快速免疫检测组合用于快速诊断肝素诱导的血小板减少症。
Combinations of rapid immunoassays for a speedy diagnosis of heparin-induced thrombocytopenia.
机构信息
Division of Haematology and Central Haematology Laboratory, Lausanne University Hospital (CHUV) and University of Lausanne (UNIL), Lausanne, Switzerland.
出版信息
J Thromb Haemost. 2022 Oct;20(10):2407-2418. doi: 10.1111/jth.15811. Epub 2022 Jul 27.
BACKGROUND
Early recognition and treatment of heparin-induced thrombocytopenia (HIT) are key to prevent severe complications.
OBJECTIVE
To assess the diagnostic performance of rapid immunoassays (IA) in detecting anti-PF4/heparin-antibodies.
METHODS
Diagnostic performances of lateral-flow IA (LFIA; STic Expert HIT) and latex IA (LIA; HemosIL HIT-Ab) were analyzed in pilot (n = 74) and derivation cohorts (n = 267). Two novel algorithms based on the combination of HIT clinical probability with sequentially performed LIA and chemiluminescent IA (CLIA; HemosIL AcuStar-HIT-IgG) were compared with published rapid diagnostic algorithms: the "Lausanne algorithm" sequentially combining CLIA and particle-gel IA (PaGIA) and the "Hamilton algorithm" based on simultaneously performed LIA and CLIA.
RESULTS
LFIA missed 6/30 HIT. The sensitivity and specificity of LIA were 90.9% and 93.5%. The Lausanne algorithm correctly predicted HIT in 19/267 (7.1%), excluded it in 240/267 (89.9%), leaving 8/267 (3%) cases unsolved. The algorithm sequentially combining CLIA and LIA predicted HIT in 19/267 (7.1%) with 1/19 wrong prediction, excluded it in 236/267 (88.4%), leaving 11/267 (4.1%) cases unsolved. The algorithm employing LIA as a first assay predicted HIT in 22/267 (8.2%), excluded it in 235/267 (88%), leaving 9/267 (3.4%) cases unsolved. Finally, the Hamilton algorithm correctly predicted HIT in 10/267 (3.7%), excluded it in 229/267 (85.7%), leaving 28/267 (10.5%) cases unsolved.
CONCLUSION
LFIA cannot be used to exclude or predict HIT when using frozen plasma. A Bayesian approach sequentially employing two rapid immunoassays for anti-PF4/heparin antibodies is most effective for the accurate diagnosis of HIT. Based on retrospective data, the combination LIA/CLIA is a candidate for a prospective validation.
背景
早期识别和治疗肝素诱导的血小板减少症（HIT）是预防严重并发症的关键。
目的
评估快速免疫测定（IA）在检测抗 PF4/肝素抗体中的诊断性能。
方法
在试点（n=74）和推导队列（n=267）中分析了侧向流动 IA（LFIA；STic Expert HIT）和乳胶 IA（LIA；HemosIL HIT-Ab）的诊断性能。两种基于 HIT 临床概率与连续进行的 LIA 和化学发光 IA（CLIA；HemosIL AcuStar-HIT-IgG）相结合的新算法与已发表的快速诊断算法进行了比较：“洛桑算法”依次结合 CLIA 和颗粒凝胶 IA（PaGIA），以及基于同时进行的 LIA 和 CLIA 的“汉密尔顿算法”。
结果
LFIA 漏诊了 30 例中的 6 例 HIT。LIA 的敏感性和特异性分别为 90.9%和 93.5%。洛桑算法正确预测了 267 例中的 19 例 HIT（7.1%），排除了 240 例中的 267 例（89.9%），还有 8 例（3%）未解决。依次结合 CLIA 和 LIA 的算法预测了 267 例中的 19 例 HIT（7.1%），其中 1 例预测错误，排除了 236 例中的 267 例（88.4%），还有 11 例（4.1%）未解决。采用 LIA 作为初次检测的算法预测了 267 例中的 22 例 HIT（8.2%），排除了 235 例中的 267 例（88%），还有 9 例（3.4%）未解决。最后，汉密尔顿算法正确预测了 267 例中的 10 例 HIT（3.7%），排除了 229 例中的 267 例（85.7%），还有 28 例（10.5%）未解决。
结论
当使用冷冻血浆时，LFIA 不能用于排除或预测 HIT。一种基于贝叶斯方法的连续使用两种快速免疫测定方法检测抗 PF4/肝素抗体的方法是准确诊断 HIT 的最有效方法。基于回顾性数据，LIA/CLIA 的组合是前瞻性验证的候选方法。
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