The clinical and laboratory diagnosis of vaccine-induced immune thrombotic thrombocytopenia.
The clinical and laboratory diagnosis of vaccine-induced immune thrombotic thrombocytopenia.
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DOI：
10.1182/bloodadvances.2022007766
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发表时间：
2022-07-26
期刊：
影响因子：
7.5
通讯作者：
Nazy, Ishac
中科院分区：
文献类型：
--
作者：
Bissola, Anna-Lise;Daka, Mercy;Arnold, Donald M.;Smith, James W.;Moore, Jane C.;Clare, Rumi;Ivetic, Nikola;Kelton, John G.;Nazy, Ishac
在加拿大，VITT的临床诊断经常导致疾病大肆宣扬，因为大多数疑似患者的抗PF4抗体均为阴性。EIA检测抗PF4-Vitt抗体具有良好的敏感性和特异性，对诊断Vitt具有重要意义。疫苗诱导的免疫性血栓性血小板减少症(VITT)是一种罕见但严重的不良反应，发生在腺病毒载体新冠肺炎接种后5~30天。因此，随着腺病毒载体疫苗在全球的继续使用，需要对维生素T的临床评估和实验室测试进行实用评估，以防止出现重大不良后果。我们收到了2021年4月至7月期间加拿大156名疑似维生素T患者的临床信息和血液样本。针对血小板因子4(PF4)-14C-5羟色胺释放试验(SRA)的各种诊断实验室试验的性能特征进行了评估，包括商品化的抗PF4/肝素免疫球蛋白G(IgG)/IgA/IgM酶免疫分析(EIA，PF4增强型；免疫粘液)、内部特异性的抗PF4和抗PF4/肝素-EIA、标准SRA和PF4/肝素-SRA。在这些患者中，43例(27.6%)根据PF4-SRA阳性结果在血清学上确认为Vitt阳性，113例(72.4%)为Vitt阴性。市售抗PF4/肝素EIA、室内抗PF4-EIA和抗PF4/肝素-EIA均为阳性(100%敏感性)，少数假阳性(平均特异性为95.6%)。其特异性分别为95.6%(95%可信区间，90.0-98.6)、96.5%(95%可信区间，91.2-99.0)和97.4%(95%可信区间，92.4-99.5)。功能试验，包括标准SRA和PF4/肝素-SRA，对维生素T有较高的特异性(100%)，但敏感性较低(分别为16.7%[95%CI，7.0~31.4]和46.2%[95%CI，26.6~66.6])。这些发现表明，可以直接检测PF4或PF4/肝素抗体的EIA方法具有良好的性能特点，在F4-SRA不可用的情况下可用作诊断试验。
Clinical diagnosis of VITT often leads to disease overcall in Canada because most suspected patients are negative for anti-PF4 antibodies. EIAs have an excellent sensitivity and specificity for detecting anti-PF4 VITT antibodies and play an important role in diagnosis of VITT. Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare but serious adverse syndrome occurring 5 to 30 days after adenoviral vector COVID-19 vaccination. Therefore, a practical evaluation of clinical assessments and laboratory testing for VITT is needed to prevent significant adverse outcomes as the global use of adenoviral vector vaccines continues. We received the clinical information and blood samples of 156 patients in Canada with a suspected diagnosis of VITT between April and July 2021. The performance characteristics of various diagnostic laboratory tests were evaluated against the platelet factor 4 (PF4)-14C-serotonin release assay (SRA) including a commercial anti-PF4/heparin immunoglobulin G (IgG)/IgA/IgM enzyme immunoassay (EIA, PF4 Enhanced; Immucor), in-house IgG-specific anti-PF4 and anti-PF4/heparin-EIAs, the standard SRA, and the PF4/heparin-SRA. Of those, 43 (27.6%) had serologically confirmed VITT-positive based on a positive PF4-SRA result and 113 (72.4%) were VITT-negative. The commercial anti-PF4/heparin EIA, the in-house anti-PF4-EIA, and anti-PF4/heparin-EIA were positive for all 43 VITT-confirmed samples (100% sensitivity) with a few false-positive results (mean specificity, 95.6%). These immunoassays had specificities of 95.6% (95% confidence interval [CI], 90.0-98.6), 96.5% (95% CI, 91.2-99.0), and 97.4% (95% CI, 92.4-99.5), respectively. Functional tests, including the standard SRA and PF4/heparin-SRA, had high specificities (100%), but poor sensitivities for VITT (16.7% [95% CI, 7.0-31.4]; and 46.2% [95% CI, 26.6-66.6], respectively). These findings suggest EIA assays that can directly detect antibodies to PF4 or PF4/heparin have excellent performance characteristics and may be useful as a diagnostic test if the F4-SRA is unavailable.
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影响因子：
12.8
作者：
Kanack AJ;Singh B;George G;Gundabolu K;Koepsell SA;Abou-Ismail MY;Moser KA;Smock KJ;Green D;Major A;Chan CW;Wool GD;Reding M;Ashrani AA;Bayas A;Grill DE;Padmanabhan A
通讯作者：
Padmanabhan A
DOI：
10.1056/nejmoa2104840
发表时间：
2021-06-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Greinacher A;Thiele T;Warkentin TE;Weisser K;Kyrle PA;Eichinger S
通讯作者：
Eichinger S
影响因子：
10.4
作者：
Nazy, Ishac;Sachs, Ulrich J.;Bakchoul, Tamam
通讯作者：
Bakchoul, Tamam
影响因子：
10.4
作者：
Platton, Sean;Bartlett, Andrew;Pavord, Sue
通讯作者：
Pavord, Sue
DOI：
10.1016/j.lanepe.2021.100274
发表时间：
2022-01
期刊：
The Lancet regional health. Europe
影响因子：
--
作者：
Makris M;Pavord S
通讯作者：
Pavord S