1 3Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L Expiration Date/Fecha de caducidad/verfallsdatum/date d expiration/data di scadenza: when stored in a non-self defrosting freezer at -25 to /si se almacena en un congelador sin auto-descongelaci n entre -25 y / bei Lagerung in einem nichtselbstentfrostenden Gefrierschrank bei -25 zu / پ0 8 condition d tre entrepos -25 et dans un cong lateur non auto-d givrant/ se conservato in un congelatore senza disgelamento automatico tra -25 e For In Vitro Diagnostic Use For more information refer to CardioImmune XL Insert Conventional Units / Unidades convencionales / Klassische Einheiten / Unit s ordinaires / Unit convenzionali ABBOTT AEROSET/ARCHITECT SYSTEMS BNP CMIA ** 85.3 68.2-102 480 384-576 1495 1196-1794 pg/ml CK-MB CMIA 3.00 2.40-3.60 7.08 5.66-8.50 29.5 23.6-35.4 81.5 65.2-97.7 ng/ml Homocysteine CMIA ** 5.36 2.78-7.94 11.0 8.28-13.7 24.9 19.9-29.9 پ0 8mol/L hscrp Immunoturbidimetric 0.05 0.02-0.08 0.17 0.14-0.20 0.41 0.33-0.49 0.97 0.78-1.16 mg/dl Myoglobin MEIA ** ** ** ** ng/ml Troponin - I CMIA 0.041 0.025-0.057 0.208 0.125-0.291 0.77 0.62-0.92 13.1 10.5-15.7 ng/ml ABBOTT AxSYM BNP MEIA ** 82.8 65.0-101 444 345-543 1383 1106-1660 pg/ml CK-MB MEIA 5.05 4.04-6.06 12.0 9.58-14.4 48.8 39.1-58.6 137 110-164 ng/ml Homocysteine FPIA ** 6.70 5.36-8.04 11.6 9.30-13.9 23.5 18.8-28.3 پ0 8mol/L Myoglobin MEIA 13.8 9.67-18.0 18.1 14.4-21.7 91.6 60.8-122 194 154-234 ng/ml Troponin - I (Adv.) MEIA 0.169 0.101-0.237 0.658 0.395-0.921 2.17 1.74-2.60 22.8 18.2 - >22.8 ng/ml BECKMAN COULTER ACCESS SYSTEMS BNP Chemiluminescence ** 171 137-205 716 572-859 1889 1511-2267 pg/ml CK-MB Chemiluminescence 2.86 2.20-3.52 6.88 5.35-8.41 28.6 21.7-35.4 82.2 62.0-102 ng/ml Myoglobin Chemiluminescence 23.6 15.1-32.2 42.3 27.1-57.5 176 113-239 381 244-518 ng/ml Troponin - I (AccuTnI) Chemiluminescence (Optimized) 0.049 0.022-0.076 0.212 0.127-0.297 0.71 0.47-0.95 11.9 8.40-15.5 ng/ml Troponin - I (Enhanced AccuTnI) Chemiluminescence (Optimized) 0.038 0.005-0.071 0.188 0.053-0.323 0.62 0.32-0.92 10.3 5.38-15.3 ng/ml BECKMAN COULTER DxI SYSTEMS BNP Biosite Reagent ** ** ** ** pg/ml CK-MB Chemiluminescence 2.86 2.20-3.52 6.88 5.35-8.41 28.6 21.7-35.4 82.2 62.0-102 ng/ml Myoglobin Chemiluminescence 20.3 13.0-27.7 38.6 24.7-52.4 169 108-230 391 250-532 ng/ml Troponin - I (AccuTnI) Chemiluminescence (Optimized) 0.048 0.021-0.075 0.224 0.134-0.314 0.75 0.51-0.99 12.2 8.56-15.8 ng/ml Troponin - I (Enhanced AccuTnI) Chemiluminescence (Optimized) 0.044 0.011-0.077 0.204 0.081-0.327 0.69 0.36-1.02 11.3 5.85-16.7 ng/ml BECKMAN COULTER AU SERIES CK-MB Immunoturbidimetric (Activity) <10.0 <10.0 13.0 10.4-15.6 37.3 29.9-44.8 U/L Digitoxin Microparticle ** 13.8 11.1-16.6 25.5 20.4-30.5 58.8 47.0-70.5 ng/ml hscrp (CRP Latex) Immunoturbidimetric 0.05 0.03-0.07 0.17 0.14-0.20 0.40 0.32-0.48 0.88 0.70-1.06 mg/dl Myoglobin Immunoturbidimetric <30.0 37.5 <30.0-46.9 205 156-254 420 336-504 ng/ml BECKMAN COULTER SYNCHRON/DxC SYSTEMS hscrp Immunoturbidimetric 0.05 0.03-0.07 0.17 0.14-0.20 0.42 0.34-0.50 0.99 0.79-1.19 mg/dl Digitoxin Turbidimetric ** ** ** ** ng/ml BIOMERIEUX VIDAS Troponin - I ELFA ** ** ** ** ng/ml ORTHO-CLINICAL VITROS CHEMISTRY SYSTEMS hscrp Immunoturbidimetric 0.04 0.02-0.06 0.18 0.14-0.22 0.44 0.35-0.53 1.08 0.86-1.30 