Quidel Corporation

Theodore T Lee

Allan D Pronovost

David H Katz

Shung-Ho Chang

Steven W Cooper

Methods and devices for distinguishing between normal and abnormal pregnancies are provided. The methods rely on determining the concentration of progesterone or progesterone metabolite in a patient sample, where a concentration above a threshold value is indicative of a normal pregnancy. Preferably, the concentration of hCG is determined simultaneously, where an hCG concentration above a threshold value provides confirmation that the individual being tested is pregnant. An exemplary test device comprises a lateral flow membrane having zones for capturing label in response to the progesterone and hCG concentrations, respectively. Visible label is accumulated when the hCG concentration exceeds the threshold value but is absent when the progesterone concentration exceeds the threshold value.

Assays and devices for distinguishing between normal and abnormal

Human chorionic gonadotropin (HCG) is detected by enzyme immunoassay by bonding biotinylated antibody to an avidin coupled paper disc, reacting the antibody on the disc with the solution suspected of containing HCG, and determining the amount of HCG on the disc by enzymatic assay detection techniques.

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San Diego, CA, United States of America

Theodore T Lee