David Saikin

Run some panel cells; negative, heterozygous and homozygous.

Wish I could offer you some experience w these patients. Currently we've only had one positive pt and that individual was not admitted. We don't anticipate component usage for these folks but you never know.

Drucker says they used to make those for CA. Their serofuge has a different body but the same rotor and guts. FYI.

If you have done the alloabsorption, do you not elute and test the absorbed abs? I find it hard to believe that a patient would be sensitized to all the ags except C and E. (The most abs I've ever encountered were 10).

That's up to you and your Medical Director. One thing to consider - that would be a lab developed test. I thought I read a few years ago that the FDA was going to look at those (LDTs) - I think there was going to be a $250,000.00 fee (the initial fee for them to evaluate proposed new tests/drugs). Also, when the Orthos and Immucors validate their antisera I believe they run considerably more than the "20" samples (including variants), so, while you may validate your process I don't believe your validation is as extensive, esp since you will be using reagent "off label". I'd be more concerned with the LDT. I'd check w the FDA to see their take on your proposal. FYI - I've used gel off label for years w antigen typing (and a few other assorted tests).

That's the truth John. Us small places are at the mercy of the blood suppliers.

Anybody use Drucker Diagnostics SERO 12 blood bank serofuge? If yes, what is your opinion. Thanks.

No offense at all. Who knows if I do things the way the ARC does them . . . or even AABBs "modern method", which to me is a serial 1:3 dilution (1 drop cell suspension and 2 drops test plasma/dilutions)- though that is read microscopically. I don't save send out titers as we do them routinely anymore here.

Original specimen titer was 2. Monthly. Went to 4 and then 8. (Red Cross did the first 2, I did the last as Titer was not ordered so phlebs only drew a small lavender. ARC wants a lot more than that, as they do another abid, r/o G, and a few other things in addition to the titer ordered.

My thoughts exactly. I don't know how far along - I'm guesstimating this was her 26 week antenatal experience.

I have this prenatal patient who presented with a weak anti-D,-C (G ruled out). G4p2. Her initial D titer was 2 f/u with 4 and 8. After her 3rd titer she was given RhIg in the office. My question: are further titers a moot point? The anti-C was not titerable initially and has been undetected in subsequent samples.

if I sign out emergency release, I am keeping the request regardless if rbcs are used or not.

Those are probably chemistry/hematology analyzers. They do the same here in the USA - for those lab areas. The FDA has guidance for computer validation - it recommends making your own validation studies based on how you will use the BBIS. I would anticipate that the same will be true for BB instrumentation.

Did you test your A2 cells in gel or in tube? If in tube, did you look at it microscopically?

Does look like a AsubB w anti-A1. I'd test pt cells w A1 lectin. Also run a small IS/rt panel of screening cells, A1, A2, auto cells and see what it looks like. By running the screening cells along with A1/A2 cells I can get an idea if it is a cold specificity or anti-A1. a