Abstract：
OBJECTIVE: Intravenous immunoglobulins (IVIgs) contain various autoantibodies, including those against glutamic acid decarboxylase (GADAb), a valuable biomarker of type 1 diabetes mellitus. Passive transfer of GADAb from IVIgs to patients poses a risk of misdiagnosis, and information on the specific titres of GADAb and their impact on diagnostic accuracy remains limited. This study aimed to provide further insights into the origin of GADAb detected in patient serum following IVIg infusion.
METHODS: GADAb titres in IVIg products from Japan and the United States were measured using enzyme-linked immunosorbent assay-based assays. For reliable quantification, GADAb titres in pooled plasma were quantified and compared with those in the IVIg products. The determined titres were used to estimate the likelihood of passively detecting acquired GADAb in individuals receiving IVIgs.
RESULTS: GADAbs were prevalent in IVIg products; however, the titres varied significantly among different lots and products. Importantly, IVIg-derived GADAb was estimated to remain detectable in patient serum for up to 100 days following a dosage of 2000 mg/kg.
CONCLUSIONS: Clinicians should consider that IVIg preparations may contain GADAb, which can lead to false-positive results in serological assays. Careful interpretation of the assay results is key to the definitive diagnosis of type 1 diabetes mellitus.
METHODS: GADAb titres in IVIg products from Japan and the United States were measured using enzyme-linked immunosorbent assay-based assays. For reliable quantification, GADAb titres in pooled plasma were quantified and compared with those in the IVIg products. The determined titres were used to estimate the likelihood of passively detecting acquired GADAb in individuals receiving IVIgs.
RESULTS: GADAbs were prevalent in IVIg products; however, the titres varied significantly among different lots and products. Importantly, IVIg-derived GADAb was estimated to remain detectable in patient serum for up to 100 days following a dosage of 2000 mg/kg.
CONCLUSIONS: Clinicians should consider that IVIg preparations may contain GADAb, which can lead to false-positive results in serological assays. Careful interpretation of the assay results is key to the definitive diagnosis of type 1 diabetes mellitus.
摘要：
目的：静脉免疫球蛋白（IVIg）含有各种自身抗体，包括抗谷氨酸脱羧酶（GADAb），1型糖尿病的有价值的生物标志物。GADAb从IVIg被动转移到患者存在误诊的风险，以及关于GADAb的特定滴度及其对诊断准确性的影响的信息仍然有限。这项研究旨在提供对IVIg输注后患者血清中检测到的GADAb起源的进一步见解。
方法：使用基于酶联免疫吸附测定的测定法测量来自日本和美国的IVIg产品中的GADAb滴度。为了可靠的量化，定量汇集的血浆中的GADAb滴度,并与IVIg产品中的GADAb滴度进行比较。确定的滴度用于估计在接受IVIg的个体中被动检测获得性GADAb的可能性。
结果：GADAb在IVIg产品中普遍存在；然而，不同批次和产品的滴度差异很大。重要的是,在2000mg/kg的剂量后,估计IVIg衍生的GADAb在患者血清中保持可检测长达100天。
结论：临床医生应考虑IVIg制剂可能含有GADAb，这可能导致血清学检测中的假阳性结果。对测定结果的仔细解释是明确诊断1型糖尿病的关键。
方法：使用基于酶联免疫吸附测定的测定法测量来自日本和美国的IVIg产品中的GADAb滴度。为了可靠的量化，定量汇集的血浆中的GADAb滴度,并与IVIg产品中的GADAb滴度进行比较。确定的滴度用于估计在接受IVIg的个体中被动检测获得性GADAb的可能性。
结果：GADAb在IVIg产品中普遍存在；然而，不同批次和产品的滴度差异很大。重要的是,在2000mg/kg的剂量后,估计IVIg衍生的GADAb在患者血清中保持可检测长达100天。
结论：临床医生应考虑IVIg制剂可能含有GADAb，这可能导致血清学检测中的假阳性结果。对测定结果的仔细解释是明确诊断1型糖尿病的关键。
