Parvovirus B19 Mixed Titer Performance Panel PVP201

Transcription

1 A SERACARE PANEL PRODUCT INTENDED USE The is a panel of naturally occurring plasma specimens. This panel is intended for use by diagnostic manufacturers and clinical laboratories to evaluate their Parvovirus B19 test systems using well characterized specimens, and to provide comprehensive data for comparative analysis. For Research Use Only. Not for use in diagnostic procedures. PRODUCT DESCRIPTION consists of a set of 21 members positive for Parvovirus B19 DNA, IgM and/or IgG antibodies. Units were aseptically filtered; no preservative was added. Cat. No vial per member 21 members, 1.2 ml per vial STORAGE Panel members should be stored frozen at -10ºC or colder. SeraCare Life Sciences recommends that the panel members be divided into smaller aliquots for ease in repeated testing and 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 is available at Select from the list of panel data sheets. The Data Sheet lists results for panel members generated using commercially available tests. 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 are available. LIMITATIONS 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 These materials have not been treated and should be considered biohazardous. Follow Universal Precautions. 1 The units that make up this panel were tested and found negative for anti-hiv, 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. CDC recommendations for prevention of HIV transmission in health care settings. MMWR 36 (supp.2) For assistance, contact SeraCare Technical Support at ASK ABOUT RELATED SERACARE PRODUCTS The Data Sheet for this panel in PDF form can be found at The printed Data Sheet may be requested by to info@seracare.com, or by phone to ACCURUN independent quality controls SeraCon and other processed plasma products Global Patient Sample (GPS) Program access to a vast and evolving inventory of single test patient samples November

2 OVERVIEW SeraCare s is the world s first commercially available of naturally occurring plasma samples characterized for IgM and IgG antibodies to parvovirus and for parvovirus B19 DNA. This Data Sheet provides test results from fourteen commercially available Parvovirus B19 IgG, IgM, and DNA assays. Results vary among different assays, indicating differing sensitivities, specificities, and calibrations for the included assays. is a 21 member, 1.2 ml per member panel of undiluted aliquots from plasma units. No preservatives were added. CAUTION: Potentially infectious materials. Follow Universal Precautions. All panel members were found non-reactive for HBsAg, Anti- HIV and Anti-HCV. For Research Use Only. Not for use in diagnostic procedures. Data are offered for informational purposes only. SeraCare Life Sciences does not claim these results can be duplicated exactly. For assistance, contact SeraCare Technical Support at Signal to Cutoff Ratio (s/co) Parvo B19 IgG and IgM Panel Member Parvo B19 IgM Parvo B19 IgG This graph demonstrates IgG and IgM concentrations among panel members with the Biotrin Parvo B19 IgG and IgM test. Page 1 of 5 September

3 Parvo IgM Diasorin DRG Focus r-biopharm Virion- LIAISON International Diagnostics AG SERION Panel Biotrin Parvo Parvo B19 Parvo B19 Parvo B19 RIDASCREEN Parvo B19 Member B19 IgM IgM IgM IgM Parvo IgM IgM Index 2 IU/mL < < < > > < >200.0 > > >200.0 > < < < < < Test Date 13-Sep Sep Sep Sep Sep Nov-11 Test Site SC RL SC SC SC SC Kit Part Code V619IMUS EIA-3504 EL0100M K6031 ESR122M Kit Lot No. 36KT255US M/K071 X C SMA.AQ Kit Exp Date 29-Feb Feb Jul May Oct Apr-12 1 Results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and are noted in red. 2 Results are means of duplicates expressed as Index values. Results 1.0 are considered reactive and are noted in red. 3 Results are means of duplicates expressed in IU/mL. Results >12.0 are considered reactive and are noted in red. Values between IU/mL are considered equivocal. SC = SeraCare; RL = Reference Lab Page 2 of 5 September

4 Parvo IgG Diasorin DRG Focus r-biopharm Virion- LIAISON International Diagnostics AG SERION Panel Biotrin Parvo Parvo B19 Parvo B19 Parvo B19 RIDASCREEN Parvo B19 Member B19 IgG IgG IgG IgG Parvo IgG IgG Index 2 IU/mL > < < < < < < < < < < < < < Test Date 06-Sep Sep Sep Sep Sep Sep-11 Test Site SC RL SC SC SC SC Kit Part Code V519IGUS EIA-3503 EL0100G K6021 ESR122G Kit Lot No. 35KT217US G/K031 X C SBB.DL Kit Exp Date 29-Feb Feb Apr Jul Jul Feb-13 1 Results are means of duplicates expressed as signal to cutoff ratios (s/co). Ratios 1.0 are considered reactive and are noted in red. 2 Results are means of duplicates expressed as Index values. Values 1.0 are considered reactive and are noted in red. 3 Results are means of duplicates expressed in IU/mL. Results >5.0 are considered reactive and are noted in red. Values between IU/mL are considered equivocal. SC = SeraCare; RL = Reference Lab Page 3 of 5 September

