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Posted: May 3, 2003

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What is a reasonable parallel testing scheme for verifying equivalence between a manual tube techique and a gel automated techique?

A colleague outside the USA is considering switching from a manual LISS tube technique to a gel-automated technique for routine blood bank typing and screening. His main concern is the amount of parallel testing required for a sensible comparison of the LISS tube technique and the gel automated technique. He has a fear that a statistician would require an enormous amount of ABO, Rh, and other phenotyping (weak and problematic phenotyping), antibody identifications and titers in order for an institution to have a firm and statistically sound database prior to adopting the gel technique as a the standard technique. He wonders if anyone (especially our European colleagues) have experience with a validation protocol that holds statistically for the purpose of comparing the above two techniques?


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