mg/dl ORTHO-CLINICAL VITROS IMMUNOASSAY SYSTEMS CK-MB Chemiluminescence 2.53 2.02-3.04 5.75 4.60-6.90 22.5 18.0-27.0 59.4 47.5-71.2 ng/ml Myoglobin Chemiluminescence 41.6 33.3-49.9 79.4 63.5-95.3 385 270-501 901 721-1081 ng/ml NT-proBNP (a) Chemiluminescence 218 115-320 1323 1058-1587 5158 3440-6875 22550 18040-27060 pg/ml Troponin - I (ES) Chemiluminescence 0.076 0.046-0.106 0.301 0.181-0.421 1.20 0.96-1.44 20.7 16.5-24.8 ng/ml ROCHE COBAS 6000 CK-MB ECLIA ** ** ** ** ng/ml CK-MB ECLIA (STAT) ** ** ** ** ng/ml Digitoxin ECLIA ** 15.3 12.2-18.3 27.4 22.0-32.9 63.6 50.8-76.3 ng/ml hscrp ECLIA ** ** ** ** mg/dl Myoglobin ECLIA ** ** ** ** ng/ml
1 3Insert update/actualizaci n del folleto interno/sollwertaktualisierung/mise jour de la fiche technique/aggiornamento dell inserto Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L Conventional Units / Unidades convencionales / Klassische Einheiten / Unit s ordinaires / Unit convenzionali ROCHE COBAS 6000 CONT D Myoglobin ECLIA (STAT) ** ** ** ** ng/ml NT-proBNP(a) ECLIA ** ** ** ** pg/ml NT-proBNP(a) ECLIA (STAT) ** ** ** ** pg/ml Troponin - I ECLIA (STAT) ** ** ** ** ng/ml Troponin - T ECLIA ** ** ** ** ng/ml Troponin - T ECLIA (STAT) ** ** ** ** ng/ml Troponin - T (hs) ECLIA ** ** ** ** ng/ml ROCHE ELECSYS SYSTEMS CK-MB ECLIA 3.13 2.50-3.76 6.78 5.42-8.14 24.9 19.9-29.8 68.8 55.0-82.5 ng/ml CK-MB ECLIA (STAT) 3.17 2.54-3.80 6.96 5.57-8.35 24.7 19.7-29.7 67.7 54.2-81.3 ng/ml Digitoxin ECLIA ** ** ** ** ng/ml Myoglobin ECLIA 25.8 <21.0-34.5 38.6 28.1-49.1 153 122-183 320 256-384 ng/ml Myoglobin ECLIA (STAT) 26.4 21.1-31.7 39.3 31.4-47.1 154 123-185 310 248-372 ng/ml NT-proBNP (a) ECLIA 105 83.9-126 431 324-538 1980 1481-2480 10231 8185-12278 pg/ml Troponin - I ECLIA (STAT) 0.34 <0.30-0.43 0.63 0.50-0.76 1.43 1.14-1.72 16.0 12.8-19.2 ng/ml Troponin - T (4th Gen.) ECLIA (2010/1010) ** 0.10 0.04-0.16 0.22 0.07-0.37 9.10 6.76-11.4 ng/ml Troponin - T (4th Gen.) ECLIA (E170) ** 0.08 0.06-0.10 0.18 0.14-0.22 10.4 8.31-12.5 ng/ml Troponin - T (4th Gen. STAT) ECLIA ** 0.08 0.05-0.11 0.18 0.12-0.24 4.69 3.75-5.63 ng/ml Troponin - T (hs) (b) ECLIA ** 264 211-316 517 413-620 >10000 pg/ml ROCHE HITACHI / MODULAR SYSTEMS Digitoxin CEDIA ** 7.75 5.05-10.5 17.2 13.8-20.7 45.9 36.8 - >49.3 ng/ml hscrp Immunoturbidimetric ** ** ** ** mg/dl ROCHE INTEGRA CKMB (CKMBL) IFCC ** ** ** ** U/L hscrp Turbidimetric ** ** ** ** mg/dl Myoglobin (2nd Gen.) Tina-Quant ** ** ** ** ng/ml SIEMENS ADVIA CENTAUR BNP Chemiluminescence ** 39.8 31.7-47.8 172 138-207 536 429-643 pg/ml CK-MB Chemiluminescence 4.32 3.39-5.25 7.68 6.14-9.22 23.4 18.8-28.1 62.4 49.3-75.4 ng/ml CK-MB (Centaur CP) Chemiluminescence 2.64 2.11-3.17 6.00 4.80-7.20 22.5 18.0-27.0 61.5 49.2-73.8 ng/ml Digitoxin Chemiluminescence ** 9.88 7.90-11.9 18.9 15.1-22.7 46.8 37.5-56.2 ng/ml Homocysteine Chemiluminescence ** 3.65 2.81-4.49 7.31 5.85-8.77 16.3 13.0-19.6 پ0 8mol/L Myoglobin Chemiluminescence ** ** ** ** ng/ml Troponin - I Chemiluminescence 0.088 0.053-0.123 0.439 0.263-0.615 1.53 1.17-1.89 27.4 21.7-33.2 ng/ml Troponin - I (TnI - Ultra) Chemiluminescence 0.079 0.047-0.111 0.401 0.241-0.561 1.54 1.23-1.85 26.4 21.2-31.7 ng/ml SIEMENS BN II/PROSPEC hscrp Nephelometric 0.04 0.02-0.06 0.14 0.11-0.17 0.39 0.31-0.47 0.91 0.73-1.09 mg/dl SIEMENS DIMENSION SYSTEMS CK-MB