i-STAT Alinity

"Integrating the Canadian CT Head Rule with GFAP-based biomarker testing may optimize CT utilization in mTBI. We propose a sequential diagnostic algorithm consisting of initial evaluation with the Canadian CT Head Rule, followed by biomarker testing in CCHR-positive cases, with CT reserved for biomarker-positive patients. This stepwise approach has the potential to support more efficient referral decisions and resource utilization in settings with limited access to neuroimaging, while reducing unnecessary brain CT use in centers with imaging availability, adapting to diverse healthcare contexts. Cost-effectiveness analyses and validation in resource-limited environments remain needed."

"Integrating LVO scores combined with GFAP measurements into the prehospital work-up of patients with acute stroke improves diagnostic accuracy for LVO prediction. In the future, this could enable direct transfers of patients with suspected LVO to endovascular centers with reduced misdiagnosis rates. Independent replication in diverse prehospital cohorts is warranted to confirm these findings."

Umbilical cord arterial blood lactate demonstrates good diagnostic accuracy for perinatal asphyxia and is a strong predictor of short-term adverse neonatal outcomes among term neonates. Given its high sensitivity and specificity at defined cut-off values, UCAB lactate represents a simple, cost-effective, and practical alternative to blood gas analysis, particularly in low- and middle-income settings where access to advanced laboratory facilities is limited.

"Most healthcare professionals use and prefer accurate blood sampling devices, suggesting implementing a recommendation to use these is likely feasible. However, guidance on the timing of testing is needed."

"This study identified two hs-cTnI thresholds (<5 ng/L or <8 ng/L) to identify patients at low risk and two thresholds (>25 ng/L and >60 ng/L) to identify patients at high risk for MI. Our findings provide promise for improving care in rural and inner-city medical settings."

"We noted a decrease in ionized calcium measurements post-reinfusion. Future studies should assess changes after larger volume transfusions and assess repletion methods."

"The POCT devices were acceptable and practical for use by our specialist paramedic participants. The results of this feasibility study should inform the design of a larger study to test the impact of using POCT, to understand challenges in recruitment and retention where POCT is utilised and to determine the clinical presentations where POCT can be applied."

"Plasma GFAP and UCH-L1 in combination, measured ≤24 hours postinjury, demonstrated high sensitivity for clinically significant acute traumatic intracranial lesions. Further research is needed to determine whether deploying these biomarkers in the proposed implementation cohort decreases avoidable brain CT scans."

Traumatic brain injury requires rapid and accurate diagnostics, driving growing interest in point-of-care testing and multivariable biomarker models. While numerous biomarkers show diagnostic promise, limitations remain regarding standardization, time-sensitive applicability, and prognostic performance. Further large-scale, well-designed clinical studies are needed to translate multimodal POCT approaches into reliable clinical practice.

"Laboratory GFAP measurements on a point-of-care platform in blood samples collected from patients with symptoms of acute stroke in the prehospital phase can help to identify ICH with moderate to high PPV. Following confirmation in larger independent cohorts using optimized eligibility criteria and validated age-specific cutoff values, GFAP testing could facilitate optimized triage and the initiation of blood pressure-lowering therapy and anticoagulation reversal in earlier time frames."

"The difference between the mean SmO2 and ScvO2 was not statistically significant and the mean bias between SmO2 and ScvO2 is low. Despite this, the substantially large standard deviation and limits of agreement preclude the use of SmO2 as a direct surrogate of ScvO2."

The noninvasive DBC methodology demonstrated variable agreement with the invasive i-STAT® POCT device across measured blood parameters in healthy participants. While acceptable concordance was observed for selected analytes, systematic differences were identified for hemoglobin, potassium, and sodium. Overall, the results indicate potential for noninvasive real-time blood value assessment, warranting further validation in larger and clinically diverse populations.

"Comparing civilian and military guidelines highlights areas for potential improvements in TBI management, such as integrating advanced monitoring and the implementation of (i-STAT, Abbott Laboratories, Chicago, IL) testing in air transport to enhance patient care and outcomes."

"Early measurements of GFAP and UCH-L1 on a point-of-care device are significantly associated with CT-diagnosed TBI in patients with polytrauma and shock. Early elevated GFAP measurements are associated with worse head CT scan Rotterdam scores, TBI progression, and worse GOSE scores, and these associations are independent of other injury attributes, shock severity, and early resuscitation characteristics."

