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TRM.40200 DAT Controls Phase II When performing an antiglobulin test with anti-IgG or polyspecific antiglobulin reagents, IgG-coated red blood cells are used as a control in all negative antiglobulin tests. NOTE: IgG-coated red blood cells must be used to confirm all negative antiglobulin test results when the antiglobulin reagent used for testing has anti-IgG reactivity. Tests found negative by tube methodology must be verified by obtaining a positive test result after adding IgGcoated (control) red blood cells. If a licensed blood typing system is used that does not require verification of negative test results using IgG-coated red blood cells, an appropriate quality control procedure must be followed, as recommended by the manufacturer. Evidence of Compliance: ✓ Records of testing that include control results confirming negative antiglobulin tests TRM.40210 DAT Phase II When performing an antiglobulin test with anti-C3 antiglobulin reagents, C3-coated red blood cells are used as a control in all negative antiglobulin tests. NOTE: Complement-coated red blood cells must be used to confirm all negative antiglobulin test results when the antiglobulin reagent used for testing has anti-C3 reactivity. Tests found negative by tube methodology must be verified by obtaining a positive test result after adding C3- coated (control) red blood cells. If a licensed blood typing system is used that does not require verification of negative test results using C3-coated red blood cells, an appropriate quality control procedure must be followed, as recommended by the manufacturer. If a polyspecific antiglobulin reagent is used, refer to checklist item TRM.40200. Evidence of Compliance: ✓ Records of testing that include control results confirming negative antiglobulin tests ********************************************************************************************************************************************** I was cited for this years ago. I called CAP and was told that because poly AHG has anti-C3 reactivity as well as anti-IgG reactivity, both had to be confirmed. In addition to this std, she also referred me to the all common checklist which requires that we perform QC on reagents every day of use. So unless the manufacturer of our reagent had some other recommended QC procedure for C3 reactivity, we were required to use the complement coated cells. I put a standing order in for C3 coated cells that day, sent the confirmation email to CAP and my citation was considered corrected on site. I would assume that AABB would view this in a similar way, not to mention CLIA. When we do a DAT, we are looking for both anti-IgG and anti-C3 activity. If the DAT is positive with poly and anti-IgG, that doesn't preclude anti-C3 activity. If you aren't doing QC for the anti-C3 activity of your poly AHG, how can you demonstrate that your reagent is reacting properly? If you send all DATs out to check for C3 activity, then you would only have to QC the anti-IgG activity and your reference lab would be responsible for the C3 activity. Having said all that.....have I ever seen a failure with the C3 activity? Nope and I don't expect to. I've given students anti-C3b, -C3d reagent that's outdated by years and it still works just fine. But that's irrelevant and not how the game is played. We don't do very many DATs, but that's also irrelevant. So, I stock the C3 coated cells. Cost of doing business. I find ways to save in other areas.

Your product would have a life of 4 hrs upon thawing. The extreme cold is not bacteriocidal.

For most species, freezing (even in liquid phase liquid nitrogen (-196C) will not kill the bacteria. There is a lot of literature concerning this subject for cell processing for BMT and I have personal experience with Staph species and Strep species being alive and perfectly happy in a thawed stem cell product. Even after lengthy storage at <-150C.

Interesting idea? Sounds like a stupid idea to me.

and I still don't understand why they thought that this patient was polyagglutining anyway!

why the frozen/thawed AB plasma not react with the treated cells?