AccuSet Anti-HIV-1 Mixed Titer Performance Panel

Transcription

1 PACKAGE INSERT PRB205(M3) / ( ) INTENDED USE The Performance Panel PRB205(M3) / ( ) is intended for use by diagnostics manufacturers and clinical laboratorians to evaluate their HIV-1 test systems using wellcharacterized 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 16 members: 15 members are positive for anti-hiv-1 at different levels, one member which is negative for anti-hiv-1 is included as a nonreactive control. Specimens are undiluted aliquots from plasma units collected between 1997 and 2008 from plasma donors in the United States. All panel members were 0.8 µm filtered; no preservatives were added. Item No vial per member 16 members, 1.0 ml per vial STORAGE Panel members should be stored frozen at -20 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 AccuSet Anti-HIV-1 Mixed Titer 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 is available. LIMITATIONS AccuSet Anti-HIV-1 Mixed Titer PRB205(M3) / ( ) is offered for research use only. Not for use in diagnostic procedures. Data is 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 HIV-1 RNA, HIV-1 antigen and anti-hiv. Some of the units that make up this panel were found positive for anti-hcv and HBsAg. The potential for disease transmission is present. 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 April 2017

2 signal to cut-off (s/co) DATA SHEET OVERVIEW PRB205(M3) is a modified 16-member panel originating from Anti- HIV-1 Mixed Titer PRB205(M2). Panel members 3, 5, 6, 17, 21, 22, 23, 24, and 25 from the original panel are no longer available. Panel members are naturally-occurring plasma samples ranging from negative to strong positive for anti-hiv, with test results from 11 anti-hiv or antigen/antibody methods, including three rapid assays and two confirmatory methods. Fiebig stage and test results for HIV p24 antigen and HIV RNA are also included. All members were processed by filtration through 0.8 μm filters. No preservatives were added. CAUTION: Potentially infectious materials. Follow Universal Precautions. Some panel members were found positive for HIV Ag and/or anti-hiv-1; some were found positive for HBsAg (Member 2) and anti-hcv (Member 2 & 16). 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. AccuSet Anti-HIV-1 Mixed Titer This graph demonstrates anti-hiv reactivity amongst panel members utilizing test results from the Ortho HIV-1/HIV-2 VITROS ECi assay, members #3, 5, 6, 17, 21, 22, 23, 24, 25 are no longer available. Data is shown for informational purposes only. Page 1 of 6

3 Information SeraCare Batch # Fiebig Stage V VI 03 ER III 04 BM VI VI III 07 BM III IV VI V VI 12 BM III VI NA V VI 17 ER V IV VI VI NA VI V 24 BM III V 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: *Panel members 3, 5, 6, 17, 21, 22, 23, 24 and 25 are no longer available and noted in grey; data are provided for informational purposes only. NA = Not Available Page 2 of 6

4 HIV RNA and HIV-1 Confirmatory Roche HIV RNA CAP/CTM v1.0 (copies/ml) Western Blot Band Pattern Western Blot Innogenetics INNO-LIA HIV I/II Band Pattern Innogenetics INNO-LIA HIV I/II x , f31, f51, 55, 160 POS 24, 41 POS x , 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS x 10 4 No Bands NEG No Bands NEG x 10 6 f18,24, 31, 41, 51, 55, 65, 120, 160 POS 24, 31, 41, 120 POS x , 24, 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS x 10 3 No Bands NEG No Bands NEG x 10 5 No Bands NEG No Bands NEG x , 160 IND 41 IND x 10 2 f18, 24, 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS x , 24, f31, 41, 51, 55, 65, 120, 160 POS 17, 24, 41, 120 POS x 10 2 f18, 24, 31, 41, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS x 10 5 No Bands NEG No Bands NEG x , 24, 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS 14 BLD No Bands NEG No Bands NEG x , 24, f41, f51, 55, 65, 160 POS 17, 24, 41, 120 POS x , 24, 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS x 10 4 f18, 24, f41, 51, 55, f65, f120, 160 POS 17, 24, 41, 120 POS x 10 4 f160 IND 41 IND x , 24, 31, f51, 55, f65, 160 POS 17, 24, 41, 120 POS x , 24, 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS 21 BLD No Bands NEG No Bands NEG x , 31, 41, 51, 55, 65, 120, 160 POS 17, 24, 31, 41, 120 POS 23 BLD f18, 24, 51, 55, 160 POS 17, 24, 41, 120 POS x 10 5 No Bands NEG No Bands NEG 25 BLD f18, f24, 41, f51, 55, f65, 120, 160 POS 17, 24, 41, 120 POS 18-May Jul-10 Test Date 20-Sep May Jul-10 Test Site SC SC RL Kit Part Code M Kit Lot No Kit Exp. Date 31-Jan Dec May-11 BLD = Below the limit of detection; POS = Positive; NEG = Negative; IND = Indeterminate; f = Faint Band RL = Reference Lab; SC = SeraCare Page 3 of 6

