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PIFA PLUSS P4 Assay for Screening of Heparin-Induced Thrombocytopenia.

Laboratory Medicine 2018 August 7
Background: The PIFA PLUSS PF4 Rapid Assay (PIFA) is a rapid screening test used for the diagnosis of heparin-induced thrombocytopenia (HIT).

Objective: To determine the usefulness of this assay as a screening method in our institution.

Methods: A total of 159 specimens from patients with suspected HIT were included in our study. We simultaneously performed PIFA assay and confirmatory polyspecific enzyme-linked immunosorbent assay (ELISA). We subjected most of the specimens with false-negative results to serotonin release assay (SRA).

Results: The initial sensitivity and specificity of the PIFA assay were calculated as 27.3% and 71.5%, respectively. A total of 12 of 16 false-negative results were further tested using the SRA method. The revised sensitivity and specificity were 50.0% and 73.5%, respectively.

Conclusions: Despite its appealing feature of yielding rapid results, the PIFA assay is inadequate as a sole screening test for HIT because of its high probability of missing many true cases of HIT.

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