Journal article

Publication year: 2011

Pages: 1197-1202

Journal: Thrombosis and Haemostasis

Volume number: 106

Issue number: 6

ISSN: 0340-6245

eISSN: 2567-689X

DOI Link: https://doi.org/10.1160/TH-11-06-0390

Publisher: Thieme Publishing

Abstract: 
Heparin-induced thrombocytopenia (HIT) is an adverse complication of heparin caused by HIT antibodies (abs) that recognise platelet factor 4-heparin (PF4/hep) complexes. Several laboratory tests are available for the confirmation and/or refutation of HIT. A reliable and rapid single-sample test is still pending. It was the objective of this study to evaluate a new lateral-flow immunoassay based on nanoparticle technology. A cohort of 452 surgical and medical patients suspected of having HIT was evaluated. All samples were tested in two IgG-specific ELISAs, in a particle gel immunoassay (PaGIA) and in a newly developed lateral-flow immunoassay (LFI-HIT) as well as in a functional test (HIPA). Clinical pre-test probability was determined using 4T's score. Platelet-activating antibodies were present in 34/452 patients, all of whom had intermediate to high clinical probability. PF4/hep abs were detected in 79, 87, 86, and 63 sera using the four different immunoassays. The negative predictive values (NPV) were 100% for both ELISA tests and LFI-HIT but only 99.2% for PaGIA. There were less false positives (n=29) in the LFI-HIT compared to any other test. Additionally, significantly less time was required to perform LFI-HIT than to perform the other immunoassays. In conclusion, a newly developed lateral-flow assay, LFI-HIT, was capable of identifying all HIT patients in a cohort in a short period of time. Beside an NPV of 100%, the rate of false-positive signals is significantly lower with LFI-HIT than with other immunoassay(s). These performance characteristics suggest a high potency in reducing the risk and costs in patients suspected of having HIT.

Harvard Citation style: Sachs, U., von Hesberg, J., Santoso, S., Bein, G. and Bakchoul, T. (2011) Evaluation of a new nanoparticle-based lateral-flow immunoassay for the exclusion of heparin-induced thrombocytopenia (HIT), Thrombosis and Haemostasis, 106(6), pp. 1197-1202. https://doi.org/10.1160/TH-11-06-0390

APA Citation style: Sachs, U., von Hesberg, J., Santoso, S., Bein, G., & Bakchoul, T. (2011). Evaluation of a new nanoparticle-based lateral-flow immunoassay for the exclusion of heparin-induced thrombocytopenia (HIT). Thrombosis and Haemostasis. 106(6), 1197-1202. https://doi.org/10.1160/TH-11-06-0390