뿉 諛쒖넚븯떎. 2017뀈룄 1쉶李 떊鍮숇룄議곗궗 寃泥대뒗 珥 4媛(IL-17-01, IL-17-02, IL-17-03, IL-17-04)쓽 寃泥대 936媛 湲곌뿉, 2쉶李⑥뿉룄 1쉶李⑥ 留덉갔媛吏濡 珥 4媛(IL-17-05, IL-17-06, IL-17-07, IL-17-08)쓽 寃泥대 1,015媛 湲곌뿉 媛곴컖 2017뀈 5썡怨 10썡뿉 諛쒖넚븯떎.

2. 떊鍮숇룄議곗궗 긽醫낅ぉ

떊鍮숇룄議곗궗 긽醫낅ぉ HbsAg, anti-HBs, anti-HBc total, anti-HBc IgM, HbeAg, anti-Hbe, anti-HCV, anti-HAV total, anti-HAV IgG, anti-HAV IgM 珥 10醫낅ぉ씠뿀怨, 2016뀈怨 2017뀈룄 1쉶李⑥ 2쉶李 紐⑤몢 룞씪븳 醫낅ぉ쓣 긽쑝濡 븯떎.

3. 떊鍮숇룄議곗궗 寃泥 젣議곕갑踰

2016뀈룄 떊鍮숇룄議곗궗瑜 쐞븳 寃泥대뒗 꽌슱븘궛蹂묒썝뿉꽌 젣議고븯쑝硫, 2017뀈룄 寃泥대뒗 꽌슱꽦紐⑤퀝썝뿉꽌 젣議고븯떎. 섑븳留덉쓬삁븸썝숈쑝濡쒕꽣 삁옣쓣 遺꾩뼇諛쏆븘 媛 醫낅ぉ쓽 뼇꽦怨 쓬꽦 떊鍮숇룄議곗궗 寃泥대 옄媛젣議고븯떎. 젣議곕갑踰뺤 떊꽑룞寃고삁옣(fresh frozen plasma), thrombin, CaCl2 瑜 옒 샎빀븳 썑 37째C 빆삩닔議(water bath) 깋룞뿉꽌 諛섏쓳떆궎怨, 3,000 rpm, 4째C, 20遺꾧컙 썝떖遺꾨━怨쇱젙쓣 넻븯뿬 샎빀삁泥(pooled serum)쓣 젣議고븯떎. 0.22 關m 븘꽣뿉꽌 1쉶 뿬怨쇱떆궓 떎쓬 媛 醫낅ぉ뿉 뵲씪 쟻젅븳 뿭媛媛 릺룄濡 뼇꽦 삁泥쓣 샎빀븯뿬 援먮컲湲곗뿉꽌 1떆媛 젙룄 꽎뒗 怨쇱젙쓣 嫄곗낀떎. 1쉶李 諛 2쉶李⑥뿉 젣議곕맂 2016뀈룄 5媛 寃泥댁 2017뀈룄 8媛 寃泥댁쓽 긽 寃궗빆紐⑷낵 삁긽寃곌낵뒗 Table 1뿉 젙由ы븯쑝硫, 理쒖쥌 洹좎쭏꽦 솗蹂대 쐞븯뿬 4째C, 援먮컲湲곗뿉꽌 18떆媛 룞븞 샎빀怨쇱젙쓣 嫄곗튇 썑 3媛 씠긽쓽 젣議고쉶궗 옣鍮꾨줈 寃泥댁쓽 젙꽦寃곌낵 媛믪씠 씪移섑븯뒗吏 솗씤븯떎(Table 2).

Table 1 . Intended results of external quality control specimens for hepatitis viral antigen and antibody assessment.

꺿꺿귺nalyteHBsAgAnti-HBsAnti-HBc totalAnti-HBc IgMHBeAgAnti-HBeAnti-HCVAnti-HAV totalAnti-HAV IgGAnti-HAV IgM
2016-1st trial
긆L-16-01-++--++++-
긆L-16-02+-+--+-++-
2016-2nd trial
긆L-16-03------+---
긆L-16-04+-+-+--++-
긆L-16-05-++----++-
2017-1st trial
긆L-17-01-+----
긆L-17-02+-+--+
긆L-17-03-+++
긆L-17-04+++-
2017-2nd trial
긆L-17-05+-+-+-
긆L-17-06-+----
긆L-17-07----
긆L-17-08+++-

Abbreviations: HBsAg, hepatitis B surface antigen; anti-HBs, antibody to HBsAg; anti-HBc, antibody to hepatitis B core antigen; HBeAg, hepatitis B envelope antigen; anti-HBe, antibody to HBeAg; anti-HCV, antibody to hepatitis C virus; anti-HAV, antibody to hepatitis A virus.


Table 2 . Methods used for mock survey of external quality control specimens for hepatitis viral antigen and antibody assessment.

꺿꺿긎ethod꺿꺿긆nstruments꺿꺿긓eagents
Electrochemiluminescence immunoassayCobas e600, e800 series/E170, RocheReagent for E170
Chemiluminescence immunoassayArchitect, AbbottReagent for Architect
Centaur XP/XPT, SiemensReagent for Centaur XP
UniCel DxI 800, Beckman CoulterReagent for UniCel DxI 800
Vitros 3600, Ortho-Clinical DiagnosticsReagent for Vitros 3600
Fluorescence enzyme immunoassayVIDAS, BioM챕rieuxReagent for VIDAS

The instruments used were from the following companies: Cobas e600 series/E170 (Roche Diagnostics GmbH, Mannheim, Germany), Architect (Abbott Diagnostics, Abbott Park, IL, USA), Centaur XP/XPT (Siemens Healthcare Diagnostics, Tarrytown, NY, USA), UniCel DxI 800 (Beckman Coulter Inc., Brea, CA, USA), Vitros 3600 (Ortho Clinical Diagnostics, Raritan, NJ, USA), and VIDAS (BioM챕rieux, Marcy-L섷toile, France).


4. 寃곌낵遺꾩꽍 諛 넻怨

臾쇱쭏쓣 닔졊븳 李몄뿬湲곌뿉꽌뒗 寃궗 떆뻾 썑 궗쟾뿉 怨듭맂 씪젙뿉 뵲씪 吏젙맂 쉶떊 留덇컧씪 씠궡뿉 寃궗寃곌낵瑜 븳엫긽寃궗젙룄愿由ы삊쉶 떊鍮숇룄議곗궗궗뾽 솃럹씠吏(http://eqas.keqas.org)뿉 엯젰븯룄濡 븯떎. 媛 寃궗빆紐⑸퀎濡 李몄뿬湲곌뿉꽌 궗슜븯怨 엳뒗 옣鍮꾩뿉 뵲씪 遺꾨쪟븯뿬 寃곌낵瑜 遺꾩꽍븯떎. 넻怨꾨텇꽍뿉뒗 IBM SPSS Statistics for Windows ver. 24.0 (IBM Corp., Armonk, NY, USA)怨 MedCalc Statistical Software ver. 16.8.4 (MedCalc Software bvba, Ostend, Belgium)瑜 궗슜븯떎. 媛 湲곌蹂 遺꾩꽍寃곌낵 諛 湲곌린蹂 넻怨꾧껐怨쇰 삊쉶 솃럹씠吏뿉꽌 吏곸젒 議고쉶븯怨 異쒕젰븷 닔 엳룄濡 븯떎.

寃 怨

1. 李몄뿬湲곌 諛 쉶떊쑉

2016뀈룄 理쒖냼 1醫낅ぉ 씠긽 떊鍮숇룄議곗궗뿉 李몄뿬븳 湲곌뱾쓣 湲곗쑝濡 1쉶李⑤뒗 965湲곌 以 915湲곌씠, 2쉶李⑤뒗 962湲곌 以 913湲곌씠 쉶떊븯뿬 쉶떊쑉 媛곴컖 94.8%, 95.0%떎. 2李 떊鍮숇룄議곗궗瑜 湲곗쑝濡 媛 湲곌 쑀삎蹂 李몄뿬쁽솴 諛 꽭遺 醫낅ぉ蹂 李몄뿬쁽솴 Table 3뿉 젙由ы븯떎. 2017뀈룄 理쒖냼 1醫낅ぉ 씠긽 떊鍮숇룄議곗궗뿉 李몄뿬븳 湲곌뱾쓣 湲곗쑝濡 1쉶李⑤뒗 936湲곌 以 920湲곌씠, 2쉶李⑤뒗 1,015湲곌 以 996湲곌씠 쉶떊븯뿬 쉶떊쑉 媛곴컖 98.3%, 98.1%떎. 2李 떊鍮숇룄議곗궗瑜 湲곗쑝濡 媛 湲곌 쑀삎蹂 李몄뿬쁽솴 諛 꽭遺 醫낅ぉ蹂 李몄뿬쁽솴 Table 3뿉 젣떆븯떎. 2013뀈遺꽣 2015뀈源뚯쓽 諛붿씠윭뒪 빆썝/빆泥 諛 留ㅻ룆빆泥닿궗[6-8] 諛 2016뀈怨 2017뀈쓽 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 2李 떊鍮숇룄議곗궗쓽 李몄뿬湲곌 諛 쉶떊쑉쓣 젙由ы븯떎(Fig. 1).

