Linearity Panels hiv rna, hcv rna, hbv dna, and cmv dna linearity Panel Design


Download 432.5 Kb.
Sana10.01.2019
Hajmi432.5 Kb.


Linearity Panels HIV RNA, HCV RNA, HBV DNA, and CMV DNA


Linearity Panel Design

  • Mimic clinical specimen

  • Whole virus in defibrinated plasma diluent

  • Challenges the entire analytical process

  • One negative, and Nine positive members

  • Series of sequential one log or half log dilutions

  • Results expressed as specified by kit manufacturers

  • Serial dilutions of the WHO International Standards analyzed simultaneously to assign IU values, where appropriate



Intended Use

  • Assay Effectiveness

    • Evaluate sensitivity and dynamic range of quantitative
    • viral nucleic acid assays
    • Identifying consistency over a broad linear range
    • Establish calibrations vs. IU Standards
    • Verification of performance at kit lot changes
  • Training

  • Part of Laboratory Quality Assurance program



HCV RNA Linearity Panel (PHW804)

  • Diluent:

    • Normal human plasma
    • Negative for antibody to HIV-1/2, HBsAg, HCV, HTLV-I/II
    • Negative for HBsAg, HIV-1 RNA, HBV RNA and HCV DNA
  • Virus Spike:

  • Results on Data Sheet:

    • Roche COBAS Amplicor HCV Monitor v2.0
    • Bayer Versant HCV 3.0 bDNA Assay
    • Abbott LCx HCV Quantitative Assay
    • QuantaSure Plus HCV Roche Taqman ASR








HIV RNA Linearity Panel (PRD801)

  • Diluent:

    • Normal human plasma
    • Negative for anti-HIV-1/2, anti-HBsAg, anti-HCV, anti-HTLV-I/II
    • Negative for HBsAg, HIV-1 RNA, HBV RNA and HCV DNA
  • Virus Spike:

    • Culture supernatant: HIV-1 Type B 8E5 virus
    • Intact, but defective virus genome
  • Results on Data Sheet:

    • Roche COBAS Amplicor HIV Monitor v1.5
    • Roche COBAS Amplicor HIV Monitor v1.5 Ultra
    • Bayer Versant HIV-1 RNA bDNA 3.0 Assay
    • Chiron/Genprobe Procleix HIV-1 RNA Discriminatory Qualitative
    • BioMerieux Nuclisens HIV-1 QT






HBV DNA Linearity/Sensitivity Panel (PHD801)

  • Diluent:

    • Normal human plasma
    • Negative for antibody to HIV-1/2, HBsAg, HCV, HTLV-I/II
    • Negative for HBsAg, HIV-1 RNA, HBV RNA and HCV DNA
  • Virus Spike:

    • High titer HBV DNA positive human plasma
    • HBV DNA:Type A virus by Roche Taqman and Innogentics InnoLIPA
    • Serotype ad
  • Results on Data Sheet:

    • Roche COBAS Amplicor HBV
    • Digene HBV DNA Quantitative Assay
    • Bayer Versant HBV DNA Quantitative bDNA Assay
    • Taqman HBV DNA Quantitative Assay






CMV DNA Linearity/Sensitivity Panel (PTC801)

  • Diluent:

    • Normal human plasma
    • Negative for antibody to HIV-1/2, HBsAg, HCV, HTLV-I/II
    • Negative for HBsAg, HIV-1 RNA, HBV RNA and HCV DNA
    • Negative for anti-CMV and CMV DNA
  • Virus Spike:

    • Culture supernatant from CMV cultures
  • Results on Data Sheet:

    • Roche COBAS Amplicor CMV Monitor Test




Conclusions

  • BBI Linearity panels are made from natural virus in plasma diluent

  • Nine positive members spanning a broad range of virus concentrations and a negative member

  • Calibrated against WHO standards and expressed in IU/ml

  • Data from available commercial assays

  • Useful for monitoring linearity and dynamic range of assays




Download 432.5 Kb.

Do'stlaringiz bilan baham:




Ma'lumotlar bazasi mualliflik huquqi bilan himoyalangan ©fayllar.org 2020
ma'muriyatiga murojaat qiling