Prospective evaluation of a rapid nanoparticle-based lateral flow immunoassay (STic Expert(®) HIT) for the diagnosis of heparin-induced thrombocytopenia.

Abstract

A rapid lateral flow immunoassay (LFIA) (STic Expert(®) HIT), recently developed for the diagnosis of heparin-induced thrombocytopenia (HIT), was evaluated in a prospective multicentre cohort of 334 consecutive patients. The risk of HIT was estimated by the 4Ts score as low, intermediate and high in 28·7%, 61·7% and 9·6% of patients, respectively. Definite HIT was diagnosed in 40 patients (12·0%) with positive results on both enzyme-linked immunosorbent assay (Asserachrom(®) HPIA IgG) and serotonin release assay. The inter-reader reproducibility of results obtained was excellent (kappa ratio > 0·9). The negative predictive value of LFIA with plasma samples was 99·6% with a negative likelihood ratio (LR) of 0·03, and was comparable to those of the particle gel immunoassay (H/PF4-PaGIA(®) ) performed in 124 cases. Positive predictive value and positive LR were 44·4% and 5·87, respectively, and the results were similar for serum samples. The probability of HIT in intermediate risk patients decreased from 11·2% to 0·4% when the LFIA result was negative and increased to 42·5% when it was positive. In conclusion, the STic Expert(®) HIT combined with the 4Ts score is a reliable tool to rule out the diagnosis of HIT.

• Authors: Dorothée Leroux, Nathalie Hezard, Aurélien Lebreton, Anne Bauters, Pierre Suchon, Emmanuel de Maistre, Christine Biron, Marie-Genevieve Huisse, Catherine Ternisien, Sophie Voisin, Yves Gruel, Claire Pouplard
• Journal: British journal of haematology (Br J Haematol) Vol. 166 Issue 5 Pg. 774-82 (Sep 2014) ISSN: 1365-2141 [Electronic] England
• PMID: 24815503 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 John Wiley & Sons Ltd.

Chemical References

• Heparin

Topics

• Adult
• Aged
• Aged, 80 and over
• Female
• Heparin (adverse effects)
• Humans
• Immunoassay (methods)
• Male
• Middle Aged
• Nanoparticles (chemistry)
• Prospective Studies
• Thrombocytopenia (chemically induced, diagnosis)