Recent Advances in Mainstream Hemostasis Diagnostics and Coagulation Testing

Abstract

The authors provide a narrative review of mainstream hemostasis analyzers. The review is presented in two parts. In the first part, the authors give voice to several internationally representative manufacturers of mainstream hemostasis analyzers. They ask these manufacturers to (1) answer a series of survey questions that may otherwise reflect common questions asked by users or potential users of their equipment, (2) provide a bullet list of their main focus areas, and (3) provide other information in regard to their instrumentation. The authors then offer their own personal perspective of the benefits of various aspects of such equipment, as well as a sampling of some hemostasis tests as currently available, or potentially in progress. It is hoped that this snapshot of mainstream hemostasis diagnostics and coagulation testing drives positive future changes that will ultimately provide the best outcomes for laboratories performing hemostasis assays and the patients they help diagnose and manage.

Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network

“…Naturally, some elements of our rule sets may be more or less relevant according to laboratory instrumentation. For example, in our case, the instrumentation comprised mechanical clot detection (Stago instrumentation) that is fairly resistant to interference from haemolysis, icteria and lipaemia (“HIL”) . Nevertheless, as the instruments do not currently have a means of assessing for HIL, we felt it important to identify the presence of such pre‐analytical events because of potential biological effects on clot formation (as opposed to spectral effects, to which the instruments are relatively insensitive) .…”

“…For example, in our case, the instrumentation comprised mechanical clot detection (Stago instrumentation) that is fairly resistant to interference from haemolysis, icteria and lipaemia ("HIL"). 10 Nevertheless, as the instruments do not currently have a means of assessing for HIL, we felt it important to identify the presence of such pre-analytical events because of potential biological effects on clot formation (as opposed to spectral effects, to which the instruments are relatively insensitive). 13 Some more modern (especially optical-based) instrumentation automatically assesses for HIL, 10 and thus, this aspect of the current rule set may be removed in future iterations should such instruments be utilized.…”

“…The LIS used in the Pathology West network at the time of project implementation was Cerner Millennium PathNet (version 2015.01.04), derived from Cerner Corporation, an American supplier of health information technology solutions, services, devices and hardware. All coagulation tests in our network are performed on a single instrument platform (STA line from Diagnostic Stago) consisting of 3 instrument models, all employing mechanical clot detection, and reflecting large (STAR Evolution), medium (STA‐Compact MAX) and small (STA‐Satellite) test capacity in different sized laboratories . All analysers in the network were interfaced to the LIS and after completion of the project were linked to the expert rule set that governs automated validation, as residing in the LIS.…”

A diagnosis of von Willebrand disease despite normal test results for factor VIII and von Willebrand factor antigen and activity

“…For example, VWF:CB is performed by most VWF test laboratories in Australia, a high proportion in Europe, but few laboratories in the USA . This in part relates to greater availability of regulatory approved/cleared VWF:CB assays in Australia and Europe, vs absence in the USA . In contrast, VWF multimer testing is performed by more laboratories in the USA than in Australia .…”

Innovations in Thrombosis and Hemostasis: A Glimpse Towards the Future of Diagnostic Analyzers

“…For several decades, coagulation analyzers have detected clot formation in one of two ways: optical or mechanical. 1 Most automated analyzers currently used in hemostasis laboratories are capable of performing other types of testing as well, such as chromogenic, latex agglutination, and even enzymatic immunoassays. 1 In this special issue of Seminars in Thrombosis and Hemostasis (STH), we particularly wished to explore whether new methods of clot detection, or other novel types of coagulation analyzers, are in development or will soon be ready for prime time for use in routine diagnostics of hemostasis disorders.…”