title: 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.affiliation: Haemostasis Laboratory and UMR CNRS 7292, Hôpital Trousseau and Université François Rabelais Tours, Tours, France.
authors.forename: Dorothée
authors.initials: D
authors.lastname: Leroux
authors.forename: Nathalie
authors.initials: N
authors.lastname: Hezard
authors.forename: Aurélien
authors.initials: A
authors.lastname: Lebreton
authors.forename: Anne
authors.initials: A
authors.lastname: Bauters
authors.forename: Pierre
authors.initials: P
authors.lastname: Suchon
authors.forename: Emmanuel
authors.initials: E
authors.lastname: de Maistre
authors.forename: Christine
authors.initials: C
authors.lastname: Biron
authors.forename: Marie-Genevieve
authors.initials: MG
authors.lastname: Huisse
authors.forename: Catherine
authors.initials: C
authors.lastname: Ternisien
authors.forename: Sophie
authors.initials: S
authors.lastname: Voisin
authors.forename: Yves
authors.initials: Y
authors.lastname: Gruel
authors.forename: Claire
authors.initials: C
authors.lastname: Pouplard
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006493:Heparin / Q000009:adverse effects*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles / Q000737:chemistry*; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced / Q000175:diagnosis*
chemical_list: D006493:Heparin
keywords: Bayes' theorem; Immunoassay; diagnosis; heparin-induced thrombocytopenia