Journal Article

Rapid immunoassays for diagnosis of heparin-induced thrombocytopenia: Comparison of diagnostic accuracy, reproducibility, and costs in clinical practice

Alberio, Lorenzo, Horn, Michael P., Nagler, Michael, Bankova, Andriyana, Andres, Yvonne

2017

Overview

Immunoassays are crucial in the work-up of patients with suspected heparin-induced thrombocytopenia (HIT) and rapid tests have been recently developed. However, comparative data on diagnostic accuracy, reproducibility, and analytical costs of different immunoassays in clinical practice are limited. Samples of 179 consecutive patients evaluated for suspected HIT in clinical practice using a polyspecific enzyme-linked immunoabsorbent assay (GTI diagnostics; ELISA) and a rapid particle gel immunoassay (PaGIA), were additionally analysed with a IgG-specific chemiluminescent immunoassay (AcuStar HIT-IgG). Presence of HIT was defined as a positive functional heparin-induced platelet aggregation test. Diagnostic accuracy was determined for low, intermediate and high thresholds as previously established (ELISA: optical density 0.4, 1.3, and 2.0 respectively; PaGIA: positive/negative, titre of 4, titre of 32; AcuStar HIT-IgG: 1.0 U/ml, 2.8, 9.4) and reproducibility was assessed by repeated measurements. Costs of test determination were calculated taking reagents, controls, and working time of technicians according to Swiss health care system into account. Data on PaGIA results were available for 171 patients (95.5%), ELISA for 144 patients (80.4%), and AcuStar HIT-IgG for 179 patients (100%). Sensitivity was above 95% for all assays at low and intermediate thresholds. Specificity increased with higher thresholds and was above 90% for all assays with intermediate and high thresholds. Specificity of AcuStar HIT-IgG (92.8%; 95% CI 87.7, 96.2) was significantly higher than PaGIA (83.0%; 95% CI 76.3, 88.5) and higher than ELISA (81.8%, 95% CI 74.2, 88.0) at low threshold (p<0.05). Reproducibility was adequate for all assays. Total costs per test were CHF 51.02 for ELISA, 117.70 for AcuStar HIT-IgG, and 83.13 for PaGIA. We observed favourable diagnostic accuracy measures and a high reproducibility for PaGIA and AcuStar HIT-IgG. Implementation into 24-hours-service might improve patient care but the results must be confirmed in other settings and larger populations as well.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Accuracy / Agglomeration / Anticoagulants / Assaying / Automation / Biology and Life Sciences / Chemiluminescence / Clinical medicine / Comparative analysis / Control systems / Cost analysis / Cost engineering / Costs / Density / Diagnosis / Diagnostic systems / Economic aspects / Enzyme-Linked Immunosorbent Assay / Enzymes / Functional anatomy / Health care / Hematology / Heparin / Heparin - toxicity / Humans / Immune response / Immunoassay / Immunoassay - economics / Immunoassay - methods / Immunoassays / Immunoglobulin G / Laboratories / Luminescent Measurements / Mathematical analysis / Medical diagnosis / Medicine and Health Sciences / Optical density / Patients / People and Places / Platelet aggregation / Populations / Reagents / Reproducibility / Research and Analysis Methods / Sensitivity / Sensitivity and Specificity / Side effects / Studies / Technicians / Thresholds / Thrombocytopenia / Thrombocytopenia - blood / Thrombocytopenia - chemically induced / Thrombocytopenia - diagnosis