A SERACARE PANEL PRODUCT Seroconversion INTENDED USE The Seroconversion 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 frozen, except for the interval of dispensing into vials. No preservatives were added. Cat No. -1.0 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 1 vial per member 1 6 members, 1.0 ml per vial Precautions. Some panel members were found positive by tests for HIV markers including RNA, antigen and anti-hiv. 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. 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 Seroconversion 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 available screening, 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. 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 to info@seracare.com, or by phone to 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 July 2010 12192-02
Seroconversion OVERVIEW This Data Sheet contains test results specific for Seroconversion. s are undiluted aliquots from plasma units collected from a single donor. No preservatives were added. CAUTION: Potentially infectious materials. Follow Universal Precautions. Some panel members were found positive for anti- 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 these results can be duplicated exactly. EVOLUTION OF HIV MARKERS IN EARLY INFECTION 70 60 50 HIV Ag HIV anti- anti-/2 Positive cut-off 1.0E+08 1.0E+07 1.0E+06 s/co 40 30 1.0E+05 1.0E+04 copies/ml 20 1.0E+03 10 1.0E+02 0 0 5 10 15 20 1st 1.0E+01 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 August 2010 12219-02
Seroconversion (copies/ml) 1 st Fiebig Stage 1 Abbott m2000 Roche CAP/CTM v1.0 Siemens bdna -01 20-Jul-01 0 NA BLD BLD BLD -02 23-Jul-01 3 I BLD 6.1 x 10 1 BLD -03 27-Jul-01 7 I 4.8 x 10 3 6.7 x 10 3 2.2 x 10 3-04 06-Aug-01 17 III 3.7 x 10 6 5.9 x 10 6 >5.0 x 10 5-05 08-Aug-01 19 III 4.5 x 10 6 9.0 x 10 6 >5.0 x 10 5-06 13-Aug-01 24 VI 1.1 x 10 5 1.8 x 10 5 5.8 x 10 4 Test 13-May-10 19-May-10 18-Jun-10 Test Site RL SC RL Kit Part Code 6L18 3542998 127418 A&B Kit Lot No. 422866 M15645 D079 Kit Exp 05-May-11 31-Jan-11 28-Sep-10 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. HIV Antigen 1 st Perkin Elmer HIVAg p24 (s/co) 2 Zeptometrix HIVAg p24 (s/co) 2 biomerieux HIVAg VIDAS p24 (pg/ml) 3-01 20-Jul-01 0 0.2 0.4 <3.0-02 23-Jul-01 3 0.2 0.4 <3.0-03 27-Jul-01 7 0.6 0.9 <3.0-04 06-Aug-01 17 >47.6 53.7 >400.0-05 08-Aug-01 19 >47.6 45.2 >400.0-06 13-Aug-01 24 4.4 1.6 10.5 Test 11-May-10 25-May-10 30-Jun-10 Test Site SC SC RL Kit Part Code NEK050B 801111 30 117 Kit Lot No. 990-100306 306346 838404801 Kit Exp 01-Nov-10 12-Mar-11 17-Oct-10 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. 3 Quantitative HIV Antigen results are means of duplicates expressed in pg/ml. Results 3.0 are considered positive and noted in red. Page 2 of 4 August 2010 12219-02
Seroconversion HIV Antigen/Antibody (s/co) 1 1 st AxSYM PRISM ARCHITECT Genscreen Ultra HIV Murex HIV -01 20-Jul-01 0 0.4 0.1 0.1 0.4 0.3-02 23-Jul-01 3 0.4 0.1 0.1 0.4 0.3-03 27-Jul-01 7 0.6 0.4 0.6 0.6 0.4-04 06-Aug-01 17 60.1 136.2 299.1 >11.0 >19.7-05 08-Aug-01 19 42.5 81.5 204.9 >11.0 >19.7-06 13-Aug-01 24 9.1 8.4 140.1 >11.0 16.5 Test 27-May-10 12-Jul-10 03-Jun-10 29-Jun-10 22-Jun-10 Test Site RL RL RL SC RL Kit Part Code 268320 7G46-48 4J27-30 72386 7G79-02 Kit Lot No. 87248LF00 89287HN00 81321HN00 0A1050 L397910 Kit Exp 02-Sep-10 07-Dec-10 06-Aug-10 30-May-11 31-Dec-10 HIV Antibody (s/co) 1 Days Since 1 st Avioq Microelisa System Genetic Systems rlav Abbott /HIV-2 rdna /HIV-2 Plus O Gen Sys Ortho /HIV-2 Vitros Eci -01 20-Jul-01 0 0.2 0.1 0.3 0.1 0.1 0.1-02 23-Jul-01 3 0.2 0.1 0.3 0.1 0.1 0.1-03 27-Jul-01 7 0.2 0.1 0.2 0.1 0.1 0.0-04 06-Aug-01 17 0.3 0.2 2.5 >11.1 12.4 5.9 Siemens HIV1/O/2 Enhanced Advia Centaur -05 08-Aug-01 19 0.9 0.5 8.3 >11.1 34.9 24.9-06 13-Aug-01 24 4.2 2.6 8.4 >11.1 44.5 >50.0 Test 14-Jun-10 11-May-10 25-May-10 28-May-10 15-Jul-10 08-Jul-10 22-Jun-10 Test Site SC SC SC SC RL RL Kit Part Code 100384 32511 3A77-68 32588 6801861 01463908 Kit Lot No. J0904 197DAA-05 87018M500 042EBB-05 0330 53445061 Kit Exp 12-Jan-11 01-Jun-10 28-Jul-10 14-Oct-10 25-Jan-11 19-Sep-10 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 August 2010 12219-02
Seroconversion Anti-HIV Confirmatory and Rapid Tests 1 st Western Blot Band Pattern Western Blot Result Innogenetics INNO-LIA HIV I/II Band Pattern Innogenetics INNO-LIA HIV I/II Result Inverness Determine /2 HIV Ag -01 20-Jul-01 0 No Bands NEG No Bands NEG NEG NEG -02 23-Jul-01 3 No Bands NEG No Bands NEG NEG NEG -03 27-Jul-01 7 No Bands NEG No Bands NEG NEG NEG -04 06-Aug-01 17 No Bands NEG No Bands NEG POS NEG -05 08-Aug-01 19 No Bands NEG 41 IND POS POS -06 13-Aug-01 24 24, 31, 55, 160 Inverness Determine /2 /2 POS 24, 41, f120 POS NEG POS Test 22-Jun-10 30-Jun-10 25-Jun-10 Test Site SC RL SC Kit Part Code 32508 80540 7D26-46 Kit Lot No. 966550 202524 100203 Kit Exp 03-Dec-10 01-Jan-11 04-Dec-10 For assistance, contact SeraCare Technical Support at 508.244.6400 A printed PI and Data Sheet may be requested by email to info@seracare.com, or by phone to 508.244.6400 Page 4 of 4 August 2010 12219-02