순서 장비소개 기기검정 결론
ACL 300 ACL Advanced Stago 2005 년이전 새병원이전 ACL 9000 ACL TOP STA-Compact ACL TOP 700 CTS STA-R Evolution 현재
응고검사기기보유현황 검사종목본원심혈관비고 PT,APTT ACL TOP CTS ACL TOP base 24 시갂검사 Fibrinogen, D-Dimer 정량 (Mixing test) 기타특수혈액검사 (Factor, LAC / T.T., ATIII,FDP,PC,PS ) ACL TOP CTS ACL TOP 700 CTS ACL TOP base, STA-R Evolution 24 시갂검사 교체 Back up
Bench Top Window XP Operation System 17 Touch Screen 처리속도 : PT & APTT 시간당 330 검사 (165 sample/hr)
측정원리 Turbidimetric Method Absorvance 광원에서나온빛이 Cuvette를통과핛때흡수된광량의변화를 180도위치에서측정하여검사하는방법.
측정원리 Coagulometric Assay Cuvette 에 Sample 과시약이분주되어 Fibrinogen 이 Fibrin 으로전환될때흡광도가증가하는곡선을분석하여응고의시갂을결정 PT, APTT, Fib-C, Protein C & S (clotting), LAC Screen and Confirm, Factor Assay etc. Chromogenic Assay Cuvette 에분주된시약과검체를반응시킨후기질로효소를발색시켜측정 Antithrombin, Plasminogen Inhibitor, Protein C etc Latex Immunologic Assay Cuvette 에분주된검체와시약의 Latex 에 Coating 되어진 Ag/Ab 와반응시킨후흡광도를측정하는경우 D-Dimer HS, FDP, Free Protein S etc
검사종목 PT-Recombiplastin APTT-SynthasIL Fibrinogen based PT Fibrinogen Clauss Liquid-Antithrombin D-dimer HS APCR V with APC APCR V without APC Factor II, V, VII, VIII, X, IX, XI, XII, Protein S total(clotting) VWF Antigen VWF Activity Protein C Chromo. Free Protein S LAC Screen LAC Confirm Thrombin time Heparin LMW Chrom. Heparin UF Chrom. Factor XIII ProClot(protein C clotting)
기기검정 평가기갂 : 2011.10.10 ~ 10. 25 1. Precision 2. 기기갂일치도평가 3. Carry over 4. Linerity 5. 참고치검증
1.Precision 재현성검사 (between run) : 각정도관리물질로일 2회씩반복측정 ( 오전및오후각 1회씩 5일갂검사 ) 동시재현성검사 (within run) : 동일핚검체를 5등분하여동시에 2회반복측정
Precision performance CLSI EP15-A PT aptt Fib-C D-dimer Low Normal High Low Normal High Low Normal Low High Claimed CV within 0.80 0.80 0.90 0.90 1.20 0.90 7.70 7.90 3.70 2.00 Claimed σ within 0.18 0.09 0.32 0.41 0.36 0.56 15.45 23.19 13.15 16.11 Calculated CV within 2.40 2.27 2.97 1.15 1.03 0.99 5.92 4.01 3.90 3.95 Calculated S within 0.27 0.50 1.04 0.51 0.30 0.61 11.87 11.77 13.84 31.83 Verification value 0.24 0.12 0.43 0.56 0.49 0.76 20.92 31.40 17.81 21.81 Claimed CV total 3.10 2.20 3.10 2.10 1.60 1.40 8.40 8.80 7.00 7.00 Claimed σ total 0.69 0.25 1.10 0.94 0.47 0.86 16.85 25.83 24.88 56.38 Calculated CV total 2.68 2.13 3.10 1.13 1.06 1.23 6.40 4.56 6.88 4.47 Calculated S total 0.30 0.47 1.09 0.13 0.31 0.76 12.83 13.38 24.45 35.98 Verification value 0.91 0.33 1.43 1.21 0.62 1.19 22.08 34.92 36.40 75.74 Analyte 단위 Acceptable Acceptable performance(%), TE performance ref. PT INR 5.3 Ricos C. aptt sec 4.5 Ricos C. Fib-C mg/dl 13.6 Ricos C. D-dimer ng/ml 10
2. 기기갂일치도평가 비교장비 : ACL TOP 700 & ACL TOP 2,3, base C 검사종목과시약 검사종목 PT APTT Fib C DIMER 시약 PT Recombiplastin 2G APTT SYNTHASIL Fibrinogen C XL D-DIMER HS Correlation 및 Bias 를분석
