PACKAGE INSERT PHM941(M) (0605-0061) INTENDED USE PHM941(M) (0605-0061) is a group of serial bleeds from an individual plasma donor during HBV seroconversion. This panel is intended for use by diagnostics manufacturers and clinical laboratories to evaluate their HBV test systems using well-characterized specimens, and to provide comprehensive data for comparative analysis. For Research Use Only. Not for use in diagnostic procedures. PRODUCT DESCRIPTION This product is a modified 7-member panel originating from HBV PHM941, (0605-0060). Panel members 4 & 6 from the original 9-member panel are no longer available. Panel members are naturallyoccurring undiluted plasma samples from a single plasma donor collected during a period of HBV seroconversion. All units were maintained frozen, except for the interval of dispensing into vials. No preservatives were added. Item No. 0605-0061 1 vial per member 7 members, 1.5 ml per vial STORAGE Panel members should be stored frozen at -20 C or colder for serology use and -70 C or colder for NAT use. SeraCare recommends that the panel members be divided into smaller aliquots, if appropriate, to avoid multiple freeze-thaw cycles. If turbidity or particulate matter is observed, the samples should be centrifuged in accordance with each test kit manufacturer s instructions for sample preparation. INTERPRETATION OF RESULTS The data sheet for AccuVert HBV 0605-0061 is available at www.seracare.com. The data sheet lists results for panel members generated using commercially available screening, monitoring and confirmatory tests approved in the U.S. and/or the European Union. The tests that are listed were performed at SeraCare or at recognized reference laboratories (RL) by individuals who routinely use these procedures. Information regarding specific test methods is available on the data sheet. Data sheets are updated when new data are available. LIMITATIONS The AccuVert HBV PHM941(M) (0605-0061) is offered 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. PRECAUTIONS These materials have not been treated and should be considered biohazardous. Follow Universal Precautions 1. Some panel members were found positive by tests for HBV markers including. The units that make up this panel were tested and found negative for anti-hcv and anti-hiv 1/2. This does not ensure the absence of these or other human pathogens. Do not pipette by mouth. Do not smoke, eat, or drink in areas where specimens are handled. These materials should be disposed of in a manner that will inactivate pathogenic agents. REFERENCES 1. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. For assistance, contact SeraCare at 508.244.6400. The package insert for this panel can be found at www.seracare.com 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 1 of 1 13315-01 April 2017 February 2017
HBV Ag and Ab Assays (s/co)* (Log IU/mL) DATA SHEET OVERVIEW PHM941(M), 0605-0061 is a 7-member modified panel originating from the 9- member HBV Seroconversion panel PHM941, 0605-0060. Members 04 and 06 from the original panel are no longer available. This panel is made of undiluted, naturally occurring plasma samples, collected over 142 days in 2008 from a 43-year old female and characterized as genotype A. No preservatives were added. Test results from commercially-available HBV antigen, antibody, and DNA assays are included. This panel converts from negative to positive for hepatitis B surface antigen (), hepatitis B envelope antigen (HBeAg), anti-hbc (core total), and anti-hbc IgM (core IgM). All panel members are positive for. 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. Panel members were found positive for HBV DNA; all were found negative for anti-hiv-1/2 and anti-hcv. AccuVert HBV 10000 1000 100 HBc Total HBc IgM Anti-HBs HBeAg s/co cut-off 10.0 9.0 8.0 7.0 6.0 10 5.0 4.0 1 3.0 2.0 0.1 1.0 0 2 7 9 14 17 99 120 141 Days Since First Bleed This graph demonstrates the evolution of early HBV infection, illustrated with the m2000,, HBc Total, HBc IgM assays, and Anti-HBs and HBeAg test methods. Page 1 of 4
