AccuVert HBV Seroconversion Panel PHM941(M) ( )

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1 PACKAGE INSERT PHM941(M) ( ) INTENDED USE PHM941(M) ( ) 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, ( ). 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 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 is available at 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) ( ) 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 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 1 of April 2017 February 2017

2 HBV Ag and Ab Assays (s/co)* (Log IU/mL) DATA SHEET OVERVIEW PHM941(M), is a 7-member modified panel originating from the 9- member HBV Seroconversion panel PHM941, 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 HBc Total HBc IgM Anti-HBs HBeAg s/co cut-off 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

3 Information SeraCare Batch # SeraCare Donor ID # Bleed date Days Since First Bleed BD Apr BD Apr BD Apr BD Apr BD Apr BD Apr BD Jul BD Aug BD Aug 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) x 10 1 POS POS 4.8 x x 10 1 POS POS 3.8 x x 10 2 POS POS 5.7 x x 10 2 POS POS 7.8 x x 10 3 POS POS 5.6 x x 10 3 POS POS 1.4 x x 10 7 POS POS 5.9 x x 10 8 POS POS >1.7 x 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 Kit Lot No. NA R07643 R13006 Kit Exp. Date NA 15-Aug Jan 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

4 Bio-Rad Genetic Systems EIA ETI-MAK-2 Siemens ADVIA Centaur Ortho VITROS NEG NEG NEG NEG POS NEG POS POS POS POS POS POS > POS POS > POS POS > POS POS Test Date 27-Aug Jul Jul Jul Aug Aug-2013 Test Site SC SC SC RL RL Kit Part Code 1L P NA NA Kit Lot No LF00 331GCC GCC A NA NA Kit Exp. Date 10-Jan Sep Nov 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

5 HBV Antibody and Other Tests Core Total Core IgM Anti-HBs HBeAg Anti-HBe (co/s) Test Date 15-Aug Aug Jul Sep Jul-2013 Test Site SC SC SC SC SC Kit Part Code 6L22 6L23 P P P Kit Lot No LI LI B A A/2 Kit Exp. Date 25-Mar Mar Sep Feb 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 A printed copy of the package insert or data sheet may be requested by at info@seracare.com, or by phone at Page 4 of 4