AccuSet HCV Performance Panel

Transcription

1 Signal to cutoff (s/co) DATA SHEET OVERVIEW AccuSet HCV ( ) 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 Positive cut-off (s/co) This graph demonstrates reactivity amongst panel members from the ARCHITECT () test method. Page 1 of 6

2 Information SeraCare Batch # SeraCare Donor ID # Bleed Date BD May BM BD Jan BD Feb BD Feb BD May BD Aug BD Oct NA NA NA NA BD Nov BM BD Oct BD Jun BD Jun NA 26-Jan NA 29-Jul BM BD Feb NA 06-Jun BD Aug NA NA NA 15-Dec BM BD Jan NA 21-Aug BD May BM BD Dec BD Jul-2013 NA = Not Available Page 2 of 6

3 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, E E TND TND E E E E E E E E E E E E E E <12 TND TND, <12 TND TND TND E E TND TND TND TND E E TND TND E E E E TND TND TND TND TND TND TND TND E E TND TND 0.0 Test Date 25-Jan Jan 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

4 HCV Antibody ARCHITECT PRISM DiaSorin LIAISON XL Murex HCV Ab Ortho HCV Version 3.0 ELISA Test System Test Date 24-Jan Jan Jan Jan-2018 Test Site SC RL RL SC Kit Part Code 1L79 NA NA Kit Lot No LI00 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

5 HCV Antibody Ortho VITROS Roche ELECSYS Siemens ADVIA Centaur > > > > > > > > > > > > > > > Test Date 24-Jan Feb 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

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 Jan-2018 Test Site RL SC Kit Part Code NA Kit Lot No Kit Exp. Date 31-Aug 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 at info@seracare.com or by phone at Page 6 of 6