Table 3 . Principles of methods used for viral antigens or antibodies tests in the laboratories participating in the second trial of 2016 and 2017 proficiency testing.

Test itemsCLIAECLIAEIAFEIAICAMEIATotal







20162017201620172016201720162017201620172016201720162017
HBsAg402 (45.0)401 (40.8)294 (32.9)319 (32.4)1 (0.1)2 (0.2)29 (3.2)32 (3.3)165 (18.5)227 (23.1)2 (0.2)3 (0.3)893 (100.0)984 (100.0)
Anti-HBs395 (45.7)396 (41.3)278 (32.1)305 (31.8)1 (0.1)2 (0.2)29 (3.4)32 (3.3)160 (18.5)221 (23.0)2 (0.2)3 (0.3)865 (100.0)959 (100.0)
Anti-HBc total84 (67.2)87 (68.5)36 (28.8)36 (28.3)--5 (4.0)4 (3.1)----125 (100.0)127 (100.0)
Anti-HBc IgM56 (60.9)52 (59.1)27 (29.3)27 (30.7)--9 (9.8)9 (10.2)----92 (100.0)88 (100.0)
HBeAg141 (56.9)140 (55.3)81 (32.7)86 (34.0)--11 (4.4)11 (4.3)15 (6.0)15 (5.9)-1 (0.4)248 (100.0)253 (100.0)
Anti-HBe139 (61.0)138 (59.2)76 (33.3)81 (34.8)--11 (4.8)11 (4.7)2 (0.9)2 (0.9)-1 (0.4)228 (100.0)233 (100.0)
Anti-HCV338 (50.1)359 (45.8)176 (26.1)200 (25.5)4 (0.6)7 (0.9)2 (0.3)8 (1.0)155 (23.0)198 (25.3)-11 (1.4)675 (100.0)783 (100.0)
Anti-HAV total55 (36.4)62 (36.7)78 (51.7)90 (53.3)--18 (11.9)16 (9.5)-1 (0.6)--151 (100.0)169 (100.0)
Anti-HAV IgG114 (83.8)122 (82.4)16 (11.8)20 (13.5)--1 (0.7)1 (0.7)5 (3.7)5 (3.4)--136 (100.0)148 (100.0)
Anti-HAV IgM136 (57.1)145 (60.2)74 (31.1)71 (29.5)--22 (9.2)20 (8.3)6 (2.5)5 (2.1)--238 (100.0)241 (100.0)

Values are presented as number (%).

Abbreviations: CLIA, chemiluminescence immunoassay; ECLIA, electrochemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence EIA; ICA, immunochromatography assay; MEIA, microparticle EIA; HBsAg, hepatitis B surface antigen; anti-HBs, antibody to HBsAg; anti-HBc, antibody to hepatitis B core antigen; HBeAg, hepatitis B envelope antigen; IgM, immunoglobulin; anti-HBe, antibody to HBeAg; anti-HCV, antibody to hepatitis C virus; anti-HAV, antibody to hepatitis A virus; IgG, immunoglobulin G.


Figure 1.

Changes in response in the second trial of viral markers proficiency testing.


2. 寃궗諛⑸쾿 諛 寃궗옣鍮

떊鍮숇룄議곗궗뿉 李몄뿬븳 湲곌뱾쓽 寃궗빆紐⑸퀎 寃궗諛⑸쾿 諛 궗슜옣鍮꾨뒗 삊쉶 솃럹씠吏뿉 媛 湲곌씠 湲곗옱븳 肄붾뱶瑜 諛뷀깢쑝濡 遺꾩꽍븯떎. 2李 떊鍮숇룄議곗궗瑜 湲곗쑝濡 媛 寃궗떎뿉꽌 궗슜븳 寃궗諛⑸쾿쓣 젙由ы빐蹂대㈃, HbsAg 諛 anti-HBs寃궗뒗 2016뀈룄뿉 媛곴컖 81.5%쓽 湲곌, 2017뀈룄뿉 媛곴컖 76.9%, 77.0%쓽 湲곌, anti-HBc total 諛 anti-HBc IgM寃궗뒗 2016뀈 諛 2017뀈룄뿉 쟾湲곌뿉꽌, HbeAg 諛 anti-Hbe寃궗뒗 2016뀈룄뿉 媛곴컖 94.0% 99.1%쓽 湲곌, 2017뀈룄뿉 媛곴컖 94.1% 99.1%쓽 湲곌, anti-HCV寃궗뒗 2016뀈룄뿉 77.0% 湲곌, 2017뀈룄뿉 74.7% 湲곌, anti-HAV total, anti-HAV IgG 諛 anti-HAV IgM寃궗뒗 2016뀈룄뿉 媛곴컖 100.0%, 96.3%, 97.5%쓽 湲곌, 2017뀈룄뿉 媛곴컖 99.4%, 96.6%, 97.9%쓽 湲곌씠 솕븰諛쒓킅硫댁뿭寃궗踰(chemiluminescence immunoassay, CLIA), 쟾湲고솕븰諛쒓킅硫댁뿭寃궗踰(electrochemiluminescence immunoassay, ECLIA), 슚냼硫댁뿭寃궗踰(enzyme immunoassay, EIA), 삎愿묓슚냼硫댁뿭寃궗踰(fluorescence enzyme immunoassay, FEIA) 諛 誘몄꽭엯옄슚냼硫댁뿭寃궗踰(microparticle enzyme immunoassay, MEIA) 벑 誘쇨컧룄媛 슦닔븳 옄룞솕 寃궗踰뺤쑝濡 寃궗瑜 떎떆븯怨 엳뿀떎. 젙꽦遺꾩꽍踰뺤씤 硫댁뿭겕濡쒕쭏넗洹몃옒뵾踰(immunochromatographic assay, ICA) HbsAg 諛 anti-HBs寃궗뒗 2016뀈룄뿉 媛곴컖 18.5%쓽 湲곌, 2017뀈룄뿉 媛곴컖 23.1%, 23.0%쓽 湲곌씠, HbeAg 諛 anti-Hbe寃궗뒗 2016뀈룄뿉 媛곴컖 6.0% 0.9%쓽 湲곌, 2017뀈룄뿉 媛곴컖 5.9% 0.9%쓽 湲곌, anti-HCV寃궗뒗 2016뀈룄뿉 23.0% 湲곌, 2017뀈룄뿉 25.3% 湲곌, anti-HAV total, anti-HAV IgG 諛 anti-HAV IgM寃궗뒗 2016뀈룄뿉 anti-HAV total寃궗瑜 젣쇅븯怨 媛곴컖 3.7%, 2.5%쓽 湲곌뿉꽌, 2017뀈룄뿉 媛곴컖 0.6%, 3.4%, 2.1%쓽 湲곌뿉꽌 궗슜릺怨 엳뿀떎(Table 3).

寃궗옣鍮꾨퀎濡 遺꾨쪟빐蹂대㈃ CLIA옣鍮꾨줈뒗 Abbott궗(Abbott Diagnostics, Abbott Park, IL, USA)쓽 Architect, Roche궗(Roche Diagnostics GmbH, Mannheim, Germany)쓽 Cobas e411/Elecsys怨 Cobas e600, e800 series/E170, Siemens궗(Siemens Healthcare Diagnostics, Tarrytown, NY, USA)쓽 ADVIA Centaur XP/XPT 벑씠 留롮씠 궗슜릺怨 엳뿀怨, EIA옣鍮꾨줈뒗 BioM챕rieux궗(BioM챕rieux, Marcy l섷toile, France)쓽 VIDAS 옣鍮꾧 留롮씠 궗슜릺怨 엳뿀떎(Tables 4, 5).

Table 4 . Instruments used to measure viral antigens or antibodies in the second trial of proficiency testing: 2016 proficiency testing.

꺿긎anufacturer꺿꺿긆nstrumentMethodHBsAgAnti-HBsAnti-HBcHBeAgAnti-HBeAnti-HCVAnti-HAV


TotalIgMTotalIgGIgM
AbbottARCHITECTCLIA2382347146112111229410992
Beckman CoulterUniCel DxI800CLIA1615-1--16738
Access1919----62-2
BiomerieuxVidasFEIA2929591111218122
FujirebioLumipulseCLIA87--------
Ortho Clinical DiagnosticsVitros 3600, 5600CLIA55----54-3
ECi, ECiQ109--1-6---
RadimAliseiEIA11----1---
RocheCobase411/ ElecsysECLIA15915633262390181022
Cobas e600, e800 series/E170135122332455538660652
SiemensCentaur XP/XPTCLIA10010013927277135129
Immulite 2000/XPi55--------
Quadriga BeFree------4---
TosohAIA-360MEIA22--------
DiaSorinLIAISONCLIA11--111312
Bio-RadEvolisEIA------3---
Others2020----181-1
Total75072712592233226538152131233

The instruments used were from the following companies: Architect (Abbott Diagnostics, Abbott Park, IL, USA), UniCel DxI 800, Access (Beckman Coulter Inc., Brea, CA, USA), BEST 2000 (Biokit, Barcelona Spain), Vidas (BioM챕rieux, Marcy l섷toile, France), Lumipulse (Fujirebio, Tokyo, Japan), Vitros 3600, 5600, ECi, ECiQ (Ortho Clinical Diagnostics, Raritan, NJ, USA), Alisei (Radim, Pomezia, Italy), Cobas e411/ Elecsys, Cobas e600, e800 series/E170 (Roche Diagnostics GmbH, Mannheim, Germany), Centaur XP/XPT,Immulite 2000/XPi,Quadriga BeFree (Siemens Healthcare Diagnostics, Tarrytown, NY, USA), AIA-360 (Tosoh, Tokyo, Japan), Liaison, ETI-Max 3000 (DiaSorin, Saluggia, Italy), and Evolis (Bio-Rad Laboratories, Hercules, CA, USA).

