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 demonstrating the clinical, analytical, operational, and economic value of APOC products.

Emergency Department

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Title	Source	Sample size	Summary
Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury	ACADEMIC EMERGENCY MEDICINE. Bazarian et al 2021; 00:1–10	2011	Objectives: To determine the accuracy of a new, rapid blood test combining measurements of both glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) for predicting acute traumatic intracranial injury (TII) on head CT scan after mild traumatic brain injury (mTBI). Findings: i-STAT TBI Plasma test had high sensitivity for prediction of acute TII, comparable to lab-based platforms. The speed, portability, and high accuracy of this test may facilitate clinical adoption of brain biomarker testing as an aid to head CT decision making in EDs.
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.

Title

Source

Sample size

Summary

Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury

ACADEMIC EMERGENCY MEDICINE. Bazarian et al 2021; 00:1–10

2011

Objectives: To determine the accuracy of a new, rapid blood test combining measurements of both glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) for predicting acute traumatic intracranial injury (TII) on head CT scan after mild traumatic brain injury (mTBI).

Findings: i-STAT TBI Plasma test had high sensitivity for prediction of acute TII, comparable to lab-based platforms. The speed, portability, and high accuracy of this test may facilitate clinical adoption of brain biomarker testing as an aid to head CT decision making in EDs.

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
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.

Title

Source

Sample size

Summary

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.

Outpatient Settings

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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-month 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.

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-month 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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Clinical Evidence

Emergency Department

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Sample size

Summary

Cardiovascular Operating Room

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Source

Sample size

Summary

Outpatient Settings

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