Continuation of Over-the-Counter Biotin Supplements in the Inpatient Setting: An Unexpected Source of Laboratory Error

2020 ◽  
Author(s):  
Anna E Merrill ◽  
Natalie M Malvik ◽  
Diana C Ford ◽  
Matthew D Krasowski
Keyword(s):  
Cardiac Troponin ◽  
Troponin T ◽  
High Dose ◽  
Inpatient Setting ◽  
Pharmacokinetic Data ◽  
Over The Counter ◽  
The Past ◽  
Laboratory Error ◽  
Patient Reported ◽  
Potential Impact

Abstract Background Over the past decade, use of high-dose biotin has increased significantly and can lead to erroneous results on some clinical immunoassays. In collaboration with pharmacists at our institution, we discovered that high biotin doses were being administered to inpatients as a continuation of patient-reported home biotin use. Methods This retrospective study evaluated high-dose biotin administration in 226 inpatient encounters from 2009 to 2019 and its potential impact on concurrent immunoassay testing. Results In 96% of cases, biotin was administered in the inpatient setting as a continuation of patient-reported home use. In total, 322 immunoassays capable of biotin interference were performed across 100 inpatient encounters with high-dose biotin administration. Troponin T and TSH were the most commonly performed immunoassays in this cohort. Discussion Even though less than 5% of all high-dose biotin orders at our institution are placed for inpatients, hospitalized patients are still at risk for mismanagement due to erroneous immunoassay results. Immunoassay testing susceptible to biotin interference was performed in approximately 45% of inpatient encounters with biotin administration. Laboratories utilizing biotin-susceptible, sensitive cardiac troponin assays should be particularly cautious. Pharmacokinetic data for biotin clearance is especially lacking for certain populations likely to be hospitalized, such as those with renal failure. Given that medical conditions requiring high-dose biotin therapy are extremely rare, we recommend restricting biotin dosing during inpatient encounters for all other patients.

Independent and combined effects of biotin and hemolysis on high-sensitivity cardiac troponin assays

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Kellisha Harley ◽  
Sarah Bissonnette ◽  
Rosanna Inzitari ◽  
Karen Schulz ◽  
Fred S. Apple ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Clinical Laboratory ◽  
Troponin T ◽  
High Sensitivity ◽  
Combined Effects ◽  
Over The Counter ◽  
Heparin Plasma ◽  
Abbott Architect ◽  
Roche Cobas

Abstract Objectives This study compared the independent and combined effects of hemolysis and biotin on cardiac troponin measurements across nine high-sensitivity cardiac troponin (hs-cTn) assays. Methods Parallel cTn measurements were made in pooled lithium heparin plasma spiked with hemolysate and/or biotin using nine hs-cTn assays: Abbott Alinity, Abbott ARCHITECT i2000, Beckman Access 2, Ortho VITROS XT 7600, Siemens Atellica, Siemens Centaur, Siemens Dimension EXL cTnI, and two Roche Cobas e 411 Elecsys Troponin T-hs cTnT assays (outside US versions, with and without increased biotin tolerance). Absolute and percent cTn recovery relative to two baseline concentrations were determined in spiked samples and compared to manufacturer’s claims. Results All assays except the Ortho VITROS XT 7600 showed hemolysis and biotin interference thresholds equivalent to or greater than manufacturer’s claims. While imprecision confounded analysis of Ortho VITROS XT 7600 data, evidence of biotin interference was lacking. Increasing biotin concentration led to decreasing cTn recovery in three assays, specifically both Roche Cobas e 411 Elecsys Troponin T-hs assays and the Siemens Dimension EXL. While one of the Roche assays was the most susceptible to biotin among the nine studied, a new version showed reduced biotin interference by approximately 100-fold compared to its predecessor. Increasing hemolysis also generally led to decreasing cTn recovery for susceptible assays, specifically the Beckman Access 2, Ortho VITROS XT 7600, and both Roche Cobas e 411 Elecsys assays. Equivalent biotin and hemolysis interference thresholds were observed at the two cTn concentrations considered for all but two assays (Beckman Access 2 and Ortho VITROS XT 7600). When biotin and hemolysis were present in combination, biotin interference thresholds decreased with increasing hemolysis for two susceptible assays (Roche Cobas e 411 Elecsys and Siemens Dimension EXL). Conclusions Both Roche Cobas e 411 Elecsys as well as Ortho VITROS XT assays were susceptible to interference from in vitro hemolysis at levels routinely encountered in clinical laboratory samples (0–3 g/L free hemoglobin), leading to falsely low cTn recovery up to 3 ng/L or 13%. While most assays are not susceptible to biotin at levels expected with over-the-counter supplementation, severely reduced cTn recovery is possible at biotin levels of 10–2000 ng/mL (41–8,180 nmol/L) for some assays. Due to potential additive effects, analytical interferences should not be considered in isolation.

