Kohlhase Konstantin, Schaefer Jan Hendrik, Miesbach Wolfgang, Hintereder Gudrun, Kirchmayr Konstantin, Zwinge Birga, Yalachkov Yavor, Foerch Christian, Schaller-Paule Martin A
Department of Neurology, University Hospital Frankfurt, Goethe-University, Frankfurt am Main, Germany.
Department of Haemostaseology and Hemophilia Center, Medical Clinic 2, Institute of Transfusion Medicine, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
Front Neurol. 2022 Oct 20;13:951802. doi: 10.3389/fneur.2022.951802. eCollection 2022.
Measurement of D-dimer in cerebrospinal fluid (CSF) allows insight into coagulation system activation in the central nervous system and can be utilized to monitor intracranial hemorrhage as well as acute phase processes beyond hemostasis in inflammatory and neoplastic diseases. So far, the measurability of D-dimer in low and very low concentrations in CSF was limited in conventional immunoassays. Novel high-sensitivity chemiluminescent immunoassays such as the luminescent oxygen channeling immunoassay (LOCI) are getting increasingly available but have not been validated in CSF. The aim of this study was to investigate the accuracy and linearity of the LOCI in assessing D-dimer in CSF.
INNOVANCE LOCI hs D-dimer reagent cartridge was used for the measurement of D-dimer in CSF of patients with different neurological diseases. For the evaluation of linearity, dilution series were performed in a pooled CSF sample with the determination of intra-assay precision (CV, coefficient of variation) in 3 individual samples with 20 replicates. Furthermore, D-dimer concentrations measured by LOCI were compared with the respective results of a routinely available clinical latex-enhanced immunoassay (HemosiIL D-Dimer HS 500).
Linear regression analysis of the LOCI method revealed a of 1.00 ( < .001) with a regression coefficient B of 1.012 ± 0.003 (CI: 1.005-1.019, < .001) and an intercept of -1.475 ± 1.309 (CI: -4.493 to 1.543); the median intra-assay CV was 0.69% (range: 0.68-0.75). In total, 185 CSF samples were measured by LOCI technology, showing a mean concentration of 204.84 ± 2,214.93 ng/ml. D-dimer concentration between LOCI and latex-enhanced immunoassay differed by a factor of 10.6 ± 13.6 on average with a maximum deviation by a factor of 61.3; the maximum deviation was found at low concentrations.
D-dimer in CSF of patients with neurological disease can be reliably measured by the LOCI method with high linearity and accuracy at low concentrations.
脑脊液（CSF）中D - 二聚体的检测有助于深入了解中枢神经系统的凝血系统激活情况，可用于监测颅内出血以及炎症和肿瘤性疾病中止血以外的急性期过程。到目前为止，在传统免疫测定中，脑脊液中低浓度和极低浓度D - 二聚体的可测量性有限。新型高灵敏度化学发光免疫测定法，如发光氧通道免疫测定法（LOCI）越来越普及，但尚未在脑脊液中得到验证。本研究的目的是探讨LOCI在评估脑脊液中D - 二聚体时的准确性和线性。
使用INNOVANCE LOCI hs D - 二聚体试剂卡盒检测不同神经系统疾病患者脑脊液中的D - 二聚体。为评估线性，在混合脑脊液样本中进行稀释系列，并在3个单独样本中进行20次重复测定以确定批内精密度（CV，变异系数）。此外，将LOCI测定的D - 二聚体浓度与常规临床乳胶增强免疫测定法（HemosiIL D - Dimer HS 500）的相应结果进行比较。
LOCI方法的线性回归分析显示r为1.00（P <.001），回归系数B为1.012±0.003（CI：1.005 - 1.019，P <.001），截距为 - 1.475±1.309（CI： - 4.493至1.543）；批内CV中位数为0.69%（范围：0.68 - 0.75）。总共用LOCI技术检测了185份脑脊液样本，平均浓度为204.84±2214.93 ng/ml。LOCI与乳胶增强免疫测定法之间的D - 二聚体浓度平均相差10.6±13.6倍，最大偏差为61.3倍；最大偏差出现在低浓度时。
LOCI方法能够可靠地检测神经系统疾病患者脑脊液中的D - 二聚体，在低浓度下具有高线性和准确性。
