期刊
JOURNAL OF THROMBOSIS AND HAEMOSTASIS
卷 15, 期 6, 页码 1203-1212出版社
WILEY
DOI: 10.1111/jth.13692
关键词
diagnosis; enzyme-linked immunosorbent assay; heparin; thrombocytopenia; thrombosis
资金
- National Institute of Health [T32 HL007971-13]
- HTRS/Novo Nordisk Clinical Fellowship Award in Hemophilia and Rare Bleeding Disorders
Background: There are conflicting data on whether the IgG-specific or polyspecific antiplatelet factor 4/heparin (PF4/H) enzyme-linked immunosorbent assay (ELISA) is preferred for the laboratory diagnosis of heparin- induced thrombocytopenia (HIT). Objectives: To directly compare diagnostic accuracy of IgG-specific versus polyspecific ELISA in HIT. Patients/Methods: A systematic search yielded nine studies comprising 1948 patients with suspected HIT tested by both IgG-specific and polyspecific ELISAs and a reference standard against which the diagnostic accuracy of the ELISAs could be measured. Study quality was assessed by QUADAS-2 criteria. Results: There was identical sensitivity for IgG-specific and polyspecific ELISAs (0.97; 95% confidence interval (CI), 0.95-0.99) and superior specificity of IgG-specific compared with polyspecific ELISA (0.87 [0.85-0.88] vs. 0.82 [0.80-0.84], respectively). Performance was similar in subgroups using the serotonin release assay and a single commercial ELISA manufacturer. The negative predictive values of IgG-specific and polyspecific ELISA were similarly high (0.99, [0.99-1.00], but the positive predictive value was superior with IgGspecific compared with polyspecific ELISA (0.56 [0.52-0.61] vs. 0.32 [0.28-0.35], respectively). The positive likelihood ratio (LR) was higher in IgG-specific than polyspecific ELISA, although negative LRs were similar. There was high risk of quality concerns in domains of index test and reference standard. Conclusions: The superior diagnostic accuracy of IgG-specific ELISA reinforces the ISTH-SSC recommendation for standardization of laboratory testing for HIT. Likelihood ratios of individual assays may be used in combination with clinical scoring systems as part of an integrated diagnostic algorithm for HIT.
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