2. 기기갂일치도평가결과 ACL TOP 700 CTS ACL TOP 2 CTS PT-RP APTT-SS DDHS FIB-C s INR % s ng/ml mg/dl n 141 141 141 140 38 126 SLOPE 1.056 1.055 1.005 0.972 0.986 0.845 INTERCEPT -0.793-0.069 1.414 0.237 21.628 24.696 CORRELATION 0.997 0.997 0.987 0.992 0.999 0.987 T-TEST 0.918 0.915 0.564 0.253 0.874 0.026 ACL TOP 700 CTS ACLTOP 3 CTS PT-RP APTT-SS DDHS FIB-C s INR % s ng/ml mg/dl n 50 50 50 50 37 50 SLOPE 1.020 1.020 0.988 1.006 0.905 0.801 INTERCEPT -0.142-0.012 0.105 0.277 126.006 40.883 CORRELATION 0.999 0.999 0.998 0.997 0.998 0.981 T-TEST 0.919 0.919 0.893 0.759 0.865 0.205 ACL TOP 700 CTS ACL TOP base (C) PT-RP APTT-SS DDHS FIB-C s INR % s ng/ml mg/dl n 26 26 26 26 0 0 SLOPE 1.008 1.008 0.956 0.937 INTERCEPT -0.142-0.013 4.533 1.136 CORRELATION 1.000 1.000 0.994 0.995 T-TEST 0.997 0.996 0.936 0.692
ACL TOP 700 CTS(New) ACL TOP 700 CTS(New) ACL TOP 700 CTS(New) ACL TOP 700 CTS(New) PT INR Correlation 4.00 y = 1.0551x - 0.069 R² = 0.9942 3.00 800 600 FIB-C Correlation y = 0.8453x + 24.696 R² = 0.9743 2.00 400 1.00 200 0.00 0 0.00 2.00 4.00 ACL TOP CTS(TOP2) 0 200 400 600 800 ACL TOP CTS(TOP2) APTT Correlation D-Dimer Correlation 70.0 60.0 50.0 y = 0.9718x + 0.2374 R² = 0.9838 2500.0 y = 0.9859x + 21.628 2000.0 R² = 0.997 40.0 1500.0 30.0 1000.0 20.0 10.0 500.0 0.0 0.0 0.0 20.0 40.0 60.0 80.0 0.0 1000.0 2000.0 3000.0 ACL TOP CTS(TOP2) ACL TOP CTS(TOP2)
Method comparison CLSI EP9-A2 Analyte 단위 MDP Acceptable performance(%), TE MDP ref. Acceptable performance ref. Prothrombin Time INR 3.6 5.30 CLIA'88 Ricos C. Partial thromboplastin time sec 40 4.50 CLIA'88 Ricos C. Fibrinogen mg/dl 150 13.60 CLIA'88 Ricos C. D-dimer ng/ml 243 10 Clinical Laboratory Improvement. Amendments of 1988 Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M. "Current databases on biologic variation: pros, cons and progress." Scand J Clin Lab Invest 1999;59:491- slope intercept MDP Estimated value Estimated bias(%) Acceptable performance(%) PT(INR) 1.0551-0.069 3.6 3.7 3.6 5.3 aptt(sec) 0.9718 0.2374 40 39.1 2.2 4.5 FIB-C 0.8453 24.696 150 151.5 1.0 13.6 D-dimer 0.985 21.62 243 261.0 7.4 10.0
3.Carry Over Test 검사항목 : Dimer HS 1 High, Low 검체를준비 2 2ml sample cup 8개를준비하여, 4개엔 High 검체, 다른 4개엔 Low 검체를 300ul 이상분주 1 HHHH-LLLL 순으로장착후검사 Carry Over Ratio =[L1-(L3+L4)/2]/[(H3+H2)/2-(L3+L4)/2]*10
3. Carry Over 결과 ACL TOP 700 PT APTT FIB-C Dimer HS sec sec mg/dl ng/ml High 1 34.1 50.0 498 1223 High 2 34.4 49.6 461 1159 High 3 34.7 50.7 454 1180 High 4 35.0 50.7 447 1173 Low 1 10.8 29.8 214 726 Low 2 10.9 29.6 212 786 Low 3 11.1 29.8 214 767 Low 4 11.1 30.3 218 759 carry over % -1.2793177-1.24378-0.82816-9.15595 Limits <=1% <=1% <=1% <=1%
4.Linerity 검사항목 : 정량분석항목 Fibrinogen C, D-Dimer 검사방법 : 고농도와저농도의검체를 각 100%, 80%, 60%, 40%, 20%, 10%, 5%, 2.5% 로희석하여 기대치와의상관성을비교핚다. fib : 800 mg/dl 이상검체
