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pink tube validation questions


armymt2002

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We are switching to pink tubes and I am currently writing the validatin plan. I believe we are going to be using the 10 ml BD tubes. On the BD site it states the tubes must filled plus or minus 10% is stating that they must be filled to the top of the label good enough?

The QA manager and myself were also discussing reaction grading. We still use the manual tube method and were wondering about a reaction variation for the red top vs pink top tubes. My question was what if someone says the red top is 4+ but the pink top is 2+ (I realize this is extreme but I work with Soldiers who are not MLTs/MTs so I have to prepare for just about everything) is that a valid difference? Thanks.

Kristine

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As part of our competency on each employee, we include a strength of reaction grading exercise. Just a simple dilutional wet sample that they read the reactions and grade them to make sure they are somewhat close to the expected results. I have never found anyone in 25 years that was variant enough in their grading to make me ponder even for a second. You may find it not to be an issue. On the other hand, maybe you need to do a competency on grading of reactions. You may have a bigger issue with that than the variation between a red top and pink top tube. Just something to think about.

I would think you would want your reactions to be extremely close with the two tubes, unless of course you were getting consistantly stronger reactions with the pink top tubes you are going to. Then that may be a good reason to switch!

Good Luck!

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Hi, Karen,

How do you prepare your specimen for grading? Do you have nice pictures for training? I found one on google but it is black and white and not that good. I also want to give my staff training on mixfield reaction. Could you please share your souce for grading pics if you have one?

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The colored chart I have for grading of reactions is from Gamma - now Immucor/Gamma. It is very old (dated Nov 1992) but I would think they would still have something available. The chart also includes mixed field descriptions.

I just do a serial dilution of Anti-A and have them add a drop of A1 cells and spin and read.

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  • 2 years later...

Assuming that you are using the same ABS technique for both tube types I don't see why a series of serial dilutions (titers) of one or more anti-seras would not surfice your need. These titers should also work out your hypothetical reaction varience between the two tube types.

As far as the level of fill of the pink tube I would further question the manufacturer for specifics.

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