Abbreviations: HBsAg, hepatitis B surface antigen; anti-HBs, antibody to HBsAg; anti-HBc, antibody to hepatitis B core antigen; IgM, immunoglobulin M; HBeAg, hepatitis B envelope antigen; anti-HBe, antibody to HBeAg; anti-HCV, antibody to hepatitis C virus; IgG, immunoglobulin G; anti-HAV, antibody to hepatitis A virus; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence EIA; ECLIA, eletro-chemiluminescence immunoassay; MEIA, microparticle enzyme immunoassay.


Table 5 . Instruments used to measure viral antigens or antibodies in the second trial of proficiency testing: 2017 proficiency testing.

꺿긎anufacturer꺿꺿긆nstrumentMethodHBsAgAnti-HBsAnti-HBcHBeAgAnti-HbeAnti-HCVAnti-HAV


TotalIgMTotalIgGIgM
AbbottARCHITECTCLIA2442437344114113233411293
Beckman CoulterUniCel DxI 800CLIA2020----199611
Access2525----13213
BiokitBEST 2000EIA11----1---
BiomerieuxVidasFEIA3232491111816120
FujirebioLumipulseCLIA76--------
Ortho Clinical DiagnosticsVitros 3600, 5600CLIA55----53-3
ECi, ECiQ88--1-12---
RadimAliseiEIA11----3---
RocheCobas e411/ ElecsysECLIA171171432623101241321
Cobas e600, e800 series/E170148134322460589966750
SiemensCentaur XP/XPTCLIA878714824247641133
Immulite 2000/XPi22--------
Quadriga BeFreeEIA------4---
TosohAIA-360MEIA33--11----
DiaSorinLiaisonCLIA----11-312
ETI-Max 3000------2-1-
Bio-RadEvolisEIA------3---
Others1311----11-1-
Total76774912788238231590168144236

The instruments used were from the following companies: Architect (Abbott Diagnostics, Abbott Park, IL, USA), UniCel DxI 800, Access (Beckman Coulter Inc., Brea, CA, USA), BEST 2000 (Biokit, Barcelona Spain), Vidas (BioM챕rieux, Marcy l섷toile, France), Lumipulse (Fujirebio, Tokyo, Japan), Vitros 3600, 5600, ECi, ECiQ (Ortho Clinical Diagnostics, Raritan, NJ, USA), Alisei (Radim, Pomezia, Italy), Cobas e411/ Elecsys, Cobas e600, e800 series/E170 (Roche Diagnostics GmbH, Mannheim, Germany), Centaur XP/XPT, Immulite 2000/XPi, Quadriga BeFree (Siemens Healthcare Diagnostics, Tarrytown, NY, USA), AIA-360 (Tosoh, Tokyo, Japan), Liaison, ETI-Max 3000 (DiaSorin, Saluggia, Italy), and Evolis (Bio-Rad Laboratories, Hercules, CA, USA).

Abbreviations: HBsAg, hepatitis B surface antigen; anti-HBs, antibody to HBsAg; anti-HBc, antibody to hepatitis B core antigen; IgM, immunoglobulin M; HBeAg, hepatitis B envelope antigen; anti-HBe, antibody to HBeAg; anti-HCV, antibody to hepatitis C virus; IgG, immunoglobulin G; anti-HAV, antibody to hepatitis A virus; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence EIA; ECLIA, eletro-chemiluminescence immunoassay; MEIA, microparticle enzyme immunoassay.


3. 醫낅ぉ蹂 寃곌낵遺꾩꽍

1) B삎媛꾩뿼몴硫댄빆썝

HBsAg寃궗뿉 븳 떊鍮숇룄議곗궗쓽 쉶떊寃곌낵瑜 遺꾩꽍븯硫, 2016뀈 1李⑥쓽 IL-16-02 寃泥댁 2李⑥쓽 IL-16-04 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 914湲곌 以 99.1% (906湲곌), 913湲곌 以 99.1% (905湲곌)뿉꽌 젙떟쓣 蹂닿퀬븯떎(Table 6). 븳렪 1李⑥쓽 IL-16-01 寃泥댁 2李⑥쓽 IL-16-03怨 IL-16-05 寃泥대뒗 쓬꽦 寃泥대줈꽌 1李 寃곌낵 915湲곌 以 899湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 98.3%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 912湲곌 以 904湲곌, 913湲곌 以 906湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.1% 99.2%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 6). 2017뀈 1李⑥쓽 IL-17-02 寃泥댁 2李⑥쓽 IL-17-05 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 920湲곌 以 99.2% (913湲곌), 996湲곌 以 99.7% (993湲곌)뿉꽌 젙떟쓣 蹂닿퀬븯떎(Table 7). 븳렪 1李⑥쓽 IL-17-01 寃泥댁 2李⑥쓽 IL-17-06 寃泥대뒗 쓬꽦 寃泥대줈꽌 媛곴컖 920湲곌 以 915湲곌, 996湲곌 以 992湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.5% 99.6%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 7).

Table 6 . Results of 2016 HBsAg proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA39752400402-14014002
ECLIA284103290287642902913
EIA2-111--11-
FEIA32--3229128281
ICA163-2161163211641641
MEIA2--22--22-
Others191-202011920-
Total899168906904889059067

Abbreviations: HBsAg, hepatitis B surface antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 7 . Results of 2017 HBsAg proficiency testing.

Method1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA394123931400401-
ECLIA2964329713183163
EIA2--2-22-
FEIA31--31-3232-
ICA181-217912262261
MEIA1--1-33-
Others10--10-1212-
Total9155791339939924

Abbreviations: HBsAg, hepatitis B surface antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


2) B삎媛꾩뿼몴硫댄빆泥

Anti-HBs寃궗뿉 븳 떊鍮숇룄議곗궗쓽 遺꾩꽍寃곌낵, 2016뀈 1李⑥쓽 IL-16-01 寃泥댁 2李⑥쓽 IL-16-05 寃泥대뒗 뼇꽦 寃泥대줈 媛곴컖 886湲곌 以 849湲곌, 885湲곌 以 870湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 95.8% 98.3%쓽 씪移섏쑉쓣 蹂댁떎(Table 8). 븳렪 1李⑥쓽 IL-16-02 寃泥댁 2李⑥쓽 IL-16-03怨 IL-16-04 寃泥대뒗 쓬꽦 寃泥대줈 1李 寃곌낵 886湲곌 以 876湲곌 湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 98.9%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 884湲곌 以 868湲곌, 885湲곌 以 874湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 98.2% 98.8%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 8). 2017뀈 1李⑥쓽 IL-17-01 寃泥댁 2李⑥쓽 IL-17-06 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 893湲곌 以 884湲곌, 970湲곌 以 966湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.0% 99.6%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 9). 븳렪 1李⑥쓽 IL-17-02 寃泥댁 2李⑥쓽 IL-17-05 寃泥대뒗 쓬꽦 寃泥대줈꽌 媛곴컖 893湲곌 以 889湲곌, 970湲곌 以 969湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.6% 99.9%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 9).

Table 8 . Results of 2016 anti-HBs proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA339439433801539052393
ECLIA42732706277-27534274
EIA-11-1-1--1
FEIA-3232-29-281128
ICA26131157-159115826154
MEIA-22-2-2--2
Others41620-20-20-218
Total378498769868168741115870

Abbreviations: Anti-HBs, antibody to hepatitis B surface antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 9 . Results of 2017 anti-HBs proficiency testing.

긎ethod1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA-3893881396-1395
ECLIA3280280330412303
EIA-22-2--2
FEIA-3131-32--32
ICA4173177-221-1220
MEIA-11-3--3
Others2810-11--11
Total9884889496914966

Abbreviations: Anti-HBs, antibody to hepatitis B surface antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


3) B삎媛꾩뿼以묒떖빆泥

Anti-HBc total寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01怨 IL-16-02 寃泥댁 2李⑥쓽 IL-16-04怨 IL-16-05 寃泥대뒗 뼇꽦 寃泥대줈 1李 寃곌낵 媛곴컖 125湲곌 以 124湲곌, 125湲곌 以 123湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.2% 98.4%쓽 씪移섏쑉쓣 蹂댁떎. 2李 寃곌낵 媛곴컖 125湲곌 以 123湲곌, 125湲곌 以 124湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 98.4% 99.2%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 10). 븳렪 2李⑥쓽 IL-16-03 寃泥대뒗 쓬꽦 寃泥대줈 125湲곌 以 124湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 99.2%쓽 씪移섏쑉쓣 蹂댁떎(Table 10). 2017뀈 1李⑥쓽 IL-17-02 寃泥댁 2李⑥쓽 IL-17-05 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 125湲곌 以 124湲곌, 127湲곌 以 127湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.2% 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 11). 븳렪 1李⑥쓽 IL-17-01 寃泥댁 2李⑥쓽 IL-17-06 寃泥대뒗 쓬꽦 寃泥대줈꽌 媛곴컖 125湲곌 以 125湲곌, 127湲곌 以 127湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 11).

