Signal to cutoff (s/co) DATA SHEET OVERVIEW AccuSet HCV (0810-0204) is a 25-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members represent bleeds from multiple individuals positive for antibodies to HCV. Each sample represents a single collection event. No preservatives were added. Test results from commercially-available HCV assays are included for characterization of the panel members. This panel of human plasma samples demonstrates a range of antibody reactivity for anti-hcv test methods. Additional tests performed on HCV RNA and HCV antigen are also provided. One sample is included as a non-reactive sample and is negative for all HCV test methods performed. For Research Use Only. Not for use in diagnostic procedures. Data are provided for informational purposes. SeraCare Life Sciences does not claim that others can duplicate test results exactly. CAUTION: Potentially infectious materials. Follow Universal Precautions. The units that make up this panel were tested and found negative for anti-hiv-1/2 and HBsAg. This does not ensure the absence of these or other human pathogens. AccuSet HCV 18.0 16.0 Positive cut-off (s/co) 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 This graph demonstrates reactivity amongst panel members from the ARCHITECT () test method. Page 1 of 6
Information SeraCare Batch # SeraCare Donor ID # Bleed Date 01 9243979 BD110090 22-May-2009 02 BM217428 BD104208 03-Jan-2007 03 9239430 BD107568 05-Feb-2009 04 9239418 BD107565 02-Feb-2009 05 9240632 BD110015 19-May-2009 06 9218804 BD105326 11-Aug-2007 07 9239001 BD107545 21-Oct-2008 08 9140907 NA NA 09 9140906 NA NA 10 9222544 BD105882 09-Nov-2007 11 BM217269 BD103806 25-Oct-2006 12 9216263 BD104949 18-Jun-2007 13 9216184 BD104885 05-Jun-2007 14 9145058 NA 26-Jan-2000 15 9145061 NA 29-Jul-2000 16 BM217376 BD104126 26-Feb-2007 17 9145052 NA 06-Jun-2000 18 9218802 BD105326 04-Aug-2007 19 9227732 NA NA 20 9145044 NA 15-Dec-1999 21 BM217357 BD104067 30-Jan-2007 22 9145085 NA 21-Aug-2001 23 9145129 BD110688 21-May-2002 24 BM217285 BD103826 26-Dec-2006 25 10054053 BD210231 22-Jul-2013 NA = Not Available Page 2 of 6
HCV RNA and Antigen m2000 Realtime HCV (IU/mL) 1,3 Roche COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 (IU/mL) 1,3 ARCHITECT HCV Ag (TV) 2,3 01 2.7E+06 3.4E+06 14990.2 02 TND TND 0.0 03 1.8E+03 2.7E+03 45.3 04 1.2E+05 1.6E+05 408.7 05 4.1E+05 4.7E+05 1745.9 06 8.0E+05 7.4E+05 2240.8 07 3.4E+05 3.0E+05 3222.4 08 1.3E+03 2.3E+03 449.1 09 8.8E+03 1.3E+04 1927.0 10 <12 TND 0.0 11 TND, <12 TND 0.0 12 TND TND 0.0 13 2.7E+03 6.2E+03 40.2 14 TND TND 0.0 15 TND TND 0.0 16 6.0E+02 1.2E+03 13.5 17 TND TND 0.0 18 6.1E+05 6.2E+05 2513.0 19 8.6E+02 1.5E+03 45.8 20 TND TND 0.0 21 TND TND 0.0 22 TND TND 0.0 23 TND TND 0.0 24 1.9E+04 2.8E+04 158.4 25 TND TND 0.0 Test Date 25-Jan-2018 24-Jan-2018 13-Feb-2018 Test Site RL RL RL Kit Part Code NA NA NA Kit Lot No. NA NA 80301LP47 Kit Exp. Date NA NA 29-Jun-2018 Kit Regulatory Status IVD IVD/CE IVD/CE 1 Results are reported as international units per ml (IU/mL); positive/reactive results are noted in bold red. 2 Results are reported as test value (TV); positive/reactive results are noted in bold red. 3 Results are reported as the mean result of duplicate testing. RL = Reference Lab; NA = Not Available; TND = Target Not Detected Page 3 of 6
