Flow Cytometry-based Functional Assay is a Valuable Diagnostic Approach for Confirmation of Heparin-Induced Thrombocytopenia

Norouzi, Mahshaad; Balagholi, Sahar; Teimourpour, Amir; Ahmadinejad, Minoo

doi:10.61186/ijbc.16.4.30

Volume 16, Issue 4 (December 2024 2024) Iranian Journal of Blood and Cancer 2024, 16(4): 30-38 | Back to browse issues page

‎ 10.61186/ijbc.16.4.30

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Norouzi M, Balagholi S, Teimourpour A, Ahmadinejad M. Flow Cytometry-based Functional Assay is a Valuable Diagnostic Approach for Confirmation of Heparin-Induced Thrombocytopenia. Iranian Journal of Blood and Cancer 2024; 16 (4) :30-38
URL: http://ijbc.ir/article-1-1644-en.html

Flow Cytometry-based Functional Assay is a Valuable Diagnostic Approach for Confirmation of Heparin-Induced Thrombocytopenia

Mahshaad Norouzi¹

, Sahar Balagholi¹

, Amir Teimourpour¹

, Minoo Ahmadinejad ^*²

1- Blood Transfusion Research Center, High Institute for Education and Research in Transfusion Medicine, Tehran, Iran.
2- Blood Transfusion Research Center, High Institute for Education and Research in Transfusion Medicine, Tehran, Iran. , minooam@gmail.com

Abstract: (474 Views)

Background: Heparin-induced thrombocytopenia (HIT) is a serious immunological adverse drug reaction that rarely occurs in patients receiving heparin. The heparin-induced platelet activation (HIPA) test, a gold-standard assay for HIT, is time-consuming, challenging, and produces qualitative results. We aimed to compare the performance properties of a flow cytometry-based functional assay for HIT diagnosis with HIPA assay.
Materials and Methods: This research was carried out on HIT-suspected patients referred to the Iranian Blood Transfusion Organization between 2021 and 2023. After clinical evaluation and 4Ts scores calculation, anti-PF4 screening and HIPA test were conducted. Thirty HIPA-positive and 30 HIPA-negative samples were selected. Subsequently, a flow cytometry-based functional assay, Emo-Test HIT confirm, was performed, and the sensitivity and specificity for HIT diagnosis were measured.
Results: Among the 30 samples with negative HIPA results, one was positive with the Emo-test HIT Confirm® assay, and the remaining were negative. Among 30 positive HIPA samples, the result of one sample was inconclusive, two samples were negative with flowcytometry Emo-test and the others were positive. The sensitivity and specificity of this flow cytometry-based functional assay were 90% (95% CI: 79.3-100) and 96.6% (95% CI:90.2-100). The negative predictive value and positive predictive value were 93.5% and 96.4% respectively.
Conclusion: Flow cytometry-based functional assay has a good sensitivity and specificity for HIT diagnosis confirmation, indicating that it may be a promising approach in the clinical setting.

Keywords: Heparin-induced thrombocytopenia (HIT), Diagnosis, Flow cytometry, Functional assay

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: Original Article | Subject: Adults Hematology & Oncology
Received: 2024/11/10 | Accepted: 2024/12/3 | Published: 2024/12/30

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