Biotin Interference in Clinical Immunoassays: A Cause for Concern

Holmes, Earle W.; Samarasinghe, Shanika; Emanuele, Mary Ann; Meah, Farah

doi:10.5858/arpa.2017-0107-le

Cited by 40 publications

(28 citation statements)

References 3 publications

(1 reference statement)

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“…Depending on the manufacturer and the type of used test, the threshold level of biotin above which it will interfere with the assay is between 2.4 and 1968 μg/L (between 10 and 8200 nmol/L) (in the previously mentioned analysers) [12]. For the majority of tests that threshold value is < 51 μg/L [13]. Unfortunately, that kind of data is not available for all tests.…”

Section: Immunochemical Tests Based On the Streptavidin (Avidin)-biotmentioning

confidence: 99%

“…W zależności od producenta i rodzaju stosowanego testu progowe stężenie biotyny, powyżej którego będzie ona interferowała w oznaczenie, wynosi 2,4-1968 μg/l (10-8200 nmol/l) (wśród wcześniej wymienionych analizatorów) [12]. W większości testów próg ten wynosi < 51 μg/l [13]. Niestety, nie dla wszystkich testów te dane są dostępne, ponadto producenci nie informują, jakiej dawce…”

Section: Prace Poglądoweunclassified

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The effect of biotin interference on the results of blood hormone assays

Ostrowska

Bartoszewicz

Bednarczuk

et al. 2019

Endokrynologia Polska

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Approximately 70% of medical decisions are made based on results of laboratory investigations. Immunochemical methods are used most commonly in routine laboratory diagnostics of endocrine disorders. Those methods are limited by susceptibility of the immunochemical reaction to various interferences. Interference may be caused by the presence of autologous antibodies, heterophilic antibodies, or paraproteins in the blood serum, by cross-reactions with similar reagents, haemolysis, significant lipidaemia, or hyperbilirubinaemia. Some recent reports have indicated a significant effect of biotin on the reliability of laboratory investigations. Biotin is a water-soluble vitamin belonging to the B group. It is present in popular dietary supplements -alone or as a component of multi-vitamin formulas -and it is advertised as a remedy to falling out and fragility of hair and nails. Due to its low molecular weight and a strong affinity to streptavidin, biotin is used in many immunochemical tests. Due to a strong and stable bond of streptavidin and biotin, analytical methods using the streptavidin (avidin)-biotin system are characterised by superior sensitivity, and they allow determination of very low levels of the tested substance in biological material. The presence of exogenous biotin in a sample may cause interference when using tests that utilise the streptavidin (avidin)-biotin system. Interference of biotin with immunochemical tests depends on several factors: the construction of the immunochemical test, the dose used by the patient, the biotin concentration in the sample, and most of all -the time from the last dose to the collection of biological material for laboratory testing. In this paper we present some practical recommendations and a procedure to be followed in the case of suspected interference of biotin in immunochemical assays, for clinicians and laboratory diagnosticians. (Endokrynol Pol 2019; 70 (1): 102-111)

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Section: Immunochemical Tests Based On the Streptavidin (Avidin)-biotmentioning

confidence: 99%

Section: Prace Poglądoweunclassified

The effect of biotin interference on the results of blood hormone assays

Ostrowska

Bartoszewicz

Bednarczuk

et al. 2019

Endokrynologia Polska

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“…Das Ausmaß von Laborveränderungen ist abhängig vom verwendeten Assay [14], sodass beim Sandwich-Immunoassay falsch niedrige Resultate vorkommen, beim kompetitivem Immunoassay jedoch falsch erhöhte Werte ermittelt werden. Eine Verfälschung von Laborwerten ist im Ausmaß und hinsichtlich bestimmter Tests daneben abhängig vom verwendeten Nachweissystem des Herstellers [15]. Nach einer 100 mg Einzeldosis von Biotin können je nach Interferenz-Schwellenwert des verwendeten Nachweissystems falsche Laborwerte für > 6 Tage persistieren [15].…”

Section: Diskussionunclassified

Thyreotoxikose bei langjähriger Multipler Sklerose? – Fallstricke der MS-Therapie mit Biotin

Pöllmann¹,

Meier²,

Feneberg³

et al. 2018

Akt Neurol

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ZusammenfassungHochdosis-Biotin ist ein neuartiger Wirkansatz für Patienten mit progredienter Multipler Sklerose (MS), der aktuell in klinischen Studien getestet wird. Artifizielle Veränderungen von Labortests sind eine häufige Komplikation. Wir berichten von einem 44-jährigen Patienten mit vermeintlicher Thyreotoxikose unter Hochdosis-Biotintherapie. Durch potenzielle Interaktionen mit Labortests ist der Einsatz von hochdosiertem Biotin nur mit Vorsicht unter Berücksichtigung von Risikofaktoren (z. B. kardiale Erkrankungen) und erst nach intensiver Beratung sinnvoll. Das Mitführen einer Kurzinformation bei den Ausweispapieren ist anzuraten.

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“…In the USA, about 59% of the surveyed IAs are based on biotin− streptavidin chemistry. 2 Almost all the commercial IAs developed by Roche and Beijing UniDiag Technology and Diasorin are based on biotin−SA interactions. Similarly, many IAs from Siemens and other IVD companies are also based on biotin−SA interactions.…”

Section: Introductionmentioning

confidence: 99%

Chemistry of Biotin–Streptavidin and the Growing Concern of an Emerging Biotin Interference in Clinical Immunoassays

Luong

Vashist

2019

ACS Omega

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Overconsumption of biotin (5−100 mg daily) as a supplement by the general population poses a significant problem for clinical immunoassays (IAs) based on biotin−streptavidin (SA) interactions. This affinity pair has been exploited in immunoassays because of its avidity, sensitivity, specificity, and stability. The elevated biotin level in plasma varies from patient to patient, and its severe interference cannot easily be predicted and quantified. Thus, immunoassay manufacturers must investigate the biotin interference in the developed immunoassays to satisfy the threshold of 3510 ng/mL (14 367 nM), as stipulated by the FDA. There is no concrete solution to circumvent the biotin interference without extra costs and technical difficulties, albeit different strategies have been attempted. They include the IA format with biotinylated reagents prebound to streptavidin, the removal of biotin from the specimen, sample treatment, and biotin interference-free assays. The general public has been instructed to stop taking biotin supplements for 48 h or even weeks before the test, depending on the specific test, dose, and frequency of biotin uptake. As lab-based techniques cannot accommodate an enormous number of public samples, a rapid analytical procedure for biotin is urgently needed to quantify for its interference in immunoassays.

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Biotin Interference in Clinical Immunoassays: A Cause for Concern

Cited by 40 publications

References 3 publications

The effect of biotin interference on the results of blood hormone assays

The effect of biotin interference on the results of blood hormone assays

Thyreotoxikose bei langjähriger Multipler Sklerose? – Fallstricke der MS-Therapie mit Biotin

Chemistry of Biotin–Streptavidin and the Growing Concern of an Emerging Biotin Interference in Clinical Immunoassays

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