HIV-1 AccuVert TM Seroconversion Panel

Transcription

1 PACKAGE INSERT PRB954 ( ) INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot test methods. Characterized samples and comprehensive data are provided for comparative analysis. For research use only. Not for use in diagnostic procedures. PRODUCT DESCRIPTION This product is a 7-member -1 seroconversion panel. members represent serial bleeds from a single donor during the development and progression of a -1 infection. members consist of undiluted, naturally occurring plasma samples. Each sample represents a single collection event. No preservatives were added. Cat. No vial per member 7 members, 1.0 ml per vial STORAGE members should be stored frozen at -70 C or colder. SeraCare Life Sciences recommends that the panel members be divided into smaller aliquots to avoid multiple freeze-thaw cycles, if appropriate. 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 the Seroconversion is available at The Data Sheet lists results for panel members generated using commercially-available screening, monitoring, and confirmatory test methods. Tests 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 The 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 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 Technical Support at The Package Insert and Data Sheet for this panel in PDF form can be found at A printed copy of the Data Sheet may be requested by at info@seracare.com, or by phone at ASK ABOUT RELATED SERACARE PRODUCTS AccuType TM Viral Isolates ACCURUN Quality Controls Disease State Biological Materials AccuSet TM Performance s Page 1 of 1 April

2 s/co copies/ml OVERVIEW Seroconversion Performance is a 7-member panel of undiluted, naturally-occurring plasma samples collected from a single donor over 21 days (1 vial per member, 1.0 ml per vial). Each sample represents a single collection event. No preservatives were added. Test results from commercially-available assays are included for characterization of the panel members. This panel of human plasma samples converts from negative to positive for antibody, p24 antigen, and -1 RNA. 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. CAUTION: Potentially infectious materials. Follow Universal Precautions. The units that make up this panel were tested for HBsAg and anti-hcv and found to be negative. This does not ensure the absence of these or other human pathogens. Progression of Markers in Early Infection p24 Antigen Antibody Ag/Ab Positive Cut-Off RNA This graph demonstrates the progression of markers amongst panel members utilizing test results from the Roche COBAS Ampliprep/COBAS TaqMan -1 RNA Test v2.0, Zeptometrix Type 1 p24 Antigen ELISA, Bio-Rad Genetic Systems TM -1/-2 Plus O EIA, and ARCHITECT Ag/Ab Combo Assay. Page 1 of 5 April

3 -1 RNA 1 1st Roche COBAS AmpliPrep/COBAS TaqMan -1 Test, v2.0 2 Chiron 3.0 bdna Org. Tek. NASBA Roche RT-PCR Oct-98 0 Not Detected BLD BLD BLD Oct-98 2 Not Detected BLD BLD BLD Oct-98 7 Not Detected BLD BLD BLD Oct BLD Oct Oct Nov > > > Test Date 02-Jan Apr Apr Apr-99 Test Site RL SC SC SC Kit Part Code NA Kit Lot No. NA Z005H Kit Exp. Date NA 07-Jun-99 Feb-00 Jun-99 BLD = Below the limit of detection, SC = SeraCare, RL = Reference Lab 1-1 RNA results are single observations, expressed as RNA copies/ml. 2 Kit regulatory status = FDA and CE approved. -1 p24 Antigen 1,2 Date Days Since 1st Zeptometrix Type 1 p24 Antigen ELISA 3 Perkin Elmer Zeptometrix Ag Innogenetics Innotest Monoclonal Oct Oct Oct Oct Oct Oct Nov > Coulter Ag Test Date 11-Aug May May May Apr May-99 Test Site SC SC SC SC SC SC Kit Part NEK050A K A Code Kit Lot No B 49710M L744 Kit Exp. Date 21-Mar Feb Nov-08 Jul May Aug-99 SC = SeraCare 3 Kit regulatory status = Research Use Only (RUO). Page 2 of 5 April

4 -1/2 Antibody 1,2 Days Since 1st Bio-Rad Genetic Systems TM -1/-2 Plus O EIA 3-1/2 Genetic Systems Bio-Rad - 1/2 Org. Tek Oct Oct Oct Oct Oct Oct Nov Test Date 26-Dec Apr Apr Apr May Apr-99 Test Site SC SC SC SC SC SC Kit Part Code A11 3A Kit Lot No. 163JBB M M QAA BBB Kit Exp. Date 31-Mar Jun Jun Sep Aug Nov-99 SC = SeraCare 3 Kit regulatory status = FDA and CE approved. -1/2 Antibody 1,2 Date Days Since 1st 3rd Gen. PLUS AxSYM PRISM Diag. Past. Access Diag. Past. Genscreen Oct Oct Oct Oct Oct Oct Nov Murex 1.2.O Test Date 20-May May May May May Apr-99 Test Site RL RL RL RL RL RL Kit Part Code 7A84 9A44 4A GE94 Kit Lot No. 5120HP LU HP D011U F Kit Exp. Date 30-Oct Oct Sep Oct Mar Sep-99 RL = Reference Lab Page 3 of 5 April

5 -1/2 Antibody 1,2 1st Ortho Vitros Eci Sanofi Fujirebio -1/2 PA Ortho Capture Roche DAGS Oct Oct Oct Oct Oct Oct Nov Test Date 12-May Jun Jun May-99 Test Site RL RL RL RL Kit Part Code Kit Lot No. HVK B1032 M Kit Exp. Date Jul Aug Apr Dec-99 RL = Reference Lab Western Blot 1 Cambridge Biotech Western Blot 1st Band Pattern BandResult Oct-98 0 No Bands Negative Oct-98 2 No Bands Negative Oct-98 7 No Bands Negative Oct No Bands Negative Oct No Bands Negative Oct No Bands Negative Nov No Bands Negative Test Date 06-Apr-99 Test Site SC Kit Part Code Kit Lot No. A Kit Exp. Date 12-Aug-99 1 Western Blots are interpreted using ASTPHLD/CDC criteria (MMWR, vol. 38, S-7, 1989). Page 4 of 5 April

6 Antigen/Antibody 1,2 1st ARCHITECT Ag/Ab Combo 3 BioMerieux Vidas DUO Dade Behring Integral Org. Tek Uni-Form II Roche Enzymun- Test Oct Oct Oct Oct Oct Oct Nov Test Date 31-Dec May Jun May Jul-99 Test Site SC RL RL RL RL Kit Part Code 2P OQTO Kit Lot No LI Kit Exp. Date 26-Jul Sep Jun-99 Jul Mar-01 RL = Reference Lab 3 Kit regulatory status = FDA and CE approved. The Package Insert for this panel in PDF form 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 ASK ABOUT RELATED SERACARE PRODUCTS Disease State Biological Materials AccuVert TM s ACCURUN independent quality controls SeraCon TM and Basematrix Processed Plasma Page 5 of 5 April