Research and Development Division, Japan Blood Products Organization, Kobe, Hyogo, Japan.
Pharmacovigilance Division, Japan Blood Products Organization, Minato-ku, Tokyo, Japan.
Transfusion. 2024 Apr;64(4):597-605. doi: 10.1111/trf.17766. Epub 2024 Feb 23.
Intravenous immunoglobulins (IVIgs) derived from the pooled plasma of thousands of donors contain numerous types of IgG molecules, including autoantibodies commonly used to diagnose autoimmunity. While these autoantibodies can cause misinterpretation of serological tests for IVIg recipients, their profiles in IVIg preparations are not fully understood.
Using binding-capability based immune assays, we measured 18 varieties of clinically relevant autoantibodies in domestic blood donor-derived IVIg products. In addition, we analyzed an IVIg product from a US brand to evaluate the influence of regional and racial differences. Based on the determined autoantibody titers, pharmacokinetics of passively acquired autoantibodies and their possible detection period in serum were estimated.
Anti-thyroglobulin (Tg), anti-thyroidperoxidase (TPO), and anti-Sjögren's-syndrome-related antigen A (SS-A) antibodies were present in considerable amounts in IVIg products. Notably, these three autoantibodies can be detected in IVIg recipients' sera for up to 3 months after infusion.
To the best of our knowledge, this is the first study that analyzed multiple autoantibody profiles in both pooled plasma and IVIg products and that further evaluated their potential influences on diagnosis of autoimmunity. Clinicians should keep in mind that IVIgs contain several autoantibodies and that their infusion can produce false-positive serology results. To establish an accurate diagnosis, serological tests must be carefully interpreted and clinical symptoms should be more purposefully considered if patients are receiving IVIg therapy.
从数千名供体的混合血浆中提取的静脉注射免疫球蛋白（IVIg）含有多种 IgG 分子，包括常用于诊断自身免疫的自身抗体。虽然这些自身抗体可能导致 IVIg 受者血清学检测结果的错误解读，但它们在 IVIg 制剂中的分布情况尚未完全了解。
我们使用基于结合能力的免疫测定法，测量了国产血源 IVIg 产品中 18 种临床相关的自身抗体。此外，我们还分析了一种来自美国品牌的 IVIg 产品，以评估区域和种族差异的影响。根据确定的自身抗体滴度，估算了被动获得的自身抗体的药代动力学及其在血清中的可能检测期。
IVIg 产品中存在大量的抗甲状腺球蛋白（Tg）、抗甲状腺过氧化物酶（TPO）和抗干燥综合征相关抗原 A（SS-A）抗体。值得注意的是，这三种自身抗体在输注后长达 3 个月的时间内可在 IVIg 受者的血清中检测到。
据我们所知，这是第一项分析混合血浆和 IVIg 产品中多种自身抗体谱并进一步评估其对自身免疫诊断潜在影响的研究。临床医生应牢记 IVIg 含有多种自身抗体，其输注可能会产生假阳性的血清学结果。为了建立准确的诊断，必须仔细解释血清学检测结果，如果患者正在接受 IVIg 治疗，应更有针对性地考虑临床症状。
