Four Different High-Sensitivity Cardiac Troponin Assays With Important Analytical Performance Differences

Kavsak, Peter A.; Ainsworth, Craig; Clark, Lorna; Devereaux, P.J.; Worster, Andrew

doi:10.1016/j.cjca.2019.03.005

Cited by 7 publications

(5 citation statements)

References 5 publications

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“…We tested 41 plasma samples from 15 patients with suspected acute coronary syndrome collected by Mayo Clinic Arizona for cTnT testing. Since the absolute values of the results from different instruments and methods have low comparability, − we mainly focused on comparing the concentration changes in serial measurements at 2 and 6 h to the initial value at 0 h (Figure ). We compared the change in cTnT value detected from our method with the results from Mayo’s commercial instrument (Figure ).…”

Section: Resultsmentioning

confidence: 99%

Gradient-Based Rapid Digital Immunoassay for High-Sensitivity Cardiac Troponin T (hs-cTnT) Detection in 1 μL Plasma

et al. 2020

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Rapid and sensitive detection of biomarkers is the key to the diagnosis of acute diseases. One example is the detection of troponin in myocardial infarction. Here, we report a gradient-based digital immunoassay method, which can achieve high-sensitivity cardiac troponin T (hs-cTnT) detection with only 1 μL of plasma sample. We designed a multizone microfluidic channel functionalized with capture antibody specific to troponin. Taking advantage of limited sample volume, a troponin concentration gradient is created along the channel because of binding induced depletion. We quantified the concentration gradient by counting the detection antibody conjugated gold nanoparticles bound to different test zones with optical imaging. Differential counting between the zones removes most common noises and nonspecific bindings. The total analytical time is about 30 min, and the limit of quantification is 6.2 ng/L. We examined 41 clinical plasma samples from 15 patients and the change in hs-cTnT concentration in serial samples showed good linear correlation with clinical results (R 2 = 0.98). Therefore, this simple and sensitive gradient-based digital immunoassay method is a promising technology for clinical hs-cTnT detection and could be adapted for detection of other biomarkers.

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Section: Resultsmentioning

confidence: 99%

Gradient-Based Rapid Digital Immunoassay for High-Sensitivity Cardiac Troponin T (hs-cTnT) Detection in 1 μL Plasma

et al. 2020

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“…In this regard, we have provided evidence of analytical issues that affect interpretation around and below 5 ng/L. 8 , 9 , 10 , 11 , 12 Laboratory recommendations on appropriate monitoring of the hs-cTnI assays will help mitigate some of these issues; 13 however, what has not been evaluated thoroughly is the impact of a low hs-cTnI result for risk stratification in a general ED population in North America. To address this gap, our goal was to compare Abbott hs-cTnI published cutoffs (eg, 5 ng/L and the overall 99th percentile of 26 ng/L) alone vs a simple laboratory algorithm (ie, Clinical Chemistry Score [CCS]) 14 at presentation in a general ED population to determine low- and high-risk patients for subsequent all-cause death.…”

mentioning

confidence: 99%

High-Sensitivity Cardiac Troponin I vs a Clinical Chemistry Score for Predicting All-Cause Mortality in an Emergency Department Population

Kavsak

Cerasuolo

et al. 2020

CJC Open

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Background For patients investigated for suspected acute coronary syndrome, there is uncertainty if a single measurement of high-sensitivity cardiac troponin I (hs-cTnI) at emergency department (ED) presentation can identify patients at both low and high risk for mortality. Methods We included consecutive adult patients in the ED who had a Clinical Chemistry Score (CCS) taken at presentation (ie, combination of glucose, creatinine for estimated glomerular filtration rate determination, and hs-cTnI assay) in a Canadian city between 2012 and 2013. Outcomes were 3-month, 1-year, and 5-year all-cause mortality using the provincial death registry. Mortality rates and test performance (eg, sensitivity and specificity) with 95% confidence intervals (CIs) were obtained for the CCS or hs-cTnI assay alone using established cutoffs for these tests. Results Our cohort included 5974 patients with a 1-year mortality rate of 17.2% (95% CI, 16.2-18.3). A CCS ≥ 1 yielded a sensitivity of 99.2% (95% CI, 98.4-99.6) compared with the hs-cTnI ≥ 5 ng/L cutoff sensitivity of 88.4% (95% CI, 86.3-90.3), with the mortality rate being significantly lower for patients with CCS < 1 (2.0%; 95% CI, 0.9-4.0) vs patients with hs-cTnI < 5 ng/L (5.0%; 95% CI, 4.2-6.0) at 1 year ( P = 0.01). A CCS of 5 also yielded a higher specificity (88.5%; 95% CI, 87.5-89.3) compared with hs-cTnI > 26 ng/L (83.9%; 95% CI, 82.9-84.9), with no difference in mortality rates (37.4% vs 36.3%; P = 0.66). This trend was consistent at 3-month and 5-year mortality. Conclusion For patients in the ED with a potential cardiac issue, using the CCS cutoffs can better identify patients at low and high risk for mortality than using published cutoffs for hs-cTnI alone.

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“…For cTn measurements obtained following resolution of the illness to be informative cTn monitoring during the illness may be required for appropriate interpretation; testing with comparison to appropriate controls should be carried out over subsequent months to evaluate if concentrations have stabilized, decreased, or even increased after the virus has cleared. cTn measurement would need to be performed using the same hs-cTn assay/methodology for accurate interpretation, as differences between assays are evident even in the low concentration range (39). To avoid any misinterpretation of cTn concentrations, patients here would be advised to go to the same outpatient setting that uses the same cTn assay that was tested during their acute illness.…”

Section: Testing Strategiesmentioning

confidence: 99%

Cardiac Troponin Testing in Patients with COVID-19: A Strategy for Testing and Reporting Results

et al. 2020

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Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that emerged late in 2019 causing COVID-19 (coronavirus disease-2019) may adversely affect the cardiovascular system. Publications from Asia, Europe and North America have identified cardiac troponin as an important prognostic indicator for patients hospitalized with COVID-19. We recognized from publications within the first 6 months of the pandemic that there has been much uncertainty on the reporting, interpretation, and pathophysiology of an increased cardiac troponin concentration in this setting. Content The purpose of this mini-review is: a) to review the pathophysiology of SARS-CoV-2 and the cardiovascular system, b) to overview the strengths and weaknesses of selected studies evaluating cardiac troponin in patients with COVID-19, and c) recommend testing strategies in the acute period, in the convalescence period and in long-term care for patients who have become ill with COVID-19. Summary This review provides important educational information and identifies gaps in understanding the role of cardiac troponin and COVID-19. Future, properly designed studies will hopefully provide the much-needed evidence on the path forward in testing cardiac troponin in patients with COVID-19.

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Four Different High-Sensitivity Cardiac Troponin Assays With Important Analytical Performance Differences

Cited by 7 publications

References 5 publications

Gradient-Based Rapid Digital Immunoassay for High-Sensitivity Cardiac Troponin T (hs-cTnT) Detection in 1 μL Plasma

Gradient-Based Rapid Digital Immunoassay for High-Sensitivity Cardiac Troponin T (hs-cTnT) Detection in 1 μL Plasma

High-Sensitivity Cardiac Troponin I vs a Clinical Chemistry Score for Predicting All-Cause Mortality in an Emergency Department Population

Cardiac Troponin Testing in Patients with COVID-19: A Strategy for Testing and Reporting Results

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