5 HIV Antigen & HIV Antigen/Antibody (s/co) 1,2 Perkin Elmer HIV Ag p24 ARCHITECT AxSYM PRISM Genscreen Ultra HIV Ag/Ab DiaSorin Murex > > > > > > > > > > > > > > > > > > > > > > Test Date 14-May Aug Sep Aug Sep Aug Aug-10 Test Site SC RL RL RL SC RL Kit Part Code NEK050B 4J G8320 7G G79-09 Kit Lot No HN LF HN00 OF1056 L Kit Exp. Date 01-Nov Jan Oct Jan Nov Jan-11 1 s are reported as the mean result of duplicate testing. 2 s are expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and noted in bold red. RL = Reference Lab; SC = SeraCare Page 4 of 6

6 HIV Antibody (s/co) 1,2 HIV-1/HIV-2 rdna Avioq HIV-1 Microelisa System HIV-1rLAV Gen. Sys. HIV-1/HIV-2 Plus O Gen. Sys. Ortho HIV-1/HIV-2 VITROS ECi Siemens HIV-1/O/2 Enhanced ADVIA Centaur > > > > > >50 04 >18.5 > > >50 05 >18.5 > > > > > > > >18.5 > > >50 10 >18.5 > > >50 11 >18.5 > > > >18.5 > > > > >18.5 > > > > > > > > >50 20 >18.5 > > > > > > > > >18.5 > > >50 Test Date 23.Aug Sep May Sep Aug Sep Aug-10 Test Site SC SC SC SC RL RL Kit Part Code 3A SP Kit Lot No M600 J DAA EBB Kit Exp. Date 03-Nov Jan Jun Dec Jan Dec-10 1 s are reported as the mean result of duplicate testing. 2 s are expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and noted in bold red. RL = Reference Lab; SC = SeraCare Page 5 of 6

7 HIV-1 Confirmatory Multispot HIV-1 Multispot HIV-2 OraSure OraQuick Advance HIV-1/2 Inverness Determine HIV Ag Inverness Determine HIV Ab 01 POS NEG NEG NEG POS 02 POS NEG POS NEG POS 03 POS NEG NEG POS POS 04 POS NEG POS NEG POS 05 POS NEG POS NEG POS 06 POS NEG NEG NEG POS 07 NEG NEG NEG POS POS 08 NEG NEG NEG POS POS 09 POS NEG POS NEG POS 10 POS NEG POS NEG POS 11 POS NEG POS NEG POS 12 NEG NEG NEG NEG NEG 13 POS NEG POS NEG POS 14 NEG NEG NEG NEG NEG 15 POS NEG POS NEG POS 16 POS NEG POS NEG POS 17 POS NEG POS NEG POS 18 POS NEG NEG NEG POS 19 POS NEG POS NEG POS 20 POS NEG POS NEG POS 21 NEG NEG NEG NEG NEG 22 POS NEG POS NEG POS 23 POS NEG POS NEG POS 24 NEG NEG NEG NEG NEG 25 POS NEG POS NEG POS Test Date 07-Sep Sep Sep-10 Test Site SC SC SC Kit Part Code D26-46 Kit Lot No Kit Exp. Date 02-Feb Nov Dec-10 POS = Positive; NEG = Negative; SC = SeraCare 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 6 of 6