A SERACARE PANEL PRODUCT Seroconversion INTENDED USE The is a group of serial bleeds from an individual plasma donor during seroconversion. This is intended for use by diagnostics manufacturers and clinical laboratorians to evaluate their 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 consists of a set of six undiluted plasma samples from a single plasma donor collected during a period of seroconversion. All units were maintained in a frozen state, except for the interval of dispensing into vials. No preservatives were added. Cat. No. -1.0 1 vial per member 6 members, 1.0 ml per vial STORAGE members should be stored frozen at -65 C to -80 C to preserve RNA. HIV antibody and antigen will be preserved at -10 C or colder. 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 is available at www.seracarepanels.com. Select from the list of panel data sheets. The Data Sheet lists results for panel members generated using commercially The Data Sheet for this panel in PDF form can be found at www.seracarepanels.com The printed Data Sheet may be requested by email at info@seracare.com, or by phone at 508.244.6400 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 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 HIV markers, including RNA and antigen. The units that make up this panel were found negative for anti- HCV and HBsAg. 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. CDC recommendations for prevention of HIV transmission in health care settings. MMWR 36 (supp.2) 1987. For assistance, contact SeraCare Technical Support at 508.244.6400. ASK ABOUT RELATED SERACARE PRODUCTS ACCURUN independent quality controls SeraCon and other processed plasma products Global Patient Sample (GPS) Program Page 1 of 1 January 2012 11753-02
Data Sheet Seroconversion OVERVIEW This Data sheet contains test results specific for. members are undiluted, aliquots from plasma units without preservatives collected over 22 days in 2006 from a 27-year-old male. -06 is a challenging sample for HIV antigen or antigen/antibody assays. CAUTION: Potentially infectious materials. Follow Universal Precautions. Some panel members were found positive for markers of HIV; all were found negative for HBsAg and anti-hcv. For Research Use Only. Not for use in diagnostic procedures. Data are offered for informational purposes only. SeraCare Life Sciences does not claim test results can be duplicated exactly. EVOLUTION OF HIV MARKERS IN EARLY INFECTION 4.0 3.5 3.0 HIV Ag HIV Ag/Ab ant i-/ 2 Cutoff (s/co) RNA 7.0E+04 6.0E+04 5.0E+04 2.5 4.0E+04 s/co 2.0 1.5 3.0E+04 2.0E+04 copies/ml 1.0 1.0E+04 0.5 0.0E+00 0.0-1.0E+04 0 3 10 15 17 22 Since 1st This graph demonstrates the evolution of early HIV infection, illustrated with test results over time for different analytes or analyte combinations. Page 1 of 4 January 2012 12424-01
