HCV Low Titer AccuSet TM Performance Panel

Transcription

1 HCV Low Titer AccuSet TM Performance PACKAGE INSERT INTENDED USE The HCV Low Titer AccuSet TM Performance is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot HCV 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 an 11-member panel consisting of undiluted, naturally occurring plasma samples. members represent bleeds from multiple individuals positive for HCV with low titer reactivity for anti-hcv. Each sample represents a single collection event. One sample is included as a non-reactive sample and is negative for all HCV methods tested. No preservatives were added. Cat. No vial per member 11 members, 1.2 ml per vial STORAGE members should be stored frozen at -20 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 HCV Low Titer AccuSet TM Performance 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 HCV Low Titer AccuSet TM Performance 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 anti-hiv 1/2 and HBsAg. 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 AccuVert TM Seroconversion s Page 1 of 1 February

2 Antibody Reactivity (s/co) HCV Low Titer AccuSet TM Performance OVERVIEW HCV Low Titer AccuSet TM Performance ( ) is an 11-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.2 ml per vial). members represent bleeds from multiple individuals positive for antibodies to HCV. Each sample represents a single collection event. No preservatives were added. Test results from commercially-available HCV assays are included for characterization of the panel members. This panel of human plasma samples demonstrates a range of antibody reactivity which approach the sensitivity limits for several anti-hcv test methods. One sample is included as a non-reactive sample and is negative for all HCV test methods performed. 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-1/2 and HBsAg. This does not ensure the absence of these or other human pathogens. HCV Low Titer AccuSet TM Performance Abbott ARCHITECT Anti-HCV DiaSorin Liaison XL Murex HCV Ab Ortho VITROS Anti-HCV Positive Cut-off HCV Mixed Titer AccuSet TM Performance This graph demonstrates HCV antibody reactivity amongst panel members utilizing test results from the Abbott ARCHITECT, DiaSorin Liaison XL Murex, and Ortho VITROS test methods. Page 1 of 4 May

3 Performance Information SeraCare Batch # SeraCare Donor ID # BD110581* NA NA BD110090* BD107565* BD NA NA BD110072* BD107545* NA * members 1, 4, 5, 9, and 10 were also utilized in SeraCare HCV Mixed Titer AccuSet TM Performance ( ). NA = Not Available HCV RNA and Antigen Abbott Realtime HCV m2000 (IU/mL) 1,3 Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test, v2.0 (IU/mL) 1,3 Abbott ARCHITECT HCV Ag (fmol/l) 2,3 01 Not Detected Not Detected Not Detected Not Detected Not Detected Not Detected Not Detected Not Detected 0.00 Test Date 26-Apr Mar Apr-15 Test Site RL RL RL Kit Part Code NA NA NA Kit Lot No. NA NA 47161LP33 Kit Exp. Date NA NA 21-Sep-15 Kit Regulatory Status IVD/CE IVD/CE IVD/CE 1 Results are reported as international units per ml (IU/mL); positive/reactive results are noted in bold red. 2 Results are reported as international units per femtomole per liter (fmol/l); positive/reactive results are noted in bold red. 3 Results are reported as the mean result of duplicate testing. RL = Reference Lab; IVD = In Vitro Diagnostic; CE = Conformité Européenne or CE Marking Page 2 of 4 May

4 Performance HCV Antibody Abbott ARCHITECT Anti-HCV DiaSorin Liaison XL Murex HCV Ab DiaSorin Murex anti- HCV (version 4.0) Ortho HCV Version 3.0 ELISA * * * * * * * Test Date 25-Mar Apr Apr Mar-15 Test Site SC RL RL SC Kit Part Code 1L79 NA NA Kit Lot No LI00 NA NA TXE618 Kit Exp. Date 01-Nov-15 NA NA 31-Jul-15 Kit Regulatory Status IVD/CE IVD/CE IVD/CE IVD 1 Results are reported as a signal to cutoff ratio (s/co); positive/reactive results are noted in bold red. 2 Results are reported as the mean result of duplicate testing. *Results are off-scale. SC = SeraCare; RL = Reference Lab; IVD = In Vitro Diagnostic; CE = Conformité Européenne or CE Marking Page 3 of 4 May

5 Performance HCV Antibody Ortho VITROS anti-hcv Siemens ADVIA Centaur HCV Ab Fujirebio INNO-LIA HCV Score OraSure OraQuick HCV Rapid Antibody Test Positive Non-Reactive Positive Non-Reactive Negative Non-Reactive >11.00 Positive Reactive >11.00 Positive Reactive >11.00 Positive Reactive >11.00 Positive Reactive >11.00 Positive Reactive >11.00 Positive Reactive Positive Non-Reactive Negative Non-Reactive Test Date 01-Apr Apr Apr Mar-15 Test Site RL RL RL SC Kit Part Code NA NA NA Kit Lot No. NA NA Kit Exp. Date NA NA 31-Dec Oct-15 Kit Regulatory Status IVD IVD RUO IVD/CE 1 Results are reported as a signal to cutoff ratio (s/co); positive/reactive results are noted in bold red. 2 Results are reported as the mean result of duplicate testing. SC = SeraCare; RL = Reference Lab; IVD = In Vitro Diagnostic; CE = Conformité Européenne or CE Marking; RUO = Research Use Only 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 HCV AccuVert TM Seroconversion s HCV Disease State Biological Materials ACCURUN independent quality controls SeraCon TM and Basematrix Processed Plasma Page 4 of 4 May