"Increased GFAP plasma concentrations in patients with acute coma identify intracranial hemorrhage with high diagnostic accuracy. Prehospital GFAP measurements on a point-of-care platform allow rapid stratification according to the underlying cause of coma by rescue services. This could have major impact on triage and management of these critically ill patients."

In this Dutch multi-center cohort, rapid point-of-care measurement of GFAP and UCH-L1 using the i-STAT TBI assay demonstrated high sensitivity for detecting CT abnormalities in patients with mild traumatic brain injury. While combined biomarker testing showed limited additional benefit over GFAP alone and was associated with low specificity, the strong negative predictive value supports their potential role in safely ruling out intracranial lesions and guiding CT decision-making. These findings suggest that blood-based biomarkers may contribute to a more efficient and cost-effective management of mTBI, although further validation in larger prospective cohorts is required.

"There is not a clear consensus on diagnostic assessments for TBI, and CT scans are often used because of their availability in acute settings. As described, CT scans are useful for visualizing the presence and location of hemorrhages but are not as sensitive as MRIs for axonal injury visualization. It is also unclear how clinically useful these neuroimaging techniques are for long-term prognosis and quality of life. Abbott’s Alinity i TBI test may be beneficial in evaluating common biomarkers released upon brain injury such as GFAP and UCH-L1. The newfound increasing availability of Abbott’s Alinity i laboratory instrument contrary to the previous i-STAT TBI Plasma test demonstrates the potential cost-effectiveness of the test and its usefulness in detecting lasting brain damage. This development brings a new opportunity for TBI research to grow and make useful conclusions for long-term physiological and neurocognitive prognosis. The ultimate goal would be to use aggregate data to pinpoint those mild TBI patients with the highest risk of long-term debilitating neurologic problems and then implement mitigating actions to avert these consequences."

"This small feasibility study observed that training selected patients to competently use hand-held devices to self-test kidney function at home is possible. Self-test creatinine results showed good analytical and clinical agreement with standard clinic test results. Self-test potassium results showed poorer agreement with standard clinic test results; however, patient self-use of i-STATs at home was not a statistically significant source of difference between paired potassium test results."

"Pre-analytical error for three point of care venous blood testing platforms in acute ambulatory settings: A mixed methods service evaluation."

"The i-STAT analyzers produce more reproducible ACT results [than the Hemochron], but the target range should be lowered to 200 to 250 seconds. This range appears to provide adequate and safe heparin therapy, confirmed by anti-Xa assay results and clinical outcome."

"Accuracy of meters [Contour Next, Accu-Chek Guide, FreeStyle Optium Neo and LifeSmart] was higher when using venous samples than when using capillary samples. Contour Next and Accu-Chek Guide meters met accuracy standards in all analyses."

"No point-of-care Hgb device [HemoCue®, i-STAT®, Rad-67®]demonstrated limits of agreement that were smaller than the agreement difference of 4 g L-1. Despite this, HemoCue can be safely used to inform transfusion decisions in surgery, given its error probability of <4% in transfusion scenarios."

Point-of-care haemoglobin testing can support transfusion decision-making in major noncardiac surgery, but its results should be interpreted with caution. Although none of the evaluated devices met predefined agreement thresholds with laboratory measurements, the HemoCue® demonstrated the lowest risk of prompting inappropriate red cell transfusion. Awareness of patient-, sample-, and device-related factors remains essential to ensure safe and informed clinical use of POC haemoglobin measurements.

"The observed similarity in performance between the two devices [Abbott i-STAT® and the Nova Biomedical Lactate (LA) Plus™ meter] suggests that both are capable of reliably measuring lactate levels in a trauma situation. The LA Plus™ meter provides fast results with only one drop of blood. This study supports the prehospital use of POC devices."

We demonstrated that laboratory-based FPG has the potential to be used as a diagnostic test for GDM and that the POC glucometers [i-STAT, Xpress, LDX, VivaChek-Ino, Accu-Chek Active, StatStrip, Codefree] cannot replace OGTT laboratory-based measurements.

"The lactate Statstrip and iSTAT-1 POCT analyzers were analytically equivalent. The clinical verification study showed that lactate is a good predictor of fetal distress, although more false positive results were found in our limited dataset. However, unnecessary interventions due to failed pH measurements might be prevented when a lactate measurement is introduced."

"Based on these results, kaolin-activated point-of-care ACT devices [ACT Plus, i-STAT] cannot be used interchangeably. Device-specific predefined target values are warranted to avert overly dosing of heparin during CPB."

