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June 13, 2007. Performance of Chiron Quantitative and Qualitative HBV PCR Assay and Confirmation of HBV Yield Cases. Yiu-Lian Fong, Ph.D, Associate Director. Agenda.

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slide1

June 13, 2007

Performance of Chiron Quantitative and Qualitative HBV PCR Assay and Confirmation of HBV Yield Cases

Yiu-Lian Fong, Ph.D, Associate Director

agenda
Agenda

A qualitative and quantitative HBV DNA assay has been developed and validated in house for sensitive detection and accurate quantification of HBV DNA for confirmatory purposes.

  • Assay Performance
  • Confirming HBV Yield Cases
  • Issues raised for standardized calibration of various genotypes
assay performance
Assay Performance
  • Analytical Sensitivity and LOD for WHO HBV Standard
  • Analytical Sensitivities for DDL Genotypes A-G
  • Linearity, LLOQ, reproducibility and precision
  • Clinical Sensitivity
  • Analytical and Clinical Specificities
slide5

Analytical Sensitivity and LOD for WHO HBV Standard

*Procleix Ultrio PI, IN0166EN Rev. A

reproducibility linearity accuracy and lloq
Reproducibility, Linearity, Accuracy, and LLOQ

R2 = 0.995 - 0.999

CV = 0.4% - 1.3%

LLOQ = 3.3 IU/mL

clinical sensitivity early detection of seroconversion panel 6289

15 days

Clinical Sensitivity: Early Detection of Seroconversion Panel #6289

*Acrometrix PI. **Combined testing results from multiple sites.

clinical sensitivity early detection of seroconversion panel 11006

23-28 days

Clinical Sensitivity: Early Detection of Seroconversion Panel #11006

*Acrometrix PI. **Combined testing results from multiple sites.

clinical sensitivity early detection of seroconversion panel 11008
Clinical Sensitivity: Early Detection of Seroconversion Panel #11008

18-33 days

*Acrometrix PI. **Combined testing results from multiple sites

analytical and clinical specificities
Analytical and Clinical Specificities

In-house Assay Validation:

  • 100 random donor samples tested in triplicates: all negative
  • Freeze/thaw up to five cycles with 5, 20, and 5000 IU/mL WHO HBV standard
  • Potential Interfering Substances Tested
    • Anticoagulants: ACD, CPD, K2EDTA, K3EDTA, Na Citrate, Na Heparin
    • Protein at > 7 g/dL
    • Lipid/Triglyceride at > 3000 mg/dL
    • Hemoglobin at > 500 mg/dL
    • Bilirubin at >20 mg/dL
    • Bacteria (>105 CFU/mol) commonly seen in blood related products
    • Blood-born pathogens:HCV, HTLV, HAV, CMV, EBS, HSV, and HIV-1
confirming hbv yield cases chiang mai university study hbsag negative
Confirming HBV Yield Cases: Chiang Mai University Study (HBsAg Negative)*

*Nantachit, N. et al, in press, 2007.

**Later HBsAg positive.

nd, not determined.

quantitation of ddl genotype a g
Quantitation of DDL Genotype A-G

* Supplied as 30,000 Cp/mL.

summary
Summary
  • A sensitive qualitative and quantitative HBV DNA assay has been developed and validated in house
    • LOD at 3.3 IU/mL for WHO HBV standard
    • Detects various genotypes
    • Detects window phase low viremia samples
    • Confirms yield cases
  • Conclusion: This highly sensitive and reliable assay is suitable for confirmatory purposes
  • Remaining Issues:
    • How to standardize?
      • How to calibrate various genotypes?
      • Which test method to use?
acknowledgement
Acknowledgement
  • Dennis Madriaga
  • Baohe Shen
  • Barney Krebs
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