슬라이드 1

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이한 매
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1 목요세미나 Anti-HCV 검사의재검기준 S/CO 설정 짂단면역학파트 최향숙

2 재검기준설정배경 목차 자료조사및분석방법 짂단성능및재검기준분석결과 결롞 2

3 Hepatitis C virus 만성갂질홖의주요원인바이러스 수혈매개감염의원인 감염전파방지를위하여정확핚짂단이필수 C형갂염짂단을위핚검사 혈청학적검사 분자유전학검사 3

4 HCV 감염짂단을위핚검사 HCV assays Indirect Serological assays Antibody assays EIA (CLIA) RIBA Direct Virological assays HCV RNA detection - Qualitative - Quantitative HCV genotyping 4

5 HCV 현재감염확인을위해추천되는검사숚서 (2013 년미국질병통제센터 ) Anti- HCV Nonreactive Reactive HCV 항체미검출 미검출 HCV RNA 검출 현재 HCV 감염아님 현재 HCV 감염 종료 * 적절한추가검사필요 치료 CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR 2013;62(18). 5

6 C 형갂염관련검사결과의해석 결과해석필요한조치 Anti-HCV 음성 Anti-HCV 양성 항체미검출 Presumptive HCV 감염 검체는음성으로결과보고. 최근감염이의심되면 HCV RNA 검사권고됨 * 연속검사결과, 양성일경우현재 HCV 감염을의미하거나과거감염을의미 Anti-HCV 양성 HCV RNA 검출 HCV 현재감염짂료등, 조치필요 Anti-HCV 양성 HCV RNA 미검출 HCV 현재감염아님 대부분의경우조치필요없음짂단이필요하거나최초검사가연속양성을보이면다른항체검사법으로검사하고 HCV RNA 검사가필요함 * If HCV RNA testing is not feasible and person tested is not immunocompromised, do follow-up testing for HCV antibody to demonstrate seroconversion. If the person tested is immunocompromised, consider testing for HCV RNA. It is recommended before initiating antiviral therapy to retest for HCV RNA in a subsequent blood sample to confirm HCV RNA positivity. If the person tested is suspected of having HCV exposure within the past 6 months, or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR 2013;62(18). 6

7 현재본원시행중인 HCV 감염관련검사 C 형갂염짂단을위핚혈청학적검사 Anti-HCV 화학발광면역측정법 (Chemiluminescence immunoassay, CLIA) C 형갂염짂단을위핚분자유전학적검사 HCV PCR Hybridization ( 정성 ) HCV RQ-PCR ( 정량 ) HCV Genotyping 7

8 주요 anti-hcv 검사시약별재검기준 시약이름제조사검사원리 Signal-tocut-off Ratio* Ortho HCV 3.0 ELISA Ortho EIA (enzyme immunoassay) 3.8 Abbott HCV EIA 2.0 Abbott EIA (enzyme immunoassay) VITROS anti-hcv Ortho CIA (chemiluminescent immunoassay) AxSYM anti-hcv Abbott MEIA (microparticle enzyme immunoassay) Architect anti-hcv Abbott CMIA (chemiluminescent microparticle immunoassay) 5.0 Advia Centaur HCV Siemens CIA (chemiluminescent immunoassay) 11.0 Elecsys anti-hcv II Roche ECLIA (Electrochemiluminescent immunoassay)? * predictive of a true positive 95% of the time 8

9 평가배경 Anti-HCV 는선별검사이므로통상적으로민감도를높이기위핚판정기준치가적용됨 국내 C 형갂염의유병률이낮아 anti-hcv 검사의위양성이많으므로재검이필요핚경우가흔함 30 대이상 C 형갂염유병률 0.2% (2010 년국민건강영양조사 ) Anti-HCV 검사시약제조사별로재검이필요핚 S/CO 값에대핚기준이다름 성능이개선된 Elecsys anti-hcv II 시약이출시되면서재검기준 S/CO 값을설정핛필요가있음 9

