Department of Laboratory Medicine, West China Second University Hospital, Sichuan University, No. 20, Section 3, Renmin Road South, Wuhou District, Chengdu, Sichuan, People's Republic of China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, Sichuan, China.
Sci Rep. 2024 Sep 4;14(1):20529. doi: 10.1038/s41598-024-71549-2.
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by vascular thrombosis and obstetric morbidity, with accurate laboratory examination of antiphospholipid antibodies (aPLs) being crucial for diagnosis. This study focused on anti-β2 glycoprotein I (aβ2GPI) antibodies and aimed to establish the first population-based cutoff values for aβ2GPI IgA/IgM/IgG antibodies in non-pregnant women of reproductive age in Southwest China. The study cohort comprised 181 healthy women of reproductive age for study. Blood samples were collected on an early morning fast. Anti-β2GPI antibodies including IgA, IgM and IgG were measured in serum using the HOB BioCLIA kit. According to the Clinical and Laboratory Standards Institute (CLSI) guidelines, the study used non-parametric percentile methods to calculate the 95th, 97.5th, and 99th percentiles cutoff values for aβ2GPI IgA/IgM/IgG antibodies, along with corresponding 90% confidence intervals (CI), while excluding outliers. A total of 168 independent samples were collected for verification, including 85 samples from healthy subjects and 83 samples from APS patients, in order to evaluate the analytical performance of the obtained cutoff values. The 99th percentile cutoff values were 3.36 RU/mL for aβ2GPI IgA, 27.54 RU/mL for aβ2GPI IgM and 1.81 RU/mL for aβ2GPI IgG, which indicated that the levels of aβ2GPI IgM antibodies were generally higher compared to those of IgA and IgG antibodies. Our established reference range was confirmed to be successful in validating the detected values of aβ2GPI antibodies in all healthy controls. With the 99th percentile cutoff value, the sensitivity was 14.46% for aβ2GPI IgA, 22.89% for aβ2GPI IgG, and 9.64% for aβ2GPI IgM in APS patients. This study established population-based cutoff values that are applicable to the local population for the accurate laboratory examination of aβ2GPI antibodies in non-pregnant women of reproductive age. The study also recommends paying more attention to IgM positivity in women of reproductive age.
抗磷脂综合征（APS）是一种自身免疫性疾病，其特征为血管血栓形成和产科发病率，准确的抗磷脂抗体（aPLs）实验室检查对诊断至关重要。本研究专注于抗β2糖蛋白 I（aβ2GPI）抗体，并旨在为中国西南部生育年龄的非妊娠妇女建立首个基于人群的 aβ2GPI IgA/IgM/IgG 抗体的参考值范围。研究队列包括 181 名生育年龄的健康女性。采集清晨空腹血样。使用 HOB BioCLIA 试剂盒在血清中测量抗β2GPI 抗体，包括 IgA、IgM 和 IgG。根据临床和实验室标准化协会（CLSI）指南，该研究使用非参数百分位法计算 aβ2GPI IgA/IgM/IgG 抗体的第 95、97.5 和 99 百分位参考值范围，同时排除离群值。共收集了 168 份独立样本进行验证，包括 85 份健康受试者样本和 83 份 APS 患者样本，以评估获得的参考值范围的分析性能。aβ2GPI IgA 的第 99 百分位参考值范围为 3.36 RU/mL，aβ2GPI IgM 为 27.54 RU/mL，aβ2GPI IgG 为 1.81 RU/mL，这表明 aβ2GPI IgM 抗体的水平通常高于 IgA 和 IgG 抗体。我们建立的参考范围成功验证了所有健康对照组中 aβ2GPI 抗体的检测值。使用第 99 百分位参考值范围，aβ2GPI IgA、aβ2GPI IgG 和 aβ2GPI IgM 在 APS 患者中的灵敏度分别为 14.46%、22.89%和 9.64%。本研究为非妊娠生育年龄妇女 aβ2GPI 抗体的准确实验室检查建立了基于人群的参考值范围，适用于当地人群。研究还建议在生育年龄的妇女中更加关注 IgM 阳性。