Activity (CKMB) Immunoinhibition 1.89 0.90-2.88 4.89 3.09-6.69 19.1 15.3-22.9 54.0 43.2-64.8 U/L CK-MB Mass (MMB) EIA 1.94 1.46-2.42 4.98 3.98-5.98 25.8 20.7-31.0 79.6 63.7-95.5 ng/ml CK-MB (MBI) IFCC 5.13 <3.00-9.63 12.7 9.01-16.3 55.7 44.5-66.8 >125 U/L Digitoxin (DGTX) ACMIA ** 13.2 9.97-16.5 24.5 19.6-29.4 50.4 37.6-63.1 ng/ml hscrp (CCRP) Colorimetric Immunoassay 0.05 0.03-0.07 0.22 0.18-0.26 0.49 0.39-0.59 0.96 0.77-1.15 mg/dl hscrp (RCRP) PETIA ** ** 0.42 0.34-0.50 1.08 0.86-1.30 mg/dl Myoglobin (MYO) EIA 22.0 16.2-27.8 40.6 32.5-48.7 238 191-286 616 493-740 ng/ml NT-proBNP (a) (NPT) LOCIپ6¾4 ** 282 226-338 1692 1353-2030 10567 8454-12681 pg/ml NT-proBNP (a) (PBNP) EIA *** *** *** *** pg/ml Troponin - I (CTNI) EIA 0.050 <0.040-0.070 0.216 0.105-0.327 0.84 0.57-1.11 13.4 10.2-16.6 ng/ml Troponin - I (TNI) LOCIپ6¾4 0.167 0.100-0.234 0.637 0.382-0.892 1.90 1.52-2.28 22.8 17.8-27.9 ng/ml 2
1 3Insert update/actualizaci n del folleto interno/sollwertaktualisierung/mise jour de la fiche technique/aggiornamento dell inserto Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L Conventional Units / Unidades convencionales / Klassische Einheiten / Unit s ordinaires / Unit convenzionali SIEMENS DIMENSION VISTA CK-MB Activity (CKMB) Immunoinhibition ** ** ** ** U/L CK-MB Mass (MMB) LOCIپ6¾4 2.98 2.38-3.58 7.15 5.72-8.58 28.7 23.0-34.4 82.2 65.8-98.6 ng/ml CK-MB (MBI) IFCC 3.67 <3.00-6.13 7.50 5.85-9.15 29.5 23.6-35.4 79.5 63.6-95.4 U/L Digitoxin (DGTX) ACMIA ** 12.1 9.70-14.5 22.5 18.0-27.0 45.8 36.6-55.0 ng/ml Homocysteine (HCYS) Nephelometric ** 4.44 3.55-5.33 7.98 6.38-9.58 16.6 13.3-19.9 پ0 8mol/L hscrp (hscrp) Nephelometric 0.05 0.03-0.07 0.16 0.13-0.19 0.43 0.34-0.52 0.93 0.74 - >0.95 mg/dl Myoglobin (MYO) LOCIپ6¾4 19.6 15.7-23.5 32.3 25.9-38.8 191 152-229 461 369-553 ng/ml NT-proBNP (a) (PBNP) LOCIپ6¾4 (Sample Cup) 88.0 69.9-106 427 341-512 2157 1725-2588 11603 9282-13923 pg/ml NT-proBNP (a) (PBNP) LOCIپ6¾4 (On Board Vial) 89.5 71.6-107 447 358-537 2152 1722-2583 11658 9327-13990 pg/ml Troponin - I (CTNI) LOCIپ6¾4 (Sample Cup) 0.145 0.087-0.203 0.579 0.347-0.811 1.82 1.46-2.18 22.0 17.6-26.4 ng/ml Troponin - I (CTNI) LOCIپ6¾4 (On Board Vial) 0.175 0.105-0.245 0.699 0.419-0.979 1.97 1.58-2.36 22.9 18.3-27.5 ng/ml SIEMENS IMMULITE SERIES CK-MB Chemiluminescence 4.26 2.46-6.06 8.94 6.72-11.2 29.5 23.6-35.3 81.3 65.0-97.5 ng/ml CK-MB (STAT/Turbo) Chemiluminescence ** ** ** ** ng/ml Digitoxin Chemiluminescence ** 10.2 7.32-13.0 22.7 15.8-29.6 56.3 45.1 - >60.0 ng/ml Homocysteine Chemiluminescence ** 8.91 6.84-11.0 14.8 11.6-18.1 30.3 24.3-36.4 پ0 8mol/L hscrp Chemiluminescence 0.04 0.02-0.06 0.15 0.12-0.18 0.40 0.32-0.48 1.00 0.80-1.20 mg/dl Myoglobin Chemiluminescence 19.0 15.2-22.8 33.0 26.4-39.7 154 122-186 381 304-457 ng/ml Myoglobin (STAT/Turbo) Chemiluminescence ** ** ** ** ng/ml NT-proBNP (a) Chemiluminescence 321 257-386 2148 1719-2578 9657 7726-11588 >35000 pg/ml Troponin - I Chemiluminescence 0.662 0.397-0.927 3.146 1.888-4.404 9.05 5.27-12.8 >100 ng/ml Troponin - I (STAT/Turbo) Chemiluminescence ** ** ** ** ng/ml SIEMENS STRATUS CS CK-MB FEIA 3.43 2.68-4.18 8.19 6.55-9.83 33.1 26.5-39.7 96.6 77.3-116 ng/ml hscrp (CCRP) FEIA 0.10 0.08-0.12 0.31 0.25-0.37 0.70 0.56-0.84 1.42 1.14-1.70 mg/dl Myoglobin FEIA 19.9 15.8-24.0 35.0 27.5-42.5 