10 정성검사의 cutoff (CLSI EP12-A2) 양성결과가진양성인최소기준 정성결과판정을위한 cutoff 음성결과가진음성인최대기준 10

11 방법 기갂 : ~ 대상 : 세브란스병원짂단검사의학과에서시행핚 anti-hcv 결과분석 ( 직원신검포함 ) 총 건 ( 중복검사제외 ) 시약 : Elecsys Anti-HCV II (Roche Diagnostics GmbH, Mannheim, Germany) Anti-HCV 검사결과의 S/CO 가 인경우검사대상자의의무기록검토 11

12 방법 정의 True positive case ( 짂양성 ) 검사시점이전또는이후 anti-hcv 검사가지속적으로양성 검사시점에 HCV RIBA 또는 HCV PCR 양성 다른검사법 (Ortho anti-hcv) 로재검양성 의무기록상 HCV 감염기왕력이분명하면서 Roche elecsys anti-hcv II 또는 Ortho anti-hcv 검사중하나이상이양성 True negative case ( 짂음성 ) Anti-HCV 검사가음성이면서의무기록상 C 형갂염기왕력이없거나이전 anti-hcv/hcv PCR/HCV RIBA 중하나이상의검사결과가음성 Elecsys anti-hcv II 검사결과가양성이어서 Ortho anti-hcv 로재검하여음성이면서의무기록상 C 형갂염기왕력이없거나이전 anti-hcv/hcv PCR/HCV RIBA 중하나이상의검사결과가음성 12

13 총 건 짂양성 : 935 건 짂음성 : 건 위음성 : 1 건 위양성 : 339 건 Anti-HCV 결과요약 판정불가 : 16 건 ( 분석제외 ) 13

14 Frequency Anti-HCV S/CO 분포 (<1.0) 대부분 (96.9%) 의경우 S/CO 0.2 이하 Anti-HCV (S/CO) 14

15 Anti-HCV S/CO 분포 (<1.0) Class Frequency Relative frequency Cumulative frequency Cumulative relative frequency 0 to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to <

16 Frequency Anti-HCV S/CO 분포 ( 1.0) Anti-HCV S/CO 16

17 Anti-HCV S/CO 분포 ( 1.0) Class Frequency Frequency Distribution Cumulative frequency Cumulative relative frequency 0 to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to < to <

18 Log10 SCO (Vitros) Ortho 사 Anti-HCV 재검결과와의상관성 N = 347 r = Log10 SCO (cobas)

19 Elecsys Anti-HCV II 짂단성능 HCV 감염 Positive Anti-HCV 결과 Negative Total 양성 음성 Total 진단성능 비율 95% 신뢰구갂 민감도 to 특이도 to 위양성 to 위음성 to

20 TPF (Sensitivity) 상대수행능곡선분석 No discrimination Anti-HCV S/CO ROC Curve FPF (1 - Specificity) Area Under Curve (AUC, 곡선하면적 ) Test AUC 95% 신뢰구갂 표준오차 Anti-HCV to

21 Percent positive results Probit 분석 Log 10 anti-hcv SCO 21

22 Anti_HCV_SCO의 95% 신뢰핚계 log(anti_hcv_sco) 의 95% 신뢰핚계확률 b 추정하핚상핚추정하핚상핚

23 결롞 국내에는 HCV 감염유병률이낮아 anti-hcv 검사의위양성이흔함 Anti-HCV 검사결과가양성시재검기준필요 Elecsys anti-hcv II 검사의민감도및특이도각각 99.9% 및 99.4% 상대수행능곡선하면적 짂단성능이우수하였음 본평가를통하여분석핚 anti-hcv 검사의재검기준은 S/CO <70.3 이었음 95% 신뢰구갂 58.2~

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<333820B1E8C0BAC8F12D42C7FC20B0A3BFB0C7D7BFF820B9D720C7D7C3BC20B0CBBBE7B8A62E687770> Journal of the Korea Academia-Industrial cooperation Society Vol. 14, No. 7 pp. 3419-3424, 2013 http://dx.doi.org/10.5762/kais.2013.14.7.3419 B 형간염항원및항체검사를위한화학발광면역검사법 (CIA) 과면역크로마토그래피법 (ICA) 의비교분석 김혜정