Abstract Disclosure: S.S. Sundar: None. S. Shankar: None. M.S. Vaishnav: None. L. Lekkala: None. S. Sathyanarayana: None. C. Siddlingappa: None. K. M: None. T.-. Kamala: None. R.B. V: None. V. Nath: None. M.D. Chitra: None. P. Ravikumar: None. Introduction: Immunoassay interferences include: Cross-reactions, heterophile antibodies, biotin and anti-analyte antibodies, with positive or negative bias, leading to difficulties in clinical decision-making (confounding diagnosis, unnecessary investigations or inappropriate treatments). The interfering substance may be exogenous (e.g., drug or substance absorbed by patient) or endogenous (e.g., antibodies produced by patient). Clinical Case 2023 Dec 1 Dermatology management for hyperandrogenism 28-year-old female evaluated for acne 3 years (increased 4 months), hair fall 6 months and hirsutism 3 years (threading) Total Testosterone 443 ng/dL (10-55) CLIA Free Testosterone 8.9 pg/mL (0.1-6.4) ELISA DHEAS 209 µg/dL (35-430) CLIA S Cortisol 8 am 6.9 µg/dL (2.6-10.5) CLIA LH 4.2 mIU/mL (1.9-12.5); FSH 5.3 mIU/mL (3.0-8.0) T3 133 ng/dL (80-200); T4 8.5 ug/dL (4.8-12.7), TSH 3.78 µIU/mL (0.5-5.3) HbA1c 5.0%; Glucose fasting 81 mg/dL; Insulin fasting 39.4 mU/L (3-25); HOMA-IR 5.2; HOMA%B 380; HOMA%S 19.2; T3 133 ng/dL (80-200) 2023 Dec 14 Endocrinology for “scaringly” very high testosterone levels Menstrual history: Menarche 11 years; Cycles regular. Unmarried Family history: Diabetes++; Hirsutism+; Infertility- Physical exam: Height 159 cm; Weight 55 kg; BMI 21.8 kg/m2; Ferriman Gallwey score 11; Pulse 75; BP 79/62; Thyroid: Grade 0. In view of total testosterone levels in “neoplastic androgen excess” range, further endocrinology evaluations (multiple labs and assays) were carried out. However, discordance between the mild clinical versus severe biochemical hyperandrogenism was noted. Review of the dermatology prescription indicated that patient had consumed only one 10 mg tablet of biotin 36 hours before the earlier blood draw obtained by dermatologist. Total Testosterone 22.3 and 33.8 ng/dL (6-82) ECLIA; 19.7 (15-70) LCMS Free Testosterone 0.69 pg/mL (< 2.85) (ELISA) DHEAS 101 µg/dL (45-380) LCMS Androstenedione 104 ng/dL (75-205) LCMS 17OH Progesterone 0.89 ng/mL (0.16-2.05) EIA; 0.40 (0.35-2.9) LCMS S Cortisol 5.92 ug/dl (6-18) ECLIA; 5.45 (5-23) LCMS FSH 2.74; LH 6.07; Prolactin 20.1 ng/mL (4.7-23.3) T3 114 ng/dL; T4 7.2 µg/dL; TSH 1.29 Diagnosis Falsely elevated total testosterone (and free testosterone) levels due to biotin immunoassay interference. Clinical Lessons: Very limited studies exist confirming the exact clinical indications for biotin (eg: improvement of hair quality or quantity, or nail growth). FDA warning highlights biotin’s interference (false elevations or reductions) with immunoassays relying on biotin-streptavidin technology. Physicians must ask patients about supplement usage, and discontinue biotin for 8 hours for patients taking 10 mg/day, 3 days for 100-300 mg/day, 7 days for children taking 2 and 15 mg/kg/daily, and inform laboratory if diagnostic test was performed while taking biotin. Presentation: 6/2/2024
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