Table 10 . Results of 2016 anti-HBc total proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA-8318284--84-84
ECLIA13613635--35-35
EIA----------
FEIA-5-55-14-5
ICA----------
MEIA----------
Others----------
Total11242123124-1123-124

Abbreviations: Anti-HBc, antibody to hepatitis core antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 11 . Results of 2017 anti-HBc total proficiency testing.

긎ethod1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA83--83-8787-
ECLIA36-135-3636-
EIA-------
FEIA5--5-44-
ICA--------
MEIA--------
Others1--1----
Total125-1124-127127-

Abbreviations: Anti-HBc, antibody to hepatitis core antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Anti-HBc IgM寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01怨 IL-16-02 寃泥댁 2李⑥쓽 IL-16-03, IL-16-04 IL-16-05 寃泥대뒗 紐⑤몢 쓬꽦 寃泥댁떎. 1李 寃곌낵 媛곴컖 92湲곌 以 90湲곌, 92湲곌 以 92湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 97.8% 100.0%쓽 씪移섏쑉쓣 蹂댁떎. 2李 寃곌낵 媛곴컖 92湲곌 以 92湲곌, 91湲곌, 91湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 100.0%, 98.9%, 98.9%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 12). 2017뀈 1李⑥쓽 IL-17-01, IL-17-02 寃泥댁 2李⑥쓽 IL-17-05, IL-17-06 寃泥대뒗 紐⑤몢 쓬꽦 寃泥대줈꽌 1李 寃곌낵 媛곴컖 89湲곌 以 89湲곌, 2李 寃곌낵 88湲곌 以 88湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 13).

Table 12 . Results of 2016 anti-HBc immunoglobulin M proficiency testing.

긎ethod1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA55156-56-551551
ECLIA26127-27-27-27-
EIA----------
FEIA909-9-9-9-
ICA----------
MEIA----------
Others----------
Total90292-92-911911

Abbreviations: Anti-HBc, antibody to hepatitis core antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 13 . Results of 2017 anti-HBc immunoglobulin M proficiency testing.

긎ethod1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA53-53-52-52-
ECLIA27-27-27-27-
EIA--------
FEIA9-9-9-9-
ICA--------
MEIA--------
Others--------
Total89-89-88-88-

Abbreviations: Anti-HBc, antibody to hepatitis core antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


4) B삎媛꾩뿼쇅뵾빆썝

HBeAg寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 2李⑥쓽 IL-16-04 寃泥대뒗 뼇꽦 寃泥대줈 248湲곌 以 233 湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 94.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 14). 1李⑥쓽 IL-16-01怨 IL-16-02 寃泥댁 2李⑥쓽 IL-16-03怨 IL-16-05 寃泥대뒗 쓬꽦 寃泥댁떎. 1李 寃곌낵 媛곴컖 249湲곌 以 247湲곌, 249湲곌 以 220湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.2% 88.4%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 248湲곌 以 248湲곌, 248湲곌 以 248湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 14). 2017뀈 2李⑥쓽 IL-17-05 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 253湲곌 以 239 湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 94.5%쓽 씪移섏쑉쓣 蹂댁떎(Table 15). 븳렪 1李⑥쓽 IL-17-01, IL-17-02 寃泥댁 2李⑥쓽 IL-17-06 寃泥대뒗 쓬꽦 寃泥대줈꽌 1李 寃곌낵 媛곴컖 250湲곌 以 250湲곌, 250湲곌 以 248湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 100.0% 99.2%쓽 씪移섏쑉쓣, 2李 寃곌낵 253湲곌 以 252湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 99.6%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 15).

Table 14 . Results of 2016 HBeAg proficiency testing.

긎ethod1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA138-11226141--141141-
ECLIA82-82-81-18081-
EIA----------
FEIA11-11-11--1111-
ICA16215315-14115-
MEIA----------
Others----------
Total247222029248-15233248-

Abbreviations: HBeAg, hepatitis B envelope antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 15 . Results of 2017 HBeAg proficiency testing.

긎ethod1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA139-1381-1401391
ECLIA85-85--8686-
EIA--------
FEIA11-11--1111-
ICA14-13114115-
MEIA-----11-
Others1-1-----
Total250-2482142392521

Abbreviations: HBeAg, hepatitis B envelope antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


5) B삎媛꾩뿼쇅뵾빆泥

Anti-HBe寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01怨 IL-16-02 寃泥대뒗 뼇꽦 寃泥대줈 媛곴컖 227湲곌 以 221湲곌, 227湲곌 以 224湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 97.4% 98.7%쓽 씪移섏쑉쓣 蹂댁떎(Table 16). 븳렪 2李⑥쓽 IL-16-03, IL-16-04 IL-16-05 寃泥대뒗 쓬꽦 寃泥대줈 媛곴컖 228湲곌 以 228湲곌, 226湲곌, 224湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 100.0%, 99.1%, 98.2%쓽 씪移섏쑉쓣 蹂댁떎(Table 16). 2017뀈 1李⑥쓽 IL-17-02 寃泥대뒗 뼇꽦 寃泥대줈꽌 231湲곌 以 225湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 97.4%쓽 씪移섏쑉쓣 蹂댁떎(Table 17). 븳렪 1李⑥쓽 IL-17-01 寃泥댁 2李⑥쓽 IL-17-05, IL-17-06 寃泥대뒗 쓬꽦 寃泥대줈꽌 1李 寃곌낵 231湲곌 以 227湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 98.3%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 233湲곌 以 233湲곌, 233湲곌 以 233湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 17).

Table 16 . Results of 2016 anti-HBe proficiency testing.

긎ethod1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA41332135139-1381138-
ECLIA- 77- 77 76- 751 76-
EIA----------
FEIA- 11- 11 11- 11- 92
ICA2-1 1 2- 2- 11
MEIA----------
Others----------
Total62213224228-22622243

Abbreviations: Anti-HBe, antibody to hepatitis B envelope antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immuno짯chromatography assay; MEIA, microparticle enzyme immunoassay.


Table 17 . Results of 2017 anti-HBe proficiency testing.

Method1st trial2nd trial


IL-17-01IL-17-02IL-17-05IL-17-06




NPNPNPNP
CLIA13523134138-138-
ECLIA 7911 79 81- 81-
EIA--------
FEIA 11-- 11 11- 11-
ICA 112- 2- 2-
MEIA---- 1- 1-
Others 1-- 1----
Total22746225233-233-

Abbreviations: Anti-HBe, antibody to hepatitis B envelope antigen; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immu짯noassay; ICA, immunochromatography assay; MEIA, micro짯particle enzyme immunoassay.


6) C삎媛꾩뿼빆泥

Anti-HCV寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01 寃泥댁 2李⑥쓽 IL-16-03 寃泥대뒗 뼇꽦 寃泥대줈 媛곴컖 689湲곌 以 682湲곌, 692湲곌 以 683湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.0% 98.7%쓽 넂 씪移섏쑉쓣 蹂댁떎(Table 18). 븳렪 1李⑥쓽 IL-16-02 寃泥댁 2李⑥쓽 IL-16-04 IL-16-05 寃泥대뒗 쓬꽦 寃泥대줈 1李 寃곌낵 689湲곌 以 559湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 81.1%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 693湲곌 以 690湲곌, 693湲곌 以 686湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.6%, 99.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 18). 2017뀈 1李⑥쓽 IL-17-04 寃泥댁 2李⑥쓽 IL-17-08 寃泥대뒗 뼇꽦 寃泥대줈꽌 媛곴컖 707湲곌 以 706湲곌, 783湲곌 以 781湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.9% 99.7%쓽 씪移섏쑉쓣 蹂댁떎(Table 19). 븳렪 1李⑥쓽 IL-17-03 寃泥댁 2李⑥쓽 IL-17-07 寃泥대뒗 쓬꽦 寃泥대줈꽌 媛곴컖 707湲곌 以 706湲곌, 783湲곌 以 783湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.9% 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 19).

Table 18 . Results of 2016 anti-HCV proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA4336336 41337338-338-
ECLIA2173 51123217417511751
EIA- 5 5-- 4 4- 4-
FEIA- 2 2-- 2 2- 2-
ICA1146145 2415115411496
MEIA----------
Others- 20 20-2 15 171 18-
Total7682559129968369036867

Abbreviations: Anti-HCV, anti-hepatitis C virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immuno짯chromatography assay; MEIA, microparticle enzyme immunoassay.


Table 19 . Results of 2017 anti-HCV proficiency testing.

