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Prospective evaluation of automatized PF 4/heparin immunoassays Hemos IL HIT ‐ab ( PF 4‐H) for the diagnosis of heparin‐induced thrombocytopenia
Author(s) -
Jourdy Y.,
Nougier C.,
Rugeri L.,
Bordet J. C.,
Sobas F.,
Negrier C.
Publication year - 2015
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.12275
Subject(s) - heparin induced thrombocytopenia , immunoassay , antibody , receiver operating characteristic , medicine , prospective cohort study , heparin , immunology , platelet , microbiology and biotechnology , biology
Summary Introduction Recently, rapid immunoassays have been developed to allow the detection of antibodies anti‐ PF 4/heparin. In this prospective study, we evaluated the performances of a automatized immunoassay (Hemos IL HIT ‐Ab) in comparison with an ELISA (Zymutest HIA IgG) used for the diagnosis of heparin‐induced thrombocytopenia ( HIT ) in association with the 4T's score. Methods According to the 4T's score, samples with score ≤3 had no further analysis. Two immunological assays Zymutest HIA IgG and Hemos IL HIT ‐Ab were performed in samples with score ≥4. In patients with at least one positive immunological assay or two negative immunological assays but with high‐pretest probability (4T's score ≥6), HIT was screened by one functional assay using washed platelets. Results The sensitivities of both assays were excellent and comparable (100%). The specificity was 92.3% for ELISA and 91.2% for Hemos IL HIT ‐Ab. The analysis of the operating characteristics showed that both assays have almost identical ROC s ( AUROC , 0.9951 and 0.9853, respectively, for ELISA and Hemos IL HIT ‐Ab) and the calculating of the κ coefficient revealed a good agreement (0.67). Conclusion Performance characteristics of the Hemos IL HIT ‐Ab are comparable to the Zymutest HIA IgG. The Hemos IL HIT ‐Ab can be used in association with the 4T's score to rule out HIT .