一种用于肝素诱导的血小板减少症的新型诊断算法。

A novel diagnostic algorithm for heparin-induced thrombocytopenia.

作者信息

Zheng G, Streiff M B, Allison D, Takemoto C M, Salimian K, Morris P, Jani J, McCord R, Kickler T S

机构信息

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

出版信息

Int J Lab Hematol. 2018 Oct;40(5):527-532. doi: 10.1111/ijlh.12853. Epub 2018 May 13.

DOI:10.1111/ijlh.12853

PMID:29756276

Abstract

INTRODUCTION

While diagnostic algorithm using PF4-heparin enzyme-linked immunosorbent assay (ELISA) optical density (OD), and heparin neutralization assay (HNA), or 4T score have been proposed to replace serotonin-release assay (SRA) for heparin-induced thrombocytopenia (HIT), their performance against SRA is unclear. In this study, we proposed and validated the performance of a new algorithm combining PF4-heparin ELISA optical density (OD), HNA and 4T score against SRA for HIT diagnosis.

METHODS

Heparin neutralization assays were performed on specimens submitted for HIT testing with positive PF4-heparin ELISA from December 2015 to September 2017, which were separated into a "training" and a "validation" data set. 4T scores were calculated for ELISA positive cases.

RESULTS

A total of 123 consecutive unique patient samples had positive PF4-heparin ELISA with also HNA data, SRA data, and 4T scores available. Compared to SRA, a "laboratory criteria" (ELISA OD ≥ 1.4 and HNA ≥ 70%) had a sensitivity of 88% (14/16) and specificity of 91% (42/46), and a "combined criteria" (4T score = 8, or 4T score = 6 or 7 and ELISA OD ≥ 1.0, or 4T score = 4 or 5 and ELISA OD ≥ 2.0) had a sensitivity of 75% (12/16) and specificity of 98% (45/46) in the training data set. Laboratory and combined criteria had 90% (56/62) concordance rate. Importantly, for these concordant cases, the diagnostic specificity is 100% (46/46). Based on the data, a novel diagnostic algorithm combining these 2 criteria was proposed and validated prospectively.

CONCLUSION

A novel algorithm has high diagnostic accuracy and potentially could eliminate the need for SRA testing in at least 90% patients with suspected HIT.

摘要

引言

虽然已提出使用血小板第4因子（PF4）-肝素酶联免疫吸附测定（ELISA）光密度（OD）、肝素中和试验（HNA）或4T评分的诊断算法来替代血清素释放试验（SRA）以诊断肝素诱导的血小板减少症（HIT），但其与SRA相比的性能尚不清楚。在本研究中，我们提出并验证了一种结合PF4-肝素ELISA光密度（OD）、HNA和4T评分的新算法与SRA相比用于HIT诊断的性能。

方法

对2015年12月至2017年9月提交进行HIT检测且PF4-肝素ELISA呈阳性的标本进行肝素中和试验，这些标本被分为一个“训练”数据集和一个“验证”数据集。计算ELISA阳性病例的4T评分。

结果

共有123例连续的独特患者样本PF4-肝素ELISA呈阳性，同时有HNA数据、SRA数据和4T评分。与SRA相比，“实验室标准”（ELISA OD≥1.4且HNA≥70%）在训练数据集中的敏感性为88%（14/16），特异性为91%（42/46），“联合标准”（4T评分为8，或4T评分为6或7且ELISA OD≥1.0，或4T评分为4或5且ELISA OD≥2.0）的敏感性为75%（12/16），特异性为98%（45/46）。实验室标准和联合标准的符合率为90%（56/62）。重要的是，对于这些一致的病例，诊断特异性为100%（46/46）。基于这些数据，提出并前瞻性地验证了一种结合这两个标准的新型诊断算法。