Copyright © Royal College of pathologists of Australasia. Unauthorized reproduction of this article is prohibited. Evaluation of point-of-care testing in critically unwell patients: comparison with clinical laboratory analysers and applicability to patients with Ebolavirus infection JEN KOK 1,2,3 ,JIMMY NG 1 ,STEPHEN C. LI 4 ,JOHN GIANNOUTSOS 5 ,VINEET NAYYAR 6 , JONATHAN R. IREDELL 1,2,3 ,DOMINIC E. DWYER 1,2,3 AND SHARON C-A. CHEN 1,2 1 Centre for Infectious Diseases and Microbiology Laboratory Services, Institute of Clinical Pathology and Medical Research, Pathology West, Westmead Hospital, Westmead, 2 Marie Bashir Institute for Infectious Diseases and Biosecurity, University of Sydney, Westmead Hospital, Westmead, 3 Centre for Research Excellence in Critical Infections, University of Sydney, Westmead Hospital, Westmead, 4 Department of Core Pathology and Clinical Chemistry, Institute of Clinical Pathology and Medical Research, Pathology West, Westmead Hospital, Westmead, 5 Department of Hematology, Institute of Clinical Pathology and Medical Research, Pathology West, Westmead Hospital, Westmead, and 6 Department of Intensive Care Medicine, Westmead Hospital, Westmead, NSW, Australia Summary Data on the performance of point-of-care (POC) or near- patient devices in the management of critically unwell patients are limited, meaning that there are demands for confirming POC test results in the routine clinical laboratory and so potentially leading to delay in treatment provision. We eval- uated the performance of the i-STAT CHEM 8þ and CG4þ, Hemochron Signature Elite, HemoCue Hb 201þ and WBC Diff Systems on whole blood collected from medical and surgical patients admitted to the intensive care unit at an Australian tertiary care hospital. Measurements obtained for haematology, coagulation, biochemistry and arterial blood gas parameters using POC devices were compared against clinical laboratory analysers (XE-5000, STA-R Evolution, Dimension Vista 1500 and ABL800 FLEX). Bland–Altman and Passing–Bablok regression plots were constructed to assess agreement. Good correlation was defined as a bias of <10% between the POC device and the reference method. Forty arterial blood samples were collected from 28 patients. There was good correlation demonstrated for sodium, pot- assium, chloride, ionised calcium, glucose, urea, haemo- globin and haematocrit values (i-STAT Chem 8þ); pH, pCO 2 , bicarbonate and oxygen saturation (i-STAT CG4þ); haemoglobin, white cell, neutrophil count and lymphocyte counts (Hemocue); and internationalised normal ratio (INR; Hemochron Signature Elite), but not creatinine, anion gap, pO 2 , base excess, lactate, eosinophil count, prothrombin and activated partial thromboplastin time. POC devices were comparable to clinical laboratory analysers in measuring the majority of haematology, biochemistry and coagulation parameters in critically unwell patients, including those with infections. These devices may be deployed at the bedside to allow ‘real-time’ testing to improve patient care. Key words: Biochemistry, coagulation, diagnostics, haematology, point-of-care. Received 27 April, revised 9 June, accepted 9 June 2015 INTRODUCTION Point-of-care (POC) testing is the fastest growing sector in the clinical in vitro diagnostic market, and is increasingly being used to improve patient outcomes by providing faster turn- around times (TAT). Traditional POC testing methods using immunochromatography and wire-guided droplet microfluidics for physiological measurements have been further complemen- ted by multicore processors, microchips, high-resolution cam- eras and wireless communication to advance POC testing in areas of infectious diseases, cancer and cardiac care. POC devices have the advantage of not requiring specialised laboratory equipment or expertise to operate, making them suitable for near patient deployment to provide rapid results in ‘real-time’ which translates to improved clinical decision-mak- ing and quality of care, and potentially lower healthcare costs. Confirmation of a clinical diagnosis by POC testing further obviates unnecessary testing and allows the timely provision of specific therapies. In the example of Ebolavirus infection or other diseases in remote settings, POC testing may be an alternative where routine laboratory services are unavailable, or when use of laboratory analysers may be inappropriate. Data are limited on the performance of POC devices in critically unwell patients, particularly ‘in the field’. Some POC devices were developed for specific populations in specific settings, and may not be fit for purpose when used outside these instances. Herein, we evaluate the performance of several POC devices in measuring haematology, coagulation, biochemistry and arterial parameters in critically unwell patients, and com- pare results obtained to clinical laboratory analysers. METHODS Clinical samples Arterial blood samples were collected from medical and surgical patients admitted to the intensive care unit (ICU) at Westmead Hospital, a tertiary-level hospital with trauma, solid organ and high-risk haematopoietic stem cell transplantation services, and placed into the appropriate blood tubes [BD Vacutainer K2E (EDTA), LH PST II (lithium heparin) and Citrate tubes (3.2% sodium citrate; Becton Dickinson, USA)]. Samples were collected in duplicate, and tested immediately after collection in four separate POC devices: (1) i-STAT (Abbott Point of Care, USA), (2) Hemochron Signature Elite (ITC, USA), (3) HemoCue Hb 201þ, and (4) HemoCue WBC Diff System (HemoCue, Sweden). Table 1 details the tests Pathology (August 2015) 47(5), pp. 405–409 LABORATORY PREPAREDNESS FOR EBOLAVIRUS Print ISSN 0031-3025/Online ISSN 1465-3931 Copyright # 2015 Royal College of Pathologists of Australasia. All rights reserved. DOI: 10.1097/PAT.0000000000000296