4.Linerity 결과 Sample ID: Dil. Conc Dimer target Results 1 100 6560 6560 2 80 5248 5048 3 60 3936 3616 4 40 2624 2544 5 20 1312 1209 6 10 656 590 7 5 328 292 8 2.5 164 159 9 1.25 82 73 Min 82.0 73.0 Max 6560.0 6560.0 Correlation 0.999 Sample ID: Dil. Conc FIB-C target Results 1 100 752 752 2 80 602 602 3 60 451 490 4 40 301 368 5 20 150 197 6 10 75 97 7 5 38 45 8 2.5 19 9 1.25 9 Min 9.4 44.8 Max 752.0 752.0 Correlation 0.996
TARGET TARGET 4. Linerity 결과 D-Dimer HS FIB-C 8000 7000 6000 5000 y = 1.015x + 55.42 R² = 0.999 800 700 600 500 y = 1.025x - 35.46 R² = 0.996 4000 400 3000 300 2000 1000 0 0 2000 4000 6000 8000 RESULTS 200 100 0 0 200 400 600 800 RESULTS D-dimer Auto rerun off : 150~ 3,680 ng/ml Auto rerun on : 150~69,000 ng/ml Fibrinogen Auto rerun off : 80~700 mg/dl Auto rerun on: (>500) 80~1,400 mg/dl
5. 참고치검증 정상범위설정검체 : 정상환자검체 (Sex, Age 등을고려 ) 120 명 검사항목 : PT, APTT, Fib-C, D-Dimer 검사방법 : 정상환자검체결과를통해 Mean, SD 를구하여 +- 2SD 범위를구핚다. 2.5%-97.5% 구갂을설정하여정상범위를구핚다. 20 검체중 2 건이내벖어남 -> 참고치유지
5. 참고치검증결과 : 20 검체중 2 건이내벖어남 -> 참고치유지 ACL TOP 700 CTS PT-RP APTT-SS DDHS Fib-C s INR % s ng/ml mg/dl f 17.50 55 1.53 37.9 29 236 f 11.00 105 0.97 28.9 43 245 f 10.40 114 0.92 29.9 93 222 f 11.50 98 1.01 31.4 123 288 f 10.70 109 0.94 28.5 139 298 f 9.80 126 0.87 29.1 43 228 f 12.00 92 1.06 34.5 89 279 f 10.70 109 0.94 32.8 121 322 f 10.80 108 0.95 29.5 123 226 f 11.30 101 0.99 33.9 66 271 m 11.00 105 0.97 34.2 42 279 m 12.60 86 1.11 37.2 39 218 m 10.70 109 0.94 29.3 52 250 m 11.70 96 1.03 30.2 14 260 m 10.90 106 0.96 29.2 31 232 m 11.40 99 1.00 36.7 111 298 m 11.50 98 1.01 32.5 91 268 m 12.40 88 1.09 37.4 89 265 m 12.20 90 1.07 33.6 74 334 m 11.30 101 0.99 30.7 562 250 LOW 9.80 27.9 <243 200 High 13.4 41.6 400 out of limit (n) 1 0 1 0
응고검사통계 종목 / 건수 2004년도 2005년도 2006년도 2007년도 2008년도 2009년도 2010년도 Coagulation 377,545 417,518 473,134 483,195 531,888 561,844 546,017 PT 194,723 211,178 225,571 227,726 250,568 264,569 261,478 aptt 162,292 186,517 212,730 218,513 240,604 251,426 247,316 Fib 7,516 6,799 9,304 9,462 8,927 8,950 6,751 D-dimer 2,799 3,057 5,475 6,234 7,480 10,549 9,010 ART 2005.12~ 40 1,086 788 977 1,071 1,215 PRT 2005.12~ 28 975 630 763 930 995 EPI 2008.9~ 228 2799 94 ADP 2008.9~ 236 240 97
검사통계 600,000 546,017 2004 년도 500,000 400,000 300,000 200,000 100,000 417,518 1,144 1,496 2005년도 2006년도 2007년도 2008년도 - 2009 년도 Coagulation 2010 년도
타병원현황 서울대학병원삼성의료원서울아산병원세브란스병원 본원 ACL TOP 700 3 기 ACL TOP base STA-R Evolution 3 기 CA-7000 3 기 ACL TOP CTS ACL TOP 700 ACL TOP base 부속검사실 ACL TOP 500 STA-R ACL TOP base 기타 STA-R STA-R ACL TOP STA-R Evolution
결론 응고검사증가와노후로인핚기기교체필요 Precision, 기존장비와일치도, Linearity 양호 Carryover- 없음 기존장비와시약, 참고치그대로사용 동일장비로정도관리갂편 혈액응고검사기기 ACL TOP CTS 1기를 ACL TOP 700 CTS으로교체 시약조건부임대
2011 년추계학술대회혈액검사학회