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Review
. 2022 Nov;18(2):141-147.
doi: 10.17925/EE.2022.18.2.141. Epub 2022 Aug 15.

Spurious Serum Hormone Immunoassay Results: Causes, Recognition, Management

Glenn D Braunstein  1
Affiliations
Review

Spurious Serum Hormone Immunoassay Results: Causes, Recognition, Management

Glenn D Braunstein. touchREV Endocrinol. 2022 Nov.

Abstract

For over 50 years, immunoassays have been extensively used to quantitate hormones in blood, other fluids and tissues. Each assay has its own sensitivity, specificity and other analytical components. Despite the differences between commercial products, these assays provide important clinical information about hormone levels in patients. However, inaccurate results can occur because of technical issues, as well as patient-specific factors that can interfere with immunoassay hormone measurements. The latter include excessive normal blood or serum components, the presence of cross-reacting substances, extremely high levels of hormones leading to the high-dose hook effect, and interference from a variety of endogenous factors such as human antibodies that interact with the assay components or high levels of biotin in the serum from exogenous ingestion. This article briefly reviews the sources and recognition of endogenous interference, and describes methods to determine the correct serum hormone concentration.

Keywords: Anti-streptavidin antibody; biotin; heterophile antibodies; high-dose hook effect; hormone binding proteins; hormone isoforms; human anti-animal antibodies; immunoassay.

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Conflict of interest statement

Disclosures: Glenn D Braunstein has no financial or non-financial relationships or activities to declare in relation to this article.

Figures

Figure 1:
Figure 1:. Competitive immunoassay
Figure 2:
Figure 2:. Non-competitive (‘sandwich’) immunoassay
Figure 3:
Figure 3:. High-dose hook effect
Figure 4:
Figure 4:. Heterophile or human anti-animal antibody interference in competitive immunoassays
Figure 5:
Figure 5:. Heterophile or human anti-animal antibody interference in non-competitive immunoassay
Figure 6:
Figure 6:. Effect of anti-streptavidin or anti-ruthenium antibodies or excess biotin in non-competitive immunoassays using binding of biotin to streptavidin as assay components
Figure 7:
Figure 7:. Effect of anti-streptavidin or anti-ruthenium antibodies or excess biotin in competitive immunoassays using binding of biotin to streptavidin as assay components
See this image and copyright information in PMC

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