HIV-1 Seroconversion Panel PRB973

Transcription

1 A SERACARE PANEL PRODUCT INTENDED USE The is a group of serial bleeds from an individual plasma donor during seroconversion. This panel 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 four 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 vial per member 4 members, 1.2 ml per vial STORAGE members should be stored frozen at -70ºC or colder to preserve RNA. HIV antibody and antigen will be preserved at -10ºC or colder. SeraCare recommends that the panel members be divided into smaller aliquots, if appropriate, to avoid multiple free 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 panel is available at 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 The printed Data Sheet may be requested by at info@seracare.com, or by phone at 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. Some panel members were found positive by tests for HIV markers, including HIV RNA and anti-hiv. Follow Universal Precautions. 1 The units that make up this panel were tested and found negative for HBsAg and anti-hcv. 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) For assistance, contact SeraCare Technical Support at 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 1 of 1 February

2 OVERVIEW is a four member HIV collected from a single donor over a period of 11 days in is a low titer HIV antigen sample, challenging for antigen and Ag/Ab tests, and 4 is a challenging sample for antibody assays. s are undiluted aliquots from plasma units. No preservatives were added. CAUTION: Potentially infectious materials. Follow Universal Precautions. members were found positive for markers of HIV infection; 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. For assistance, contact SeraCare Technical Support at EVOLUTION OF HIV MARKERS IN EARLY INFECTION s/co HIV Ag HIV Ag/Ab Anti-HIV 1/2 Anti-HIV 1 Positive cut-off RNA 9.0E E E E E E E E E+05 copies/m L Since 1st 0.0E+00 This graph demonstrates the evolution of early HIV infection, illustrated with test results over time for different analytes or analyte combinations Page 1 of 5 March

3 HIV RNA (copies/ml) Since 1 st Fiebig Stage 1 Abbott HIV RealTime RNA m2000 Roche COBAS Ampliprep COBAS TaqMan Test v2.0 Siemens Versant RNA 3.0 Assay (bdna) Jun-00 0 I 8.1 x x x Jun-00 2 I 6.4 x x x Jun-00 7 II 1.1 x x x Jun III/IV 8.4 x x 10 6 >5.0 x 10 5 Test 1-Feb Jan-12 2-Feb-12 Test Site RL SC RL Kit Part Code 6L A & B Kit Lot No P07463 D088 Kit Exp. 31-Dec Aug Jun-12 Kit Regulatory Status IVD IVD IVD 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 Since biomérieux Perkin Elmer Alliance 1 st VIDAS p24 II (pg/ml) 1 p24 ELISA (s/co) Jun-00 0 < Jun-00 2 < Jun Jun Test 12-Mar-12 1-Feb-12 Test Site RL SC Kit Part Code NEK050A Kit Lot No Kit Exp. 17-Jul-12 1-Oct-12 Kit Regulatory Status CE RUO 1 Quantitative HIV Antigen results are means of duplicates expressed as pg/ml. Ratios 3.0 are considered reactive and noted in red. 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 5 March

4 HIV Antigen/Antibody (s/co) 1 Since 1 st Abbott HIV Ag/Ab ARCHITECT Abbott HIV Ag/Ab AxSYM Abbott HIV Ag/Ab PRISM Bio-Rad Genscreen Ultra HIV Ag/Ab Jun Jun Jun Jun Test 30-Jan-12 6-Feb-12 6-Feb Mar-12 Test Site RL RL RL SC Kit Part Code 2P36 2G LI Kit Lot No LI LF00 7G C1067 Kit Exp. 30-Apr May Nov Aug-12 Kit Regulatory Status CE CE CE CE HIV Antigen/Antibody (s/co) 1 Since 1 st Bio-Rad GS HIV Ag/Ab EIA Murex HIV Ag/Ab Combination Alere Determine HIV -1/2 Ag/Ab HIV Ag Alere Determine /2 Ag/Ab HIV-Ab Jun NEG NEG Jun NEG NEG Jun NEG NEG Jun NEG NEG Test 15-Mar Jan Mar-12 Test Site SC RL SC Kit Part Code D D26-46 Kit Lot No. 315FJJ-02 7G ALCE Kit Exp. 27-Sep Dec Nov-12 Kit Regulatory Status IVD CE CE 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 5 March

5 HIV Antibody (s/co) 1 Since 1 st Avioq Microelisa System Bio-Rad GS /HIV-2 Plus O EIA Siemens HIV 1/O/2 Enhanced ADVIA Centaur Jun < Jun < Jun < Jun Test 1-Feb Jan-12 1-Feb-12 Test Site SC SC RL Kit Part Code Kit Lot No. J FBB Kit Exp. 12-Oct May Apr-12 Kit Regulatory Status IVD IVD IVD 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. Anti-HIV Confirmatory Since 1 st Bio-Rad GS Band Pattern Bio-Rad GS Result Calypte/MAXIM Band Pattern Calypte/MAXIM Result Jun-00 0 No bands NEG No bands NEG Jun-00 2 No bands NEG No bands NEG Jun-00 7 No bands NEG No bands NEG Jun f24 IND No bands NEG Test 9-Feb-12 6-Feb-12 Test Site SC SC Kit Part Code Kit Lot No A Kit Exp. 24-Jun Nov-12 Kit Regulatory Status IVD IVD Page 4 of 5 March

6 Anti-HIV Confirmatory and Rapid Tests Since 1 st Innogenetics INNO-LIA HIV I/II Band Pattern Innogenetics INNO-LIA HIV I/II Result Jun-00 0 No bands NEG Jun-00 2 No bands NEG Jun-00 7 No bands NEG Jun No bands NEG Test 12-Mar-12 Test Site RL Kit Part Code INX22206 Kit Lot No Kit Exp. 31-Jan-13 Kit Regulatory Status CE The Product Insert for this panel in PDF form can be found at The printed Package Insert or Data Sheet may be requested by at info@seracare.com, or by phone at 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 5 of 5 March