HIV RNA (copies/ml) Member Date Fiebig Stage 1 Roche Ultra Sensitive RNA Roche Standard RNA -01 27-Jun-06 0 NA <50 NT -02 30-Jun-06 3 NA <50 NT -03 07-Jul-06 10 NA <50 NT -04 12-Jul-06 15 I NT 2.0 x 10 3-05 14-Jul-06 17 I NT 2.4 x 10 4-06 19-Jul-06 22 II NT 5.8 x 10 4 Test Date 24-Apr-07 20-Apr-07 Test Site SC SC Kit Part Code 21118560018 21118560018 Kit Lot No. H04637 H04637 Kit Expiration Date 31-Aug-07 31-Aug-07 1 Fiebig stages are categories that define phases of early HIV infection. See Fiebig EW, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003, 17:1871-9, and Lee HY, et al. Modeling sequence evolution in acute infection. JTB 2009, 261:341-360. Antigen (s/co) 2 Member Date Coulter ELISA Perkin Elmer ELISA Roche Elecsys Zeptometrix ELISA -01 27-Jun-06 0 0.3 0.1 0.3 0.2-02 30-Jun-06 3 0.2 0.2 0.3 0.3-03 07-Jul-06 10 0.2 0.2 0.3 0.3-04 12-Jul-06 15 0.3 0.2 0.3 0.2-05 14-Jul-06 17 0.5 0.3 0.4 0.5-06 19-Jul-06 22 1.4 0.7 0.6 0.8 Test Date 20-Oct-06 24-May-07 23-May-07 14-May-07 Test Site SC SC RL SC Kit Part Code 626391 NEK 050A NA 801111 Kit Lot No. 2066F514 394387 176936-01 303199 Kit Expiration Date 18-Apr-07 16-Nov-07 31-Aug-07 18-Jan-08 2 Immunoassay results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and noted in red. Page 2 of 4 January 2012 12424-01
HIV Antigen/Antibody (s/co) 1 Member Date Since 1 st ARCHITECT AxSYM PRISM Murex Combination Dade Behring Enzygnost Integral II Roche Elecsys Combi -01 27-Jun-06 0 0.1 0.4 0.1 0.3 0.1 0.3-02 30-Jun-06 3 0.1 0.4 0.1 0.3 0.1 0.3-03 07-Jul-06 10 0.2 0.4 0.1 0.3 0.1 0.3-04 12-Jul-06 15 0.1 0.4 0.1 0.3 0.1 0.3-05 14-Jul-06 17 0.4 0.5 0.2 0.4 0.2 0.3-06 19-Jul-06 22 1.1 0.9 0.7 1.3 0.4 0.9 Test Date 10-May-07 14-May-07 16-May-07 23-May-07 23-May-07 23-May-07 Test Site RL RL RL RL RL RL Kit Part Code 4J27-30 2G83-20 7G46-48 GE41 OQTO 11 04860446NA Kit Lot No. 52051HN00 52433LU00 52387HN00 L000010 36815 178860-01 Kit Expiration Date 02-Jan-08 12-Oct-07 23-Oct-07 30-Nov-07 06-Jun-08 30-Nov-07 HIV Antibody (s/co) 1 Member Date Since 1 st AxSYM EIA /2 PRISM HIV O plus Murex HIV 1.2.O Siemens Advia Centaur Enhanced -01 27-Jun-06 0 0.5 0.1 0.3 0.3 0.1-02 30-Jun-06 3 0.4 0.1 0.2 0.3 0.1-03 07-Jul-06 10 0.4 0.1 0.3 0.2 0.1-04 12-Jul-06 15 0.4 0.1 0.3 0.2 0.2-05 14-Jul-06 17 0.4 0.1 0.3 0.2 <0.05-06 19-Jul-06 22 0.8 0.7 0.7 0.5 0.9 Test Date 24-May-07 18-May-07 24-May-07 24-May-07 25-May-07 Test Site RL SC SC RL RL Kit Part Code 3D41-20 3A77 7G46-48 GE94 01463908 Kit Lot No. 50220LU00 50178M200 52543HN00 L000710 96445025 Kit Expiration Date 17-Oct-07 10-Jul-07 8-Jan-08 28-Feb-08 19-Mar-08 1 Immunoassay results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and noted in red. Page 3 of 4 January 2012 12424-01
Anti-HIV Confirmatory and Rapid Tests Member Dates Maxim 1 Western Blot Band Pattern Maxim 1 Western Blot Result Orasure Rapid -01 27 Jun 06 0 No Bands NEG NEG -02 30 Jun 06 3 No Bands NEG NEG -03 07 Jul 06 10 No Bands NEG NEG -04 12 Jul 06 15 No Bands NEG NEG -05 14 Jul 06 17 No Bands NEG NEG -06 19 Jul 06 22 No Bands NEG NEG Test Date 31-May-07 18-May-07 Test Site SC SC Kit Part Code 98002 6341 Kit Lot No. F7242-027 6601644 Kit Expiration Date 30-Aug-07 30-Sep-07 1. Formerly Calypte Cambridge Biotech Western Blot For assistance, contact SeraCare Technical Support at 508.244.6400 The Data Sheet for this panel in PDF form can be found at www.seracarepanels.com The printed Data Sheet may be requested by email at info@seracare.com, or by phone at 508.244.6400 ASK ABOUT RELATED SERACARE PRODUCTS ACCURUN independent quality controls SeraCon and other processed plasma products Global Patient Sample (GPS) Program access to a vast and evolving inventory of single test patient samples Page 4 of 4 January 2012 12424-01