scholarly journals Analytical Concordance of Diverse Point-of-Care and Central Laboratory Troponin I Assays

2019 ◽  
Vol 3 (5) ◽  
pp. 764-774 ◽  
Author(s):  
Albert K Y Tsui ◽  
Martha E Lyon ◽  
Sean van Diepen ◽  
Bobbi Lynn Goudreau ◽  
Dylan Thomas ◽  
...  
Keyword(s):  
Troponin I ◽  
Coronary Care Unit ◽  
Point Of Care ◽  
High Sensitivity ◽  
Clinical Decision ◽  
Central Laboratory ◽  
Excellent Correlation ◽  
Fresh Blood ◽  
Coronary Care ◽  
Abbott Architect

Abstract Background Cardiac troponin I (cTnI) 99th percentile cutoffs, used in the diagnosis of acute myocardial infarction, are not standardized across cTnI assays. We compared 3 point-of-care (POC) and 1 central laboratory contemporary cTnI assays against the Abbott high-sensitivity (hs) cTnI to evaluate the analytical concordance and the feasibility of using a single cutoff value for all assays. Methods Fresh blood samples collected from 102 inpatients in the coronary care unit were measured on central laboratory instruments (Beckman Coulter DxI AccuTnI+3 TnI, Abbott Architect hs-TnI) and cTnI POC analyzers (Alere Triage Troponin I, Radiometer AQT90, Abbott i-STAT). Agreement and correlation between the contemporary cTnI assays and hs-cTnI assay were assessed using regression analysis. Proportional bias was assessed using Bland–Altman plots. Concordance between the contemporary cTnI and hs-cTnI assays was determined by diagnostic contingency tables at specific cutoffs. Results Most POC cTnI assays had excellent correlation with the Abbott hs-cTnI method (r2 = 0.955–0.970) except for Alere Triage (r2 = 0.617), while proportional bias is evident between all cTnI assays. Overall concordance between POC contemporary cTnI assays and hs-cTnI assay was 80% to 90% at their respective 99th percentile cutoffs. The concordance increased to 90% to 95% when a fixed cutoff of 0.03 to 0.05 ng/mL was used across the assays. Conclusions This study demonstrates poor analytical concordance between cTnI assays at the 99th percentile and supports the notion of a single clinical decision limit for cTnI and consequently standardization of diagnostic protocols despite the analytical differences among these assays.

scholarly journals Laboratory predictors of death from coronavirus disease 2019 (COVID-19) in the area of Valcamonica, Italy

2020 ◽  
Vol 58 (7) ◽  
pp. 1100-1105 ◽  
Author(s):  
Graziella Bonetti ◽  
Filippo Manelli ◽  
Andrea Patroni ◽  
Alessandra Bettinardi ◽  
Gianluca Borrelli ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Clinical Decision Making ◽  
Troponin I ◽  
Laboratory Data ◽  
High Sensitivity ◽  
Clinical Decision ◽  
International Normalized Ratio ◽  
Serum Glucose ◽  
Hospital Death ◽  
Laboratory Findings

AbstractBackgroundComprehensive information has been published on laboratory tests which may predict worse outcome in Asian populations with coronavirus disease 2019 (COVID-19). The aim of this study is to describe laboratory findings in a group of Italian COVID-19 patients in the area of Valcamonica, and correlate abnormalities with disease severity.MethodsThe final study population consisted of 144 patients diagnosed with COVID-19 (70 who died during hospital stay and 74 who survived and could be discharged) between March 1 and 30, 2020, in Valcamonica Hospital. Demographical, clinical and laboratory data were collected upon hospital admission and were then correlated with outcome (i.e. in-hospital death vs. discharge).ResultsCompared to patients who could be finally discharged, those who died during hospital stay displayed significantly higher values of serum glucose, aspartate aminotransferase (AST), creatine kinase (CK), lactate dehydrogenase (LDH), urea, creatinine, high-sensitivity cardiac troponin I (hscTnI), prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT), D-dimer, C reactive protein (CRP), ferritin and leukocytes (especially neutrophils), whilst values of albumin, hemoglobin and lymphocytes were significantly decreased. In multiple regression analysis, LDH, CRP, neutrophils, lymphocytes, albumin, APTT and age remained significant predictors of in-hospital death. A regression model incorporating these variables explained 80% of overall variance of in-hospital death.ConclusionsThe most important laboratory abnormalities described here in a subset of European COVID-19 patients residing in Valcamonica are highly predictive of in-hospital death and may be useful for guiding risk assessment and clinical decision-making.

