Diana Desai, M.D., Jun Lu, M.S., Sara P Wyness, B.S., Dina N Greene, Ph.D., Kalen N Olson, Ph.D., Carmen L Wiley, Ph.D., David G Grenache, Ph.D.
Volume 101, Issue 6, Pages 1671–1674
To determine the effect that lack of hCG assay harmonization has on the interpretation of a serum hCG concentration with regards to the hCG discriminatory zone.
A multisite method comparison study.
Eighty serum samples containing various concentrations of hCG.
Main Outcome Measure(s):
Concentrations of hCG obtained from seven hCG reagent platforms.
The hCG concentrations were significantly different across hCG reagent platforms. Seventy-one percent of assay pairs showed significant differences with samples selected based on hCG concentrations between 1,500 and 3,500 IU/L as determined by a comparative method. Relative to the comparative method, the calculated hCG discriminatory zones for five assays were within 9%, and one assay was within 40% of the target concentrations of 1,500 and 3,500 IU/L.
Despite significant differences in hCG concentrations across hCG immunoassays, an hCG concentration within a discriminatory zone of 1,500–3,500 IU/L can be used for all but one commonly used hCG reagent platform.
Read the full text at: http://www.fertstert.org/article/S0015-0282(14)00176-9/fulltext