5 Panel Member Abbott m2000 Roche LightCycler copies/ml Real-Time PCR copies/ml -01 PENDING BLD BLD -02 PENDING BLD BLD -03 PENDING BLD 1.3 x PENDING 3.5 x x PENDING BLD 1.2 x PENDING 7.8 x x PENDING 1.1 x x PENDING BLD BLD -09 PENDING 4.9 x x PENDING 9.0 x x PENDING 3.7 x x PENDING 2.5 x x PENDING 2.3 x 10 9* 3.5 x 10 6* -14 PENDING 2.7 x 10 9* 4.1 x 10 7**** -15 PENDING 2.9 x 10 10** 2.3 x 10 6** -16 PENDING 4.4 x 10 11*** 2.9 x 10 6*** -17 PENDING 8.6 x 10 10** 1.5 x 10 7** -18 PENDING 1.4 x x PENDING 1.0 x x PENDING 4.0 x x PENDING 1.5 x x 10 3 Test Date PENDING 15-Sep-11/30-Sep-11/12-Oct-11/ 21-Oct Sep-11/19-Nov-11 Test Site PENDING SC RL Kit Part Code PENDING NA Kit Lot No. PENDING NA Kit Exp Date PENDING 31-Mar-13 NA SC = SeraCare; RL = Reference Lab BLD = Below the limit of detection; ALR = Above the linear range * = Tested at 1:1,000 dilution ** = Tested at 1:10,000 dilution *** = Tested at 1: 100,000 dilution **** = Tested at 1:10 dilution Page 4 of 5 September

6 Parvo IgM and IgG Blot Panel Member r-biopharm RIDA Parvo IgG Band Pattern r-biopharm RIDA Parvo IgG Result r-biopharm RIDA Parvo IgM Band Pattern r-biopharm RIDA Parvo IgM Result -01 VP-N, VP-1S Pos VP-N, fvp-c Pos -02 NS-1, VP-N, fvp-c, VP-1S Pos fvp-n Neg -03 VP-N, VP-C, VP-1S Pos No Bands Neg -04 VP-N, VP-C, fvp-1s Pos VP-N, VP-C Pos -05 fns-1, VP-N, VP-C, VP-1S Pos No Bands Neg -06 VP-N, VP-C, VP-1S Pos VP-N, VP-C, VP-1S Pos -07 VP-N, VP-C Pos VP-N, VP-C Pos -08 VP-N, fvp-1s Pos No Bands Neg -09 VP-N, VP-C, VP-1S Pos VP-N, VP-C, VP-1S Pos -10 fvp-n, VP-C Pos VP-N, VP-C Pos -11 VP-N, VP-C, VP-1S Pos VP-N, fvp-c Pos -12 fvp-n, fvp-c Pos VP-N, VP-C Pos -13 fvp-c Neg VP-C Ind -14 No Bands Neg fvp-n, VP-C Ind -15 fvp-c Neg VP-C Ind -16 No Bands Neg No Bands Neg -17 No Bands Neg No Bands Neg -18 VP-N, VP-C, VP-1S Pos VP-N Ind -19 NS-1, VP-N, VP-C, VP-1S Pos No Bands Neg -20 No Bands Neg VP-C Ind -21 VP-N, VP-C, VP-1S Pos VP-N, VP-C, VP-1S Pos Test Date 13-Sep Nov-11 Test Site SC SC Kit Part Code L6003 L6003 Kit Lot No M Kit Exp Date 30-Jun Jun-12 Pos = Positive; Neg = Negative; f = Faint; Ind = Indeterminate SC = SeraCare The Data Sheet for this panel in PDF form can be found at The printed Data Sheet may be requested by at info@seracare.com, or by phone at ASK ABOUT RELATED SERACARE PRODUCTS ACCURUN independent quality controls SeraCon and other processed plasma products Global Patient Sample (GPS) Program access to a vast and evolving inventory of single test patient samples Page 5 of 5 September