Solid-phase antigen immunoassay for the detection of anti-zona pellucida-antibodies in clinically defined sera

A new solid-phase antigen immunoassay was developed for the detection of anti-zona pellucida-antibodies. The assay was validated in a double blind study with clinically defined sera. The new assay is easy to perform and large numbers of sera can be processed in one day. The antigen can be prepared in advance and stored until use. This represents an advantage over other methods, such as immunofluorescence and RIA, which require fresh antigen preparation for each set of assays. With this new test ca. 7% of females and ca. 20% of males with unexplained infertility have shown elevated antibody concentrations compared with fertile controls. The estimated intra-assay and inter-assay CV were 8.5% and less than 10% respectively.