Assayed VIROTROL® Controls - QCNet

Bio-Rad LaboratoriesI n f e c t i o u s D i s e a s e C O N T R O L SAssayed Third Party Controls forHepatitis and Retrovirus Serology TestingNow get even more options to increase yourlaboratory’s confidence in infectious disease testing.Bio-Rad VIROTROL ® controls are the first independent,third party retrovirus and hepatitis controls availablewith lot specific assayed values for popularautomated infectious disease methods.Assayed VIROTROL ® controls can help meet thespecific needs of your laboratory, including compliancewith regulatory requirements, providing informationon target values prior to testing, or checking targetvalues across instruments.Assayed VIROTROL ® I ControlsAssayed VIROTROL ® I-EMost suitable for use withRoche Elecsys ® /MODULAR SystemsAssayed VIROTROL ® I-FMost suitable for use withAbbott AxSYM ® and Architect SystemsAssayed VIROTROL ® I-C +Most suitable for use withSiemens ADVIA ® Centaur ® SeriesFor use as assayed quality controls with methods detectingHepatitis B surface Antigen, antibodies to HumanImmunodeficiency Virus Type 1, antibodies to Hepatitis CVirus, and antibodies to Hepatitis B core Antigen.• Values provided for popular automated methods(see chart)• Independent, unbiased assessment• Human serum based• Multi-analyte control allows for product consolidation• Convenient liquid formulation eliminates potentialreconstitution variability• 18 month shelf life at 2–8°C• 60 day open-vial stability at 2–8°C• Use with negative control VIROCLEAR ® (unassayed)AnalytesHBsAgAnti-HIV-1Anti-HCVAnti-HBcAnti-HTLV-I*Anti-CMV*+Product available in mid-2010* Values not providedRefer to the package insert of currently available lots for specific analyte and stability claims

Assayed VIROTROL ® II ControlsAssayed VIROTROL ® II-AFor use with the Abbott AxSYM ®Assayed VIROTROL ® II-BFor use with Abbott Architect Series, Siemens ADVIA ®Centaur ® Series and Roche Elecsys ® /MODULAR SystemsFor use as assayed quality controls with methodsdetecting antibodies to Hepatitis B surface Antigenand total antibodies to Hepatitis A Virus.• Independent, unbiased assessment• Human serum based• Multi-analyte control allows for product consolidation• Convenient liquid formulation eliminates potentialreconstitution variability• 18 month shelf life at 2–8°C• 60 day open-vial stability at 2–8°C• Use with negative control VIROCLEAR ® (unassayed)AnalytesAnti-HBsAnti-HAVRefer to the package insert of currently available lots for specific analyte and stability claimsAssayed VIROTROL Control Guidelinesfor Automated Methods● Most Suitable● Low Reactive or At RiskInstrument /Assay(s)● High Reactive● Non-ReactiveAssayed VIROTROL I-EAssayed VIROTROL I-FAssayed VIROTROL I-C +Assayed VIROTROL II-AAssayed VIROTROL II-BAbbott AxSYM ®AUSAB ® (Anti-HBs)HAVAB ® 2.0 (Anti-HAV)HIV-1/2 g0 ● ● ●HIV Ag/Ab Combo ● ● ●HCV Version 3.0 ● ● ●CORE 2.0 ● ● ●HBsAg (V2) ● ● ●Abbott ARCHITECT ®AUSAB ® (Anti-HBs)HAVAB ® 2.0 (Anti-HAV)HIV Ag/Ab Combo ● ● ●Anti-HCV ● ● ●Anti-HBc II ● ● ●HBsAg ● ● ●Roche Elecsys ® 2010 / Modular E170Anti-HAVAnti-HBsHIV Combi (Ag/Ab) ● ● ●Anti-HBc ● ● ●HBsAg ● ● ●HBsAg II ● ● ●Siemens ADVIA ® Centaur ® SeriesAnti-HBsAnti-HAVHIV 1/0/2 (HIV) ● ● ●HCV ● ● ●HBcTotal (aHBcT) ● ● ●HBsAg ● ● ●●●●●●●●●+Product available in mid-2010Performance may vary based on specific lots of control or manufacturers’ test kits. Please refer to lot specific product insert for detailed performance information.