Latex protein levels in external condom catheters.
The Food and Drug Administration (FDA) allows for labeling medical products that have reduced levels of total water-extractable latex protein. The standard test method of the American Society for Testing and Materials (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 catheters, we have documented a significant difference in protein levels between two brands of external condoms. The modified Lowry assay is a significantly less specific method than is an immunochemical assay for measuring total water-extractable latex proteins. This nonspecificity of the modified Lowry assay makes it difficult to accurately identify medical products with extremely low levels of total water-extractable latex protein.
Beezhold
D H
DH
Guthrie Foundation for Medical Research, Sayre, Pennsylvania 18840, USA.
Curtis
P A
PA
Suber
F
F
Neal
J G
JG
Lara
W C
WC
Edlich
R F
RF
D000941:Antigens / Q000032:analysis; D003124:Colorimetry / Q000379:methods; D017280:Condoms / Q000706:statistics & numerical data; D007120:Immunochemistry / Q000379:methods; D008422:Materials Testing / Q000379:methods; D010940:Plant Proteins / Q000032:analysis*; D012408:Rubber / Q000032:analysis*; D012995:Solubility; D014546:Urinary Catheterization / Q000295:instrumentation* / Q000706:statistics & numerical data
D000941:Antigens; D010940:Plant Proteins; D012408:Rubber