Determination of sex-specific 99th percentile upper reference limits for a point of care high sensitivity cardiac troponin I assay

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Fred S. Apple ◽  
Karen Schulz ◽  
Christian W. Schmidt ◽  
Trees S. Y. van Domburg ◽  
Judith M. Fonville ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Point Of Care ◽  
High Sensitivity ◽  
The Novel ◽  
Limit Of Quantitation ◽  
Reference Limits ◽  
Males And Females

Abstract Objectives High sensitivity (hs) cardiac troponin (cTn) assays are defined per the IFCC Committee on Clinical Application of Cardiac Biomarker (C-CB) by the ability to measure ≥ 50% of concentrations greater than the limit of detection (LoD) with an impression of ≤10% at sex-specific 99th percentiles. Our study determined the sex-specific 99th percentile upper reference limits for males and females utilizing heparinized plasma from AACC universal sample bank for the Siemens point of care (POC) Atellica® VTLi hs-cTnI immunoassay. Methods Apparently healthy subjects, included overall 693, males 363, and females 330, following exclusionary surrogate biomarker use of hemoglobin A1c, NT-proBNP, and eGFR, along with statin medication. hs-cTnI was measured in a central laboratory, on multiple POC Atellica® VTLi immunoassay analyzers. The LoD was 1.24 ng/L and limit of quantitation (CV 20%) was 6.7 ng/L. 99th percentile URLs were determined by the nonparametric (NP) method. Results Histograms of the hs-cTnI concentrations (ng/L) for males and females were used to visualize the distributions and concentrations in men and women and differed significantly (pre- and post-exclusion, both p <0.001). 99th percentile URLs were: overall 23 ng/L (90% CI 20–32 ng/L); male 27 ng/L (CI 21–37 ng/L); female 18 ng/L (CI 9–78 ng/L). The percentages of subjects having a measurable concentration ≥ the LoD were: overall 83.7%, male 87.3%, female 79.7%. Conclusions Our findings show the novel POC Atellica® VTLi hs-cTnI assay meets the designation of a ‘high-sensitivity’ assay using heparinized plasma.

scholarly journals Determination of high sensitive cardiac troponin I 99th percentile upper reference limits in a healthy Pakistani population

2020 ◽  
Vol 36 (6) ◽  
Author(s):  
Kulsoom Bahadur ◽  
Aamir Ijaz ◽  
Momin Salahuddin ◽  
Aftab Alam
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Laboratory Data ◽  
Cardiac Troponin I ◽  
Medical Institute ◽  
Pakistani Population ◽  
Reference Limits ◽  
Males And Females ◽  
Gender Specific

Objective: This study aims to establish the 99th percentile upper reference limits of high sensitive cardiac troponin I in a healthy Pakistani population. Methods: It was an Observational cohort study carried out in Department of Chemical Pathology and Endocrinology Rehman Medical Institute Peshawar, over the period of one year (January 2019- December 2019). Total 299 cardio-healthy males and females were interviewed and taken past medical history. Based on history, clinical examination, echocardiogram and laboratory data including results of estimated glomerular filtration rate (eGFR) and N-terminal pro-B-type natriureteric peptide (NT-proBNP), subjects with possible subclinical diseases were excluded. High Sensitive Cardiac Troponin I (hs-cTtrop I) was analysed on Abbot ARCHITECT STAT ci8200 using chemiluminescent immunoassay technique. The 99th percentile upper reference limit (URL) of hs-cTtrop I was determined using a non-parametric statistic, while gender specific results were compared. Results: In this study, 178 males (59.5%) and 121 females (40.5%) were included. The median Interquartile ranges (IQR) of age was 57 (11.6) for males and 56 (13) for females. The 99th percentile URL hs-cTtrop I was found to be 33.9 ng/L, while gender specific values were 38.41ng/L and 15.73ng/L for males and females, respectively (p= 0.0045). Conclusion: High sensitivity cardiac troponin I 99th percentile URL in our study population was found to be 33.9 ng/L with gender specific values being 38.41 ng/L and 15.73ng/L for males and females respectively. Troponin I in males was substantially high in comparison with females. doi: https://doi.org/10.12669/pjms.36.6.2328 How to cite this:Bahadur K, Ijaz A, Salahuddin M, Alam A. Determination of high sensitive cardiac troponin I 99th percentile upper reference limits in a healthy Pakistani population. Pak J Med Sci. 2020;36(6):---------. doi: https://doi.org/10.12669/pjms.36.6.2328 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination

2019 ◽  
Vol 58 (1) ◽  
pp. 138-145 ◽  
Author(s):  
Federica Braga ◽  
Elena Aloisio ◽  
Andrea Panzeri ◽  
Takahito Nakagawa ◽  
Mauro Panteghini
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Point Of Care ◽  
Total Error ◽  
Method Comparison ◽  
Reference Limit ◽  
Highly Sensitive ◽  
Limit Of Quantitation

Abstract Background Highly sensitive cardiac troponin assays (hs-cTn) are not available as point-of-care (POC) measurements. As rapid testing cannot be achieved at the expense of clinical performance, there is an urgent need to develop and rigorously validate POC hs-cTn. Konica Minolta (KM) has recently developed a surface plasmon-field enhanced fluorescence spectroscopy-based POC hs-cTn I system. Methods We validated the analytical characteristics of the KM POC system according to the international guidelines. Results Limit of blank (LoB) and limit of detection (LoD) were 0.35 and 0.62 ng/L, respectively, hs-cTn I concentrations corresponding to a total CV of 20%, 10% and 5% were 1.5, 3.9 and 11.0 ng/L, respectively. Method comparison studies showed that KM calibration was successfully traced to higher-order references. Limit of quantitation (LoQ), i.e. the hs-cTn I concentration having a total error of measurement of ≤34%, was 10.0 ng/L. The upper reference limit (URL) for 600 healthy blood donors was calculated at 12.2 ng/L (90% confidence interval [CI]: 9.2–39.2), while sex-partitioned URLs were 20.6 (males) and 10.7 ng/L (females), respectively (p < 0.0001). KM assay measured hs-cTn I concentrations >LoD in 65.7% of all reference individuals, in 76.7% of males and in 54.7% of females, respectively. Conclusions The KM system joins the characteristics of POC systems to the analytical performance of hs-cTn.

Determination of the High-Sensitivity Cardiac Troponin I 99th Percentile Upper Reference Limits in Malaysian Population

2018 ◽  
Vol 273 ◽  
pp. 22
Author(s):  
lntan Nureslyna Samsudin ◽  
Lim Say Min ◽  
Subashini C. Thambiah ◽  
Siti Yazmin Zahari Sham ◽  
Roslina Omar ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Malaysian Population ◽  
Reference Limits

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.

Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Peter A. Kavsak ◽  
Tara Edge ◽  
Chantele Roy ◽  
Paul Malinowski ◽  
Karen Bamford ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Clinical Diagnostics ◽  
Ortho Clinical Diagnostics

AbstractObjectivesTo analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.MethodsThe limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).ResultsThe VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.ConclusionsLack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.

scholarly journals Copper-nickel oxide nanofilm modified electrode for non-enzymatic determination of glucose

2020 ◽  
Vol 10 (3) ◽  
pp. 245-255
Author(s):  
Mahsa Hasanzadeh ◽  
Zahra Hasanzadeh ◽  
Sakineh Alizadeh ◽  
Mehran Sayadi ◽  
Mojtaba Nasiri Nezhad ◽  
...  
Keyword(s):  
Modified Electrode ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Stability Loss ◽  
The Novel ◽  
Step Potential ◽  
Enzymatic Determination ◽  
Wide Range ◽  
Naoh Solution

CuxO-NiO nanocomposite film for the non-enzymatic determination of glucose was prepared by the novel modifying method. At first, anodized Cu electrode was kept in a mixture solution of CuSO4, NiSO4 and H2SO4 for 15 minutes. Then, a cathodization process with a step potential of -6 V in a mixture solution of CuSO4 and NiSO4 was initiated, generating formation of porous Cu-Ni film on the bare Cu electrode by electrodeposition assisted by the release of hydrogen bubbles acting as soft templates. Optimized conditions were determined by the experimental design software for electrodeposition process. Afterward, Cu-Ni modified electrode was scanned by cyclic voltammetry (CV) method in NaOH solution to convert Cu and Ni nanoparticles to the nano-scaled CuxO-NiO film. The electrocatalytic behavior of the novel CuxO-NiO film toward glucose oxidation was studied by CV and chronoamperometry (CHA) techniques. The calibration curve of glucose was found linear in a wide range of 0.04–5.76 mM, with a low limit of detection (LOD) of 7.3 µM (S/N = 3) and high sensitivity (1.38 mA mM-1 cm-2). The sensor showed high selectivity against some usual interfering species and high stability (loss of only 6.3 % of its performance over one month). The prepared CuxO-NiO nanofilm based sensor was successfully applied for monitoring glucose in human blood serum and urine samples.

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.

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