I believe it is just one of those lab methods (there are several found in other clinical laboratory areas) where there is no practical way to ensure in the testing facility that the panel is going to work 100% as advertised by using some method of QC. If someone knows of another reg in BB that is as inconsistently practiced and enforced, I would like to hear it! I find it odd that in almost all other aspects of blood banking, from refrigerator temps to centrifuge speeds, there are specific regs on everything-and yet there are so many different ways to satisfy manufacturer's "periodically check" for QC on panels. Works great for chemistry and hemo but does it give blood bankers information we don't already have/know? I'm still going to use the Echo for my primary method with tube/PeG for backup. What have I proven by doing it? Nothing much. I run an antibody screen (or ID panel if I can find a patient with a nice antibody and enough plasma to spare) using all the methods we use, get different results from those screens and interpret it as differing sensitivity - something I expect to see. Anti-Rh-hr reagents are used to determine the presence or absence of their corresponding antigens on human red blood cells. Ortho Anti-D Reagents are used for routine Rh determination. Method comparison is another of those things that we do with questionable results. Ortho Clinical Diagnostics Anti-D (Anti-Rho) and Rh-hr Typing Reagents. However, that doesn't seem to tick the box for QC for an inspector as well as a specific test defined in a policy. In my mind, a better way to control a panel is to look at it and see if it makes sense with the results you get from your antibody screen. There is no 'good' way to run QC on a panel. And.don't forget.the manufacturer's of the red cell reagents have a huge amount of stability data. I really just wanted to highlight the flaws in this whole concept, from both the regulatory side and that of the users. I'm all in favor of a minimalist approach to this issue, and it appears that similar testing algorithms are acceptable to inspectors. I'm certainly not suggesting that everyone completely phenotype their Screening Cells and Panel Cells each day (or periodically). The only value to testing a K- cell against a diluted antisera is to check the DAT on the chosen panel cell, i.e., it's potential to cause a false-positive. What about other antigens that are more likely to and are known to deteriorate over time - Le a, Le b, Fy b, to name but a few ? More Devil's Advocate: That only tests the K antigen - a very stable structure. We dilute anti-K 1:20 with 6% albumin and run a K antigen positive and negative cell for QC every day of use.
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