A few days ago, the CBBS Editor reported:

France to try HIV tainted blood case

PARIS (AP) - The debate over who is responsible for the use of HIV tainted blood in transfusions in France has endured for years and has implicated former high-ranking government officials. Three former government ministers, including a former prime minister, will go on trial Tuesday for their alleged roles in France's worst health scandal. All are charged with employing a "strategy of favoritism" that delayed systematic testing for AIDS with an American made test while a French test was being readied. Nearly 4,000 people in France contracted AIDS from blood transfusions from the early 1980s until 1986, and an experts' report in 1991 found 300 were "avoidable."

To which one of the members of CBBS commented:

This report provokes reflection on the the dilemma we're all facing now with the nationwide studies of NAT, trying to balance the benefits of testing to prevent release of many virus positive units (mainly HCV), with the current longer turnaround time that risks release of some products before NAT results are available. The anxiety of many transfusion service personnel (as evidenced on the AABB's SIG web site & in discussion with hospital staff) is understandable, but in my mind must be accepted as a necessary hurdle in the path to achieve the larger goal of improved blood safety. I would not want to be condemned in the future for sacrificing the lives of HCV-infected recipients while waiting for a test with shorter turnaround time that would avert dealing with this short-term problem. Perhaps some consolation may derive from the fact that products released & transfused before NAT results are known are mainly pheresis platelets and O-neg RBC, coming usually from frequent donors who are less likely to be in the window phase.

To which the Editor asked:

What are the members of CBBS planning to do to prepare for the implementation of NAT testing, first by an FDA approved IND, and later (perhaps) as a routine donor screening test? Please send me your answers and I will compile and share them back with the membership.

To which a CBBS member replied:

Although NAT testing will yield only a minimal benefit at significant cost and will cause some problems in that the turn around time will be longer, at least one institution feels compelled to have the samples that they collect in their hospital based donor center tested. The many complexities of testing and reporting have yet to be worked out and CBBS members may want to be reminded that there will be a half day session of the CBBS Annual Meeting (at the Hyatt Regency Hotel in Irvine) devoted to all aspects of NAT testing. The Annual Meeting will be April 14-17 and the session on NAT Testing will be on Saturday morning, April 17 (1999).

The American Red Cross plans to initiate NAT testing of all of their units in the near future*; ARC centers can provide information regarding details. However, at this time, ARC will not be able to test samples sent to them from other sources. Hospital based donor centers may wish to contact one or more of the 16 America's Blood Centers (ABC) NAT Testing Sites. A complete list can be obtained from ABC offices (202-393-5725 or 1-888-USBLOOD) or from Jim MacPherson, Executive Director, ABC (www.americasblood.org; abc@americasblood.org or jmacpherson@americasblood.org). The centers located in the West are Blood Systems, Inc., Puget Sound Blood Center and Sacramento Medical Foundation Blood Center. One will need to be part of those testing sites' IND and the centers will explain how that can be accomplished. All of the centers seem to be working on about the same time schedule and their applications to the FDA for an IND have recently been submitted or will very soon be submitted. Some of the testing centers are fully committed and cannot obligate themselves to accept further samples at this time. If not already a part of a testing center's IND, one may have to wait until the center applies for an amendment which may take some months.

It is unlikely that more than just a few hospitals will be setting up the NAT testing on their own. It would probably not be cost effective to do so.

* Testing phased in, beginning Mar. 1, 1999.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator