Difficulty of obtaining reproducibility in the Franklin and Dukes test for the detection of sperm-agglutinating antibodies in human sera.

The Franklin and Dukes (FD) test is used as a screening test for the determination of sperm-agglutinating antibodies and as a proof of therapeutic effects in cases of infertility, but various parameters of the FD test remain unclear and the application of different techniques has revealed highly different results. To test the statistical evidence for the FD technique, conditions regarded as optimal prerequisites were applied: a sperm concentration of 20 times 10(6)/ml was produced with Baker's buffer and serum dilutions were made with Baker's buffer, starting at 1:4. Only the standard deviation of parallel tests with one serum sample and one semen sample on the same day was found to be within an acceptable range. Using ejaculates of the same donor and the same serum sample on different days gave results that were not reproducible. The FD test should not, therefore, be used for quantification of sperm-agglutination antibodies except for a comparison in one test with one semen sample on the same day. Although the FD test only allowed a qualitative evaluation of sperm-agglutinating antibodies the % sperm agglutination was more informative than agglutination titres. For quantification of sperm-agglutinating antibodies, the FD test should be replaced by other techniques.