With NAT now here, should Europe (EU) drop the ALT requirement for fractionated plasma?

Cees van der Poel writes the following (edited slightly for clarity), which addresses an issue of ALT testing.

"European (EU) regulators are again discussing the ALT issue. This is in the CPMP/EMEA circuit, where medicinal products are registered. They recently refused a Dutch product for EU wide registration, one of the arguments being lack of ALT. CPMP regulations do not require ALT. It states however that individual authorities may do so. Now the question is: can regulations in one member state (or a few member states) impose on EU wide registration requirements of a product? We feel not. But it is a sensitive question. We are considering this a hindering free exchange of plasma (products) within the EU. It is now on MOH level.

In an Irish meeting 2 years ago already the joined MOH adapted a statement that ALT could be abandoned. DG-V of the EU commission (public health) does not require ALT in it's present (July 1998) "Recommendation on suitability of blood and plasma donors". Nico Lelie already showed similar data (negative PCR's on ALT elevated donors) as those of Dr. Katz, which were communicated. In addition the US positions / data were thrown in the discussion including a meta analysis of EU prospective studies on PTH (no positive effect). There is a shift of thinking when HCV NAT is mentioned. But one German scientist claims that half of the NAT pos antibody neg donors were ALT elevated. I'm afraid he concludes this on extremely low numbers NAT positives, and does not seem to take into account what the present predictive value of the ALT is. Apart from the costs I'd like to add to the discussion the criteria of Wilson and Jungner, which say that mass screening of a population should at least have demonstrated a beneficial effect, overruling the negative effects etc.

I'd like to know how many healthy donors you are presently deferring in the US because of elevated ALT, who are unnecessarily subjected to an extensive medical work-up as a result of the elevated ALT. I think in EU this would have more impact than the costs."

If any one has data that might be helpful in resolving this issue, please write me at the following email address: College.Bloedtransfusie@INTER.NL.NET

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