190 150-229 450 360-540 ng/ml NT-proBNP (a) FEIA 103 65.4-140 540 332-748 2917 2334-3501 12785 10228-15342 pg/ml Troponin - I FEIA 0.013 0.000-0.043 0.131 0.079-0.183 0.60 0.45-0.75 11.6 9.15-14.0 ng/ml THERMO FISHER SCIENTIFIC KONELAB SYSTEMS CK-MB Immunoinhibition ** ** ** ** U/L hscrp Immunoprecipitation ** ** ** ** mg/dl Myoglobin Immunoprecipitation ** ** ** ** ng/ml TOSOH AIA / ST AIA SYSTEMS CK-MB EIA 3.50 2.80-4.20 8.00 6.40-9.60 32.3 25.9-38.8 92.5 74.0-111 ng/ml Myoglobin EIA 17.4 10.2-24.6 26.9 16.1-37.8 135 101-169 257 205-308 ng/ml Troponin - I (2nd Gen.) EIA 0.110 <0.060-0.270 0.590 0.440-0.750 1.97 1.35-2.58 27.9 22.3-33.4 ng/ml 3
1 3Insert update/actualizaci n del folleto interno/sollwertaktualisierung/mise jour de la fiche technique/aggiornamento dell inserto Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L S.I. Units / Unidades S.I. / S.I.-Einheiten / Unit s S.I. / Unit S.I.* ABBOTT AEROSET/ARCHITECT SYSTEMS BNP CMIA ** 24.7 19.7-29.6 139 111-167 432 346-518 pmol/l CK-MB CMIA 3.00 2.40-3.60 7.08 5.66-8.50 29.5 23.6-35.4 81.5 65.2-97.7 پ0 8g/L Homocysteine CMIA ** 5.36 2.78-7.94 11.0 8.28-13.7 24.9 19.9-29.9 پ0 8mol/L hscrp Immunoturbidimetric 0.50 0.20-0.80 1.70 1.40-2.00 4.10 3.30-4.90 9.70 7.80-11.6 mg/l Myoglobin MEIA ** ** ** ** پ0 8g/L Troponin - I CMIA 0.041 0.025-0.057 0.208 0.125-0.291 0.77 0.62-0.92 13.1 10.5-15.7 پ0 8g/L ABBOTT AxSYM BNP MEIA ** 23.9 18.8-29.1 128 99.7-157 400 320-480 pmol/l CK-MB MEIA 5.05 4.04-6.06 12.0 9.58-14.4 48.8 39.1-58.6 137 110-164 پ0 8g/L Homocysteine FPIA ** 6.70 5.36-8.04 11.6 9.30-13.9 23.5 18.8-28.3 پ0 8mol/L Myoglobin MEIA 13.8 9.67-18.0 18.1 14.4-21.7 91.6 60.8-122 194 154-234 پ0 8g/L Troponin - I (Adv.) MEIA 0.169 0.101-0.237 0.658 0.395-0.921 2.17 1.74-2.60 22.8 18.2 - >22.8 پ0 8g/L BECKMAN COULTER ACCESS SYSTEMS BNP Chemiluminescence ** 49.4 39.5-59.3 207 165-248 546 437-655 pmol/l CK-MB Chemiluminescence 2.86 2.20-3.52 6.88 5.35-8.41 28.6 21.7-35.4 82.2 62.0-102 پ0 8g/L Myoglobin Chemiluminescence 23.6 15.1-32.2 42.3 27.1-57.5 176 113-239 381 244-518 پ0 8g/L Troponin - I (AccuTnI) Chemiluminescence (Optimized) 0.049 0.022-0.076 0.212 0.127-0.297 0.71 0.47-0.95 11.9 8.40-15.5 پ0 8g/L Troponin - I (Enhanced AccuTnI) Chemiluminescence (Optimized) 0.038 0.005-0.071 0.188 0.053-0.323 0.62 0.32-0.92 10.3 5.38-15.3 پ0 8g/L BECKMAN COULTER DxI SYSTEMS BNP Biosite Reagent ** ** ** ** pmol/l CK-MB Chemiluminescence 2.86 2.20-3.52 6.88 5.35-8.41 28.6 21.7-35.4 82.2 62.0-102 پ0 8g/L Myoglobin Chemiluminescence 20.3 13.0-27.7 38.6 24.7-52.4 169 108-230 391 250-532 پ0 8g/L Troponin - I (AccuTnI) Chemiluminescence (Optimized) 0.048 0.021-0.075 0.224 0.134-0.314 0.75 0.51-0.99 12.2 8.56-15.8 پ0 8g/L Troponin - I (Enhanced AccuTnI) Chemiluminescence (Optimized) 0.044 0.011-0.077 0.204 0.081-0.327 0.69 0.36-1.02 11.3 5.85-16.7 پ0 8g/L BECKMAN COULTER AU SERIES CK-MB Immunoturbidimetric (Activity) <0.17 <0.17 0.22 0.17-0.26 0.62 0.50-0.75 جmol/Lپ6س7sec Digitoxin Microparticle ** 18.1 14.5-21.7 33.3 26.7-40.0 77.0 61.6-92.4 nmol/l hscrp (CRP Latex) Immunoturbidimetric 0.50 0.30-0.70 1.70 1.40-2.00 4.00 3.20-4.80 8.80 7.00-10.6 mg/l Myoglobin Immunoturbidimetric <30.0 37.5 <30.0-46.9 205 156-254 420 336-504 جg/L BECKMAN COULTER SYNCHRON/DxC SYSTEMS hscrp Immunoturbidimetric 0.50 0.30-0.70 1.70 