Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I

2018 ◽  
Vol 56 (3) ◽  
pp. 492-501 ◽  
Author(s):  
Silvia Masotti ◽  
Concetta Prontera ◽  
Veronica Musetti ◽  
Simona Storti ◽  
Rudina Ndreu ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
Analytical Sensitivity ◽  
Plasma Samples ◽  
Serum Samples ◽  
Significant Difference ◽  
Heparin Plasma

AbstractBackground:The study aim was to evaluate and compare the analytical performance of the new chemiluminescent immunoassay for cardiac troponin I (cTnI), called Access hs-TnI using DxI platform, with those of Access AccuTnI+3 method, and high-sensitivity (hs) cTnI method for ARCHITECT platform.Methods:The limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CV were evaluated according to international standardized protocols. For the evaluation of analytical performance and comparison of cTnI results, both heparinized plasma samples, collected from healthy subjects and patients with cardiac diseases, and quality control samples distributed in external quality assessment programs were used.Results:LoB, LoD and LoQ at 20% and 10% CV values of the Access hs-cTnI method were 0.6, 1.3, 2.1 and 5.3 ng/L, respectively. Access hs-cTnI method showed analytical performance significantly better than that of Access AccuTnI+3 method and similar results to those of hs ARCHITECT cTnI method. Moreover, the cTnI concentrations measured with Access hs-cTnI method showed close linear regressions with both Access AccuTnI+3 and ARCHITECT hs-cTnI methods, although there were systematic differences between these methods. There was no difference between cTnI values measured by Access hs-cTnI in heparinized plasma and serum samples, whereas there was a significant difference between cTnI values, respectively measured in EDTA and heparin plasma samples.Conclusions:Access hs-cTnI has analytical sensitivity parameters significantly improved compared to Access AccuTnI+3 method and is similar to those of the high-sensitivity method using ARCHITECT platform.

Assessing matrix, interferences and comparability between the Abbott Diagnostics and the Beckman Coulter high-sensitivity cardiac troponin I assays

2018 ◽  
Vol 56 (7) ◽  
pp. 1176-1181 ◽  
Author(s):  
Peter A. Kavsak ◽  
Paul Malinowski ◽  
Chantele Roy ◽  
Lorna Clark ◽  
Shana Lamers
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Matrix Effects ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Mean Difference ◽  
Plasma Samples ◽  
Matrix Interferences ◽  
Heparin Plasma ◽  
Edta Plasma

Abstract Background: Analytical evaluation of high-sensitivity cardiac troponin (hs-cTn) assays, with particular attention to imprecision, interferences and matrix effects, at normal cTn concentrations, is of utmost importance as many different clinical algorithms use concentration cutoffs <10 ng/L for decision-making. The objective for the present analytical study was to compare the new Beckman Coulter hs-cTnI assay (Access hsTnI) to Abbott’s hs-cTnI assay in different matrices and for different interferences, with a focus on concentrations <10 ng/L. Methods: The limit of blank (LoB) and the limit of detection (LoD) were determined in different matrices for the Beckman hs-cTnI assay. Passing-Bablok regression and difference plots were determined for 200 matched lithium heparin and EDTA plasma samples for the Beckman assay and 200 lithium heparin samples for the Abbott assay. Both EDTA and heparin plasma samples were also evaluated for stability under refrigerated conditions, for endogenous alkaline phosphatase interference and for hemolysis and icterus. Results: The Beckman hs-cTnI assay LoB was 0.5 ng/L with the following range of LoDs=0.8–1.2 ng/L, with EDTA plasma yielding lower concentrations as compared to lithium heparin plasma (mean difference=−14.9%; 95% CI=−16.9 to 12.9). Below 10 ng/L, lithium heparin cTnI results from the Beckman assay were on average 1.1 ng/L (95% CI=0.7 to 1.5) higher than the Abbott results, with no difference between the methods when using EDTA plasma (mean difference =−0.1 ng/L; 95% CI=−0.3 to 0.2). Low cTnI concentrations were less effected by interferences in EDTA plasma. Conclusions: The Access hsTnI method can reliably detect normal cTnI concentrations with both lithium heparin and EDTA plasma being suitable matrices.

Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay

2017 ◽  
Vol 56 (1) ◽  
Author(s):  
Giuseppe Lippi ◽  
Anna Ferrari ◽  
Giorgio Gandini ◽  
Matteo Gelati ◽  
Claudia Lo Cascio ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
The Novel ◽  
Reference Limit ◽  
Automated Immunoassay ◽  
Upper Reference Limit

AbstractBackground:This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI).Methods:The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36±12 years; 47% women) and comparison with two other commercial cTnI immunoassays.Results:The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%–2.9%, 4.6%–5.4%, and 5.4%–6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r=1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r=0.97; mean bias, −9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r=0.95; mean bias, −55%).Conclusions:The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.

scholarly journals Comparison of the analytical performance of the PATHFAST high sensitivity cardiac troponin I using fresh whole blood vs. fresh plasma samples