Method1st trial2nd trial


IL-17-03IL-17-04IL-17-07IL-17-08




NPNPNPNP
CLIA34111341359-1358
ECLIA185--185200--200
EIA 7-- 7 7-- 7
FEIA 7-- 7 8-- 8
ICA159--159198-1197
MEIA--------
Others 7-- 7 11-- 11
Total7061170678302781

Abbreviations: Anti-HCV, anti-hepatitis C virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


7) A삎媛꾩뿼빆泥

2016뀈 anti-HAV 寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, anti-HAV IgM寃궗瑜 떆뻾븯뒗 湲곌 닔뒗 239媛 湲곌쑝濡 anti-HAV寃궗 以묒뿉꽌 媛옣 留롮븯쑝硫, 씠 以 110媛쒖쓽 湲곌(46.0%) anti-HAV IgM怨 total寃궗瑜, 102媛쒖쓽 湲곌(42.7%) anti-HAV IgM怨 IgG寃궗瑜 룞떆뿉 떆뻾븯怨 엳뿀떎. 5媛쒖쓽 湲곌(2.1%)씠 anti-HAV IgM, IgG 諛 total寃궗瑜 紐⑤몢 떆뻾븯怨 엳뿀떎. 2017뀈 떊鍮숇룄議곗궗 寃곌낵, anti-HAV IgM寃궗瑜 떆뻾븯뒗 湲곌 닔뒗 241媛 湲곌쑝濡 anti-HAV寃궗 以묒뿉꽌 媛옣 留롮븯쑝硫, 씠 以 116媛쒖쓽 湲곌(48.1%) anti-HAV IgM怨 total寃궗瑜 룞떆뿉 떆뻾븯怨 엳뿀떎. 99媛쒖쓽 湲곌(41.1%)씠 anti-HAV IgG怨 total寃궗瑜, 6媛쒖쓽 湲곌(2.5%)씠 anti-HAV IgM, IgG 諛 total寃궗瑜 紐⑤몢 떆뻾븯怨 엳뿀쑝硫, 븳 媛쒖쓽 湲곌(0.4%)씠 anti-HAV IgM怨 IgG寃궗瑜 떆뻾븯怨 엳뿀떎.

Anti-HAV total寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01, IL-16-02 寃泥댁 2李⑥쓽 IL-16-04, IL-16-05 寃泥대뒗 뼇꽦 寃泥대줈 1李 寃곌낵 媛곴컖 151湲곌 以 148湲곌, 151湲곌 以 149湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 98.0%, 98.7%쓽 씪移섏쑉쓣, 2李 寃곌낵 152湲곌 以 149湲곌, 152湲곌 以 150湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 98.0%, 98.7%%쓽 씪移섏쑉쓣 蹂댁떎. 븳렪 2李⑥쓽 IL-16-03寃泥대뒗 쓬꽦 寃泥대줈 152湲곌 以 140湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 92.1%쓽 씪移섏쑉쓣 蹂댁떎(Table 20). 2017뀈 1李⑥쓽 IL-17-03, IL-17-04 寃泥댁 2李⑥쓽 IL-17-08寃泥대뒗 뼇꽦 寃泥대줈꽌 1李 寃곌낵 媛곴컖 157湲곌 以 157湲곌, 157湲곌 以 157湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 씪移섏쑉쓣, 2李 寃곌낵 169湲곌 以 167湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 98.8%쓽 씪移섏쑉쓣 蹂댁떎. 븳렪 2李⑥쓽 IL-17-07寃泥대뒗 쓬꽦 寃泥대줈꽌 169湲곌 以 159湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 94.1%쓽 씪移섏쑉쓣 蹂댁떎(Table 21).

Table 20 . Results of 2016 anti-HAV total proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA- 55- 55 52 31 541 54
ECLIA1 731 73 74 41 77- 78
EIA1 0- 1------
FEIA- 18- 18 13 4- 18- 18
ICA- 2- 2 1-1-1-
MEIA----------
Others----------
Total214811491401131492150

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immuno짯chromatography assay; MEIA, microparticle enzyme immunoassay.


Table 21 . Results of 2017 anti-HAV total proficiency testing.

Method1st trial2nd trial


IL-17-03IL-17-04IL-17-07IL-17-08




NPNPNPNP
CLIA- 56- 56 58 4- 62
ECLIA- 82- 82 85 51 89
EIA--------
FEIA- 17- 17 15 11 15
ICA- 1- 1 1-- 1
MEIA--------
Others- 1- 1----
Total-157-157159102167

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Anti-HAV IgG寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01, IL-16-02 寃泥댁 2李⑥쓽 IL-16-04, IL-16-05 寃泥대뒗 뼇꽦 寃泥대줈 1李 寃곌낵 媛곴컖 133湲곌 以 133湲곌, 133湲곌 以 132湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 100.0%, 99.2%쓽 씪移섏쑉쓣, 2李 寃곌낵 135湲곌 以 134湲곌, 135湲곌 以 133湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.3%, 98.5%쓽 넂 씪移섏쑉쓣 蹂댁떎. 븳렪 2李⑥쓽 IL-16-03 寃泥대뒗 쓬꽦 寃泥대줈 135湲곌 以 130湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 96.3%쓽 씪移섏쑉쓣 蹂댁떎(Table 22). 2017뀈 1李⑥쓽 IL-17-03, IL-17-04 寃泥댁 2李⑥쓽 IL-17-08 寃泥대뒗 뼇꽦 寃泥대줈꽌 1李 寃곌낵 媛곴컖 136湲곌 以 135湲곌, 136湲곌 以 135湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 99.3%쓽 씪移섏쑉쓣, 2李 寃곌낵 149湲곌 以 148湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 99.3%쓽 씪移섏쑉쓣 蹂댁떎. 븳렪 2李⑥쓽 IL-17-07 寃泥대뒗 쓬꽦 寃泥대줈꽌 149湲곌 以 148湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 99.3%쓽 씪移섏쑉쓣 蹂댁떎(Table 23).

Table 22 . Results of 2016 anti-HAV immunoglobulin G proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA-11211111113-114-114
ECLIA- 17- 17 151- 16- 16
EIA----------
FEIA- 1- 1-1- 1- 1
ICA- 3- 3 4-1 32 2
MEIA----------
Others----------
Total-1331132130511342133

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 23 . Results of 2017 anti-HAV immunoglobulin G proficiency testing.

Method1st trial2nd trial


IL-17-03IL-17-04IL-17-07IL-17-08




NPNPNPNP
CLIA-116-1161211-122
ECLIA- 16- 16 20-- 20
EIA--------
FEIA- 1- 1 1-- 1
ICA1 21 2 5-1 4
MEIA--------
Others---- 1-- 1
Total1135113514811148

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Anti-HAV IgM寃궗뿉 븳 떊鍮숇룄議곗궗 寃곌낵, 2016뀈 1李⑥쓽 IL-16-01, IL-16-02 寃泥댁 2李⑥쓽 IL-16-03, IL-16-04, IL-16-05 寃泥대뒗 紐⑤몢 쓬꽦 寃泥대줈 1李 寃곌낵 媛곴컖 236湲곌 以 234湲곌, 236湲곌 以 232湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 媛곴컖 99.2%, 98.3%쓽 씪移섏쑉쓣 蹂댁떎. 2李 寃곌낵 239湲곌 以 238湲곌뿉꽌 紐⑤몢 쓬꽦쑝濡 蹂닿퀬븯뿬 99.6%쓽 씪移섏쑉쓣 蹂댁떎(Table 24). 2017뀈 1李⑥쓽 IL-17-03 寃泥대뒗 뼇꽦 寃泥대줈꽌 232湲곌 以 213湲곌뿉꽌 뼇꽦쑝濡 蹂닿퀬븯뿬 91.8%쓽 씪移섏쑉쓣 蹂댁떎. 븳렪 1李⑥쓽 IL-17-04 寃泥댁 2李⑥쓽 IL-17-07, IL-17-08 寃泥대뒗 쓬꽦 寃泥대줈꽌 1李 寃곌낵 232湲곌 以 229湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 98.7%쓽 씪移섏쑉쓣, 2李 寃곌낵 媛곴컖 241湲곌 以 241湲곌, 241湲곌 以 241湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯뿬 紐⑤몢 100.0%쓽 씪移섏쑉쓣 蹂댁떎(Table 25).

Table 24 . Results of 2016 anti-HAV IgM proficiency testing.

Method1st trial2nd trial


IL-16-01IL-16-02IL-16-03IL-16-04IL-16-05





NPNPNPNPNP
CLIA135-135-136-136-136-
ECLIA 701 683 731 731 731
EIA----------
FEIA 22- 22- 22- 22- 22-
ICA 6- 6- 6- 6- 6-
MEIA----------
Others 1- 1- 1- 1- 1-
Total23412323238123812381

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


Table 25 . Results of 2017 anti-HAV IgM proficiency testing.