1.40-2.00 4.20 3.40-5.00 9.90 7.90-11.9 mg/l Digitoxin Turbidimetric ** ** ** ** nmol/l BIOMERIEUX VIDAS Troponin - I ELFA ** ** ** ** پ0 8g/L ORTHO-CLINICAL VITROS CHEMISTRY SYSTEMS hscrp Immunoturbidimetric 0.40 0.20-0.60 1.80 1.40-2.20 4.40 3.50-5.30 10.8 8.60-13.0 mg/l ORTHO-CLINICAL VITROS IMMUNOASSAY SYSTEMS CK-MB Chemiluminescence 2.53 2.02-3.04 5.75 4.60-6.90 22.5 18.0-27.0 59.4 47.5-71.2 پ0 8g/L Myoglobin Chemiluminescence 41.6 33.3-49.9 79.4 63.5-95.3 385 270-501 901 721-1081 پ0 8g/L NT-proBNP (a) Chemiluminescence 25.7 13.6-37.8 156 125-187 609 406-811 2661 2129-3193 pmol/l Troponin - I (ES) Chemiluminescence 0.076 0.046-0.106 0.301 0.181-0.421 1.20 0.96-1.44 20.7 16.5-24.8 پ0 8g/L ROCHE COBAS 6000 CK-MB ECLIA ** ** ** ** پ0 8g/L CK-MB ECLIA (STAT) ** ** ** ** پ0 8g/L Digitoxin ECLIA ** 20.0 16.0-24.0 36.0 28.8-43.1 83.3 66.6-99.9 nmol/l hscrp ECLIA ** ** ** ** mg/l Myoglobin ECLIA ** ** ** ** پ0 8g/L Myoglobin ECLIA (STAT) ** ** ** ** پ0 8g/L NT-proBNP (a) ECLIA ** ** ** ** pmol/l NT-proBNP (a) ECLIA (STAT) ** ** ** ** pmol/l NT-proBNP (a) ECLIA (STAT) ** ** ** ** پ0 8g/L Troponin - T ECLIA ** ** ** ** پ0 8g/L 4
1 3Insert update/actualizaci n del folleto interno/sollwertaktualisierung/mise jour de la fiche technique/aggiornamento dell inserto Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L S.I. Units / Unidades S.I. / S.I.-Einheiten / Unit s S.I. / Unit S.I.* ROCHE COBAS 6000 CONT D Troponin - T ECLIA (STAT) ** ** ** ** پ0 8g/L Troponin - T (hs) ECLIA ** ** ** ** پ0 8g/L ROCHE ELECSYS SYSTEMS CK-MB ECLIA 3.13 2.50-3.76 6.78 5.42-8.14 24.9 19.9-29.8 68.8 55.0-82.5 پ0 8g/L CK-MB ECLIA (STAT) 3.17 2.54-3.80 6.96 5.57-8.35 24.7 19.7-29.7 67.7 54.2-81.3 پ0 8g/L Digitoxin ECLIA ** ** ** ** nmol/l Myoglobin ECLIA 25.8 <21.0-34.5 38.6 28.1-49.1 153 122-183 320 256-384 پ0 8g/L Myoglobin ECLIA (STAT) 26.4 21.1-31.7 39.3 31.4-47.1 154 123-185 310 248-372 پ0 8g/L NT-proBNP (a) ECLIA 12.4 9.90-14.9 50.8 38.2-63.4 234 175-293 1207 966-1449 pmol/l Troponin - I ECLIA (STAT) 0.34 <0.30-0.43 0.63 0.50-0.76 1.43 1.14-1.72 16.0 12.8-19.2 پ0 8g/L Troponin - T (4th Gen.) ECLIA (2010/1010) ** 0.10 0.04-0.16 0.22 0.07-0.37 9.10 6.76-11.4 پ0 8g/L Troponin - T (4th Gen.) ECLIA (E170) ** 0.08 0.06-0.10 0.18 0.14-0.22 10.4 8.31-12.5 پ0 8g/L Troponin - T (4th Gen. STAT) ECLIA ** 0.08 0.05-0.11 0.18 0.12-0.24 4.69 3.75-5.63 پ0 8g/L Troponin - T (hs) (b) ECLIA ** 264 211-316 517 413-620 >10000 ng/l ROCHE HITACHI / MODULAR SYSTEMS Digitoxin CEDIA ** 10.2 6.62-13.7 22.6 18.1-27.1 60.2 48.1 - >64.6 nmol/l hscrp Immunoturbidimetric ** ** ** ** mg/l ROCHE INTEGRA CKMB (CKMBL) IFCC ** ** ** ** جmol/L sec hscrp Turbidimetric ** ** ** ** mg/l Myoglobin (2nd Gen.) Tina-Quant ** ** ** ** پ0 8g/L SIEMENS ADVIA CENTAUR BNP Chemiluminescence ** 11.5 9.16-13.8 49.8 39.9-59.8 155 124-186 pmol/l CK-MB Chemiluminescence 4.32 3.39-5.25 7.68 6.14-9.22 23.4 18.8-28.1 62.4 49.3-75.4 پ0 8g/L CK-MB (Centaur CP) Chemiluminescence 2.64 2.11-3.17 6.00 4.80-7.20 22.5 18.0-27.0 61.5 49.2-73.8 پ0 8g/L Digitoxin Chemiluminescence ** 12.9 10.4-15.5 24.8 19.8-29.7 61.4 49.1-73.6 nmol/l Homocysteine Chemiluminescence ** 3.65 2.81-4.49 7.31 5.85-8.77 16.3 13.0-19.6 پ0 8mol/L Myoglobin Chemiluminescence ** ** ** ** پ0 8g/L Troponin - I Chemiluminescence 0.088 0.053-0.123 0.439 0.263-0.615 1.53 