A pilot study assessing the implementation of 96-well plate-based aggregometry (Optimul) in Australia

Hsu, Hannah, Chan, Melissa V, Armstrong, Paul C, Crescente, Marilena ORCID: https://orcid.org/0000-0003-3164-512X, Donikian, Dea, Kondo, Mayuko, Brighton, Timothy, Chen, Vivien, Chen, Qiang, Connor, David, Joseph, Joanne, Morel-Kopp, Marie-Christine, Stevenson, William S, Ward, Christopher, Warner, Timothy D and Rabbolini, David J (2022) A pilot study assessing the implementation of 96-well plate-based aggregometry (Optimul) in Australia. Pathology, 54 (6). pp. 746-754. ISSN 0031-3025

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Abstract

Identification of disordered platelet function is important to guide peri-operative bleeding management as well as long term treatment and prognostic strategies in individuals with platelet bleeding disorders. Light transmission aggregometry (LTA), the current gold standard diagnostic test of platelet function is a time consuming technique almost exclusively performed in specialised laboratories and almost universally unavailable in regional centres in Australia, where there is an unmet need for access to specialised platelet function diagnostic services. 96-well plate-based aggregometry (Optimul, UK), has been utilised in research laboratories as a novel platform to investigate platelet function. We evaluated the Optimul assay at two centres in Australia, one regional and one tertiary metropolitan, to assess its feasibility as a screening test applicable to remote regional centres. Concentration-response curves were established from 45 healthy volunteers at the participating regional hospital and from 31 healthy volunteers at the tertiary institution. Optimul successfully detected anti-platelet effects in individuals taking aspirin (n=4), NSAID (n=2), clopidogrel (n=2) and dual therapy with aspirin and clopidogrel (n=1). When tested in parallel to LTA in individuals referred for the evaluation of abnormal bleeding symptoms there was overall a very good level of agreement between Optimul and LTA [Cohen's kappa (k2)=0.84], supporting its role as a useful screening tool in the assessment of platelet function. Optimul assay performance was quick and the methodology simple, requiring no specialised training or resources to be implemented at either the regional or metropolitan laboratory. Widespread implementation, particularly in regional laboratories within Australia where specialised platelet function testing is unavailable, has the potential to drastically improve the inequity of access to such services.