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Vinajak Gopi ◽  
Barbara Milles ◽  
Eberhard Spanuth ◽  
Matthias Müller-Hennessen ◽  
Moritz Biener ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Whole Blood ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Point Of Care ◽  
High Sensitivity ◽  
Plasma Samples ◽  
Discriminatory Ability ◽  
Coronary Syndrome ◽  
Significant Difference

Abstract Objectives The PATHFAST hs-cTnI (high-sensitivity cardiac troponin) assay is the first point-of-care assay with a high-sensitivity designation that received FDA approval for diagnosis of myocardial infarction (MI). Testing from whole blood does not need centrifugation and therefore is faster and more convenient in the emergency room instead of plasma. However, there is sparse evidence whether point-of-care testing of Tn from whole blood is as reliable as from plasma samples. Methods We investigated the agreement between plasma and whole blood hs-cTnI by using the PATHFAST hs-cTnI assay. Hs-cTnT measured on Cobas 602 in the central laboratory and compared to a final diagnosis of NSTEMI using serial hs-cTnT served as reference. We assessed biases, limits of agreement (±1.96 SD) and coefficients of correlation, and tested the discriminatory ability of the baseline sample of plasma and whole blood hs-cTnI and plasma hs-cTnT to discriminate non-ST-segment elevation myocardial infarction (NSTEMI). Results A total of 224 paired fresh samples were collected simultaneously from 191 patients presenting with suspected acute coronary syndrome. There was an excellent correlation between plasma and whole blood hs-cTnI (r=0.99), and a very good inter-rater agreement (k=0.93) between elevated and normal plasma and whole blood results. Precision evaluation according to CLSI ep 15 revealed comparable coefficients of variation (CV) in whole blood and plasma. The discriminatory ability of baseline hs-cTnT, plasma and whole blood hs-cTnI was excellent (AUC 0.967, AUC 0.954 and AUC 0.953) without significant difference. Conclusions Whole blood can be used interchangeably with plasma for more convenient and less time and labor-consuming testing of hs-cTnI on the PATHFAST instrument.

Evaluation and Comparison with Other High-Sensitivity Methods of Analytical Performance and Measured Values of a New Laboratory Test for Cardiac Troponin I Assay

2021 ◽  
Author(s):  
Silvia Masotti ◽  
Veronica Musetti ◽  
Concetta Prontera ◽  
Simona Storti ◽  
Claudio Passino ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Clinical Results ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
Multicenter Studies ◽  
Automated Platform ◽  
Chemiluminescent Method

Abstract Bakground The aim of this study was to evaluate both analytical characteristics and clinical results of a new chemiluminescent method for the measurement of cardiac troponin I (cTnI), named VITROS ® High Sensitivity Troponin I Assay, using the VITROS® 3600 automated platform. The results found with this new method were compared to those observed with hs-cTnI ARCHITECT and ECLIA hs-cTnT ELECSYS methods. Methods For evaluation of analytical performance and comparison of clinical results, plasma samples (lithium-heparin), were collected from apparently healthy subjects and patients with cardiovascular diseases. Results The hs-cTnI VITROS method showed values for limit of blank (LoB 0.33 ng/L), limit of detection (LoD, 0.91 ng/L), limit of quantifications at 20% (LoQ 20% CV, 1.82 ng/L), and 10% (LoQ 10% CV, 4,74 ng/L), which are comparable to those previously reported for other hs-cTnI methods. Moreover, the clinical results of the hs-cTnI VITROS method were found to be closely correlated to those of hs-cTnI ARCHITECT (R = 0,9883, N = 198) and ECLIA hs-cTnT Elecsys (R = 0,9704, N = 293) methods. Conclusions The hs-cTnI VITROS method shows analytical performance comparable to other cTnI and cTnT assay. The results of this study confirm that there are significant systematic differences among hs-cTnI methods. Further multicenter studies using larger reference populations are needed in order to obtain a better estimation, especially of the 99° percentile URL values categorized for sex and age of hs-cTnI and hs-cTnT methods.

Comparison of Abbott AxSYM, Behring Opus Plus, DPC Immulite and Ortho-Clinical Diagnostics Vitros ECi for measurement of cardiac troponin I

2001 ◽  
Vol 38 (2) ◽  
pp. 140-146 ◽  
Author(s):  
Jau-Tsuen Kao ◽  
I-Li Wong ◽  
Jeen-Yih Lee ◽  
Ruey-Chean Chen
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Regression Line ◽  
Cardiac Troponin I ◽  
Clinical Diagnostics ◽  
Serum Samples ◽  
Total Percentage ◽  
Significant Difference ◽  
Ortho Clinical Diagnostics

