Limited concordance of heparin/PF4 antibody assays for the diagnosis of heparin-induced thrombocytopenia: an analysis of the TORADI-HIT study.

Hammerer-Lercher, Angelika; Nilius, Henning; Studt, Jan-Dirk; Tsakiris, Dimitrios A; Greinacher, Andreas; Mendez, Adriana; Schmidt, Adrian; Wuillemin, Walter A; Gerber, Bernhard; Kremer Hovinga, Johanna A; Vishnu, Prakash; Graf, Lukas; Bakchoul, Tamam; Nagler, Michael (2023). Limited concordance of heparin/PF4 antibody assays for the diagnosis of heparin-induced thrombocytopenia: an analysis of the TORADI-HIT study. Journal of thrombosis and haemostasis, 21(9), pp. 2559-2568. Wiley-Blackwell 10.1016/j.jtha.2023.05.016

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BACKGROUND

Anecdotal reports suggest that the correlation between heparin/PF4 antibody assays for the diagnosis of heparin-induced thrombocytopenia (HIT) is limited. To address this issue, we investigated the correlation between widely used assays and examined possible factors contributing to variability.

METHODS

This is a large, prospective cohort study with 10 participating tertiary care hospitals including 1'393 patients with suspected HIT in clinical practice. HIT was defined by a positive heparin-induced platelet activation assay (HIPA; washed-platelet reference standard test). Three different immunoassays were used to measure heparin/PF4 antibodies: chemiluminescent immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), and particle gel immunoassay (PaGIA). Various factors that could influence the assays were examined: sex (male, female), age (< 65 years, ≥ 65 years), unfractionated heparin exposure, presence of thrombosis, cardiovascular surgery, and intensive care unit. Spearman's correlation coefficients were calculated. Z-scores, and diagnostic odds ratios (DOR) were determined in above-mentioned subgroups of patients.

RESULTS

Among 1,393 patients, 119 were classified as HIT positive (prevalence 8.5%). The median 4Ts score was 5 in patients with HIT (interquartile range, IQR, 4-6), compared to 3 in patients without (IQR 2-4). Correlations (rs) between immunoassays were weak (0.53 to 0.65). Inconsistencies between immunoassays could not be explained by further analyses of z-scored test results and DOR in subgroups of patients.

CONCLUSIONS

The correlation between widely used heparin/PF4 antibody assays was weak and key factors could not explain this variability. Standardization of immunoassays is requested to improve comparability.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory

Graduate School:

Graduate School for Health Sciences (GHS)

UniBE Contributor:

Nilius, Henning Jürgen Jean, Kremer Hovinga Strebel, Johanna Anna, Nagler, Michael

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1538-7836

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Pubmed Import

Date Deposited:

30 May 2023 10:14

Last Modified:

21 Aug 2023 00:13

Publisher DOI:

10.1016/j.jtha.2023.05.016

PubMed ID:

37247669

Uncontrolled Keywords:

contributing factors correlation diagnostic odds ratio heparin induced platelet activation assay heparin-induced thrombocytopenia heparin/PF4 antibody assays

BORIS DOI:

10.48350/183012

URI:

https://boris.unibe.ch/id/eprint/183012

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