Clinical Evidence

Point of Care

Clinical Evidence

Abbott Point of Care (APOC) partners with physicians and researchers globally to advance scientific knowledge and evidence of our products in various clinical settings to help accelerate patient care. Below is a compilation of peer reviewed journal articles and editorials, generated through our Investigator Sponsored Study (ISS) Program, as well as independent research, demonstrating the clinical, analytical, operational, and economic value of APOC products.

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Emergency Department

Cardiovascular Operating Room

Outpatient Department

Emergency department

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Title	SOurce	Sample size	Summary
Implementation of Point of Care Testing in the Emergency Department of a Teaching Hospital in U.A.E	JOURNAL OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE, Howayyer et al 2019; 2:123	50 (method comparison)	Objectives: Analytical performance of i-STAT Alinity testing system was evaluated against laboratory methods in the Emergency Department (ED) of a tertiary care hospital. i-STAT CG4+ and CHEM8+ cartridges were used. User satisfaction was evaluated through a post operator training survey by non-laboratory personnel. Findings: i-STAT Alinity demonstrated good correlation with standard laboratory methods along with satisfactory precision and linearity for all analytes tested. Analytical ranges for all the tested analytes were within the reportable range except creatinine which was slightly higher. The user friendly features of i-STAT Alinity, portability of the instrument and rapid results led to high operator confidence and a positive impact on patient treatment and disposition.
Early Point-of-Care Testing at Triage Reduces Care Time in Stable Adult Emergency Department Patients	THE JOURNAL OF EMERGENCY MEDICINE, Singer et al 2018; 55:172-178	104 (52 patients and 52 matched controls)	Objectives: Value of early point of care testing (POCT) at the time of patient triage prior to physician evaluation in the Emergency Department (ED) was evaluated at a tertiary care medical center. POCT was available for basic metabolic panel, troponin I, lactate, International Normalized Ratio (INR), or urine pregnancy test. Findings: ED care times reduced by approximately 1 hour with early POCT at triage compared with traditional core laboratory testing. Approximately 6% of the patients were immediately transferred to critical care areas to be seen by an ED physician. Slightly more than half of the treating physicians felt that early POCT at the time of initial assessment improved patient care, by changing the focus of their evaluation or leading to earlier treatment or disposition. In this study, although ED care times were reduced, total ED length of stay was not reduced.
Does Rapid Assessment Shorten the Amount of Time Patients Spend in the Emergency Department?	BRITISH JOURNAL OF HOSPITAL MEDICINE, Jarvis* et al 2014; 75:648-651 *Dr. Jarvis no longer works as a consultant at Calderdale Royal Hospital and he is currently employed by Abbott Laboratories.	4,622	Objectives: Traditional patient triage (nurse-led triage model with blood samples analyzed in a centralized hospital laboratory) was compared with a consultant-supported rapid assessment model (EDIT model) with blood samples analyzed using the i-STAT System as the point of care (POC) solution in the Emergency Department (ED) of a district general hospital. Findings: The combination of consultant-led early assessment and point of care testing reduced the time from patient arrival in the ED to disposition decision by 41% when compared with traditional patient triage. Level of improvement which can be attributed to POC or clinicians assessing the patients within minutes of their arrival in the ED remains unclear.
Time is Money— The Economic Impact of Point of Care on the Emergency Department of a Tertiary Care University Hospital	POINT OF CARE, Schilling 2014; 13:21-23	41	Objectives: Economic value of point of care testing (POCT) was assessed in a Swedish Emergency Department. Direct cost of POCT vs. central laboratory and indirect costs such as reduction in waiting time was analyzed. i-STAT CHEM8+, CG4+, and cTnI cartridges were used. Findings: For similar tests, there was a direct cost saving of US $111/patient with POCT as compared to central laboratory. Indirect cost savings were US $72.75/patient, including staffing costs and time saving. These findings might not reflect the findings in other clinical settings. Numbers should be recalculated in the actual local setting to reveal if the direct savings of POCT testing can be realized at the respective hospital.
Effect of Troponin I Point-of-Care Testing on Emergency Department Throughput Measures and Staff Satisfaction	ADVANCED EMERGENCY NURSING JOURNAL, Koehler et al 2013; 35:270-277	201	Objectives: Impact of point of care (POC) troponin testing on turnaround times, door-to-troponin result time, ED Length of Stay (LOS) in patients with chest pain, and staff satisfaction with POC testing was evaluated. Findings: Average door-to-troponin result time reduced significantly from 105 to 51 minutes with POC testing. Average LOS decreased from 290 to 255 minutes however this change was not significant. High satisfaction among ED staff members was reported.