scholarly journals Susceptibility of Cardiac Troponin Assays to Biotin Interference

2019 ◽  
Vol 151 (5) ◽  
pp. 486-493 ◽  
Author(s):  
Ithiel J Frame ◽  
Parag H Joshi ◽  
Caroline Mwangi ◽  
Ian Gunsolus ◽  
James A De Lemos ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Troponin T ◽  
Plasma Concentrations ◽  
High Sensitivity ◽  
Over The Counter ◽  
Agarose Beads ◽  
Spiked Plasma ◽  
Missed Diagnosis ◽  
Biotin Supplementation

Abstract Objectives To investigate biotin interference on three cardiac troponin (cTn) assays and demonstrate a method to overcome biotin interference. Methods cTn levels were measured in (1) plasma from healthy volunteers on 10-mg daily biotin supplementation mixed with a plasma with known elevated troponin, (2) plasmas with known elevated cTn after mixing in reagent biotin to simulate supplementation, and (3) biotin-spiked plasma specimens pretreated with streptavidin-agarose beads. Results Daily biotin ingestion (10 mg) and studies simulating daily biotin use resulted in significant interference in the Gen5 cardiac troponin T (cTnT) assay; the contemporary Gen 4 cTnT and high-sensitivity cardiac troponin I (hs-cTnI) assays were unaffected. The biotin interference threshold was 31, 315, and more than 2,000 ng/mL for Gen5 cTnT, cTnT, and hs-cTnI assays, respectively. Streptavidin pretreatment blocked biotin interference in cTn assays. Conclusions Biotin interference is possible at plasma concentrations achievable by ingestion of over-the-counter supplements that may lead to delayed or missed diagnosis of myocardial injury with the Gen5 cTnT assay.

scholarly journals High Dose Melphalan Followed By Autologous Stem Cell Transplant in AL Amyloidosis: a Single-Center Experience

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5909-5909
Author(s):  
Mariella D'Adda ◽  
Francesca Schieppati ◽  
Samantha Ferrari ◽  
Claudia Crippa ◽  
Annalisa Peli ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Stem Cell Transplant ◽  
Troponin T ◽  
Autologous Stem Cell Transplant ◽  
High Dose ◽  
Al Amyloidosis ◽  
Cell Transplant ◽  
Single Center Experience ◽  
High Dose Melphalan

