Thromb Haemost 2016; 115(05): 1044-1055
DOI: 10.1160/TH15-06-0523
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

Diagnostic accuracy of rapid immunoassays for heparin-induced thrombocytopenia

A systematic review and meta-analysis
Lova Sun
1   Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
,
Phyllis A. Gimotty
2   Department of Biostatistics & Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
,
Suvasini Lakshmanan
3   Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA
,
Adam Cuker
1   Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
4   Department of Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
› Author Affiliations
Financial Support: This work was supported by K23 HL112903 from the National Institutes of Health to AC.
Further Information

Publication History

Received: 30 June 2015

Accepted after major revision: 03 January 2015

Publication Date:
06 December 2017 (online)

Summary

The platelet factor 4/heparin ELISA has limited specificity for heparininduced thrombocytopenia (HIT) and frequently does not provide same-day results. Rapid immunoassays (RIs) have been developed which provide results in 30 minutes or less. We conducted a systematic review and meta-analysis to evaluate the diagnostic accuracy of RIs for HIT. We searched the literature for studies in which samples from patients with suspected HIT were tested using a RI and a functional assay against which the performance of the RI could be measured. We performed sensitivity analyses of studies that directly compared different RIs with each other and with ELISAs. Estimates of sensitivity and specificity for each RI were calculated. Twenty-three articles, collectively involving six different RIs, met eligibility criteria. All RIs exhibited high sensitivity (0.96 to 1.00); there was wider variability in specificity (0.68 to 0.94). Specificity of the IgG-specific chemiluminescent assay (IgG-CA) was greater than the polyspecific chemiluminescent assay [0.94 (95 %CI 0.89–0.99) vs 0.82 (0.77–0.87)]. The particle gel immunoassay demonstrated greater specificity than the polyspecific ELISA [0.96 (0.95–0.97) vs 0.91 (0.89–0.92)]. The IgG-CA and lateral flow immunoassay [0.94 (0.91–0.97)] exhibited greater specificity than the IgG-specific ELISA [0.86 (0.82–0.90)]. Given their high sensitivity and rapid turnaround time, RIs are a reliable means of excluding HIT at the point-of-care in patients with low or intermediate clinical probability. Additionally, some RIs have greater specificity than HIT ELISAs. In summary, IgG-specific RIs appear to have improved diagnostic accuracy compared with ELISAs in patients with suspected HIT and may reduce misdiagnosis and overtreatment.