Longitudinal Quality Assurance of HIV Nucleic Acid Testing in Blood Screening

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Longitudinal Quality Assurance of HIV Nucleic Acid Testing in Blood Screening. D Jardine, S Best , EM Dax (National Serology Reference Laboratory, Australia) and Participating Blood & Blood Product Screening Laboratories. Blood Screening NAT EQAS. - PowerPoint PPT Presentation

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  • Longitudinal Quality Assurance of HIV Nucleic Acid Testing in Blood ScreeningD Jardine, S Best, EM Dax (National Serology Reference Laboratory, Australia) and Participating Blood & Blood Product Screening Laboratories

  • Blood Screening NAT EQASEQAS is designed to monitor an entire testing process 3 NAT EQAS panels annually2 NRL; 1 VQC Laboratory (The Netherlands)Each NRL panel designed to fulfil a specific objective10 laboratories (Australia, NZ, SE Asia)Chiron TMA: 8 laboratoriesRoche Ampliscreen: 2 laboratories2 replicate panels to each laboratory

  • Blood Screening NAT EQAS Panel 6, September 02: Composition HIV component7 HIV positive samples randomly distributedHIV loads: 130 36000 geq/mL determined in Roche Amplicor HIV MonitorResults Samples A& BInvestigation; follow-up action

    Chiron TMARoche AmpliscreenSample IDABABHIV load (geq/mL)130170130170No. of results161622No. reactive161522

  • Blood Screening NAT QC Run No.0246810121416182022242628303234363840424446S/Co051015202530MeanMean-2SDMean+2SDcutoffLuminometer 1Luminometer 2Panel 6, replicate 1Panel 6, replicate 2Reagent Batch ChangeChiron TMA HIV external run control* results in laboratory with aberrant EQAS resultInvalidated run*250 geq HIV RNA/mL; VQC

  • Blood Screening NAT EQASSubtype BSubtype ASubtype CSubtype DSubtype E2500250252.5S/Co0510152025cut-offgeq HIV RNA/mLChiron TMA results in dilution series of various HIV-1 subtypesPanel 3, June 01

  • Blood Screening NAT EQAS All reactiveAll reactive ( 140 geq/mL) Results1603.8 - 1400HIV loads (geq/mL)1010No. HIV positive samples NRLApril 03VQCDec 02

    OriginDistributedPanel 8Panel 7Panels 7 & 8: HIV components

  • DiscussionEQAS Panel 6, sample B should be reactive 100% in TMA95% COV: 28 (95% CI 16-62) geq HIV RNA/mL (NRL evaluation)Corroborated by data obtained in EQAS Panel 3 0.35% failure rate (S/CO ratio

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