Method1st trial2nd trial


IL-17-03IL-17-04IL-17-07IL-17-08




NPNPNPNP
CLIA141211341145-145-
ECLIA 2 67 672 71- 71-
EIA--------
FEIA- 21 21- 20- 20-
ICA 3 3 6- 5- 5-
MEIA--------
Others- 1 1-----
Total192132293241-241-

Abbreviations: Anti-HAV, anti-hepatitis A virus antibody; N, negative; P, positive; CLIA, chemiluminescence immunoassay; ECLIA, electro-chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence enzyme immunoassay; ICA, immunochromatography assay; MEIA, microparticle enzyme immunoassay.


怨 李

2016뀈 李⑥꽭 떊鍮숇룄議곗궗궗뾽 떆뻾뿉 뵲씪 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽 寃궗 빆紐⑹씠 湲곗〈쓽 4媛쒖뿉꽌 10媛쒕줈 利앷릺뼱 A삎, B삎 諛 C삎 媛꾩뿼諛붿씠윭뒪쓽 삁泥븰쟻 寃궗뿉 븳 쇅遺젙룄愿由ш 떆뻾릺뿀떎.

2016뀈 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 떊鍮숇룄議곗궗궗뾽 6썡怨 10썡뿉 떎떆릺뿀뒗뜲, 媛곴컖 965湲곌怨 962湲곌뿉 寃泥대 諛쒖넚븯뿬 1, 2李⑥뿉 李몄뿬븳 湲곌씠 媛곴컖 915湲곌(94.8%), 913湲곌(95.0%)쑝濡 넂 李몄뿬쑉쓣 蹂댁떎. 2017뀈 떊鍮숇룄議곗궗궗뾽 5썡怨 10썡뿉 떎떆릺뿀쑝硫, 媛곴컖 936 湲곌怨 1,015湲곌뿉 寃泥대 諛쒖넚븯뿬 1, 2李⑥뿉 李몄뿬븳 湲곌씠 媛곴컖 920湲곌(98.3%), 996湲곌(98.1%)쑝濡 留ㅼ슦 넂 李몄뿬쑉쓣 蹂댁떎. 2017뀈 李몄뿬湲곌 2016뀈룄 李몄뿬湲곌 닔 鍮꾧탳븯뿬 53湲곌(5.2%)씠 利앷븯떎. 떊鍮숇룄議곗궗궗뾽뿉 궗슜릺뒗 寃泥대뒗 2016뀈룄뒗 꽌슱븘궛蹂묒썝뿉꽌 젣議고븯쑝硫, 2017뀈룄뒗 꽌슱꽦紐⑤퀝썝뿉꽌 젣議고븯떎. Matrix effect瑜 諛곗젣븯湲 쐞빐 섑븳留덉쓬 삁븸썝숈쑝濡쒕꽣 삁옣쓣 遺꾩뼇諛쏆븘 媛 醫낅ぉ쓽 뼇꽦怨 쓬꽦 떊鍮숇룄議곗궗 寃泥대 옄媛젣議고븯떎. 젣議곕맂 寃泥댁쓽 젙꽦寃곌낵 媛믪쓽 솗씤 諛 옣鍮 媛 寃곌낵媛 씪移 뿬遺瑜 寃利앺븯湲 쐞븯뿬 3媛 씠긽쓽 젣議고쉶궗 옣鍮 諛 떆빟쑝濡 痢≪젙 썑 諛쒖넚븯떎.

媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗뿉 븳 寃궗諛⑸쾿 2011뀈遺꽣 RPHA, PHA踰 諛 RIA踰뺤쓽 쟾넻쟻씤 諛⑸쾿쓽 떆빟씠 떒醫낅맖뿉 뵲씪 CLIA 諛 ECLIA踰뺤쑝濡 쟾솚릺뼱 2016뀈 77.0%-100.0%쓽 湲곌뿉꽌, 2017뀈 74.7%-99.4%쓽 湲곌뿉꽌 궗슜븯怨 엳뿀떎. 씠뒗 2015뀈룄 65%-69%쓽 湲곌뿉꽌 궗슜븯뜕 寃껉낵 鍮꾧탳븯뿬 긽떦엳 利앷맂 뼇긽쑝濡쒖꽌 寃궗떎쓽 옄룞솕 옣鍮꾩쓽 궗슜씠 利앷븯湲 븣臾몄쑝濡 깮媛곷맂떎[8]. 삉븳 媛꾩씠寃궗踰뺤씤 ICA踰뺤쓣 옣鍮꾨 궗슜븯吏 븡뒗 湲곌쓣 룷븿븯뿬 2016뀈 0.9%-23.0%쓽 湲곌, 2017뀈 0.6%-25.3%쓽 湲곌뿉꽌 궗슜븯怨 엳뿀떎. 씠뒗 2015뀈룄뿉 27%-34%쓽 湲곌뿉꽌 ICA踰뺤쓣 궗슜븯뜕 寃곌낵 鍮꾧탳븯硫, ICA 궗슜湲곌쓽 遺꾪룷媛 媛먯냼맂 뼇긽쓣 蹂댁씠뒗 寃껋쑝濡, 2016뀈遺꽣 寃궗떎쓽 옄룞솕 옣鍮꾩쓽 궗슜씠 利앷븯湲 븣臾몄쑝濡 깮媛곷맂떎. 10媛쒖쓽 醫낅ぉ 以묒뿉꽌 2016뀈룄뿉뒗 anti-HBc寃궗뿉꽌 CLIA 諛 ECLIA踰뺤쓣 궗슜븯뒗 湲곌쓽 鍮꾩쑉씠 媛옣 넂븯쑝硫, 諛섎㈃뿉 anti-HCV寃궗뿉꽌 ICA踰뺤쓣 궗슜븯뒗 湲곌쓽 鍮꾩쑉씠 媛옣 넂븯떎. 2017뀈룄뿉뒗 anti-HAV寃궗뿉꽌 CLIA 諛 ECLIA踰뺤쓣 궗슜븯뒗 湲곌쓽 鍮꾩쑉씠 媛옣 넂븯쑝硫, 諛섎㈃뿉 anti-HCV寃궗뿉꽌 ICA踰뺤쓣 궗슜븯뒗 湲곌쓽 鍮꾩쑉씠 2016뀈룄 룞씪븯寃 媛옣 넂븯떎.

