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Fertil Steril. 2014 Jun;101(6):1671-4. doi: 10.1016/j.fertnstert.2014.02.023. Epub 2014 Mar 22.

Human chorionic gonadotropin discriminatory zone in ectopic pregnancy: does assay harmonization matter?

Author information

1
Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah.
2
ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories, Salt Lake City, Utah.
3
Northern California Kaiser Permanente Regional Laboratory, Berkeley, California.
4
HealthPartners/Regions Hospital, St. Paul, Minnesota.
5
PAML, Spokane, Washington.
6
Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah; ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories, Salt Lake City, Utah. Electronic address: david.grenache@path.utah.edu.

Abstract

OBJECTIVE:

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.

DESIGN:

A multisite method comparison study.

SETTING:

Clinical laboratories.

PATIENT(S):

Eighty serum samples containing various concentrations of hCG.

INTERVENTION(S):

None.

MAIN OUTCOME MEASURE(S):

Concentrations of hCG obtained from seven hCG reagent platforms.

RESULT(S):

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.

CONCLUSION(S):

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.

KEYWORDS:

Ectopic pregnancy; hCG; hCG discriminatory zone; harmonization

[Indexed for MEDLINE]
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