scholarly journals Point-of-care high-sensitivity assay on PATHFAST as the backup in the emergency room

2021 ◽  
Vol 5 ◽  
pp. 239920262110550
Author(s):  
Joško Osredkar ◽  
Katja Krivic ◽  
Teja Fabjan ◽  
Kristina Kumer ◽  
Jure Tršan ◽  
...  
Keyword(s):  
Blood Serum ◽  
Troponin I ◽  
Point Of Care ◽  
High Sensitivity ◽  
Turnaround Time ◽  
Serum Samples ◽  
Linear Relationships ◽  
Accuracy And Precision ◽  
Laboratory Results ◽  
Key Indicators

Aim: Although the levels of cardiac troponin I (cTnI) have proved to be a useful diagnostic biomarker of acute myocardial infarction, there are a wide variety of point-of-care (POC) analysers, which provide measurements of cTnI. The aim of this study was to compare the results obtained by the ADVIA Centaur ultra-assay cTnI assay (us-cTnI), ADVIA Centaur high-sensitive cTnI assay (hs-cTnI) and a POC high-sensitivity assay using PATHFAST. We also aimed to explore total turnaround time (TAT) for laboratory results using the POC PATHFAST analyser. Methods: Samples from 161 patients were taken. Of these samples, 129 were tested with all three assays (us-cTnI, hs-cTnI and PATHFAST), and 32 samples were tested on PATHFAST for the comparison of whole blood, serum and plasma. Results: Comparison of the POC testing methods in this study demonstrated that there are strong linear relationships between all three cTnI assays (us-cTnI, hs-cTnI and POC on PATHFAST). Furthermore, we also show there are strong linear relationships between the two high-sensitive cTnI assays (hs-cTnI and PATHFAST) for blood serum samples, as determined by Passing–Bablok regression analyses. In our comparison of our new data with our older study, the TAT went down. Conclusion: The timeliness of laboratory results is, in addition to accuracy and precision, one of the key indicators of laboratory performance, and at the same time has a significant impact on the course of the patient’s condition. It is therefore important that the laboratory strives to meet the expectations of clinicians regarding the time from the order to the result of the analysis.

scholarly journals Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I

2020 ◽  
Vol 75 (10) ◽  
pp. 1111-1124 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Thomas Nestelberger ◽  
Luca Koechlin ◽  
Desiree Wussler ◽  
Pedro Lopez-Ayala ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Early Diagnosis ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Point Of Care ◽  
High Sensitivity ◽  
Cardiac Troponin I

scholarly journals Clinical Decision Support Tool and Rapid Point-of-Care Platform for Determining Disease Severity in Patients with COVID-19

2020 ◽  
Author(s):  
Michael P. McRae ◽  
Glennon W. Simmons ◽  
Nicolaos J. Christodoulides ◽  
Zhibing Lu ◽  
Stella K. Kang ◽  
...  
Keyword(s):  
Decision Support ◽  
Disease Severity ◽  
Clinical Decision Support ◽  
Severity Score ◽  
Troponin I ◽  
Point Of Care ◽  
Clinical Decision ◽  
Adverse Outcomes ◽  
Number Of Patients ◽  
Severity Scores

AbstractSARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to overwhelm healthcare systems globally. Likewise, there is a compelling need for a COVID-19 disease severity test to prioritize care and resources for patients at elevated risk of mortality. Here, an integrated point-of-care COVID-19 Severity Score and clinical decision support system is presented using biomarker measurements of C-reactive protein (CRP), N-terminus pro B type natriuretic peptide (NT-proBNP), myoglobin (MYO), D-dimer, procalcitonin (PCT), creatine kinase–myocardial band (CK-MB), and cardiac troponin I (cTnI). The COVID-19 Severity Score combines multiplex biomarker measurements and risk factors in a statistical learning algorithm to predict mortality. The COVID-19 Severity Score was trained and evaluated using data from 160 hospitalized COVID-19 patients from Wuhan, China. Our analysis finds that COVID-19 Severity Scores were significantly higher for the group that died versus the group that was discharged with median (interquartile range) scores of 59 (40–83) and 9 (6–17), respectively, and area under the curve of 0.94 (95% CI 0.89– 0.99). These promising initial models pave the way for a point-of-care COVID-19 Severity Score system to impact patient care after further validation with externally collected clinical data. Clinical decision support tools for COVID-19 have strong potential to empower healthcare providers to save lives by prioritizing critical care in patients at high risk for adverse outcomes.

