Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia.
NSW Health Pathology, NSW, Australia.
J Thromb Haemost. 2021 Feb;19(2):417-428. doi: 10.1111/jth.15157. Epub 2020 Nov 21.
Thrombotic thrombocytopenic purpura (TTP) is a rare but potentially fatal disorder caused by ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) deficiency. Prompt identification/exclusion of TTP can thus be facilitated by rapid ADAMTS13 testing. The most commonly utilized (enzyme-linked immunosorbent assay [ELISA]-based) assay takes several hours to perform and so does not generally permit rapid testing.
To evaluate the utility of a new automated test for ADAMTS13 activity, the HemosIL AcuStar ADAMTS13 Activity assay, based on chemiluminescence and able to be performed on an ACL AcuStar instrument within 33 minutes.
PATIENTS/METHODS: This multicenter (n = 8) assessment included testing of more than 700 test samples, with similar numbers of prospective (n = 348) and retrospective (n = 385) samples. The main comparator was the Technozym ADAMTS13 Activity ELISA. We also assessed comparative performance for detection of ADAMTS13 inhibitors using a Bethesda assay.
Overall, the chemiluminescent assay yielded similar results to the comparator ELISA, albeit with slight negative bias. ADAMTS13 inhibitor detection was also comparable, albeit with slight positive bias with the AcuStar assay. Assay precision was similar with both assays, and we also verified assay normal reference ranges.
The HemosIL AcuStar ADAMTS13 Activity assay provided results rapidly, which were largely comparable with the Technozym ADAMTS13 Activity ELISA assay, albeit lower on average. Conversely, inhibitor levels tended to be identified at a higher level on average. Thus, the HemosIL AcuStar ADAMTS13 Activity assay provides a fast and accurate means to quantitate plasma levels of ADAMTS13 for TTP/ADAMTS13 identification/exclusion, and potentially also for other applications.
血栓性血小板减少性紫癜（TTP）是一种罕见但潜在致命的疾病，由 ADAMTS13（一种具有血小板反应蛋白 1 型基序的解整合素和金属蛋白酶 13）缺乏引起。因此，通过快速 ADAMTS13 检测可以促进 TTP 的快速识别/排除。最常用的（基于酶联免疫吸附试验 [ELISA] 的）检测方法需要几个小时才能完成，因此通常不允许快速检测。
评估一种新的 ADAMTS13 活性自动化检测方法的实用性，该方法基于化学发光，可在 ACL AcuStar 仪器上在 33 分钟内完成，称为 HemosIL AcuStar ADAMTS13 活性检测。
患者/方法：这项多中心（n=8）评估包括对 700 多个测试样本的测试，前瞻性样本（n=348）和回顾性样本（n=385）数量相似。主要比较器是 Technozym ADAMTS13 活性 ELISA。我们还评估了使用贝塞斯达检测法检测 ADAMTS13 抑制剂的比较性能。
总体而言，化学发光检测法与比较 ELISA 产生了相似的结果，尽管存在轻微的负偏倚。ADAMTS13 抑制剂的检测结果也相似，尽管 AcuStar 检测法存在轻微的正偏倚。两种检测方法的精密度相似，我们还验证了检测正常参考范围。
HemosIL AcuStar ADAMTS13 活性检测法提供了快速的结果，与 Technozym ADAMTS13 活性 ELISA 检测法基本相当，尽管平均水平略低。相反，抑制剂水平平均倾向于以更高的水平识别。因此，HemosIL AcuStar ADAMTS13 活性检测法为 TTP/ADAMTS13 的识别/排除提供了一种快速准确的定量检测血浆 ADAMTS13 水平的方法，并且可能还有其他应用。