HCV Antibody ARCHITECT PRISM DiaSorin LIAISON XL Murex HCV Ab Ortho HCV Version 3.0 ELISA Test System 01 12.1 4.7 7.8 6.5 02 11.9 5.0 9.4 6.5 03 12.4 6.7 7.9 6.5 04 11.7 6.3 9.2 6.5 05 7.9 3.9 6.2 6.5 06 12.8 5.3 10.0 6.5 07 7.1 4.9 5.9 5.7 08 7.5 3.7 4.5 3.9 09 6.0 2.4 4.0 2.4 10 10.9 4.9 4.3 6.5 11 4.2 3.3 7.3 4.6 12 7.1 3.9 4.3 6.5 13 13.3 5.7 12.0 6.5 14 5.3 2.2 3.2 4.1 15 3.3 2.9 3.1 3.9 16 10.3 5.2 8.5 6.5 17 4.4 1.7 2.9 4.3 18 12.9 5.4 10.0 6.5 19 17.1 10.0 9.1 6.5 20 4.3 2.2 2.8 3.9 21 10.6 5.8 9.3 6.5 22 2.7 1.1 2.0 1.6 23 4.4 2.5 3.4 3.3 24 12.4 5.8 7.9 6.5 25 0.1 0.1 0.0 0.0 Test Date 24-Jan-2018 23-Jan-2018 30-Jan-2018 22-Jan-2018 Test Site SC RL RL SC Kit Part Code 1L79 NA NA 930740 Kit Lot No. 78045LI00 NA NA TXE663 Kit Exp. Date 12-May-2018 NA NA 02-Aug-2018 Kit Regulatory Status IVD IVD/CE CE IVD 1 Results are reported as a signal to cutoff ratio (s/co); positive/reactive results are noted in bold red. 2 Results are reported as the mean result of duplicate testing. RL = Reference Lab; SC = SeraCare; NA = Not Available Page 4 of 6
HCV Antibody Ortho VITROS Roche ELECSYS Siemens ADVIA Centaur 01 24.5 113.4 >11.0 02 22.4 54.7 >11.0 03 14.4 35.0 >11.0 04 24.3 32.4 >11.0 05 21.3 72.1 8.0 06 26.4 90.6 >11.0 07 15.0 106.2 >11.0 08 6.5 80.8 >11.0 09 4.6 92.6 9.9 10 13.4 37.4 >11.0 11 11.5 102.8 5.3 12 10.6 96.1 >11.0 13 30.7 46.7 >11.0 14 5.4 68.0 4.9 15 8.0 64.3 3.8 16 21.9 69.0 >11.0 17 6.6 108.0 5.7 18 26.0 83.9 >11.0 19 30.7 44.8 >11.0 20 5.6 112.0 5.7 21 27.0 130.5 >11.0 22 5.7 63.6 1.7 23 5.5 93.1 9.6 24 14.6 48.3 >11.0 25 0.0 0.0 0.2 Test Date 24-Jan-2018 02-Feb-2018 26-Jan-2018 Test Site RL RL RL Kit Part Code NA NA NA Kit Lot No. NA NA NA Kit Exp. Date NA NA NA Kit Regulatory Status IVD IVD IVD/CE 1 Results are reported as a signal to cutoff ratio (s/co); positive/reactive results are noted in bold red. 2 Results are reported as the mean result of duplicate testing. RL = Reference Lab; NA = Not Available Page 5 of 6
HCV Confirmatory Fujirebio INNO-LIA HCV Score Fujirebio INNO-LIA HCV Score Interpretation OraSure OraQuick Rapid HCV Antibody Test 01 C1, C2, E2, NS3 POS POS 02 C1, C2, NS3, NS4 POS POS 03 NS3 IND POS 04 C1, C2, NS3 POS POS 05 C1, C2, NS3 POS POS 06 C1, C2, NS3 POS POS 07 C1, C2, NS3 POS POS 08 C1, NS3 POS POS 09 C1, NS3 POS POS 10 NS3, NS4, NS5 POS POS 11 C1, C2, NS3, NS4 POS POS 12 NS3, NS4 POS POS 13 C1, C2, E2, NS3, NS4 POS POS 14 NS3, NS4 POS POS 15 C1, NS3, NS4 POS POS 16 C1, C2, NS3, NS4 POS POS 17 NS3, NS4 POS POS 18 C1, C2, NS3 POS POS 19 C1, C2, E2, NS3, NS4, NS5 POS POS 20 NS3, NS4 POS POS 21 C1, C2, NS3, NS4, NS5 POS POS 22 C1, C2, NS3 POS NEG 23 C1, NS3, NS4 POS POS 24 NS3 IND POS 25 NEG NEG NEG Test Date 13-Feb-2018 29-Jan-2018 Test Site RL SC Kit Part Code NA 1001-0181 Kit Lot No. 404463 0006658412 Kit Exp. Date 31-Aug-2018 31-Oct-2018 Kit Regulatory Status IVD/CE IVD/CE POS = Positive; NEG = Negative; IND = Indeterminate RL = Reference Lab; SC = SeraCare; NA = Not Available The package insert for this panel can be found at. A printed copy of the package insert or data sheet may be requested by email at info@seracare.com or by phone at 508.244.6400. Page 6 of 6