Consideration of the implementation of the Procleix Ultrio Hepatitis B assay

A colleague in Pennsylvania reports that he is aware of some North American blood centers that are now considering implementation of the Ultrio Hepatitis B test in routine blood donor screening to improve the sensitivity of detecting HBV infected donors. Details about this testing scheme in a European setting can be seen at Procleix Ultrio Assay: Multi Center Analysis; Giuseppe Cambié, MD; Lodi Blood Center, Italy; EURO’SAT Paris, October 22, 2002. (link no longer available). Today, he notes that neither the United States FDA nor the AABB 'require' this test. He admits that this new testing scheme may slightly narrow the window period prior to detection of Hepatitis B surface antigen, and hopes that those considering the implementation of this testing scheme would comment on its cost effectiveness (or lack thereof), as well as commenting on alternative testing strategies that might produce a similar improvement in blood product safety.

The following comments have been received.

ADDENDA May 6, 2004

1. Dr. Michael Busch of Northern California reports that he and others have conducted a series of studies over the past several years to address the issue of the relative value (window period closure, yield, cost-effectiveness) of HBV NAT, performed on minipools or individual donation specimens, versus serological assays for HBsAg and anti-HBc in the U.S. blood donor screening setting. This work, and relevant literature from other countries, was recently reviewed in a published article (Busch MP. Should HBV DNA NAT replace HBsAg and/or anti-HBc screening of blood donors? Transfusion Clin Biol 11 26-321, 2004.) This article concludes that HBV minipool-NAT will have minimal value over current HBsAg and anti-HBc screening. Significant window period closure and clinical benefit will not be possible until individual donation HBV NAT is possible. Moreover, it is unlikely that even individual donor-NAT will allow discontinuation of HBsAg or anti-HBc screening, due to exisitence of various types of occult HBV infection associated with very low HBV DNA levels in seroreactive donors. This later issue was recently reviewed in detail in an article by Allain JP. Occult HBV infection. Vox Sanguinis 86;83-91, 2004.

Other relevant citations include:

• Biswas R, Tabor E, Hsia CC, et al. Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection. Transfusion 43:788-98, 2003.
• Kleinman SH, Kuhns, Todd DS, et al. Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion transmission and donor screening. Transfusion 43:696-704, 2003
• Kuhns MC, Kleinman SH, McNamara SL, et al. Lack of Correlation Between HBsAg and HBV DNA Levels in Blood Donors Who Test Positive for HBsAg and Anti-HBc: Implications for Future HBV Screening Policy. Transfusion. 2004 Sep;44(9):1332-9.
• Jackson BR, Busch MP, Stramer SL, AuBuchon JP. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion 43:721-9, 2003.
• Kleinman SH, Busch MP. HBV: amplified and back in the blood safety spotlight. (editorial) Transfusion 41:1081-5, 2001.

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