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A prospective, blinded study of a PF4-dependent assay for HIT diagnosis
- Source :
- Blood
- Publication Year :
- 2020
-
Abstract
- Heparin-induced thrombocytopenia (HIT) is a life-threatening, prothrombotic, antibody-mediated disorder. To maximize the likelihood of recovery, early and accurate diagnosis is critical. Widely available HIT assays, such as the platelet factor 4 (PF4) heparin enzyme-linked immunosorbent assay (ELISA) lack specificity, and the gold-standard carbon 14–labeled serotonin release assay (SRA) is of limited value for early patient management because it is available only through reference laboratories. Recent studies have demonstrated that pathogenic HIT antibodies selectively activate PF4-treated platelets and that a technically simpler assay, the PF4-dependent P-selectin expression assay (PEA), may provide an option for rapid and conclusive results. Based upon predefined criteria that combined 4Ts scores and HIT ELISA results, 409 consecutive adults suspected of having HIT were classified as disease positive, negative, or indeterminate. Patients deemed HIT indeterminate were considered disease negative in the primary analysis and disease positive in a sensitivity analysis. The ability of PEA and SRA to identify patients judged to have HIT was compared using receiver operating characteristic curve statistics. Using these predefined criteria, the diagnostic accuracy of PEA was high (area under the curve [AUC], 0.94; 95% confidence interval [CI], 0.87-1.0) and similar to that of SRA (AUC, 0.91; 95% CI, 0.82-1.0). In sensitivity analysis, the AUCs of PEA and SRA were also similar at 0.88 (95% CI, 0.78-0.98) and 0.86 (95% CI, 0.77-0.96), respectively. The PEA, a technically simple nonradioactive assay that uses ∼20-fold fewer platelets compared with the SRA, had high accuracy for diagnosing HIT. Widespread use of the PEA may facilitate timely and more effective management of patients with suspected HIT.
- Subjects :
- 0301 basic medicine
Adult
Male
medicine.medical_specialty
Immunology
Enzyme-Linked Immunosorbent Assay
030204 cardiovascular system & hematology
Platelet Factor 4
Biochemistry
Gastroenterology
Antibodies
Thrombosis and Hemostasis
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Humans
Prospective Studies
Aged
Immunoassay
Receiver operating characteristic
business.industry
Heparin
Area under the curve
Anticoagulants
Effective management
Cell Biology
Hematology
Gold standard (test)
Middle Aged
Thrombocytopenia
Confidence interval
P-Selectin
030104 developmental biology
Radioactivity
Female
business
Platelet factor 4
medicine.drug
Blinded study
Subjects
Details
- ISSN :
- 15280020
- Volume :
- 137
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Blood
- Accession number :
- edsair.doi.dedup.....46ae08cfbc1829deede64ac0b8416611