Information SeraCare Batch # SeraCare Donor ID # Bleed date Days Since First Bleed 01 9229670 BD106646 08-Apr-2008 0 02 9229671 BD106646 10-Apr-2008 2 03 9229672 BD106646 15-Apr-2008 7 04 9229673 BD106646 17-Apr-2008 9 05 9229674 BD106646 22-Apr-2008 14 06 9229675 BD106646 25-Apr-2008 17 07 9230606 BD106646 16-Jul-2008 99 08 9231427 BD106646 06-Aug-2008 120 09 9232141 BD106646 27-Aug-2008 141 Members 04 and 06 from PHM941 are no longer available, data provided for informational purposes only. m2000 (IU/mL) Gen-Probe PROCLEIX ULTRIO Roche Multiplex S201 Roche COBAS AmpliPrep / TaqMan (IU/mL) 01 2.4 x 10 1 POS POS 4.8 x 10 1 02 2.2 x 10 1 POS POS 3.8 x 10 1 03 4.4 x 10 2 POS POS 5.7 x 10 2 04 5.7 x 10 2 POS POS 7.8 x 10 2 05 3.0 x 10 3 POS POS 5.6 x 10 3 06 8.5 x 10 3 POS POS 1.4 x 10 4 07 8.8 x 10 7 POS POS 5.9 x 10 7 08 4.3 x 10 8 POS POS >1.7 x 10 8 09 2.2 x 10 8 POS POS >1.7 x 10 8 Test Date 30-Jul-2013 NA NA 29-Jul-2013 Test Site RL RL RL SC Kit Part Code NA NA NA 5027012190 Kit Lot No. NA 615200 R07643 R13006 Kit Exp. Date NA 15-Aug-2014 31-Jan-2014 31-Jul-2014 Kit Regulatory Status IVD/CE IVD/CE IVD/CE IVD/CE NA = Not Available; POS = Positive RL = Reference Lab; SC = SeraCare Page 2 of 4
Bio-Rad Genetic Systems EIA ETI-MAK-2 Siemens ADVIA Centaur Ortho VITROS 01 0.5 0.4 0.2 NEG NEG 02 0.5 0.6 0.2 NEG NEG 03 2.5 1.7 0.9 POS NEG 04 3.9 2.4 1.5 POS POS 05 21.9 11.0 7.4 POS POS 06 69.7 20.3 21.0 POS POS 07 2540 >81.3 232 POS POS 08 3220 >81.3 232 POS POS 09 3720 >81.3 232 POS POS Test Date 27-Aug-2013 25-Jul-2013 30-Jul-2013 26-Jul-2013 02-Aug-2013 01-Aug-2013 Test Site SC SC SC RL RL Kit Part Code 1L80 32591 P001932 NA NA Kit Lot No. 29248LF00 331GCC-05 362GCC-05 0710380A NA NA Kit Exp. Date 10-Jan-2014 23-Sep-2013 30-Nov-2013 27-Oct-2013 NA NA Kit Regulatory Status IVD IVD IVD/CE IVD/CE IVD 1 Results are reported as the mean result of duplicate testing expressed as signal to cut-off value (s/co). NA = Not Available; POS = Positive; NEG = Negative RL = Reference Lab; SC = SeraCare Page 3 of 4
HBV Antibody and Other Tests Core Total Core IgM Anti-HBs HBeAg Anti-HBe (co/s) 2 01 0.2 0.1 0.1 0.1 0.6 02 0.1 0.1 0.1 0.1 0.5 03 0.1 0.1 0.1 0.1 0.5 04 0.1 0.1 0.1 0.1 0.6 05 0.2 0.1 0.1 0.3 0.5 06 0.1 0.1 0.1 0.8 0.6 07 9.0 19.5 0.1 156 0.1 08 9.8 6.8 0.1 156 0.1 09 10.0 2.5 0.1 156 0.1 Test Date 15-Aug-2013 15-Aug-2013 24-Jul-2013 18-Sep-2013 26-Jul-2013 Test Site SC SC SC SC SC Kit Part Code 6L22 6L23 P001931 P001930 P001929 Kit Lot No. 26417LI00 23495LI00 0650330B 0600450A 0490510A/2 Kit Exp. Date 25-Mar-2014 25-Mar-2014 04-Sep-2013 28-Feb-2014 30-Jan-2014 Kit Regulatory Status IVD IVD IVD IVD/CE IVD/CE 1 Results are reported as the mean result of duplicate testing expressed as signal to cut-off value (s/co). 2 Results are reported as the mean result of duplicate testing expressed as cut-off to signal value (co/s). Cut-off to signal value is inversely related to antibody reactivity. SC = SeraCare The package insert for this panel can be found at www.seracare.com 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 4 of 4