Analytical performance and clinical evaluation of CL AIA-PACK® hs-E2, a high-sensitivity estradiol sandwich immunoassay using an anti-immunocomplex antibody.
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INTRODUCTION: The CL AIA-PACK® hs-E2 (hs-E2) is a high-sensitivity estradiol (E2) sandwich immunoassay employing an anti-immunocomplex antibody. This study aimed to evaluate its analytical performance and clinical utility at low concentration ranges relevant to aromatase inhibitor therapy and pediatric endocrinology, where accurate E2 measurement is clinically important. METHODS: The hs-E2 assay was evaluated for its precision, linearity, sensitivity, and interference. Its performance was compared with a conventional competitive immunoassay (Elecsys® E2) and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Estradiol levels were measured in patients with estrogen receptor-positive breast cancer receiving selective estrogen receptor modulator or aromatase inhibitor therapy to assess clinical applicability. RESULTS: The assay showed excellent precision (CVs < 6.4 %) and linearity across a broad concentration range. The limit of detection and limit of quantification were 4.84 and 7.11 pmol/L (10 % CV), respectively. Conjugated bilirubin induced a mild concentration-dependent decrease in measured E2 values. The hs-E2 assay showed a strong correlation with LC-MS/MS, even at low concentration ranges (r = 0.998), while Elecsys showed a weaker correlation below 147 pmol/L. In breast cancer patients, hs-E2 revealed significant differences in E2 levels across treatment groups, which were not detectable by the Elecsys assay. CONCLUSIONS: The hs-E2 immunoassay using an anti-immunocomplex antibody exhibited superior analytical sensitivity and precision at low concentration ranges to conventional methods. Its strong agreement with LC-MS/MS and enhanced clinical discrimination support its utility in monitoring E2 levels in hormone-treated breast cancer patients and other low-E2 clinical conditions.