1.17-1.89 27.4 21.7-33.2 پ0 8g/L Troponin - I (TnI - Ultra) Chemiluminescence 0.079 0.047-0.111 0.401 0.241-0.561 1.54 1.23-1.85 26.4 21.2-31.7 پ0 8g/L SIEMENS BN II/PROSPEC hscrp Nephelometric 0.40 0.20-0.60 1.40 1.10-1.70 3.90 3.10-4.70 9.10 7.30-10.9 mg/l SIEMENS DIMENSION SYSTEMS CK-MB Activity (CKMB) Immunoinhibition 1.89 0.90-2.88 4.89 3.09-6.69 19.1 15.3-22.9 54.0 43.2-64.8 U/L CK-MB Mass (MMB) EIA 1.94 1.46-2.42 4.98 3.98-5.98 25.8 20.7-31.0 79.6 63.7-95.5 پ0 8g/L CK-MB (MBI) IFCC 5.13 <3.00-9.63 12.7 9.01-16.3 55.7 44.5-66.8 >125 U/L Digitoxin (DGTX) ACMIA ** 17.3 13.1-21.6 32.1 25.7-38.5 66.0 49.3-82.7 nmol/l hscrp (CCRP) Colorimetric Immunoassay 0.50 0.30-0.70 2.20 1.80-2.60 4.90 3.90-5.90 9.60 7.70-11.5 mg/l hscrp (RCRP) PETIA ** ** 4.20 3.40-5.00 10.8 8.60-13.0 mg/l Myoglobin (MYO) EIA 22.0 16.2-27.8 40.6 32.5-48.7 238 191-286 616 493-740 پ0 8g/L NT-proBNP (a) (NPT) LOCIپ6¾4 ** 33.3 26.6-39.9 200 160-240 1247 998-1496 pmol/l NT-proBNP (a) (PBNP) EIA *** *** *** *** pmol/l Troponin - I (CTNI) EIA 0.050 <0.040-0.070 0.216 0.105-0.327 0.84 0.57-1.11 13.4 10.2-16.6 پ0 8g/L Troponin - I (TNI) LOCIپ6¾4 0.167 0.100-0.234 0.637 0.382-0.892 1.90 1.52-2.28 22.8 17.8-27.9 پ0 8g/L SIEMENS DIMENSION VISTA CK-MB Activity (CKMB) Immunoinhibition ** ** ** ** پ0 8mol/Lپ6س7sec CK-MB Mass (MMB) LOCIپ6¾4 2.98 2.38-3.58 7.15 5.72-8.58 28.7 23.0-34.4 82.2 65.8-98.6 پ0 8g/L CK-MB (MBI) IFCC 0.06 <0.05-0.10 0.13 0.10-0.15 0.49 0.39-0.59 1.33 1.06-1.59 پ0 8mol/Lپ6س7sec Digitoxin (DGTX) ACMIA ** 15.9 12.7-19.1 29.5 23.6-35.4 60.0 48.0-72.0 nmol/l Homocysteine (HCYS) Nephelometric ** 4.44 3.55-5.33 7.98 6.38-9.58 16.6 13.3-19.9 پ0 8mol/L hscrp (hscrp) Nephelometric 0.50 0.30-0.70 1.60 1.30-1.90 4.30 3.40-5.20 9.30 7.40 - >9.50 mg/l Myoglobin (MYO) LOCIپ6¾4 19.6 15.7-23.5 32.3 25.9-38.8 191 152-229 461 369-553 پ0 8g/L NT-proBNP (a) (PBNP) LOCIپ6¾4 (Sample Cup) 10.4 8.25-12.5 50.4 40.3-60.4 254 204-305 1369 1095-1643 pmol/l NT-proBNP (a) (PBNP) LOCIپ6¾4 (On Board Vial) 10.6 8.45-12.7 52.8 42.2-63.3 254 203-305 1376 1101-1651 pmol/l 5
1 3Insert update/actualizaci n del folleto interno/sollwertaktualisierung/mise jour de la fiche technique/aggiornamento dell inserto Level L Lot Number/N ²mero de lote Nivel L/Level L Chargennummer/Niveau L Num ro de lot/livello L Numero di lotto: CXL1309L S.I. Units / Unidades S.I. / S.I.-Einheiten / Unit s S.I. / Unit S.I.* SIEMENS DIMENSION VISTA CONT D Troponin - I (CTNI) LOCIپ6¾4 (Sample Cup) 0.145 0.087-0.203 0.579 0.347-0.811 1.82 1.46-2.18 22.0 17.6-26.4 پ0 8g/L Troponin - I (CTNI) LOCIپ6¾4 (On Board Vial) 0.175 0.105-0.245 0.699 0.419-0.979 1.97 1.58-2.36 22.9 18.3-27.5 پ0 8g/L SIEMENS IMMULITE SERIES CK-MB Chemiluminescence 4.26 2.46-6.06 8.94 6.72-11.2 29.5 23.6-35.3 81.3 65.0-97.5 پ0 8g/L CK-MB (STAT/Turbo) Chemiluminescence ** ** ** ** پ0 8g/L Digitoxin Chemiluminescence ** 13.3 9.59-17.1 29.7 20.6-38.8 73.8 59.0 - >78.6 nmol/l Homocysteine Chemiluminescence ** 8.91 6.84-11.0 14.8 11.6-18.1 30.3 24.3-36.4 پ0 8mol/L hscrp Chemiluminescence 0.40 0.20-0.60 1.50 1.20-1.80 4.00 3.20-4.80 10.0 8.00-12.0 mg/l Myoglobin Chemiluminescence 19.0 15.2-22.8 33.0 26.4-39.7 154 122-186 381 304-457 پ0 8g/L Myoglobin (STAT/Turbo) Chemiluminescence ** ** ** ** پ0 8g/L NT-proBNP (a) Chemiluminescence 37.9 30.3-45.5 254 203-304 1140 