Characterisation, development, and validation of an in-house antibody cell panel: A prospective cross-sectional study from a tertiary care hospital.

Abstract

Background and objectives Minor blood group antigens (apart from ABO) can cause haemolytic transfusion reaction in patients who need multiple transfusions. Antibodies against these antigens are typically detected using commercial cell panels. Developing indigenous panels ensures the potential for inclusion of population-specific antigens. We aimed to develop and validate in-house antibody cell panels to detect antibodies against minor blood group antigens and compare it with commercial panel. Methods A cross-sectional study was conducted between July 2022 and December 2023 among 3000 voluntary blood donors. Participants with 'O' blood group who were direct antiglobulin test negative and transfusion-transmitted infection non-reactive underwent phenotyping for low-prevalence antigens (E, K, Ina, Cw). Extended phenotyping was performed for individuals positive for these antigens. Based on selected antigens corresponding to commonly encountered clinically significant alloantibodies, in-house panels were developed and validated using known antibody-positive and antibody-negative samples, and their diagnostic performance was evaluated against a commercial panel. Results Of the 3,000 participants, 700 belonged to 'O' blood group. The prevalence of E, K, Ina, and Cw positivity was 105 (15%), 17 (2.4%), 15 (2.1%), and 10 (1.4%), respectively. A 4- and a 12-cell panel were developed for screening and identification, respectively, from 16 participants. The sensitivity and specificity of in-house panel were 100% [95% Confidence interval (CI): 91.2-100%], and 100% (95% CI: 98.6-100%), respectively when validated with commercial cell panel. The annual cost for a commercial cell panel was INR (₹) ₹1,04,800, while in-house panel's one-time cost was ₹55,760 with recurring cost of ₹1,440 every three months. Interpretation and conclusions The in-house antibody cell panel demonstrated comparable diagnostic performance to the commercial panel, with complete concordance, along with lower cost.