HIV-1 Seroconversion Panel

Transcription

1 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 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 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) For assistance, contact SeraCare Technical Support at The Data Sheet for this panel in PDF form can be found at The printed Data Sheet may be requested by to info@seracare.com, or by phone to 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

2 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 HIV Ag HIV anti- anti-/2 Positive cut-off 1.0E E E+06 s/co E E+04 copies/ml E E st 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

3 Seroconversion (copies/ml) 1 st Fiebig Stage 1 Abbott m2000 Roche CAP/CTM v1.0 Siemens bdna Jul-01 0 NA BLD BLD BLD Jul-01 3 I BLD 6.1 x 10 1 BLD Jul-01 7 I 4.8 x x x Aug III 3.7 x x 10 6 >5.0 x Aug III 4.5 x x 10 6 >5.0 x Aug VI 1.1 x x x 10 4 Test 13-May May Jun-10 Test Site RL SC RL Kit Part Code 6L A&B Kit Lot No M15645 D079 Kit Exp 05-May Jan 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: HIV Antigen 1 st Perkin Elmer HIVAg p24 (s/co) 2 Zeptometrix HIVAg p24 (s/co) 2 biomerieux HIVAg VIDAS p24 (pg/ml) Jul < Jul < Jul < Aug > > Aug > > Aug Test 11-May May Jun-10 Test Site SC SC RL Kit Part Code NEK050B Kit Lot No Kit Exp 01-Nov Mar 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

4 Seroconversion HIV Antigen/Antibody (s/co) 1 1 st AxSYM PRISM ARCHITECT Genscreen Ultra HIV Murex HIV Jul Jul Jul Aug >11.0 > Aug >11.0 > Aug > Test 27-May Jul Jun Jun Jun-10 Test Site RL RL RL SC RL Kit Part Code G J G79-02 Kit Lot No LF HN HN00 0A1050 L Kit Exp 02-Sep Dec Aug May 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 Jul Jul Jul Aug > Siemens HIV1/O/2 Enhanced Advia Centaur Aug > Aug > >50.0 Test 14-Jun May May May Jul Jul Jun-10 Test Site SC SC SC SC RL RL Kit Part Code A Kit Lot No. J DAA M EBB Kit Exp 12-Jan Jun Jul Oct Jan 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

5 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 Jul-01 0 No Bands NEG No Bands NEG NEG NEG Jul-01 3 No Bands NEG No Bands NEG NEG NEG Jul-01 7 No Bands NEG No Bands NEG NEG NEG Aug No Bands NEG No Bands NEG POS NEG Aug No Bands NEG 41 IND POS POS Aug , 31, 55, 160 Inverness Determine /2 /2 POS 24, 41, f120 POS NEG POS Test 22-Jun Jun Jun-10 Test Site SC RL SC Kit Part Code D26-46 Kit Lot No Kit Exp 03-Dec Jan Dec-10 For assistance, contact SeraCare Technical Support at A printed PI and Data Sheet may be requested by to info@seracare.com, or by phone to Page 4 of 4 August