Home-Test Kit for Ovulation Is Withdrawn

A new home-test kit that tells a woman when ovulation is imminent is being recalled and withdrawn from the market by its distributor, Ortho Pharmaceutical Corp., because some lots of the product deteriorated before they were used by consumers.

The tests, called Ovutime Ovulation Predictor Test, is manufactured by Monoclonal Antibodies Inc. of Mountain View, Calif., which disclosed the recall Wednesday. The kits went on the market in February.

Monoclonal Antibodies in May and June had recalled its own version of the test, called Ovustick Self-Test, and replaced the kits with new ones.

Measures Hormone

The test measures the concentration of luteinizing hormone, which is present in urine in greatly increased quantities immediately before ovulation. The hormone is detected by a monoclonal antibody, a protein produced by biotechnology techniques that binds specifically to the hormone.

The monoclonal antibody is coated on the surface of a dipstick that is placed in a urine sample. When another chemical is added to the sample, the dipstick turns blue if the hormone is present.

Monoclonal Antibodies spokesman Robert Strickland said the problem arose because some of the dipsticks were not dried thoroughly before packaging and the moisture caused them to deteriorate. The problem has since been corrected, he said.

Strickland said several hundred thousand of the kits had been shipped, but that he had no idea how many had already been used.