Myocardial infarction is a common cause of morbidity and mortality in patients with chest pain. The presence of human cardiac troponin I (cTnI) in serum is considered to be a highly specific biochemical marker of acute myocardial infarction. In this study we compare the performances of the Abbott AxSYM, Behring Opus Plus, DPC Immulite and Ortho-Clinical Diagnostics Vitros ECi for the measurement of cTnI. The first two methods use a fluorogenic enzyme-linked immunoassay, whereas the last two use chemiluminescent immunometric assays. All procedures are completely automated. Total percentage coefficients of variation using pooled sera ranged from 5·9 to 6·5% for the AxSYM, 14·4 to 25·6% for the Opus, 6·9 to 9·8% for the Immulite and 4·5 to 5·2% for the Vitros ECi method. The closest correlation between methods, obtained from 120 fresh serum samples, was observed between the Vitros ECi and the Immulite methods, with r=0·99, and the regression line was Immulite cTnI=1·505 (95% confidence interval 1·474-1·536) x Vitros cTnI-0·154 (-0·702 to 0·394). Receiver operating characteristic curves were nearly identical for all assays, and the areas under the curves were 0·972, 0·927, 0·967 and 0·969 for the AxSYM, Opus, Immulite and Vitros ECi methods, respectively. There was a significant difference between the AxSYM and Opus methods ( P=0·036).

Cardiac troponin I in healthy newborn goat kids and in goat kids with cardiac nutritional muscular dystrophy

2013 ◽  
Vol 61 (4) ◽  
pp. 442-453 ◽  
Author(s):  
Mohamed Tharwat ◽  
Fahd Al-Sobayil ◽  
Mehana El-Sayed
Keyword(s):  
Muscular Dystrophy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Cardiac Troponin I ◽  
Specific Marker ◽  
Serum Samples ◽  
Healthy Newborn ◽  
Significant Difference ◽  
The Mean ◽  
Nutritional Muscular Dystrophy

This study was designed to establish serum cardiac troponin I (cTnI) concentrations in healthy newborn goat kids and in those with cardiac nutritional muscular dystrophy (NMD). Thirty-five single full-term newborn goat kids (20 males and 15 females; age: 6.1 ± 3.5 h; weight 3.4 ± 0.68 kg), together with their respective mothers (Group 1; G1) were enrolled consecutively. Thirty-one goat kids (age: 9.5 ± 4.3 days) with NMD, together with 20 control goat kids (age: 7.8 ± 4.3 days) were also included in this study (Group 2; G2). Blood samples were collected from G1 within 12 h of birth and from G2 on admission. Serum samples were collected and analysed for cTnI. In G1, the mean serum concentration of cTnI in goat kids was 0.290 ± 0.37 ng/mL, with no statistically significant difference between male and female kids (P = 0.61). The mean cTnI concentration in the does was 0.017 ± 0.04, ng/mL. Serum values of cTnI in the goat kids and in their respective mothers differed significantly (P = 0.0001). In G2, the mean cTnI concentration was 0.02 ± 0.05 ng/mL in the control and 11.18 ± 20.07 ng/mL in the diseased goat kids, with a statistically significant difference between diseased and control goat kids (P = 0.017). Serum concentrations of cTnI are higher in goat kids than in their respective mothers. In conclusion, the cTnI assay appears to be a sensitive and specific marker for myocardial injury in goat kids.

EXPRESS: Analytical characterization and clinical performance evaluation of a new point-of-care testing system for high-sensitivity cardiac troponin I assay

2021 ◽  
pp. 000456322110276
Author(s):  
Rui Zhang ◽  
Yuhong Yue ◽  
Jie Shi ◽  
Rui Zhao ◽  
Yichuan Song ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Point Of Care ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Limit Of Quantitation

Background: We aimed to evaluate the analytical performance and clinical diagnostic accuracy of the SuperFlex point-of-care testing (POCT) High-Sensitivity Cardiac Troponin I (hs-cTnI) assay system. Method: The imprecision, the limit of blank (LoB), the limit of detection (LoD), the limit of quantitation (LoQ), linearity, and comparability were assessed as per the Clinical and Laboratory Standards Institute guidelines. Also, the 99th-percentile reference value and diagnostic accuracy were evaluated. Results: The reproducibility and total imprecision were 1.52–1.92% and 2.69–2.92%, respectively. LoB and LoD were 1ng/L and 1.8ng/L, respectively, and LoQ was 12ng/L at 10% coefficient of variation (CV). The results met the requirements of linearity, and the correlation coefficient was 0.996. The SuperFlex POCT results had good agreement with those obtained by the Siemens Advia 2400. The CV% was 7.24% at the 99th percentile concentration (p99th) of 25.6ng/L (95% confidence interval: 22.0–33.3ng/L) from 620 healthy populations. The sex-partitioned CV% and p99th were 7.15% at 27ng/L (males; n = 308) and 7.35% at 24ng/L (females; n = 312), respectively (p < 0.0001). The hs-cTnI detection rate of all observed healthy individuals from LoD to 99th was 82.57% by the SuperFlex POCT assay, 89.90% for the males, and 75.48% for the females. The sensitivity, specificity, positive predictive value, and negative predictive value of diagnostic performance for acute myocardial infarction were 100%, 81.25%, 57%, and 100%, respectively. Conclusions: The SuperFlex POCT system showed the analytical performance characteristics required for enabling the clinical use of a hs-cTnI assay.

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