Principle:
This policy is a reiteration of current policy to QC reagents used for antibody screening and identification to document how current practice meets these requirements. This policy is NOT a change from current practice.
Policy:
- Each cell used for antibody detection must be checked each day of use for reactivity of at least one antigen using antisera of 1+ or greater avidity:
- We will use reactivity encountered during the daily antibody testing: reactions of 1+ in each screening cell will be deemed acceptable. For panel cells, reactions of 1+ or greater for any specificity will be deemed acceptable.
- Typing reagents such as anti-D, anti-K, anti-Fya, etc. must be checked each day of use.
- Already defined explicitly in SOPs
- Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening and crossmatching:
- Currently performed as per manufacturer’s instructions (e.g., Immunocor, Biorad, Grifols, Ortho) for gel and tube reagents.
- Typing sera and reagent cells must be checked for reactivity and specificity on each day of use, including a check against known positive and negative cells or antisera:
- Already defined explicitly in SOPs
References:
- Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
- Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
- TRM.31400, CAP Checklist, current version