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

Lippi, Giuseppe; Ferrari, Anna; Gandini, Giorgio; Gelati, Matteo; Cascio, Claudia Lo; Salvagno, Gian Luca

doi:10.1515/cclm-2017-0350

Cited by 28 publications

(12 citation statements)

References 23 publications

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“…Four samples were below the LoD and two samples were outliers, as a consequence they were excluded from the statistical analysis. Total imprecision within the laboratory was consistent with claims made by the manufacturer and in accordance with previous studies [19,20] on all instruments.…”

Section: Resultssupporting

confidence: 88%

Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?

Stenner¹,

Russo²,

Ruscio³

et al. 2019

Biomark J

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Aim of the study: To measure high-sensitive troponin (Access hsTnI) interidentical-instrument bias (DxI800 Beckman Coulter) in order to understand if it can compromise the interpretation of absolute delta value for rapid algorithms 0/1-0/3 hours. Materials and methods: One hundred fifty-nine lithium/heparin plasma samples were processed sequentially on three DxI800 (DxI1, DxI2, DxI3). The results given by the three instruments were analyzed as followed: DxI1 vs. DxI2, DxI1 vs. DxI3, DxI2 vs. DxI3. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen's Kappa statistic. Results: PB regression did not show any significant deviation from linearity and no proportional nor constant differences were observed among instruments. Moreover, the mean absolute bias, even though among the three instruments the lowest 95%CI lower limit was-3.75 and the highest 95%CI upper limit was 3.92 ng/L, was within the acceptance limits (all results

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Section: Resultssupporting

confidence: 88%

Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?

Stenner¹,

Russo²,

Ruscio³

et al. 2019

Biomark J

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show abstract

“…The diagnosis of COVID-19 was confirmed as positive result for nasopharyngeal swab and respiratory pathogen nucleic acid test with high-throughput sequencing or real-time reverse transcriptase polymerase chain reaction. Diagnosis of myocardial injury: Myocardial injury was defined as an elevated serum level of hs-cTnI greater than the 99th percentile upper reference limit recommended cut-off of 17.5 ng/L (pg/mL) by the Access hs-cTnI assay (Beckman Coulter) [9] , [10] . …”

Section: Methodsmentioning

confidence: 99%

“…Diagnosis of myocardial injury: Myocardial injury was defined as an elevated serum level of hs-cTnI greater than the 99th percentile upper reference limit recommended cut-off of 17.5 ng/L (pg/mL) by the Access hs-cTnI assay (Beckman Coulter) [9] , [10] .…”

Section: Methodsmentioning

confidence: 99%

Implications of myocardial injury in Mexican hospitalized patients with coronavirus disease 2019 (COVID-19)

Heberto¹,

Carlos²,

Antonio³

et al. 2020

IJC Heart & Vasculature

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Background Respiratory illnesses is the most common manifestation of Coronavirus disease 2019 (COVID-19); however, myocardial injury has recently emerged as a frequent complication. Methods An observational, longitudinal, prospective, and multicenter study of hospitalized Mexican patients was made. We assessed the prevalence of myocardial injury and its relationship with complications and mortality. Results 254 COVID-19 patients were included. Their average age was 53.8 years old, 167 (65.7%) were male and 87 (34.3%) female. According to troponin levels, two populations were generated, those with and without myocardial injury. There was no difference in gender or age between both groups. However, there was a greater proportion of obesity and hypertension in myocardial injury group. Multivariate logistic regression analysis revealed that obesity (OR 2.029, 95% CI 1.039–3.961; p = 0.038), arterial oxygen saturation <90% (OR 2.250, 95% CI 1.216–3.560; p = 0.025), and systolic blood pressure <90 mmHg (OR 2.636, 95% CI 1.530–4.343; p = 0.042), were directly related to higher levels of troponins. Multivariate cox proportional hazards analysis showed that primary endpoint (mortality) was determined by overweight/obesity (OR 1.290, 95% CI 0.115–0.730; p = 0.009), ferritin levels (OR 1.001, 95% CI 1.000–1.001; p < 0.001), myocardial injury (OR 3.764, 95% CI 1.307–10.838; p = 0.014), septic shock (OR 4.104, 95% CI 1.142–14.132; p = 0.024), acute respiratory distress syndrome (OR 3.001, 95% CI 1.008–10.165; p = 0.040), and treatment with Hydroxychloroquine/Azithromycin (OR 0.357, 95% IC 0.133–0.955; p = 0.040). Secondary endpoint (Mechanical ventilation risk) was associated to the same factors. Conclusions Myocardial injury represents an increased risk of complications and death in Mexican hospitalized patients with COVID-19.

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“…The purported advantages of these "high sensitivity" (hs) assays include detection of cTnI and cTnT in the majority of cardiac-healthy individuals with better risk stratification and improved diagnostic sensitivity that may lead to better clinical outcomes. The Beckman Coulter Access hsTnI is a recent addition to this category of hs assays and brief evaluations of the method have been published (1,2).…”

Section: Accepted Manuscript 1 Introductionmentioning

confidence: 99%

A critical evaluation of the Beckman Coulter Access hsTnI : Analytical performance, reference interval and concordance

Pretorius

Tate

Wilgen

et al. 2018

Clinical Biochemistry

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

Abstract: The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.

Cited by 28 publications

References 23 publications

Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?

Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?

Implications of myocardial injury in Mexican hospitalized patients with coronavirus disease 2019 (COVID-19)

A critical evaluation of the Beckman Coulter Access hsTnI : Analytical performance, reference interval and concordance

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