AACC Guidance Document on Biotin Interference in Laboratory Tests
Laboratory tests that use streptavidin-biotin binding mechanisms have the potential to be affected by high circulating biotin concentrations, which would produce positive and negative interference in biotinylated competitive and noncompetitive (sandwich) immunoassays, respectively. Consumption of hi...
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Published in | The journal of applied laboratory medicine Vol. 5; no. 3; p. 575 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
England
01.05.2020
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Abstract | Laboratory tests that use streptavidin-biotin binding mechanisms have the potential to be affected by high circulating biotin concentrations, which would produce positive and negative interference in biotinylated competitive and noncompetitive (sandwich) immunoassays, respectively. Consumption of high-dose biotin supplements for cosmetic or health-related reasons has drawn attention to biotin interference in clinical laboratory tests. Case reports and in vivo studies show that ingestion of supplemental biotin can cause clinically significant errors in select biotinylated immunoassays.
This AACC Academy document is intended to provide guidance to laboratorians and clinicians for preventing, identifying, and dealing with biotin interference. In vivo and in vitro spiking studies have demonstrated that biotin concentrations required to cause interference vary by test and by manufacturer. This document includes discussion of biotin's mechanisms for interference in immunoassays, pharmacokinetics, and results of in vitro and in vivo studies and cites examples of assays known to be affected by high biotin concentrations. This document also provides guidance recommendations intended to assist laboratories and clinicians in identifying and addressing biotin interference in laboratory testing.
The recent increase in the use of high-dose biotin supplements requires laboratorians and clinicians to be mindful of the potential for biotin interference in biotinylated immunoassay-based laboratory tests. Laboratories, clinicians, regulators, and patients should work together to ensure accurate laboratory results. Laboratories have several options for identifying suspected biotin interference in specimens. Alternatively, the relatively fast elimination of biotin allows the potential for rapid follow-up specimen analysis if necessary. |
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AbstractList | Laboratory tests that use streptavidin-biotin binding mechanisms have the potential to be affected by high circulating biotin concentrations, which would produce positive and negative interference in biotinylated competitive and noncompetitive (sandwich) immunoassays, respectively. Consumption of high-dose biotin supplements for cosmetic or health-related reasons has drawn attention to biotin interference in clinical laboratory tests. Case reports and in vivo studies show that ingestion of supplemental biotin can cause clinically significant errors in select biotinylated immunoassays.
This AACC Academy document is intended to provide guidance to laboratorians and clinicians for preventing, identifying, and dealing with biotin interference. In vivo and in vitro spiking studies have demonstrated that biotin concentrations required to cause interference vary by test and by manufacturer. This document includes discussion of biotin's mechanisms for interference in immunoassays, pharmacokinetics, and results of in vitro and in vivo studies and cites examples of assays known to be affected by high biotin concentrations. This document also provides guidance recommendations intended to assist laboratories and clinicians in identifying and addressing biotin interference in laboratory testing.
The recent increase in the use of high-dose biotin supplements requires laboratorians and clinicians to be mindful of the potential for biotin interference in biotinylated immunoassay-based laboratory tests. Laboratories, clinicians, regulators, and patients should work together to ensure accurate laboratory results. Laboratories have several options for identifying suspected biotin interference in specimens. Alternatively, the relatively fast elimination of biotin allows the potential for rapid follow-up specimen analysis if necessary. |
Author | Cervinski, Mark A Lynch, Kara L Ferguson, Angela Kyle, Patrick B Li, Danni |
Author_xml | – sequence: 1 givenname: Danni surname: Li fullname: Li, Danni organization: Department of Lab Medicine and Pathology, University of Minnesota Medical Center, Minneapolis, MN – sequence: 2 givenname: Angela surname: Ferguson fullname: Ferguson, Angela organization: Department of Pathology and Laboratory Medicine, Children's Mercy Kansas City, Kansas City, MO – sequence: 3 givenname: Mark A surname: Cervinski fullname: Cervinski, Mark A organization: Department of Pathology and Laboratory Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH – sequence: 4 givenname: Kara L surname: Lynch fullname: Lynch, Kara L organization: Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA – sequence: 5 givenname: Patrick B surname: Kyle fullname: Kyle, Patrick B organization: Department of Pathology, University of Mississippi Medical Center, Jackson, MS |
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Keywords | Biotin Interference Biotin Immunoassay Interference |
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