Interference of anti-streptavidin antibodies: More common than we thought? In relation to six confirmed cases

Ricci, Valentina; Esteban, María P.; Sand, Guillermina; Menises, María M.

doi:10.1016/j.clinbiochem.2021.01.013

Cited by 4 publications

(4 citation statements)

References 8 publications

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“…Despite their great performance characteristics, immunoassays are prone to interferences that may alter tests results, putting patients at risk for misdiagnosis [12]. All biotin-(strept)avidin-based immunoassays are susceptible to interference with biotin, but the degree of risk for patient misdiagnosis can vary considerably between immunoassays [40].…”

Section: Biotin Interferencementioning

confidence: 99%

“…Immunoassays are routinely used in laboratory diagnostics [12] due to their utilization of highly specific antibodies that exhibit remarkable diversity to selectively target a vast variety analytes of interest and measure their concentrations in a sample [13]. Antibodies are the key reagents on which the success of the immunoassay depends [6], relying on their ability to bind to a specific area of an antigen called an epitope [11].…”

Section: Introductionmentioning

confidence: 99%

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An Analysis of the Biotin–(Strept)avidin System in Immunoassays: Interference and Mitigation Strategies

Balzer,

Whitehurst

2023

CIMB

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An immunoassay is an analytical test method in which analyte quantitation is based on signal responses generated as a consequence of an antibody–antigen interaction. They are the method of choice for the measurement of a large panel of diagnostic markers. Not only are they fully automated, allowing for a short turnaround time and high throughput, but offer high sensitivity and specificity with low limits of detection for a wide range of analytes. Many immunoassay manufacturers exploit the extremely high affinity of biotin for streptavidin in their assay design architectures as a means to immobilize and detect analytes of interest. The biotin–(strept)avidin system is, however, vulnerable to interference with high levels of supplemental biotin that may cause elevated or suppressed test results. Since this system is heavily applied in clinical diagnostics, biotin interference has become a serious concern, prompting the FDA to issue a safety report alerting healthcare workers and the public about the potential harm of ingesting high levels of supplemental biotin contributing toward erroneous diagnostic test results. This review includes a general background and historical prospective of immunoassays with a focus on the biotin–streptavidin system, interferences within the system, and what mitigations are applied to minimize false diagnostic results.

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Section: Biotin Interferencementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An Analysis of the Biotin–(Strept)avidin System in Immunoassays: Interference and Mitigation Strategies

Balzer,

Whitehurst

2023

CIMB

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“…8,[17][18][19] The origin of anti-streptavidin antibodies is unknown, but may be due to prior exposure to streptavidin or the soil bacterium, Streptomyces avidinii, from which the protein is purified. 19 Anti-ruthenium antibodies directed to either ruthenium or the ruthenium-labelled antibodies may result in an increase or a decrease in the chemiluminescent signal, which in turn may lead to inaccurately elevated or decreased hormone results depending on the interfering antibody specificity and assay format. 7,20…”

Section: Heterophile and Human Anti-animal Antibodiesmentioning

confidence: 99%

“…free T3) ( Figure 7B ). 8 , 17 – 19 The origin of anti-streptavidin antibodies is unknown, but may be due to prior exposure to streptavidin or the soil bacterium, Streptomyces avidinii , from which the protein is purified. 19 …”

Section: Interference With Assay Componentsmentioning

confidence: 99%

Spurious Serum Hormone Immunoassay Results: Causes, Recognition, Management

Braunstein¹

2022

European Endocrinology

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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.

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Free thyroxine measurement in clinical practice: how to optimize indications, analytical procedures, and interpretation criteria while waiting for global standardization

D’Aurizio

Kratzsch

Gruson

et al. 2022

Critical Reviews in Clinical Laboratory Sciences

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Interference of anti-streptavidin antibodies: More common than we thought? In relation to six confirmed cases

Cited by 4 publications

References 8 publications

An Analysis of the Biotin–(Strept)avidin System in Immunoassays: Interference and Mitigation Strategies

An Analysis of the Biotin–(Strept)avidin System in Immunoassays: Interference and Mitigation Strategies

Spurious Serum Hormone Immunoassay Results: Causes, Recognition, Management

Free thyroxine measurement in clinical practice: how to optimize indications, analytical procedures, and interpretation criteria while waiting for global standardization

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