Discordance of cardiac troponin I assays on the point-of-care i-STAT and Architect assays from Abbott Diagnostics

Singh, J. J.; Akbar, Muhammad Shoaib; Adabag, Selçuk

doi:10.1016/j.cca.2009.01.017

Cited by 18 publications

(9 citation statements)

References 5 publications

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“…Singh et al 22 have also recently reported the occurrence of likely analytical false positives with the i-STAT cTnI procedure. Singh et al 22 have also recently reported the occurrence of likely analytical false positives with the i-STAT cTnI procedure.…”

Section: Discussionmentioning

confidence: 98%

Use of Plasma Testing to Decrease Discrepant Results With the i-STAT Method for Cardiac Troponin I

Bock

Vasek

Bellone

2011

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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We have previously reported that the point-of-care i-STAT method for cardiac troponin I, performed on whole blood, generally agreed well with a central laboratory method performed on plasma (Siemens TnI-Ultra), except that a few percent of positive i-STAT results could not be confirmed on plasma testing and were apparently false positives (Am J Clin Pathol. 2008;130:132Y5). Because of that finding, we modified our troponin testing protocol for the emergency department to confirm initial positive results on whole blood by retesting on the i-STAT using plasma. We report here on results of that protocol with 12,366 specimens serially received during a 1-year period. Eight hundred seventy-one (7.0%) of those specimens initially tested positive. Of those, 863 could be retested on plasma, and 803 of those (93.0%) were confirmed positive. Of the 60 (7.0%) that were not confirmed positive, in 28 cases the quantitative difference exceeded 0.10 ng/mL, and these were arbitrarily considered ''discrepant'' whole-blood results (3.4% of positive results, 0.2% of all results). Seven hundred seventy-one specimens that were confirmed positive on the i-STAT were retested again using the central laboratory method, and results were positive in all but 2 cases (0.26%). In comparing discrepant whole-blood results with nondiscrepant controls matched for demographic characteristics, the discrepant cases were associated with significantly higher white blood cell counts (14.0 vs 8.5 Â 10 9 /L) and absolute neutrophil counts (7.97 vs 5.7 Â 10 9 /L), but not with any other differences in routine test results. It is concluded that the i-STAT troponin method is vulnerable to an interference that occurs with whole blood but not plasma and that this interference may be mediated in some manner by white blood cells. RESULTSDuring the study period, 12,366 heparinized whole-blood specimens were collected in the ED for rapid cTn testing. The ORIGINAL ARTICLE

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Section: Discussionmentioning

confidence: 98%

Use of Plasma Testing to Decrease Discrepant Results With the i-STAT Method for Cardiac Troponin I

Bock

Vasek

Bellone

2011

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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“…There have been no highly sensitive troponin assays approved by the US FDA, but this is expected to change soon [25]. For troponin T, there is the laboratory-based Elecsys 5th generation highly sensitive troponin T assay (Roche) available in Europe with a LOD of 5 ng/l, and a 10% CV at a troponin T concentration of 13 ng/l.…”

Section: Discussionmentioning

confidence: 99%

Novel Nanomonitor ultra-sensitive detection of troponin T

Barrett

Shanmugam

Selvam

et al. 2015

Clinica Chimica Acta

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“…Various studies have reported extensive alarms regarding the potentially decreased accuracy of bedside analyzers and have revealed the impact of false negative and false positive results on patient management, unjustified expenditure, and test requests [8-9]. Discordances defined as one method reading at more than the 99th percentile limit and the comparator less than the limit between the cTn-I values among different POCT assays and central laboratory assays have been reported [10-11].…”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of Cardiac Troponin I Assay: A Comparison Between the Point-of-care Testing Radiometer AQT90 FLEX and the Central Laboratory Siemens Advia Centaur Analyzer

Ahmed¹,

Jafri²,

Raheem³

et al. 2019

Cureus

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Background To validate the point of care testing (POCT) Trop-I analyzer and compare it with a central laboratory-based chemiluminescence immunoassay, in order to evaluate its performance for use in critical care areas. Moreover, for clinical decision-making, it is imperative to know the extent to which patient stratification will differ based on the analytic method being used. In particular, the aim of this study was to evaluate the analytical performance of the point-of-care analyzer and demonstrate the agreement with the central laboratory measurements in patients presenting to the emergency department (ED) with chest pain and suspected acute coronary syndrome (ACS). Methods This cross-sectional study was performed at the section of chemical pathology, department of pathology and laboratory medicine, the Aga Khan University (AKU), Karachi, from October to November 2017. Samples from patients and the quality control material of Trop-I were analyzed for imprecision, linearity, and method comparison on Advia Centaur (Siemens Diagnostics, CA, USA), and the AQT90 FLEX analyzer (Radiometer Medical ApS, Brønshøj, Denmark) with photometric detection at the section of chemical pathology, AKU. Statistical analysis was done using Microsoft Excel (Microsoft Corporation, Washington, United States) and EP Evaluator version 10.3.0.556 (Data Innovations, LLC, VT, US). Quantitative variables were represented in terms of mean ± SD. For precision, the computed SD was compared with allowable random error. Furthermore, Cohen’s kappa was applied to observe the agreement between the two methods. Results The Trop-I Precision study on the POCT analyzer showed a coefficient of variation (CV) of 2.4% using a pooled patient sample with a mean Trop-I of 2.15 ± 0.05 ng/ml. Three standards ranging from 0.034 to 1.316 ng/ml were run in triplicate to verify accuracy and linearity. The allowable systematic error (SEa) was 10.0%. The maximum deviation for a mean recovery from 100% was 4.1%. All three of the mean recoveries were accurate and within the allowable error limits. The results were linear with slope 1.04, intercept 0.0. On a method comparison, Trop-I showed good agreement, yielding a kappa value of 0.95. Conclusion This study has validated the performance of a POCT Trop-I assay against a central laboratory immunoassay and found acceptable results. POCT assays for cTnI should be implanted in emergency settings to ensure the fast triage of patients with chest pain, as well as timely diagnosis.

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Discordance of cardiac troponin I assays on the point-of-care i-STAT and Architect assays from Abbott Diagnostics

Cited by 18 publications

References 5 publications

Use of Plasma Testing to Decrease Discrepant Results With the i-STAT Method for Cardiac Troponin I

Use of Plasma Testing to Decrease Discrepant Results With the i-STAT Method for Cardiac Troponin I

Novel Nanomonitor ultra-sensitive detection of troponin T

Performance Evaluation of Cardiac Troponin I Assay: A Comparison Between the Point-of-care Testing Radiometer AQT90 FLEX and the Central Laboratory Siemens Advia Centaur Analyzer

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