The gradient plate assay: a modified Ames assay used as a prescreen for the identification of bacterial mutagens.

Bacterial test systems have been used extensively to identify the mutagenic potential of new compounds. In particular, the Ames test has gained worldwide acceptance and is required by many regulatory agencies to support product registration. The gradient plate assay (GPA) is a modification of the Ames test. It is used as a high capacity prescreen to detect the mutagenic potential of synthetic intermediates, impurities, and research compounds over a concentration gradient. Since the development of the GPA, over 4000 compounds have been tested in the assay. Selection and use of the GPA in our laboratory is due to many factors: reliability; sensitivity; capacity; timeliness of reporting results; and establishment of safety standard in the laboratory. In this manuscript, results of the GPA method are compared with results from the traditional Ames assay. To date, 113 compounds of identical lots have been evaluated in both tests, and in all but 3 instances the results are the same. Thus, the GPA is an ideal assay for use as a prescreen in determining the ability of a compound to induce bacterial mutation.