Abstract INTRODUCTION: high-dose melphalan (HDM) followed by autologous stem cell transplant (ASCT) has been routinely used as a treatment option for systemic light chain AL amyloisosis since the first report in mid-1990s. The high treatment-related mortality (death before post-transplant day 100) reported in literature (11-40% in different papers) has decreased over the last years with the improvement in patient selection. Particularly, in the largest Mayo Clinic series of 422 subjects, patients with cardiac troponin-T < 0.06 ng/L and NT-proBNP < 5000 ng/L had TRM < 1%; besides, patients achieving hematologic complete response/very good partial remission (CR/VGPR) had superior overall survival than those achieving hematologic partial response (PR) and no response. Here we report our single-center experience of 14 ASCT performed in 10 patients between 2007 and 2014. PATIENTS AND METHODS: the median age at the time of ASCT was 58 years (range 44-68). Five patients had 2 or more involved organs. All 10 patients had: normal troponin-I value, NT-proBNP < 5000 ng/L, PS 0-1, cardiac ejection fraction over 50%, CO diffusion capacity over 50%; only one had creatinine clearance < 50 ml/min. Three patients collected stem cells after cyclophosphamide (1,5 g/m^2), the others after G-CSF alone. Four patients proceeded directly to ASCT after diagnosis, 3 received CyBorD and 3 other induction regimen (5 patients were non responders and 1 was in hematologic PR after “induction therapy” before HDM). Patients received melphalan 200 mg/m^2 (9 ASCT) or dose adjusted HDM (100-140 mg/m^2, 5 ASCT), depending on clinical decision. Four patients received double ASCT. RESULTS: median follow up is 48 months (range 0,5-80); all patients were alive at the last visit. Of nine evaluable patients (1 patient too early), overall hematologic and organ response rate after ASCT were 78% and 45%. Only 1 of 4 patients with double ASCT improved response after the second course (this patient maintains a hematologic CR without organ involvement after 80 months of follow up). Median hospitalization for ASCT was 24 days (range 17-45), without any threatening-life side effect. Six of 9 evaluable patients needed a 2ndline therapy for progressive disease after a median follow up of 24 months (range 13-52): 4 of them had achieved hematologic PR after ASCT, 1 patient achieved hematologic VGPR and 1 had no hematologic response. Three patients are in follow up without other therapy after ASCT (2 hematologic CR and 1 non response). CONCLUSION: HDM followed by ASCT is a very effective treatment option in AL-amyloidosis, which may be effective even in patients non responding to first-line treatment with non myeloablative drugs. According to the data of the literature, our experience suggests that a careful selection of patients is critical for good outcomes and that particular cardiac biomarkers (cardiac troponin-T < 0.06 ng/L and NT-proBNP < 5000 ng/L) are useful to guide the choice of therapy. Furthermore, consolidation therapy (IMiDs and proteasome inhibitors) should be considered for patients who do not obtain at least a VGPR/CR after HDM. Disclosures No relevant conflicts of interest to declare.

Acetaminophen: Neonatal hepatotoxicity due to late pregnancy exposure

1987 ◽  
Vol 45 ◽  
pp. 718-719
Author(s):  
G.A. Miranda ◽  
M.A. Arroyo ◽  
C.A. Lucio ◽  
M. Mongeotti ◽  
S.S. Poolsawat
Keyword(s):  
Low Dose ◽  
Fetal Liver ◽  
Late Pregnancy ◽  
Toxic Chemicals ◽  
Control Group ◽  
High Dose ◽  
Over The Counter ◽  
Liver And Kidney ◽  
Neonatal Liver ◽  
Childbearing Women

Exposure to drugs and toxic chemicals, during late pregnancy, is a common occurrence in childbearing women. Some studies have reported that more than 90% of pregnant women use at least 1 prescription; of this, 60% used more than one. Another study indicated that 80% of the consumed drugs were not prescribed, and of this figure, 95% were “over-the-counter” drugs. Acetaminophen, the safest of all over-the-counter drugs, has been reported to induce fetal liver necrosis in man and animals and to have abortifacient and embryocidal action in mice. This study examines the degree to which acetaminophen affects the neonatal liver and kidney, when a fatty diet is simultaneously fed to the mother during late pregnancy.Timed Swiss Webster female mice were gavaged during late pregnancy (days 16-19) with fat suspended acetaminophen at a high dose, HD = 84.50 mg/kg, and a low dose, LD = 42.25 mg/kg; a control group received fat alone.

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