CardioVascular Operating Room

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Title	SOurce	sample size	Summary
Intraoperative Monitoring of Heparin: Comparison of Activated Coagulation Time and Whole Blood Heparin Measurements by Different Point of Care Devices with Heparin Concentration by Laboratory-Performed Plasms Anti-Xa Assay	LAB MEDICINE, Thompson et al 2019; XX:1-9	123	Objectives: Parallel testing was performed between the i-STAT Activated Clotting Time (ACT) test, Hemochron Signature Elite ACT+, Hemochron Response Analyzer and Hepcon Hemostasis Management system (HMS) at a tertiary care facility. Laboratory anti-Xa assay was used as the criterion standard for heparin measurement. Findings: i-STAT ACT values were reported to be comparable to HMS and more consistent compared to Hemochron. Good correlation was found between i-STAT ACT and HMS as well as well as laboratory anti-Xa assay. Based on the study findings, the site transitioned to i-STAT for intraoperative ACT monitoring.
Clinical Evaluation of Measuring the ACT During Elective Cardiac Surgery with Two Different Devices	JOURNAL OF EXTRA CORPOREAL TECHNOLOGY, Falter et al 2018; 50:38-43	402	Objectives: Multi-site study across UK, South Africa and Switzerland evaluated Activated Clotting Time (ACT) measurements with two devices, i-STAT and Hemochron Jr. Patients undergoing elective cardiac surgery on cardiopulmonary bypass were included. Findings: i-STAT ACT test demonstrated good correlation with Hemochron Jr with i-STAT reading slightly higher than Hemochron Jr. Additionally, i-STAT consistently demonstrated lower within-subject coefficient of variation (WSCV) compared to Hemochron Jr, making it more reliable for clinical decision making. Authors commented that the better reliability of the i-STAT may be due to the difference in ACT methodology.
A Two Site Comparison of Two Point of Care Activated Clotting Time Systems	CLINICAL CHEMISTRY AND LABORATORY MEDICINE, Kemna EW et al 2017; 55:e13-e16	177	Objectives: i-STAT Activated Clotting Time (ACT) and Hemochron Signature Elite ACT values were compared using split samples from patients undergoing invasive surgery at two cardiothoracic institutes in the Netherlands and Germany. Findings: i-STAT ACT values demonstrated better reproducibility (mean difference - 4.3% vs. 9.1%) and correlation compared to the Hemochron. In the therapeutic area (>250 s), Hemochron duplicate measurements became less precise. There are different possible explanations for the correlation results between the Hemochron and the i-STAT. The i-STAT is less susceptible to changes in fibrinogen levels, temperature, hematocrit and hemodilution compared to the Hemochron. These findings reflects precision and not accuracy. Since there is no true ACT value, clinicians rely on the precision (reproducibility) of tests.
Clinical Evaluation of the i-STAT Kaolin Activated Clotting Time (ACT) Test in Different Clinical Settings in a Large Academic Urban Medical Center: Comparison With the Medtronic ACT Plus	AMERICAN JOURNAL OF CLINICAL PATHOLOGY, Lewandrowski et al 2011; 135:741-748	121	Objectives: Activated Clotting Time (ACT) values were compared between i-STAT and Medtronic ACT Plus using patients samples from cardiac surgery, catheterization and electrophysiology departments. Findings: Strong correlation observed between both devices with no significant difference in the ACT values. Findings were clinically acceptable and resulted in transitioning to i-STAT ACT without modifying existing target ranges. These findings reflects precision and not accuracy. Since there is no true ACT value, clinicians rely on the precision (reproducibility) of tests.

outpatient Department

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Title

SOurce

sample size

Summary

Economic Evaluation of Point-Of-Care Testing in the Remote Primary Health Care Setting of Australia’s Northern Territory

CLINICO ECONOMICS AND OUTCOME RESEARCH,
Spaeth et al 2018;
29:269-277

200

Objectives: Economic value of i-STAT point of care (POCT) testing at six primary health care facilities in rural and remote communities in Australia, where hospital and laboratory facilities are unavailable were evaluated. Economic evaluation was conducted using data from patients presenting with three common acute conditions (chest pain, chronic renal failure due to missed dialysis session(s), and acute diarrhea).

The number of unnecessary medical evacuations prevented with the use of POCT as an aid in decision making for acutely ill patients was used as a basis of calculating cost savings per patient and Northern Territory (NT) wide.

Findings: Implementing POCT helped rule out 60 unnecessary medical evacuations during six months study period. Associated cost savings per patient in chest pain, missed dialysis and acute diarrhea patient groups was AUS$ 4674, $8034 and $786 respectively translating to NT wide savings of AUD $21.75 million per annum in total. The clinical and cost effectiveness of POCT in this study was only examined for three common acute presentation types, and may differ for other acute presentations.

The results shown here are specific to one health care facility and may differ from those achieved by other institutions.

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