AccuVert HIV-1 Seroconversion Panel PRB974 ( )

Transcription

1 PACKAGE INSERT PRB974 ( ) INTENDED USE PRB974 ( ) 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 HIV-1 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 consists of a set of four undiluted plasma samples from a single plasma donor collected during a period of HIV-1 seroconversion. All units were maintained frozen, except for the interval of dispensing into vials. No preservatives were added. Item No vial per member 4 members, 1.2 ml per vial STORAGE Panel members should be stored frozen at -70 C or colder to preserve HIV-1 RNA. HIV antibody and antigen will be preserved at -20 C 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 AccuVert HIV-1 Seroconversion Panel PRB974 ( ) 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 AccuVert HIV-1 PRB974 ( ) 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. 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 August 2017

2 Signal to cutoff (s/co) Copies per ml (c/ml) DATA SHEET OVERVIEW is a 4-member panel collected of undiluted, naturally occurring plasma samples (1 vial per member, 1.2mL). Panel members represent serial bleeds collected from a single individual over 16 days in 2000 during the development of an HIV infection and subsequent response. #02 is a moderately positive HIV RNA sample, challenging for HIV antigen assays. Member #3 is detected at very low signal to cutoff by all HIV Ag/Ab methods tested, and Member #4 is a very challenging sample for anti-hiv assays. 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. CAUTION: Potentially infectious materials. Follow Universal Precautions. Some panel members were found positive for markers of HIV infection; all were found negative for HBsAg and anti-hcv. This does not ensure the absence of these or other human pathogens. Evolution of HIV Markers in Early Infection HIV-1 p24 Antigen HIV Antigen/Antibody HIV Antibody HIV-1 RNA Days Since 1st Bleed 1.0E E E E E E E E E E E+00 This graph demonstrates the evolution of early HIV infection amongst panel members from the Abbott m2000, Perkin Elmer, Abbott ARCHITECT and Siemens Centaur test methods. Note: Members 01, 02 and 03 on the Siemens Centaur HIV-1 Antibody test were plotted at 0.05 s/co. Page 1 of 5

3 Information SeraCare Batch # Bleed Date Days Since 1 st Bleed 1 Fiebig Stage Jun-00 0 NA Jun-00 7 I Jun-00 9 II Jun II/III 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 HIV-1 infection. JTB 2009, 261: HIV RNA (copies/ml) 1 Abbott HIV RealTime HIV-1 RNA m2000 Roche COBAS AmpliPrep COBAS TaqMan HIV-1 Test v2.0 Siemens Versant HIV-1 RNA 3.0 Assay (bdna) 01 BLD BLD BLD x x x x x x x x 10 5 >5.0 x 10 5 Test Date 01-Feb Jan Feb-12 Test Site RL SC RL Kit Part Code 6L A & B Kit Lot No P07463 D088 Kit Exp. Date 31-Dec Aug Jun-12 Kit Regulatory Status IVD IVD IVD 1 Quantitative HIV RNA results are expressed as copies/ml. Members considered reactive are noted in bold red. BLD = Below the Limit of Detection IVD = In vitro diagnostic use Page 2 of 5

4 HIV Antigen biomérieux VIDAS p24 II (pg/ml) 1 Perkin Elmer Alliance HIV-1 p24 Ag ELISA (s/co) 2 01 < < Test Date 12-Mar Feb-12 Test Site RL SC Kit Part Code NEK050A Kit Lot No Kit Exp. Date 17-Jul Oct-12 Kit Regulatory Status CE RUO 1 Quantitative HIV Antigen results are the means of duplicates expressed as pg/ml. Ratios 3.0 are considered reactive and noted in bold 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 bold red. CE = Conformité Européenne or CE Marking; RUO = Research Use Only HIV Antigen/Antibody (s/co) 1 Abbott HIV Ag/Ab ARCHITECT Abbott HIV Ag/Ab AxSYM Abbott HIV Ag/Ab PRISM Bio-Rad Genscreen Ultra HIV Ag/Ab Test Date 30-Jan Feb Feb Mar-12 Test Site RL RL RL SC Kit Part Code 2P36 2G G Kit Lot No LI LF LI00 1C1067 Kit Exp. Date 30-Apr May Nov Aug-12 Kit Regulatory Status CE CE CE CE Immunoassay results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and noted in bold red. CE = Conformité Européenne or CE Marking Page 3 of 5

5 HIV Antigen/Antibody Bio-Rad GS HIV Ag/Ab EIA (s/co) 1 Murex HIV Ag/Ab Combination (s/co) 1 Alere Determine HIV-1/2 Ag/Ab HIV Ag Alere Determine HIV-1/2 Ag/Ab HIV Ab NEG NEG NEG NEG NEG NEG POS NEG Test Date 15-Mar Jan Mar-12 Test Site SC RL SC Kit Part Code G D26-46 Kit Lot No. 315FJJ-02 D ALCE & ALCE Kit Exp. Date 27-Sep Dec Mar-12 & 11-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 bold red. POS = Positive; NEG = Negative CE = Conformité Européenne or CE Marking; IVD = in vitro diagnostic use HIV Antibody (s/co) 1 Avioq HIV-1 Microelisa System Bio-Rad GS HIV- 1/HIV-2 Plus O Siemens HIV1/O/2 Enhanced ADVIA Centaur < < < Test Date 01-Feb Jan Feb-12 Test Site SC SC RL Kit Part Code Kit Lot No. J FBB Kit Exp. Date 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 bold red. IVD = In vitro diagnostic use Page 4 of 5

6 HIV Confirmatory Bio-Rad GS HIV-1 Western Blot Band Pattern Bio-Rad GS HIV-1 Western Blot Result Calypte/MAXIM HIV-1 Western Blot Band Pattern Calypte/MAXIM HIV-1 Western Blot Result 01 No bands NEG No bands NEG 02 No bands NEG No bands NEG 03 No bands NEG No bands NEG 04 No bands NEG No bands NEG Test Date 09-Feb Feb-12 Test Site SC SC Kit Part Code Kit Lot No A Kit Exp. Date 24-Jun Nov-12 Kit Regulatory Status IVD IVD NEG = Negative SC = SeraCare IVD = In vitro diagnostic use HIV Confirmatory Innogenetics INNO-LIA HIV I/II Band Pattern Innogenetics INNO-LIA HIV I/II Result 01 No Bands NEG 02 No Bands NEG 03 No Bands NEG 04 No Bands NEG Test Date 12-Mar-12 Test Site RL Kit Part Code INX22206 Kit Lot No Kit Exp. Date 31-Jan-13 Kit Regulatory Status CE NEG = Negative RL = Reference Lab CE = Conformité Européenne or CE Marking; 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 5 of 5