Assessment of the Abbott IMx assay system for the measurement of human chorionic gonadotropin levels in the treatment of ectopic pregnancy

Abstract

The rapid, accurate determination of serum human chorionic gonadotropin (beta-hCG) levels in the 900- to 2000-IU/L range is a critical element in the treatment of patients with suspected ectopic pregnancy. Using the Abbott IMx system (Abbott Laboratories, North Chicago, Ill), beta-hCG levels can be determined on an undiluted sample up to 1000 IU/L. A sample with beta-hCG level greater than 1000 IU/L is automatically diluted and the diluted sample redetermined. Unfortunately, employing a 1:200 fixed dilution can produce a working sample that contains an beta-hCG concentration that does not fall on a linear portion of the standard curve (<7.5 IU/L). This results in a calculated beta-hCG concentration (200 x observed value) that has high error (coefficient of variation up to 21.8%). Additionally, interfering substances in the reagents, which vary in quantity from lot to lot of reagents, further confound accurate beta-hCG determination by the system. Consequently, the Abbott IMx assay system cannot be used as recommended by the manufacturer for routine measurement of serum beta-hCG in the 900- to 2000-IU range. An alternate protocol employing at 1:10 dilution would allow a more accurate beta-hCG determination.