LATEX PROTEIN-LEVELS IN EXTERNAL CONDOM CATHETERS

The Food and Drug Administration (FDA) allows for labeling medical pro ducts that have reduced levels of total water-extractable latex protei n. The standard test method of the American Society for Testing and Ma terials (ASTM) for analysis of latex protein in natural rubber and its products is a colorimetric assay with a precipitation step called the modified Lowry assay. In an analysis of latex external condom cathete rs, we have documented a significant difference in protein levels betw een two brands of external condoms. The modified Lowry assay is a sign ificantly less specific method than is an immunochemical assay for mea suring total water-extractable latex proteins. This nonspecificity of the modified Lowry assay makes it difficult to accurately identify med ical products with extremely low levels of total water-extractable lat ex protein.