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Bayer Molecular

Bayer Molecular. Customer HIV-1 Quantitation QA Scheme. Bayer Molecular/NIBSC HIV QA Scheme. Aims 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

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Bayer Molecular

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  1. Bayer Molecular Customer HIV-1 Quantitation QA Scheme

  2. Bayer Molecular/NIBSC HIV QA Scheme • Aims • 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 • Materials • 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

  3. Bayer Molecular/NIBSC HIV QA Scheme • Participant Laboratories • Hospital • Health Protection Agency • Virus Reference Laboratories

  4. 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

  5. Reporting Results

  6. Reporting Results

  7. Results Analysis – NIBSC A Reagent

  8. Results Analysis – NIBSC B Reagent

  9. Results – By Site/By Lot

  10. Results – By Site/By Lot

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

  12. Summary • Provision 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-Users • Bayer and UK Customers have agreed Intervention Mechanisms for Corrective and Preventative Actions to be Undertaken

  13. Special Thanks • Clare Davis NIBSC • Harvey Holmes NIBSC • Vicki Wilson Bayer UK • Mike Potten Bayer UK

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