HBsAg怨 anti-HBs寃궗뿉꽌 2016뀈 떊鍮숇룄議곗궗 寃곌낵, 뼇꽦 寃泥댁쓽 씪移섏쑉 95.8%-99.1%濡, 쓬꽦 寃泥댁쓽 씪移섏쑉 98.2%-99.2%濡 留ㅼ슦 슦닔븯떎. 2017뀈 떊鍮숇룄議곗궗 寃곌낵, HBsAg怨 anti-HBs寃궗뿉꽌 뼇꽦 寃泥댁쓽 씪移섏쑉 99.2%-99.7%濡, 쓬꽦 寃泥댁쓽 씪移섏쑉 99.5%-99.9%濡 留ㅼ슦 슦닔븯떎. Anti-HBc total 諛 IgM寃궗뿉꽌 2016뀈 뼇꽦 諛 쓬꽦 寃泥댁쓽 씪移섏쑉 98.4%-100.0%, 2017뀈 뼇꽦 諛 쓬꽦 寃泥댁쓽 씪移섏쑉 99.2%-100.0%濡 넂 씪移섏쑉쓣 蹂댁떎. HBeAg寃궗뿉꽌 2016뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 94.0%, 쓬꽦 寃泥댁쓽 씪移섏쑉 88.4%-100.0%, 2017뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 94.5%, 쓬꽦 寃泥댁쓽 씪移섏쑉 99.2%-100.0%濡 愿李곕릺뿀떎. 2016뀈 떊鍮숇룄議곗궗궗뾽뿉뒗 HBeAg寃궗뿉 븳 뼇꽦 寃泥(IL-16-04) 븳 媛쒓, 2017뀈룄뿉룄 뼇꽦 寃泥(IL-17-05) 븳 媛쒓 룷븿릺뿀떎. 2016뀈룄 ICA踰뺤쓣 궗슜븯뒗 쟾泥 15媛 湲곌 以묒뿉꽌 14媛(93.3%)쓽 湲곌뿉꽌 씠瑜 쓬꽦쑝濡 蹂닿퀬, 2017뀈룄 쟾泥 15媛 湲곌 以묒뿉꽌 14媛(93.3%)쓽 湲곌뿉꽌 쓬꽦쑝濡 蹂닿퀬븯떎. 2016뀈怨 2017뀈룄 룞씪븯寃 ICA踰뺤쓣 궗슜븯뒗 93.3%쓽 湲곌뿉꽌 쐞쓬꽦쑝濡 蹂닿퀬븯뿬 씪移섏쑉씠 궙븘議뚯쑝硫, HBeAg寃궗쓽 ICA踰뺤뿉꽌 넂 쐞쓬꽦瑜좎쓣 蹂댁씠怨 엳뿀떎. 삉븳 2016뀈 1李⑥쓽 쓬꽦 寃泥(IL-16-02)뿉 븯뿬 CLIA踰뺤쓣 궗슜븯뒗 쟾泥 138湲곌 以 26媛(18.8%)쓽 湲곌뿉꽌, ICA踰뺤쓣 궗슜븯뒗 쟾泥 18媛쒖쓽 湲곌 以묒뿉꽌 3媛(16.7%)쓽 湲곌뿉꽌留 뼇꽦쑝濡 蹂닿퀬븯뿬 쟾泥 씪移섏쑉씠 88.4%濡 궙寃 愿李곕릺뿀떎. 2014뀈룄 떊鍮숇룄議곗궗 寃곌낵뿉꽌룄 媛꾩씠寃궗踰뺤씤 ICA踰뺤쓣 궗슜븯뒗 寃쎌슦 쓬꽦 寃泥댁뿉꽌 쐞뼇꽦쑝濡 蹂닿퀬븯뒗 寃쎌슦룄 엳쑝굹 遺遺꾩쓽 寃쎌슦 뼇꽦 寃泥댁뿉꽌 쐞쓬꽦쓽 寃곌낵瑜 蹂댁씤떎怨 蹂닿퀬븯쑝硫[7], HBsAg 떊냽寃궗踰뺤뿉 븳 硫뷀遺꾩꽍寃곌낵뿉꽌룄 CLIA, EIA 諛 MEIA踰뺢낵 鍮꾧탳븯뿬 ICA踰뺤쓽 寃異쒗븳怨꾧 궙떎怨 蹂닿퀬븳 諛 엳떎[9]. 뵲씪꽌 ICA踰뺤쓽 쐞쓬꽦쓽 寃곌낵뒗 ICA踰뺤쓽 誘쇨컧룄媛 궙湲 븣臾몄씤 寃껋쑝濡 뙋떒릺誘濡 젣뭹쓽 뭹吏덊뼢긽怨 諛 꽭떖븳 젙룄愿由ш 븘슂븷 寃껋쑝濡 깮媛곷맂떎. 洹몃윭굹 HBeAg빆紐⑹쓽 떊鍮숇룄議곗궗 寃곌낵 ICA踰뺣퓧留 븘땲씪 CLIA踰뺤쓣 궗슜븯뒗 湲곌뿉꽌룄 넂 쐞뼇꽦瑜좎쓣 蹂댁떎. 씠뒗 HBeAg 쓬꽦 寃泥댁쓽 젣議곌낵젙뿉꽌 궗슜븳 샎빀삁泥쓽 matrix effect 븣臾몄씠씪 뙋떒맂떎. 洹쒕え쓽 떊鍮숇룄議곗궗 궗뾽슜 寃泥대뒗 븳 媛쒖쓽 媛쒕퀎삁泥쓣 궗슜븯뿬 젣議고븯뒗 寃껋씠 遺덇뒫븯誘濡 뿬윭 紐낆쓽 삁泥쓣 샎빀븯뿬 留뚮뱺 샎빀삁泥쓣 궗슜븳떎. 샎빀삁泥쓽 寃쎌슦 젙룄愿由щЪ吏덇낵 鍮꾧탳븯뿬 援먰솚媛뒫꽦(commutability)엳뒗 옣젏씠 엳쑝굹, 寃泥 젣議곌낵젙뿉꽌 삩룄 諛 떆媛꾩뿉 뵲씪꽌 寃泥댁쓽 matrix媛 蹂븯嫄곕굹 삁泥 궡 議댁옱븯뒗 떎뼇븳 떒諛깆쭏씠 媛꾩꽠臾쇱쭏濡 옉슜븯뿬 빆썝빆泥대컲쓳쓣 뼲젣븷 닔 엳뒗 젣븳젏씠 엳떎怨 븣젮졇 엳떎[10]. HBeAg 寃泥 젣議곗뿉 궗슜맂 뿬윭 솚옄쓽 寃泥 궡뿉 議댁옱븯뜕 anti-HBs뿉 쓽븳 matrix effect媛 쐞뼇꽦쓣 쑀諛쒗븷 媛뒫꽦씠 엳쑝誘濡, 뼢썑 샎빀삁泥 젣議 떆 샎빀븯뒗 寃泥 닔瑜 以꾩씠怨 떎瑜 빆썝 諛 빆泥닿궗瑜 넻븯뿬 씪移섎릺뒗 삁븸쓣 샎빀븯뿬 matrix effect瑜 理쒖냼솕븯뒗 끂젰씠 븘슂븷 寃껋쑝濡 깮媛곷릺뿀떎. 2017뀈룄 寃泥 젣議곌낵젙쓽 媛쒖꽑쑝濡 2016뀈룄 HBeAg 쓬꽦 寃泥댁쓽 젣議곌낵젙뿉꽌 궗슜븳 샎빀삁泥쓽 matrix effect濡 씤븯뿬 諛쒖깮븯뜕 쓬꽦 寃泥댁쓽 쐞뼇꽦瑜좎 2016뀈룄 鍮꾧탳븯뿬 넂 씪移섏쑉쓣 蹂댁떎. Anti-HBe寃궗뿉꽌 2016뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 97.4%-98.7%, 쓬꽦 寃泥댁쓽 씪移섏쑉 98.2%-100.0%, 2017뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 97.4%, 쓬꽦 寃泥댁쓽 씪移섏쑉 98.3%-100.0%濡 뼇꽦 寃泥댁쓽 씪移섏쑉蹂대떎 떎냼 넂븯떎. 씠뒗 뼇꽦 寃泥댁뿉 븯뿬 ICA踰뺤쓣 궗슜븯뒗 2媛쒖쓽 湲곌뿉꽌 紐⑤몢 쓬꽦쑝濡 蹂닿퀬븳 쐞쓬꽦 寃곌낵 븣臾몄쑝濡 깮媛곷맂떎.

Anti-HCV寃궗뿉꽌 2016뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 98.7%-99.9%濡, 쓬꽦 寃泥댁쓽 씪移섏쑉 81.1%-99.6%濡 씪遺 쓬꽦 寃泥댁뿉꽌쓽 씪移섏쑉씠 궙븯떎. 2017뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 99.7%-99.9%濡, 쓬꽦 寃泥댁쓽 씪移섏쑉 99.9%-100.0%濡 留ㅼ슦 슦닔븯떎. 2016뀈룄 뼇꽦 寃泥댁쓽 씪移섏쑉 2015뀈 떊鍮숇룄議곗궗 寃곌낵 99.5%-99.8%怨 쑀궗븳 씪移섏쑉쓣 蹂댁쑝굹, 쓬꽦 寃泥댁쓽 씪移섏쑉 99.6%-99.8% 鍮꾧탳븯뿬 궙寃 愿李곕릺뿀떎. 洹몃윭굹 2017뀈 쓬꽦 寃泥댁쓽 씪移섏쑉 2016뀈룄 鍮꾧탳븯뿬 넂 씪移섏쑉쓣 蹂댁떎. ICA踰뺤쓣 궗슜븯뒗 湲곌씠 2015뀈룄뿉뒗 34.0%뜕 諛섎㈃, 2016뀈뿉뒗 23.0%濡 媛먯냼븯떎媛, 2017뀈뿉뒗 25.3%濡 빟媛 利앷븳 뼇긽쓣 蹂댁뿬 떎瑜 寃궗빆紐⑹뿉 鍮꾪븯뿬 뿬쟾엳 ICA踰뺤쓣 留롮씠 궗슜븯怨 엳뿀떎. CLIA 諛 ECLIA踰뺢낵 鍮꾧탳븯뿬 궙 寃異 誘쇨컧룄瑜 蹂댁엫뿉룄 遺덇뎄븯怨, 뼇꽦 寃泥댁뿉꽌 넂 씪移섏쑉쓣 蹂댁뿬 援궡 ICA寃궗궎듃쓽 꽦뒫씠 뼢긽릺뿀떎怨 뙋떒맂떎. 2016뀈 1李⑥쓽 쓬꽦 寃泥(IL-16-02)뿉꽌 궙 씪移섏쑉쓣 蹂댁씤 寃껋 ECLIA踰뺤쓣 궗슜븯뒗 쟾泥 174湲곌 以묒뿉꽌 123媛(70.7%)쓽 湲곌뿉꽌 쐞뼇꽦쑝濡 蹂닿퀬븯湲 븣臾몄씠떎. 씠뒗 HBeAg 쓬꽦 寃泥댁 留덉갔媛吏濡 anti-HCV媛 쓬꽦씤 뿬윭 솚옄쓽 삁泥쓣 샎빀븯뿬 寃泥닿 젣議곕릺뿀쑝誘濡, matrix effect濡 씤븯뿬 듅젙 옣鍮 諛 떆빟뿉꽌 뼇꽦寃곌낵瑜 蹂댁씤 寃껋씠씪 뙋떒릺뿀떎. 洹몃윭굹 2017뀈룄 寃泥 젣議곌낵젙쓽 媛쒖꽑쑝濡 2016뀈룄 鍮꾧탳븯뿬 쓬꽦 寃泥 씪移섏쑉씠 뼢긽릺뿀떎.