"This comparison study of pH, pCO2, pO2, and lactate measurements between Nova pHOx plus L® and i‐STAT® analyzers showed good agreement. However, lactate measurement results >8 mmol/L on the i‐STAT® analyzer should be interpreted with caution."

"In conclusion, the fingerstick creatinine test may be considered for early use in patients presenting to the ED, as it is easily applicable in examination and treatment management and has strong agreement rates with laboratory values."

"This novel POC hs-cTn assay achieves high sensitivity and NPV when used alongside the T-MACS decision aid, but efficiency may be greater at a 5 ng/L threshold without requiring any decision aid."

"A 0/2-hour protocol using the Abbott i-STAT® hs-TnI assay safely risk stratified emergency patients with suspected ACS and had comparable performance to two central laboratory-based assays. The use of POC testing supports timely results and may improve the time to clinical decision-making."

"The whole blood POC i-STAT hs-TnI assay demonstrated performance characteristics similar to other hs-cTn assays and achieved high sensitivity and NPV for initial measurements <LoQ and <5.0 ng/L."

"Modestly and significantly elevated BAL does not lower the diagnostic accuracy of GFAP and UCH-L1 for predicting traumatic intracranial injury on CT. These biomarkers may be useful in decreasing avoidable brain CT imaging in persons with acute alcohol intoxication."

"We highlight the usefulness of measuring plasma “GFAP and UCH-L1” levels to target mTBI patients (sampling within 12 h post-injury) and optimize the reduction of CT scans."

"The introduction of the i-STAT Alinity™ and the Biomerieux VIDAS TBI blood tests mark a groundbreaking development in TBI diagnosis. It paves the way for the integration of TBI biomarker tools into clinical practice and therapeutic trials, enhancing the precision medicine approach by generating valuable data. This advancement is a critical step in addressing the long-standing gap in brain-related diagnostics and promises to revolutionize the management and treatment of mild TBI."

"We highlight the usefulness of measuring plasma “GFAP and UCH-L1” levels to target mTBI patients (sampling within 12 h post-injury) and optimize the reduction of CT scans."

"The i-STAT Alinity system, a handheld, portable, POC blood testing device, has shown adequate imprecision and comparable accuracy to the existing laboratory methods for pH, Pco2, base excess, bicarbonate, lactate, electrolytes, glucose, urea and hemoglobin measurements. However, the analytical imprecision did not meet the international recommendations for central laboratory devices showing bias in the measurements of Po2, creatinine, hematocrit and PT/INR. The i-STAT Alinity system could be an effective POC testing device for triage at patients’ bedsides in the ED or in the ICU; nevertheless, clinicians should interpret the results of the Po2, creatinine, hematocrit and PT/INR with caution. Further studies are mandatory to assess the capability of such a device to improve patient management and prognosis in real-life settings."

"In this pilot study, hyperacute plasma GFAP and UCH-L1 levels were analyzed in a unique cohort of TBI patients recruited as early as within the first 2 h from injury. The preliminary analysis demonstrated good GFAP and UCH-L1 performance for detection of CT-positive abnormalities and stratification by injury severity. These promising data warrant further research into the early kinetics of these brain-injury biomarkers in larger cohorts of TBI patients with varied CT findings and injury severity."

"In conclusion, the glial fibrillary acidic protein and ubiquitin carboxyl‐terminal hydrolase L1 biomarker panel results obtained using the i‐STAT Alinity and traumatic brain injury plasma test had high sensitivity, but limited specificity, for prediction of acute traumatic intracranial injury, comparable to lab‐based platforms. When used within 12 h of injury among adult mild traumatic brain injury patients in whom a computed tomography scan is felt to be clinically indicated, this test has the potential to reduce computed tomography use. The impact of this test on actual head computed tomography utilization has yet to be determined. The speed, portability, and high accuracy of this test may facilitate clinical adoption of brain biomarker testing as an aid to head computed tomography decision making in EDs."

"A three-step testing sequence combining a risk factor questionnaire with a point-of-care test and confirmatory laboratory testing appears to be a cost-effective use of NHS resources compared with current practice. The risk of contrast causing acute kidney injury to patients with an estimated glomerular filtration rate of < 30 ml/minute/1.73 m2 is uncertain. Cost-effectiveness of point-of-care testing appears largely driven by the potential of point-of-care tests to minimise delays within the current computed tomography pathway."