Introduction of the Abbott RealTime Hepatitis C and Hepatitis B viral load assays at NVRL

posted by Brian O'Grady on 31 July 2012
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The NVRL will replace its current Hepatitis C and Hepatitis B viral load assays (Roche Diagnostics) with the Abbott RealTime HCV and HBV assays in September 2012. This letter highlights important information regarding specimen collection and result interpretation which is relevant for users of these services.

 Hepatitis C RNA testing (viral load) 

  1. Human serum or plasma samples are suitable for testing. Freshly drawn samples must be centrifuged and separated within 6 hours and may be stored at 2 – 8°C for up to 3 days (60 days if frozen) before processing. A minimum of 1ml serum or plasma is required. An additional 1ml sample should be provided if HCV genotyping is also required.
  2. The quantitative dynamic range of the assay is 12 – 100,000,000 IU/ml.
  3. A thorough in house comparative evaluation of the current assay with the Abbott HCV RealTime assay showed strong correlation between quantitative results. This concurs with comparative analyses published in peer reviewed articles. However, in order to provide continuity for patients currently receiving either dual or triple therapy, if requested the NVRL will re-test previous samples on the new assay to facilitate direct comparisons. Please ensure the treatment details accompany the test request.

Hepatitis B DNA testing (viral load)

  1. Human serum or plasma samples are suitable for testing. Freshly drawn samples must be centrifuged and separated within 6 hours and may be stored at 2 – 8°C for up to 3 days (60 days if frozen) before processing. A minimum of 1ml serum or plasma is required.
  2. The quantitative dynamic range of the assay is 10 – 1 billion IU/ml.
  3. A strong correlation between the quantitative values generated by both the Roche and the Abbott HBV systems was observed during in house validation and reflects data generated in peer reviewed articles.

If you have any queries about this new assay please contact Professor William W. Hall, PhD, MD Director, UCD-National Virus Reference Laboratory and UCD-Centre for Research in Infectious Diseases or a member of the NVRL clinical team on 01 716 1236/1240/1349/1359.