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Multicenter Study
. 2019 Dec;17(12):2123-2130.
doi: 10.1111/jth.14611. Epub 2019 Sep 25.

Heparin-induced thrombocytopenia: An international assessment of the quality of laboratory testing

Zachary Liederman  1 , Elizabeth M Van Cott  2 , Kristi Smock  3   4 , Piet Meijer  5 , Rita Selby  6
Affiliations
Free article
Multicenter Study

Heparin-induced thrombocytopenia: An international assessment of the quality of laboratory testing

Zachary Liederman et al. J Thromb Haemost. 2019 Dec.
Free article

Abstract

Background: Accurate diagnosis of heparin-induced thrombocytopenia (HIT) is essential to ensure timely treatment and prevent complications. Current diagnostic assays include enzyme-linked immunosorbent assays (ELISAs) and rapid immunoassays (RIs). RIs offer fast turnaround times but were not significantly represented in previous external proficiency testing challenges.

Objectives: To use external proficiency testing to assess qualitative concordance for heparin/PF4 antibody detection.

Methods: From 2013 to 2017, the External Quality Control for Assays and Tests (ECAT) Foundation distributed 10 samples internationally.

Results: In total, 437 laboratories submitted 3149 results. ELISAs accounted for 1484 (47%) responses with RIs accounting for 1665 (53%) responses. RI use increased over the 5-year period. ELISAs classified 96% of both consensus positive and consensus negative samples concordantly. The coefficient of variation (CV) for positive sample optical densities (ODs) ranged from 35% to 50% when combining ELISA assay methods together. Quantitative RIs classified 97% of consensus-positive and 98% of consensus-negative samples concordantly. Qualitative RIs had a higher proportion of discordant responses and classified 88% of consensus-positive samples and 73% of consensus-negative samples concordantly. Of RIs only latex immunoassays and IgG specific chemiluminescent assays identified > 95% of samples concordantly with consensus.

Conclusion: Quantitative RIs and ELISAs classify > 95% of samples concordantly. The ODs from different ELISA methods vary considerably and are not interchangeable. Qualitative RI use is increasing despite a greater proportion of discordant classifications. This includes a higher than expected number of negative classifications for consensus-positive samples among many RIs, challenging their use as "rule out" tests.

Keywords: diagnosis; heparin; immunologic tests; thrombocytopenia; thrombosis.

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References

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