HBsAg Low Titer AccuSet TM Performance Panel Modified
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- Prosper Dawson
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1 Reactivity VERVIEW Performance ( ) is a modified 18-member panel originating from Low Titer Performance PHA members 12, 13, and 19 are no longer available. members are naturally-occurring plasma samples from different individuals with test results from eleven commercially available assays, including one quantitative method and one rapid test, an neutralization method, and tests for several other HBV markers. All members were processed by filtration through a 0.8 µm filters. No preservatives were added. CAUTION: Potentially infectious materials. Follow Universal Precautions. All panel members were found negative for anti- HIV and anti-hcv. This does not ensure the absence of these or other pathogens. 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. Performance This graph demonstrates the breadth of reactivity amongst panel members utilizing the Genetic Systems EIA test method. members 12, 13, and 19 are no longer available; data are provided for informational purposes only. Page 1 of 5 October
2 1 ARCHITECT ARCHITECT (IU/mL) PRISM Dade Behring Enzygnost DiaSorin Liaison (Index) PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA107-12* PHA107-13* PHA PHA PHA PHA PHA PHA107-19* PHA PHA Test Date 21-Sep Mar Jan Mar Dec-11 Test Site SC RL RL SC RL Kit Part Code 1L80 6C36 6D19-68 OPFM Kit Lot No LF LFOO 05186M Kit Exp. Date 02-Feb Aug Apr Sep Jun-12 Kit Regulatory Status IVD CE CE CE/IVD CE 1 Results are mean results of duplicate testing. For results expressed as signal to cutoff ratios and Index, ratios 1.0 are considered reactive and are noted in red. For results expressed as IU/mL, values 0.05 are considered reactive and are noted in red. RL = Reference Lab; SC = SeraCare CE = Conformité Européenne or CE Marking; IVD = In Vitro Diagnostic Use * members 12, 13 and 19 are no longer available; data are provided for informational purposes only. Page 2 of 5 October
3 1 DiaSorin ETI- MAK-2 Plus DSI-EIA Genetic Systems EIA 3.0 Ortho Vitros ECi Roche Elecsys Siemens Advia Centaur PHA PHA > PHA PHA PHA > PHA PHA PHA PHA > PHA PHA > PHA107-12* PHA107-13* PHA > PHA PHA > PHA PHA PHA107-19* 8.8 > PHA PHA Test Date 13-Oct Feb Oct Dec Nov Jan Dec-11 Test Site SC SC SC RL RL RL 21-Nov-11 Kit Part Code P B SP Kit Lot No A/ FCC /7170 Kit Exp. Date 26-Oct Nov Apr Aug Oct Apr Jul Jul-12 Kit Regulatory Status IVD IVD/CE IVD IVD IVD IVD 1 Results are mean results of duplicate testing; Roche Elecsys was run in singlicate. For results expressed as signal to cutoff ratios, ratios 1.0 are considered reactive and are noted in red. RL = Reference Lab; SC = SeraCare; IVD = In Vitro Diagnostic Use * members 12, 13 and 19 are no longer available; data are provided for informational purposes only. Page 3 of 5 October
4 Confirmatory, Rapid, and HBV DNA ARCHITECT Neutralization (%) Inverness Medical Determine (Rapid) Roche Taqman HBV DNA (copies/ml) PHA NEG 2.7 x 10 4 PHA NEG 1.4 x 10 4 PHA NEG 1.3 X 10 3 PHA NEG 9.8 X 10 3 PHA NEG 1.0 X 10 5 PHA NEG 1.3 X 10 4 PHA NEG 5.2 X 10 4 PHA NEG 1.1 X 10 4 PHA NEG 2.2 X 10 5 PHA NEG 4.1 X 10 4 PHA NEG 7.4 X 10 4 PHA107-12* 98.8 NEG 3.9 X 10 4 PHA107-13* 97.7 NEG 5.1 X 10 4 PHA NEG 3.3 X 10 4 PHA NEG 9.9 X 10 3 PHA NEG 2.7 X 10 2 PHA NEG BLD PHA NEG BLD PHA107-19* 92.3 NEG 3.7 X 10 2 PHA NA NEG BLD PHA NA NEG BLD Test Date 12-Dec-11/05-Jan-12/11-Jan Nov Dec-11/ 06-Dec-11/ 13-Dec-11 Test Site SC SC SC Kit Part Code 1L81 7D Kit Lot No LF00/10410LF K100 P03738/P08770 Kit Exp. Date Kit Regulatory Status 22-Apr-12/11-Jun Sep Jul-12/30-Jun-13 NA = not available SC = SeraCare IVD = in vitro diagnostic use * members 12, 13 and 19 are no longer available; data are provided for informational purposes only. IVD IVD IVD Page 4 of 5 October
5 Other HBV Results 1 ARCHITECT Core Total ARCHITECT Core IgM Diasorin ETI-EBK Plus HBeAg PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA107-12* PHA107-13* PHA PHA PHA PHA PHA PHA107-19* PHA PHA Test Date 21-Nov Nov Nov-11 Test Site SC SC SC Kit Part Code 6L22 6L23 P Kit Lot No LI Q A Kit Exp. Date 30-Jun May May-12 Kit Regulatory Status IVD IVD IVD 1 Results are mean results of duplicate testing. For results expressed as signal to cutoff ratios, ratios 1.0 are considered reactive and are noted in red. * members 12, 13 and 19 are no longer available; data are provided for informational purposes 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 AccuVert TM Seroconversion s ACCURUN independent quality controls SeraCon TM and Basematrix Processed Plasma Page 5 of 5 October
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