912-1367 >4130 pmol/l Troponin - I Chemiluminescence 0.662 0.397-0.927 3.146 1.888-4.404 9.05 5.27-12.8 >100 پ0 8g/L Troponin - I (STAT/Turbo) Chemiluminescence ** ** ** ** پ0 8g/L SIEMENS STRATUS CS CK-MB FEIA 3.43 2.68-4.18 8.19 6.55-9.83 33.1 26.5-39.7 96.6 77.3-116 پ0 8g/L hscrp (CCRP) FEIA 1.00 0.80-1.20 3.10 2.50-3.70 7.00 5.60-8.40 14.2 11.4-17.0 mg/l Myoglobin FEIA 19.9 15.8-24.0 35.0 27.5-42.5 190 150-229 450 360-540 پ0 8g/L NT-proBNP (a) FEIA 12.1 7.72-16.5 63.7 39.1-88.3 344 275-413 1509 1207-1810 pmol/l Troponin - I FEIA 0.013 0.000-0.043 0.131 0.079-0.183 0.60 0.45-0.75 11.6 9.15-14.0 پ0 8g/L THERMO FISHER SCIENTIFIC KONELAB SYSTEMS CK-MB Immunoinhibition ** ** ** ** پ0 8mol/L hscrp Immunoprecipitation ** ** ** ** mg/l Myoglobin Immunoprecipitation ** ** ** ** پ0 8g/L TOSOH AIA / ST AIA SYSTEMS CK-MB EIA 3.50 2.80-4.20 8.00 6.40-9.60 32.3 25.9-38.8 92.5 74.0-111 پ0 8g/L Myoglobin EIA 17.4 10.2-24.6 26.9 16.1-37.8 135 101-169 257.00 205-308 پ0 8g/L Troponin - I (2nd Gen.) EIA 0.110 <0.060-0.270 0.590 0.440-0.750 1.97 1.35-2.58 27.9 22.3-33.4 پ0 8g/L 6
1 3* System International Units * Unidades del Sistema Internacional (unidades S.I.) * SI-Einheiten (Syst me International) * Unit s syst me international (S.I. Units) * Unit di misura del sistema internazionale ** Data not available. If interested in participating in our value assignment process, please fax or email your contact information to our Value Assignment group at 510-771-1539, or mgc-va@thermofisher.com. ** Datos no disponibles. ** Keine Daten erhپ0ٹ1ltlich. ** Donn es non disponibles. ** Dati non disponibili. Aeroset پ0 3, Architect پ0 3, Axsym پ0 3, Reg. TM: Abbott Laboratories Inc., Abbott Park, IL AIA پ0 3 Systems, Reg. TM: Tosoh Medics, South San Francisco, CA ACS-180 پ0 3, Centaur پ0 3, Reg.TM: Siemens Healthcare Diagnostics, Tarrytown, NY Access پ0 3, DXI پ0 3 Synchron پ0 3 Series, Reg.TM: Beckman-Coulter Inc., Fullerton, CA Dimension Systems پ0 3, Immulite پ0 3, Stratus CS پ0 3, Reg.TM: Siemens Healthcare Diagnostics, Glasgow, DE Konelab Systems پ0 3, Reg.TM: Thermo Fisher Scientific, Vantaa, Finland Vitros Systems, Reg. TM: Ortho-Clinical Diagnostics, Rochester, NY Cobas 6000 پ0 3, Elecsys پ0 3, Hitachi پ0 3, Integra پ0 3,Reg. TM: Roche Diagnostics, Indianapolis, IN AU Series, Reg. TM: Beckman Coulter, Brea, CA *** Please use the target values and ranges provided on the reagent QC card. *** Por favor utilice los valores diana y los rangos propuestos en el archivo de Control de Calidad del reactivo. *** Bitte verwenden Sie ausschlieپ0 8lich die auf der beiliegenden Kontrollkarteangegebenen Zielwerte & Bereiche. *** SVP utiliser les valeurs cible et les fourchettes fournies sur la carte CQ des r actifs. *** Utilizzare i valori di riferimento e gli intervalli di acceptabilit riportati sulla carta di Controllo di Qualit del reagente. (a) NT-proBNP CXL1301L- For users outside the United States only. (a) NT-proBNP CXL1301L- Solamente para los usuarios fuera de los Estados Unidos. (a) NT-proBNP CXL1301L- Nur F ¹r Benutzer auپ0 8erhalb der Vereinigten Staaten. (a) NT-proBNP CXL1301L- Seulement pour les utilisa teurs hors Etats Unis. (a) NT-proBNP CXL1301L- Soltanto per l utilizzatori fuori degli Stati Uniti. (b) For users outside the United States only. (b) Solamente para los usuarios fuera de los Estados Unidos. (b) Nur F ¹r Benutzer auپ0 8erhalb der Vereinigten Staaten. (b) Seulement pour les utilisa teurs hors Etats Unis. (b) Soltanto per l utilizzatori fuori degli Stati Uniti. Cat. No., Nپ0 2 cat. Description, Descripci n, Beschreibung, Size, Tamaپ0ٹ9o, Grپ0 2پ0 8e, Taille, Dimensione Kat.