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About Quality_Lady

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  1. Acceptable glass tubes for blood bank testing

    The Kimble tubes showed up in our lab. Has anyone found more information regarding the new labeling? We are awaiting information from both Kimble and Fisher.
  2. Preparation of DTT for treating RBCs

    Exlimey - What I was referring to is the confirmation / validation that the use of the materials as described in the post works in the manner they are being used, provides equivalent results, and there is parallel testing with accepted methods (e.g., buffering with NaOH) showing that the use of either solution gives comparable results in the hands of the lab.. Catchnenow51 - Did not intend to hit your hot button, just wanted to give you food for thought before an inspector asked the same questions. I came from medical devices so I have heightened expectations of regulatory impact. Plus there is no data to support the expiration date and stability of the PBS prepared in this fashion.
  3. Preparation of DTT for treating RBCs

    Use of either pHix or Buffering solution as described is outside of IFU and would require extensive in-house validation to support their use. Not only would you have to provide "in-use" testing, you would also have to determine stability data.
  4. Fetal Bleed Confirmatory Testing by Flow Cytometry

    Thanks Colin - This is just the information that I needed.
  5. Fetal Bleed Confirmatory Testing by Flow Cytometry

    Thanks Colin - This is some good information. Can you provide any clarification as to what you did to initially verify the assay in your lab? Thanks and Happy New Year!
  6. Has any facility implemented the Quotient flow methodology for confirming fetal bleeds? We are looking at using it to do testing and are in the planning stages of how to “verify / validate†the assay. If you did implement, can I ask what you did to implement the assay and verify that it worked in your hands? Thanks!