Clinical validation of immunoassay HemosIL® AcuStar HIT-IgG (PF4-H) in the diagnosis of Heparin-induced thrombocytopenia.
4 T score
Chemiluminescent
Heparin
Heparin induced thrombocytopenia
Immunoassay
Journal
Journal of thrombosis and thrombolysis
ISSN: 1573-742X
Titre abrégé: J Thromb Thrombolysis
Pays: Netherlands
ID NLM: 9502018
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
accepted:
17
11
2020
pubmed:
3
1
2021
medline:
28
1
2022
entrez:
2
1
2021
Statut:
ppublish
Résumé
Heparin induced thrombocytopenia (HIT) is a life and limb-threatening complication of heparin exposure. The misdiagnosis of this disease can have major consequences on the patients. The objective of this study was to evaluate a diagnostic strategy that combines the 4Ts score with the result of HemosIL® AcuStar HIT-IgG (PF4-H) to confirm the diagnosis of HIT. Citrated plasmas from 1300 patients with suspicion of HIT were analyzed with a fully automated quantitative chemiluminescent immunoassay (HemosIL® AcuStar HIT-IgG (PF4/H)). If the IgG anti-PF4/H antibodies were positive (cut-off, 1 U/mL), HIT diagnosis was confirmed using functional tests. In total, 1300 samples of consecutive patients were enrolled, 94 (7.2%) of which gave positive results in HemosIL® AcuStar-IgG. HIT was diagnosed in 65 out of these patients, corresponding to a prevalence of 5%. Using ROC curve analysis, patients were divided into three groups according to their titer of antibodies. Higher values of the IgG (PF4-H) were associated with increased probability of HIT, and the diagnostic specificity was greatly increased using the combination of a 4Ts score > 3 and a positive titer ≥ 3.25 U/mL. Importantly, the diagnostic specificity is 100% when the titer is > 12.40 U/mL. We demonstrated that higher values of Anti PF4/H Antibodies were associated with a high probability of having HIT. A titer of HemosIL® IgG (PF4-H) > 12.40 U/mL has a specificity of 100% which should no require a functional test to confirm the diagnosis of HIT.
Identifiants
pubmed: 33386560
doi: 10.1007/s11239-020-02349-4
pii: 10.1007/s11239-020-02349-4
doi:
Substances chimiques
Anticoagulants
0
Immunoglobulin G
0
Platelet Factor 4
37270-94-3
Heparin
9005-49-6
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
601-609Informations de copyright
© 2021. Springer Science+Business Media, LLC, part of Springer Nature.
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