Interlaboratory interprotocol comparison of indirect immunobead assay for sperm-associated antibodies in serum

This investigation was designed to study the effect of two different protocols on the indirect sperm-associated antibody test on serum performed using Bio-Rad immunobead (IBT) at two andrology laboratories. Aliquots of 31 serum samples from infertile couples were analyzed by both protocols. The IBT was negative by both protocols (100% concordance) for 18 serum samples. Seven of the 13 remaining samples were positive by both protocols (> or = 10% bead attachment by protocol A and > or = 20% bead attachment by protocol B), for a concordance of 54%. The remaining six samples were positive by one of the two protocols. The overall concordance for positive and negative results was 81% (25 of 31 samples). Protocol A detected a higher percentage of bead attachments for IgG and IgA, while protocol B detected a higher percentage of bead attachments for IgM. The discordance in the results of IgA attachment obtained by the two protocols was statistically significant (p < .05). A standardized, uniform protocol for the indirect IBT is needed.