-Nr., Cat. N م, Cat. N م. Description, Descrizione CAI-XLL CardioImmune پ0 3 پ6 1 XL, Level L 6 x 3 ml CAI-XL1 CardioImmune پ0 3 پ6 1 XL, Level 1 6 x 3 ml CAI-XL2 CardioImmune پ0 3 پ6 1 XL, Level 2 6 x 3 ml CAI-XL3 CardioImmune پ0 3 پ6 1 XL, Level 3 6 x 3 ml CAI-XL4 CardioImmune پ0 3 پ6 1 XL, Multi-Pack 6 x 3 ml 286-606 Dropper Tips Pkg. 100 If you have any questions concerning this notification, in the USA please contact the Technical Support Department at 800-232-3342 or 510-979-5417. Outside the USA, please contact your local Subsidiary or Distributor. Si tiene alguna pregunta sobre esta notificaci n, llame (desde los EE.UU.) al Departamento de asistencia t cnica a los n ²meros +1-800-232-3342 o +1-510-979-5417. Desde otros pa ھses, p ngase en contacto con el distribuidor o filial local. Falls Sie Fragen zu dieser Benachrichtigung haben, wenden Sie sich innerhalb der USA bitte an den technischen Kundendienst unter der Rufnummer +1-800-232-3342 oder +1-510-979-5417. Auپ0 8erhalb der USA wenden Sie sich bitte an die پ0 2rtliche Niederlassung bzw. den پ0 2rtlichen Vertrieb. Aux پ0 7tats-Unis, pour toute question concernant cet avis, contacter le Service d assistance technique au +1 800-232-3342 ou +1 510-979-5417. En dehors des پ0 7tats-Unis, contacter la filiale ou le distributeur locaux. Per domande relative a questa notificazione, rivolgersi al servizio di assistenza tecnica (negli Stati Uniti) al numero verde +1-800-232-3342 oppure +1-510-979-5417. Se al di fuori degli Stati Uniti, rivolgersi alla sussidiaria locale o al distributore di zona. MICROGENICS CORPORATION ISO 13485 Certified Company Tel: +49 (0) 851-88 68 90 Fax: +49 (0) 851-88 68 910 7 CAXL-INS-VA Rev 8
1 3Lot Number / N ²mero de Lote / Chargennummer / Num ro de lot / Numero di lotto Use By ± date / Fecha de caducidad / Haltbarkeitsdatum / Date limite d utilisation optimale / Utilizzare entro ± Refrigerated temperature limitation / Limitaci n de la temperatura de refrigeraci n / K ¹hltemperaturgrenze / Limites de temp rature pour un colis r frig r / Limite delle temperature di raffreddamento Catalog Number / N ²mero De Cat logo / Katalognummer / Catalogue N م / Numero di catalogo Manufacturer / Fabricante / Hersteller / Fabricant / Produttore Caution / Precauci n / Vorsicht / Attention / Attenzione Consult instructions for use / Consultar las instrucciones de uso / Gebrauchsanweisung beachten / Se r f rer au mode d emploi / Consultare le istruzioni per l uso Authorized Representative / Representante autorizado / Vertragshپ0ٹ1ndler / Mandataire /Rappresentante autorizzato For In Vitro Diagnostic Use / Para uso en diagn stico in vitro / In-vitro-Diagnostikum / Diagnostics in vitro / Per uso diagnostico in vitro 8
1 39
1 3CAI-XL2 CXL13092 2 CAI-XL1 CXL13091 1 6 x 3mL CAXL-INS-1 CAXL-INS-2 6 x 3mL CAI-XL4 CXL13094 4 x 3mL CAI-XLS CXL1309S 1 3 2 CAXL-INS-4 L 1 3 2 CAXL-INS-S 6 x 3mL CAI-XLL CXL1309L 6 x 3mL CAI-XL3 CXL13093 L CAXL-INS-L 3 CAXL-INS-3 CAXL-INS 10 6 x 3mL