AccuVert HIV-1 Seroconversion Panel PRB955 ( ) / Batch #

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1 Signal to cutoff (s/co) Copies per ml (c/ml) OVERVIEW AccuVert is a 5-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members represent serial bleeds collected from a single individual over a period of 14 days in 1998 during the development of an HIV infection and subsequent response. Each sample represents a single collection event. No preservatives were added. 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 and found negative for anti-hcv and HBsAg. This does not ensure the absence of these or other human pathogens. Evolution of HIV Markers in Early Infection p24 Antigen HIV Antigen/Antibody /2 Antibody Antibody Positive cut-off (s/co) RNA 1.0E E E E E E E+00 This graph demonstrates the evolution of early HIV infection amongst panel members from the Organon Teknika ( RNA), Perkin Elmer ( p24 antigen), Dade Behring (HIV Antigen/Antibody), AxSym (/2 Antibody), and Genetic Systems ( Antibody) test methods. Page 1 of 6

2 Information SeraCare Batch # SeraCare Donor ID # Bleed Date Days Since 1 st Bleed NA 06-Jul NA 09-Jul NA 13-Jul NA 18-Jul NA 20-Jul RNA (copies/ml) 1 Chiron Quantiplex RNA 3.0 bdna Organon Teknika NASBA Roche Real Time PCR x x x x x x >5.0 x x x >5.0 x x 10 5 >8.0 x >5.0 x x x 10 5 Test Date 06-Jul Jul Jun-99 Test Site SC SC SC Kit Part Code Kit Lot No. Z007A Kit Exp. Date 15-Aug Feb Oct-99 Kit Regulatory Status NA NA NA 1 Positive/reactive results are noted in bold red. Page 2 of 6

3 HIV Antigen (s/co) 1 HIV Monoclonal EIA Coulter p24 Antigen Innogenetics p24 Innotest Perkin Elmer Alliance p24 Ag ELISA Test Date 24-Jun Jun Jul Dec-17 Test Site SC SC SC SC Kit Part Code 2A K-1048 NEK050A Kit Lot No M L Kit Exp. Date 02-Oct Aug Jan Aug-18 Kit Regulatory Status NA NA NA RUO ; RUO = Research Use Only HIV Antigen/Antibody (s/co) 1 BioMerieux VIDAS DUO Dade Behring Integral Organon Teknika Uni-Form II Roche Enzymun-Test > Test Date 23-Jul Jul Jul JuL-99 Test Site RL RL RL RL Kit Part Code OQTO Kit Lot No Kit Exp. Date 03-Sep Sep Jan Jan-01 RL = Reference Lab Page 3 of 6

4 /2 Antibody (s/co) 1 /2 EIA /2 AxSym 3 rd Generation /2 rdna EIA PLUS PRISM / > > Test Date 25-Jun Jul Jul Jul-99 Test Site SC RL RL RL Kit Part Code 3A77 9A44 7A84 4A27 Kit Lot No M LU HP HP00 Kit Exp. Date 25-Aug Oct Sep Oct-99 ; RL = Reference Lab /2 Antibody (s/co) 1 Sanofi Diagnostics Pasteur Access /2 Sanofi Diagnostics Pasteur Genscreen /2 Genetic Systems Murex /2 HIV 1.2.O > > >10.5 Test Date 23-Jul Jul Jun Jun-99 Test Site RL RL SC SC Kit Part Code GE94 Kit Lot No D011U 027RP1-05 F Kit Exp. Date 01-Oct Mar Nov Sep-99 ; RL = Reference Lab Page 4 of 6

5 /2 Antibody (s/co) 1 Ortho /2 Capture Ortho Vitros Eci /2 Roche DAGS Sanofi Fujirebio /2 PA Test Date 23-Jul Jul Aug Jul-99 Test Site RL RL RL RL Kit Part Code Kit Lot No. HVK B1033 MZ81204 Kit Exp. Date 31-Jul Aug Apr Dec-99 RL = Reference Lab Antibody (s/co) 1 EIA Organon Teknika Vironostika EIA Genetic Systems Test Date 09-Jul Jul Jul-99 Test Site SC SC SC Kit Part Code 3A Kit Lot No M QAA Kit Exp. Date 30-Jul Sep Apr-00 Kit Regulatory Status NA NA NA Page 5 of 6

6 Anti- Confirmatory 1 Cambridge Biotech Western Blot Band Pattern Cambridge Biotech Western Blot Result 01 f24 IND 02 f24 IND 03 f24 IND 04 f24 IND IND Test Date 02-Jul-99 Test Site SC Kit Part Code Kit Lot No. A Kit Exp. Date 29-Oct-99 Kit Regulatory Status 1 Western Blots are interpreted using ASTPHLD/CDC criteria (MMWR, vol. 38, S-7, 1989). Faintly staining bands are recorded, but interpreted as Indeterminate according to specific manufacturer's instructions. f = Faint; IND = Indeterminate NA 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