AccuSet HBV Worldwide Performance Panel

Transcription

1 PACKAGE INSERT INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot HBV 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 panel consisting of undiluted, naturally occurring plasma samples collected from individual donors positive for HBV infection of varying genotypes (A, B, C, D, E, F, H). Each sample represents a single collection event. No preservatives were added. LIMITATIONS AccuSet HBV Worldwide 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. The units that make up this panel were tested and found negative for anti-hiv and anti-hcv. This does not ensure the absence of these or other human pathogens. All panel members were found positive for HBV DNA. Do not pipette by mouth. Do not smoke, eat, or drink in areas where specimens are handled. Material Number: , vial per member 7 members,.2 ml per vial These materials should be disposed of in a manner that will inactivate pathogenic agents. STORAGE Panel members should be stored frozen at -70 C or colder. SeraCare recommends that the panel members be divided into smaller aliquots to avoid multiple freezethaw 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 AccuSet HBV Worldwide 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. REFERENCES. 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 of 36-0 October 207

2 IU/mL DATA SHEET OVERVIEW AccuSet HBV Worldwide is a 7-member validation panel of undiluted, naturally occurring plasma samples ( vial per member,.2 ml per vial). Panel members represent bleeds from multiple individuals positive for a variety of HBV genotypes. Each sample represents a single collection event. No preservatives were added. This panel of human plasma samples demonstrates a diverse collection of HBV genotypes A, B, C, D, E, F and H. Test results from commercially-available HBV genotype, DNA, antigen, and antibody assays are included for characterization of each panel member. 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-hiv-/2 and anti-hcv. This does not ensure the absence of these or other human pathogens. AccuSet HBV Worldwide,000,000,000 00,000,000 0,000,000 2,563,800 78,24,429 87,755,70,000,000 8,387 00,000 0,000 4,77,000, Genotype A 2 Genotype B 3 Genotype C 4 Genotype D 5 Genotype E 6 Genotype F 7 Genotype H & Genotype This graph demonstrates HBV DNA reactivity amongst panel members utilizing test results from the Abbott m2000 (IU/mL) test method. Page of 4

3 Information SeraCare Batch # Donor ID Bleed Date Genotype BD May-2008 A NA NA B NA NA C BD Oct-200 D BD Mar-2007 E BD Sep-2009 F BD Aug-20 H NA = Not Available HBV DNA Roche COBAS AmpliPrep COBAS TaqMan HBV Test v2.0 (IU/mL) Abbott m2000 RealTime HBV (IU/mL) 0 9,874,459 2,563, ,620 8, >70,000,000 78,24,429 04,03, ,855,35 87,755, ,536 4, Test Date 7-Oct Oct-207 Test Site RL RL Kit Part Code NA NA Kit Lot No. NA NA Kit Exp. Date NA NA Kit Regulatory Status CE, IVD IVD Quantitative HBV DNA results are the means of duplicates expressed as International Units/mL. Members considered reactive are noted in bold red. RL = Reference Lab; NA = Not Available CE = Conformité Européenne or CE Marking; IVD = In vitro diagnostic use Page 2 of 4

4 HBsAg and HBeAg Abbott ARCHITECT HBsAg Ortho VITROS HBsAg Abbott ARCHITECT HBeAg ETI-EBK HBeAg Test Date 6-Oct Oct Nov Oct-207 Test Site SC RL RL SC Kit Part Code 4P54 NA NA P00930 Kit Lot No FN00 NA 73324LI AB Kit Exp. Date 22-Feb-208 NA 2-Nov Apr-208 Kit Regulatory Status CE, IVD CE, IVD CE, IVD IVD Immunoassay results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios.0 are considered reactive and noted in bold red. SC = SeraCare; RL = Reference Lab; NA = Not Available CE = Conformité Européenne or CE Marking; IVD = In vitro diagnostic use Page 3 of 4

5 HBV Antibody ETI-CORE-IgMK Anti-HBc IgM ETI-AB-COREK Anti-HBc (co/s) 2 ETI-AB-EBK Anti-HBe (co/s) 2 ETI-AB-AUK Anti-HBs Test Date 7-Oct Oct Oct Oct-207 Test Site SC SC SC SC Kit Part Code P00928 P00927 P00929 P0093 Kit Lot No A A A A Kit Exp. Date 3-Jan Mar Apr Jan-208 Kit Regulatory Status IVD IVD IVD IVD Immunoassay results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios.0 are considered reactive and noted in bold red. 2 Immunoassay results are means of duplicates expressed as cutoff to signal ratios (co/s). Ratios.0 are considered reactive and noted in bold red. SC = SeraCare IVD = In vitro diagnostic use 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 4 of 4