Abstract

Background: Biotin interference has become a major problem with some laboratory immunoassays, leading to erroneous tests results and potentially harmful clinical consequences. There is therefore a clinical need to easily identify the interference and to overcome its effect to avoid harmful consequences for patients. The aim of this study was to demonstrate the VeraPrep BiotinTM procedure, a biotin depleting device, does not impact the immunoreactivity of TSH, LH and FSH immunoassays.Materials and methods: Nine samples (4 from women and 5 from men) were tested with two-sites electrochemiluminescent immunoassays (Cobas e602, Roche diagnostics) for the measurement of three pituitary hormones, TSH, LH and FSH. The samples were first measured without any treatment (baseline) and then retested after treatment with VeraPrep Biotin™ procedure. Percent (%) difference was calculated between post‐treatment and baseline to determine if the biotin depleting device impact the immunoassays immunoreactivity.Results: The median baseline concentrations for TSH, LH and FSH were 2.3 mIU/L (standard deviation (SD): 1.5), 4.9 IU/L (19.0) and 5.3 IU/L (17.5), respectively. The median concentrations after treatment with the VeraPrep Biotin™ procedure for TSH, LH and FSH were 2.3 mIU/L (1.5), 4.9 IU/L (18.9) and 4.9 IU/L (16.5), respectively, and were not statistically different from baseline (P = 0.976). The mean recoveries after treatment were 99.5%, 98.6% and 95.4% for TSH, LH and FSH, respectively.Conclusions: The concentrations of the TSH, LH and FSH assays were not impacted by the pretreatment with the VeraPrep Biotin™ procedure, confirming its ability to help clinical laboratories to overcome biotin interference.

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