Multicenter Evaluation of a High-Sensitivity Troponin I Assay and Verification of an Early Rule-Out Algorithm

2019 ◽  
Vol 4 (1) ◽  
pp. 95-100
Author(s):  
Hayley Sharrod-Cole ◽  
Clare Ford
Keyword(s):  
Troponin I ◽  
Task Force ◽  
High Sensitivity ◽  
Analytical Performance ◽  
Coronary Syndrome ◽  
High Sensitivity Troponin ◽  
Continued Use ◽  
Good Concordance ◽  
Abbott Architect ◽  
Rule Out

Abstract Background The objectives of this study were to independently evaluate the analytical performance of the STAT high-sensitivity troponin I (hs-cTnI) assay on a recently launched and CE-marked integrated chemistry and immunoassay system, confirm acceptable performance of the assay in line with The Third Global MI Task Force recommendations, and confirm suitability of the assay for continued use of an early rule-out algorithm for acute coronary syndrome at our Trust. Methods A multicenter evaluation of the analytical performance characteristics of the hs-cTnI assay on the Abbott Alinity ci series was performed in 5 clinical laboratories across Europe. Comparison studies were performed vs the existing Abbott ARCHITECT hs-cTnI assay. Results Passing and Bablok regression analysis revealed a slope of 0.99 [95% confidence interval (CI), 0.98–1.00] and an intercept of −0.09 ng/L (95% CI, −0.21–0.11). Intermediate imprecision ranged from 3.7% to 5.4%, 2.6% to 4.5%, and 2.0% to 6.1% at concentrations of 19.1–21.1 ng/L, 196.6–205.5 ng/L, and 15229–16265 ng/L, respectively. There was good concordance between the 2 assays at the early rule-out cutoff. Conclusion Comparable analytical performance of the hs-cTnI assay on new Abbott Alinity ci series supports the continued use of the early rule out algorithm for patients with suspected ACS at our Trust.

scholarly journals Impact of High-Sensitivity Troponin I Testing with Sex-Specific Cutoffs on the Diagnosis of Acute Myocardial Infarction

2016 ◽  
Vol 62 (6) ◽  
pp. 831-838 ◽  
Author(s):  
Christina Trambas ◽  
John W Pickering ◽  
Martin Than ◽  
Chris Bain ◽  
Lucy Nie ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Time Period ◽  
Before And After ◽  
Angiographic Data ◽  
Female Specific ◽  
Abbott Architect

Abstract BACKGROUND High-sensitivity cardiac troponin I (hs-cTnI) assays show sex-dependent differences in the 99th percentile of healthy populations, with concentrations in women approximately 50% lower. The adoption of sex-specific cutoffs seems appropriate, although it is not yet clear what effect these will have on acute myocardial infarction (AMI) diagnosis and management. METHODS We conducted a retrospective pre- and postchangeover analysis of troponin I testing in the 6 months before and after moving from the contemporary Abbott Architect TnI assay (cTnI) to hs-cTnI at 2 tertiary centers in Australia and New Zealand. The cTnI cutoff was 30 ng/L for both sexes, whereas a female-specific cutoff of 16 ng/L was adopted upon changeover to hsTnI. RESULTS Changeover from the cTnI assay to the hs-cTnI assay increased the number of female patients with increased troponin I concentrations at both sites (from 29.7% to 34.9% and from 22.4% to 30.8%; P < 0.001). There was no statistically significant change in the number of men with increased concentrations in the same time period (P = 0.09). The increased percentage of women with increased troponin I was not associated with an increase in the number of women with AMI diagnoses at either center. Angiographic data available from 1 center showed no change in the percentage of angiograms performed in women. CONCLUSIONS Although increasing the proportion of women with increased troponin I, adopting sex-specific cutoffs with the hs-cTnI assay did not lead to an increase in AMI diagnoses in females, or in the number of women undergoing angiography.

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