Anti-HAV total寃궗뿉꽌 2016뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 98.7%-98.0%, 쓬꽦 寃泥댁쓽 씪移섏쑉 92.1%濡 뼇꽦 寃泥댁쓽 씪移섏쑉蹂대떎 궙븯떎. IL-06-03 寃泥댁쓽 anti-HAV total寃궗뿉꽌뒗 FEIA踰, CLIA踰, ECLIA踰 닚쑝濡 넂 쐞뼇꽦瑜좎쓣 蹂댁쑝硫, 媛곴컖 30.8%, 5.8%, 5.4%쓽 湲곌뿉꽌 쐞뼇꽦쑝濡 蹂닿퀬븯떎. 2017뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 98.8%-100.0%, 쓬꽦 寃泥댁쓽 씪移섏쑉 94.1%濡 뼇꽦 寃泥댁쓽 씪移섏쑉蹂대떎 궙븯떎. IL-07-07 寃泥댁쓽 anti-HAV total寃궗뿉꽌뒗 CLIA踰, FEIA踰, ECLIA踰 닚쑝濡 넂 쐞뼇꽦瑜좎쓣 蹂댁쑝硫, 媛곴컖 6.5%, 6.7%, 5.9%쓽 湲곌뿉꽌 쐞뼇꽦쑝濡 蹂닿퀬븯떎. Anti-HAV IgG寃궗뿉꽌 2016뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 98.5%-100.0%, 쓬꽦 寃泥댁쓽 씪移섏쑉 96.3%濡 留ㅼ슦 슦닔븯떎. 洹몃윭굹 ICA踰뺤쓣 궗슜븯뒗 寃쎌슦 2016뀈 2李 떊鍮숇룄議곗궗뿉꽌 2媛쒖쓽 뼇꽦 寃泥댁뿉 븯뿬 媛곴컖 25%, 50%쓽 湲곌씠 쐞쓬꽦쑝濡 蹂닿퀬븯떎. 삉븳 쐞뼇꽦쑝濡 蹂닿퀬븳 寃쎌슦 FEIA踰, ECLIA踰, CLIA踰 닚쑝濡 넂 쐞뼇꽦瑜좎쓣 蹂댁쑝硫, 媛곴컖 100.0%, 6.3%, 2.6%쓽 湲곌뿉꽌 쐞뼇꽦쑝濡 蹂닿퀬븯떎. 2017뀈 뼇꽦 寃泥댁쓽 씪移섏쑉 99.3%, 쓬꽦 寃泥댁쓽 씪移섏쑉 99.3%濡 留ㅼ슦 슦닔븯떎. 洹몃윭굹 ICA踰뺤쓣 궗슜븯뒗 寃쎌슦 2017뀈 1李 떊鍮숇룄議곗궗뿉꽌 2媛쒖쓽 뼇꽦 寃泥(IL-07-03, IL-07-04)뿉 븯뿬 50%쓽 湲곌씠, 2李⑥뿉꽌 븳 媛쒖쓽 뼇꽦 寃泥(IL-07-08)뿉 븯뿬 20%쓽 湲곌씠 쐞쓬꽦쑝濡 蹂닿퀬븯떎. 2016뀈 anti-HAV IgM寃궗 븳 떊鍮숇룄議곗궗뒗 紐⑤몢 쓬꽦 寃泥닿 궗슜릺뿀쑝硫, 씪移섏쑉 98.3%-99.6%濡 留ㅼ슦 넂寃 愿李곕릺뿀떎. 쐞뼇꽦쑝濡 蹂닿퀬븳 寃쎌슦뒗 紐⑤몢 ECLIA踰뺤쓣 궗슜븯뒗 1.4%-4.2%쓽 湲곌씠뿀떎. 2017뀈 떊鍮숇룄議곗궗뒗 뼇꽦 寃泥(IL-17-03) 븳 媛쒓 룷븿릺뿀쑝硫, 뼇꽦 寃泥댁쓽 씪移섏쑉 91.8%, 쓬꽦 寃泥댁쓽 씪移섏쑉 98.7%-100.0%濡 뼇꽦 寃泥댁쓽 씪移섏쑉씠 궙寃 愿李곕릺뿀떎. 쐞쓬꽦쑝濡 蹂닿퀬븳 寃쎌슦뒗 CLIA踰 14媛 湲곌(10.4%), ECLIA踰 2媛 湲곌(2.9%), ICA踰 3媛쒖쓽 湲곌(50.0%)씠뿀떎. 2016뀈룄 쓬꽦 寃泥댁쓽 씪移섏쑉怨 鍮꾧탳븯뿬 2017뀈룄 anti-HAV IgM寃궗뿉꽌 쓬꽦 寃泥댁쓽 씪移섏쑉씠 뜑 뼢긽릺뿀떎. 洹몃윭굹 2017뀈룄 떊鍮숇룄議곗궗뿉꽌 泥섏쓬쑝濡 anti-HAV IgM寃궗뿉꽌 뼇꽦 寃泥대 궗슜븳 寃곌낵 쐞뼇꽦 蹂닿퀬濡 씤븳 궙 씪移섏쑉쓣 蹂댁떎. Anti-HAV寃궗뒗 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗 以묒뿉꽌 옄룞솕 옣鍮꾨 궗슜븯뒗 鍮꾩쑉씠 긽쟻쑝濡 媛옣 넂 빆紐⑹씠硫, 듅엳 anti-HAV total怨 IgM寃궗瑜 룞떆뿉 떆뻾븯뒗 湲곌 닔媛 留롮쑝誘濡 anti-HAV 옄룞솕 寃궗踰뺤쓽 誘쇨컧룄 뼢긽씠 븘슂븷 寃껋쑝濡 깮媛곷맂떎. 삉븳 anti-HAV IgM 諛 IgG寃궗쓽 ICA踰뺤쓣 궗슜븯뒗 湲곌뿉꽌 쐞쓬꽦 寃곌낵媛 留롮씠 諛쒖깮븯쑝誘濡 ICA寃궗궎듃쓽 뭹吏덇컻꽑 諛 寃궗떎뿉꽌쓽 蹂대떎 뾼寃⑺븳 吏 愿由ш 슂援щ맂떎.

寃곕줎쟻쑝濡, 2016뀈 諛 2017뀈룄 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗쓽 떊鍮숇룄議곗궗궗뾽 10媛吏 醫낅ぉ뿉 븯뿬 떆뻾븯쑝硫, 蹂 뿰援ъ쓽 넻怨꾨텇꽍옄猷뚭 李몄뿬湲곌뿉꽌 떊鍮숇룄議곗궗 寃곌낵瑜 빐꽍븯怨 寃궗踰 꽑깮 떆 쑀슜븷 寃껋쑝濡 깮媛곷맂떎. 삉븳 吏냽쟻씤 떊鍮숇룄議곗궗궗뾽 李몄뿬瑜 넻븯뿬 媛꾩뿼諛붿씠윭뒪 빆썝빆泥닿궗쓽 吏 뼢긽씠 븘슂븯떎.

媛먯궗쓽 湲

씠 끉臾몄 븳엫긽寃궗젙룄愿由ы삊쉶 2016뀈 諛 2017뀈 븰닠뿰援щ퉬 吏썝뿉 쓽빐 씠猷⑥뼱吏 寃껋씠떎.

References
  1. Kang DY, Kim KH, Lee DH, Lee YW, Park CK. Report on serology survey in Korea 1982. J Lab Med Qual Assur 1983;5:39-44.
  2. Cho HI, Kang DY, Kim SI, Kim KH, Lee YW, Choi S, et al. Annual report on quality assessment in immuno-serology and blood bank tests in Korea (1983). J Lab Med Qual Assur 1984;6:31-8.
  3. Chi HS, Kang DY, Kim HS, Park MH, Shim JW, Lee DH, et al. Annual report on external quality assessment in immunoserology in Korea (1986). J Lab Med Qual Assur 1987;9:37-46.
  4. Kim HS, Kim DW, Kim JS, Kim TY, Park MH, Park AJ, et al. Annual report on external quality assessment in immunoserology in Korea (1993). J Lab Med Qual Assur 1994;16:33-46.
  5. Cha YJ, Kwon SY, Kum DG, Kim SW, Kim TY, Kim JR, et al. Annual report on external quality assessment in immunoserology in Korea (2004). J Lab Med Qual Assur 2005;27:37-57.
  6. Lee JH, Cha YJ, Bae JH, Chae SL. Immunoserology Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratory. Annual report on external quality assessment of viral markers and serological tests for syphilis in Korea (2013). J Lab Med Qual Assur 2014;36:161-70.
    CrossRef
  7. Cha YJ, Bae JH, Park Q, Chae SL. Immunoserology Subcommittee, The Korean Association of External Quality Assessment Service. Annual report on the external quality assessment scheme of viral markers and serological tests for syphilis in Korea (2014). J Lab Med Qual Assur 2015;37:124-33.
    CrossRef
  8. Cha YJ, Bae JH, Jung YS, Chae SL. Immunoserology Subcommittee, Korean Association of External Quality Assessment Service. Annual report on the external quality assessment scheme of viral markers and serological tests for syphilis in Korea (2015). J Lab Med Qual Assur 2016;38:214-24.
    CrossRef
  9. Hwang SH, Oh HB, Choi SE, Kim HH, Chang CL, Lee EY, et al. Meta-analysis for the pooled sensitivity and specificity of hepatitis B surface antigen rapid tests. Korean J Lab Med 2008;28:160-8.
    Pubmed CrossRef
  10. Miller WG. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta 2003;327:25-37.
    CrossRef