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Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is a common differential diagnosis in cardiothoracic surgery. The latex immunoturbidimetric assay (LIA) is an enhanced immunoassay that has recently been introduced for the detection of total HIT immunoglobulin and retains a higher specificity of 95...

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Autores principales: Hernandez, Jessica, Patel, Hetal, Biddlecome, Phil, Kildea, Megan, Dwivedi, Ruti, Sridhara, Shashank, Silvestry, Scott, Cavarocchi, Nicholas, Francis, John L., Ventura, Davide
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10123911/
https://www.ncbi.nlm.nih.gov/pubmed/37069794
http://dx.doi.org/10.1177/10760296231166370
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author Hernandez, Jessica
Patel, Hetal
Biddlecome, Phil
Kildea, Megan
Dwivedi, Ruti
Sridhara, Shashank
Silvestry, Scott
Cavarocchi, Nicholas
Francis, John L.
Ventura, Davide
author_facet Hernandez, Jessica
Patel, Hetal
Biddlecome, Phil
Kildea, Megan
Dwivedi, Ruti
Sridhara, Shashank
Silvestry, Scott
Cavarocchi, Nicholas
Francis, John L.
Ventura, Davide
author_sort Hernandez, Jessica
collection PubMed
description BACKGROUND: Heparin-induced thrombocytopenia (HIT) is a common differential diagnosis in cardiothoracic surgery. The latex immunoturbidimetric assay (LIA) is an enhanced immunoassay that has recently been introduced for the detection of total HIT immunoglobulin and retains a higher specificity of 95% compared to the enzyme-linked immunosorbent assay. OBJECTIVES: To investigate if a semiquantitative relationship exists between increasing LIA levels beyond the current positivity threshold and its correlation to positive serotonin release assay results in cardiothoracic surgery. METHODS: This was a multicenter, observational cohort of cardiothoracic surgery patients initiated on anticoagulation with heparin-based products. To conduct sensitivity and specificity analysis of LIA values, HIT positive was defined as a LIA value ≥1 unit/mL and HIT negative was defined as a LIA level <1 unit/mL. A receiver operating characteristic (ROC) analysis was utilized to evaluate the predictive performance of the LIA. RESULTS: At manufactures’ cutoffs of ≥1.0 unit/mL, LIA sensitivity and specificity was 93.8% and 22%, respectively, yielding a false positive rate of 78%. At a higher cutoff of 4.5 units/mL, LIA sensitivity and specificity was 75% and 71%, respectively, yielding a false positive rate of 29% and an area under the ROC curve of 0.75 (P = .01; 95% confidence interval: 0.621-0.889). Bivalirudin was initiated in 84.6% of false positive LIA results. CONCLUSION: This study suggests that the diagnostic accuracy of the LIA can be optimized by increasing the LIA positivity threshold. Proposing a higher LIA cutoff, may mitigate unwarranted anticoagulation and bleeding outcomes.
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spelling pubmed-101239112023-04-25 Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery Hernandez, Jessica Patel, Hetal Biddlecome, Phil Kildea, Megan Dwivedi, Ruti Sridhara, Shashank Silvestry, Scott Cavarocchi, Nicholas Francis, John L. Ventura, Davide Clin Appl Thromb Hemost Original Manuscript BACKGROUND: Heparin-induced thrombocytopenia (HIT) is a common differential diagnosis in cardiothoracic surgery. The latex immunoturbidimetric assay (LIA) is an enhanced immunoassay that has recently been introduced for the detection of total HIT immunoglobulin and retains a higher specificity of 95% compared to the enzyme-linked immunosorbent assay. OBJECTIVES: To investigate if a semiquantitative relationship exists between increasing LIA levels beyond the current positivity threshold and its correlation to positive serotonin release assay results in cardiothoracic surgery. METHODS: This was a multicenter, observational cohort of cardiothoracic surgery patients initiated on anticoagulation with heparin-based products. To conduct sensitivity and specificity analysis of LIA values, HIT positive was defined as a LIA value ≥1 unit/mL and HIT negative was defined as a LIA level <1 unit/mL. A receiver operating characteristic (ROC) analysis was utilized to evaluate the predictive performance of the LIA. RESULTS: At manufactures’ cutoffs of ≥1.0 unit/mL, LIA sensitivity and specificity was 93.8% and 22%, respectively, yielding a false positive rate of 78%. At a higher cutoff of 4.5 units/mL, LIA sensitivity and specificity was 75% and 71%, respectively, yielding a false positive rate of 29% and an area under the ROC curve of 0.75 (P = .01; 95% confidence interval: 0.621-0.889). Bivalirudin was initiated in 84.6% of false positive LIA results. CONCLUSION: This study suggests that the diagnostic accuracy of the LIA can be optimized by increasing the LIA positivity threshold. Proposing a higher LIA cutoff, may mitigate unwarranted anticoagulation and bleeding outcomes. SAGE Publications 2023-04-17 /pmc/articles/PMC10123911/ /pubmed/37069794 http://dx.doi.org/10.1177/10760296231166370 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Manuscript
Hernandez, Jessica
Patel, Hetal
Biddlecome, Phil
Kildea, Megan
Dwivedi, Ruti
Sridhara, Shashank
Silvestry, Scott
Cavarocchi, Nicholas
Francis, John L.
Ventura, Davide
Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title_full Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title_fullStr Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title_full_unstemmed Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title_short Evaluation of Latex Immunoturbidimetric Assay Thresholds and HIT in Cardiothoracic Surgery
title_sort evaluation of latex immunoturbidimetric assay thresholds and hit in cardiothoracic surgery
topic Original Manuscript
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10123911/
https://www.ncbi.nlm.nih.gov/pubmed/37069794
http://dx.doi.org/10.1177/10760296231166370
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