肝素对免疫性肝素诱导的血小板减少症-IgG化学发光检测的影响

摘要(中文译文)

肝素诱导的血小板减少症（HIT）需要临床评估和实验室检测，采用免疫学方法检测并需通过功能性检测如5-羟色胺释放试验（SRA）加以确认。HIT-IgG化学发光免疫分析法（CLIA）是一种快速免疫学检测方法；本研究旨在评估肝素对该检测的影响。评估了低剂量（0.1 U/ml）和高剂量（100 U/ml）肝素对CLIA HIT-IgG检测的影响，这些浓度与SRA所用浓度一致。利用现有经预先检测的患者样本（血浆或血清）组成队列，包括HIT-IgG阴性样本（即<1.0 U/ml）（n=22）和HIT-IgG阳性样本（即≥1.0 U/ml）（n=25），后者分为“低阳性”（1.0-<10 U/ml；n=16）和“高阳性”（≥10 U/ml；n=9）。低剂量肝素用于在SRA中启动5-羟色胺释放，对任何HIT-IgG组的CLIA HIT-IgG检测均无明显影响。高剂量肝素用于在SRA中抑制5-羟色胺释放，对HIT-IgG检测产生可变影响，通常降低高阳性样本中检测到的HIT-IgG水平，且大多降低低阳性样本中检测到的HIT-IgG水平。然而，阴性和低阳性组的部分样本显示HIT-IgG信号出现反直觉的升高。肝素水平可能以多种方式影响HIT-IgG检测值。尽管高阳性样本在高剂量肝素作用下显示预期的信号降低，但部分低阳性和阴性样本显示意外的信号升高。这些发现是否有助于识别病理性HIT或不同的HIT亚型，尚需进一步研究。

Abstract

Heparin-induced thrombocytopenia (HIT) requires clinical evaluation and laboratory testing using immunological assays with confirmation by functional assays such as serotonin release assay (SRA). The HIT-IgG chemiluminescence immunoassay (CLIA) is a rapid immunological assay; we aimed to assess the effect of heparin on this assay. The effect of low-dose (0.1 U/ml) and high-dose (100 U/ml) heparin on the CLIA HIT-IgG assay was evaluated, these concentrations aligning to those used for SRA. A cohort of available pretested patient material (plasma or serum) comprised samples negative for HIT-IgG (i.e., <1.0 U/ml) (n = 22), or positive for HIT-IgG (i.e., ≥1.0 U/ml) ( n = 25), with the latter split into 'low positive' (1.0-<10 U/ml; n = 16) and 'high positive' (≥10 U/ml; n = 9). Low-dose heparin, used for initiating serotonin release in SRA, had no appreciable effect on the CLIA HIT-IgG assay for any HIT-IgG group. High-dose heparin, used for inhibiting serotonin release in SRA, had a variable effect on HIT-IgG testing, generally reducing detected HIT-IgG levels in high positive samples, and mostly reducing detected HIT-IgG levels in low positive samples. However, some samples from negative and low positive groups showed counterintuitive increases in HIT-IgG signal. Heparin levels may influence HIT-IgG test values in various ways. Although high positive samples showed an expected decrease in signal with high-dose heparin, some low positive and negative samples showed unexpected increases in signal. Whether these findings improve identification of pathological HIT, or of variable HIT subtypes, requires further investigation.

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