Cirrincione Lauren R, Crews Bridgit O, Dickerson Jane A, Krasowski Matthew D, Rongitsch Jessica, Imborek Katherine L, Goldstein Zil, Greene Dina N
Department of Pharmacy, University of Washington, Seattle, Washington, USA.
Department of Pathology and Laboratory Medicine, University of California Irvine, Orange, California, USA.
Endocr Connect. 2022 Feb 9;11(2):e210550. doi: 10.1530/EC-21-0550.
Recently, an estradiol immunoassay manufacturer (Beckman Coulter, USA) issued an 'important product notice' alerting clinical laboratories that their assay (Access Sensitive Estradiol) was not indicated for patients undergoing exogenous estradiol treatment. The objective of this analysis was to evaluate immunoassay bias relative to liquid chromatography tandem mass spectrometry (LC-MS/MS) in transgender women and to examine the influence of unconjugated estrone on measurements.
Cross-sectional secondary analysis.
Estradiol concentrations from 89 transgender women were determined by 3 immunoassays (Access Sensitive Estradiol ('New BC') and Access Estradiol assays ('Old BC'), Beckman Coulter; Estradiol III assay ('Roche'), Roche Diagnostics) and LC-MS/MS. Bias was evaluated with and without adjustment for estrone concentrations. The number of participants who shifted between three estradiol concentration ranges for each immunoassay vs LC-MS/MS (>300 pg/mL, 70-300 pg/mL, and <70 pg/mL) was calculated.
The New BC assay had the largest magnitude overall bias (median: -34%) and was -40%, -22%, and -10%, among participants receiving tablet, patch, or injection preparations, respectively. Overall bias was -12% and +17% for the Roche and Old BC assays, respectively. When measured with the New BC assay, 18 participants shifted to a lower estradiol concentration range (vs 9 and 10 participants based on Roche or Old BC assays, respectively). Adjustment for estrone did not minimize bias.
Immunoassay measurement of estradiol in transgender women may lead to falsely decreased concentrations that have the potential to affect management. A multidisciplinary health care approach is needed to ensure if appropriate analytical methods are available.
最近，一家雌二醇免疫分析制造商（美国贝克曼库尔特公司）发布了一份“重要产品通知”，提醒临床实验室其检测方法（Access Sensitive Estradiol）不适用于接受外源性雌二醇治疗的患者。本分析的目的是评估变性女性中免疫分析相对于液相色谱串联质谱法（LC-MS/MS）的偏差，并研究未结合雌酮对测量结果的影响。
横断面二次分析。
采用3种免疫分析方法（Access Sensitive Estradiol（“新贝克曼库尔特”）和Access Estradiol检测方法（“旧贝克曼库尔特”），贝克曼库尔特公司；雌二醇III检测方法（“罗氏”），罗氏诊断公司）和LC-MS/MS测定89名变性女性的雌二醇浓度。在调整和未调整雌酮浓度的情况下评估偏差。计算每种免疫分析方法与LC-MS/MS相比，在三个雌二醇浓度范围（>300 pg/mL、70 - 300 pg/mL和<70 pg/mL）之间转换的参与者数量。
新贝克曼库尔特检测方法的总体偏差最大（中位数：-34%），在接受片剂、贴片或注射制剂的参与者中分别为-40%、-22%和-10%。罗氏和旧贝克曼库尔特检测方法的总体偏差分别为-12%和+17%。使用新贝克曼库尔特检测方法时，18名参与者的雌二醇浓度范围降低（基于罗氏或旧贝克曼库尔特检测方法的分别为9名和10名参与者）。调整雌酮并未使偏差最小化。
变性女性中雌二醇的免疫分析测量可能导致浓度错误降低，这有可能影响治疗管理。需要多学科医疗保健方法来确保是否有合适的分析方法可用。
