Clarification on Quality Control of Reagents for Antibody Screening and Identification

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:

  1. 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:
    1. 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.
  2. Typing reagents such as anti-D, anti-K, anti-Fya, etc. must be checked each day of use.
    1. Already defined explicitly in SOPs
  3. Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening and crossmatching:
    1. Currently performed as per manufacturer’s instructions (e.g., Immunocor, Biorad, Grifols, Ortho) for gel and tube reagents.
  4. 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:
    1. Already defined explicitly in SOPs

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
  3. TRM.31400, CAP Checklist, current version