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• W3186331446 abstract "Introduction. Prompt diagnostic work-up is critical for guiding clinical management of patients with suspected heparin-induced thrombocytopenia (HIT). We assessed the diagnostic performance of three immunoassays detecting anti-PF4/heparin-antibodies in predicting the outcome of the functional gold standard HIPA assay. We derived a diagnostic algorithm with a short analytical turnaround-time (TAT) and prospectively validated its accuracy to rule in or rule out HIT. Methods. Retrospective (n=221, 5.2014-8.2015) and prospective (n=305, 9.2015-12.2016) derivation cohorts of patients with suspected HIT were studied. Plasma samples were analysed by Zymutest-HIA-IgG, HemosIL-AcuStar-HIT-IgG and ID-H/PF4-PaGIA. Likelihood ratios (LR) of result intervals and cut-off values with 100% negative (NPV) and positive (PPV) predictive value for positive HIPA were calculated. A sequential diagnostic algorithm based on Bayesian combination of pretest clinical probability and LR of first- and second-line testing by rapid immunoassays was derived and prospectively validated (n=300, 1.2017-6.2018). Results. Derivation cohorts allowed to calculate LR and cut-offs with 100% NPV ( 3.0 U/ml; ≥16, respectively) for positive HIPA. During prospective validation of the derived diagnostic algorithm, AcuStar-HIT-IgG was used as first-line and unique testing in 242/300 cases (80.7%) (TAT 30 min). In 58/300 initially unresolved cases (19.3%), ID-H/PF4-PaGIA was used as second-line testing (additional TAT 30 min). This combined approach accurately ruled in and ruled out HIT in 28/300 (9.3%) and 263/300 (87.7%) patients with clinically suspected HIT, respectively. Only 9/300 (3.0%) cases remained unresolved. The algorithm identified 3/300 (1.0%) patients with probable HIT despite a negative HIPA. Conclusion. The stepwise combination of pretest HIT clinical probability with first- and second-line testing by rapid immunoassays for anti-PF4/heparin-antibodies is accurate for ruling in or ruling out HIT in ≥95% of cases with an analytical TAT of 60 minutes. This sequential diagnostic approach improves clinical management of patients with suspected HIT. Funding: None. Declaration of Interest: The authors do not have any conflicts of interest to declare. Ethical Approval: The study was approved by the Institutional ethical board (Commission cantonale Vaudoise d’ethique de la recherche sur l’etre humain, CER-VD, protocol number 497/95). Patient informed consent was not required for this quality control assessment of clinical laboratory practice." @default.
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• W3186331446 date "2018-01-01" @default.
• W3186331446 modified "2023-09-27" @default.
• W3186331446 title "Sequential Bayesian Approach for Rapid and Accurate Diagnosis of Heparin-Induced Thrombocytopenia: A Prospective Derivation and Validation Study with 826 Patients" @default.
• W3186331446 doi "https://doi.org/10.2139/ssrn.3211575" @default.
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