Bayer Molecular Customer HIV-1 Quantitation QA Scheme

Bayer Molecular/NIBSC HIV QA Scheme AimsAims –To provide a pair of externally manufactured HIV-1 Controls for Inclusion in Bayer HIV-1 Quant bDNA assays –Provide Regular Reporting demonstrating Intra and Intersite reproducibility –Provide Continuous Monitoring of End User Results as an Early Indicator of Potential Problems MaterialsMaterials –NIBSC Code 01/544: Medium copy number subtype A virus (92UG037) Approximate 20,000 copies/ml –NIBSC Code 02/110: A low copy number subtype B virus. Based on WHO HIV-1 International Standard Approximately 1000 copies/ml

Bayer Molecular/NIBSC HIV QA Scheme Participant LaboratoriesParticipant Laboratories –Hospital –Health Protection Agency –Virus Reference Laboratories

QA Scheme Reporting Reported results compiled and analysed in a biannual report provided to all UK Versant HIV Version 3.0 bDNA customers. Reports Formatted to Permit Comparisons between – Reagent Lots –Instruments –Operators –Different Sites

Reporting Results

Results Analysis – NIBSC A Reagent

Results Analysis – NIBSC B Reagent

Results – By Site/By Lot

Results Analysis - By Site/By Lot NIBSC A Reagent NIBSC B Reagent

Summary Provision of External StandardsProvision of External Standards –Permits End-Users to Verify Manufacturer Claims –Allows a partnership between customer and manufacturer in the management of continuous good results quality Instrument and Operator Monitoring –Permits Cross-Site Comparability Continuous Improvement Project to benefit Manufacturers and End-UsersContinuous Improvement Project to benefit Manufacturers and End-Users Bayer and UK Customers have agreed Intervention Mechanisms for Corrective and Preventative Actions to be UndertakenBayer and UK Customers have agreed Intervention Mechanisms for Corrective and Preventative Actions to be Undertaken

Special Thanks Clare DavisNIBSCClare DavisNIBSC Harvey HolmesNIBSCHarvey HolmesNIBSC Vicki Wilson Bayer UKVicki Wilson Bayer UK Mike PottenBayer UKMike PottenBayer UK