Daily monitoring of a control material with a concentration near the limit of detection improves the measurement accuracy of highly sensitive troponin assays

Aloisio, Elena; Pasqualetti, Sara; Dolci, Alberto; Panteghini, Mauro

doi:10.1515/cclm-2019-0702

Cited by 7 publications

(2 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, control materials offered by the manufacturers together with hs-cTn assays do not usually cover low cTn concentrations, leaving the assay vulnerable to potential drifts that may pass unnoticed. Aloisio et al recently showed that daily monitoring of an in-house made serum pool with a concentration near the limit of detection (LoD) of the hs-cTn assay, used as an additional control material besides those offered by the manufacturer, improved the measurement accuracy of hs-cTn assays at low but clinically relevant concentrations [31]. Particularly, the laboratory results of the UK NEQAS Cardiac Markers External Quality Assessment (EQA) program, which includes a "low concentration sample" with cTn concentrations lower than the 99th percentile URL, were substantially better after the introduction of this additional quality control tool (the number of Recommended tools which medical laboratories should use to check the analytical performance at the low end of measuring range of their highly sensitive troponin (hs-cTn) assays.…”

Section: Optimizing Analytical Qualitymentioning

confidence: 99%

“…-A control material or patient pool with an hs-cTn concentration near the assay limit of detection to monitor baseline drifts following assay calibration -A low-level control material with a cTn concentration close to the 99th percentile upper reference limit to monitor assay variability at this decision level -Calibration frequency to be determined based on the imprecision performance and drift characteristics of the assay failed results in a 2-year period decreased from 40% to less than 4%) [31]. Other authors also demonstrated that, when using a control material with hs-cTn concentrations close to the LoD, they were able to demonstrate significant differences (up to 100%) in results between similar platforms from the same manufacturer [32].…”

Section: Optimizing Analytical Qualitymentioning

confidence: 99%

See 1 more Smart Citation

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

View full text Add to dashboard Cite

A number of assay-related issues can affect the performance of cardiac troponin (cTn) measurement in everyday practice. In this respect, it is vital that all information on cTn assays is known and that the performance characteristics of assays are objectively assessed and adequately described. The advent of the latest generation of more sensitive cTn assays has heralded a new wave of information about low concentrations of cTn in blood. These recent generation assays have improved analytical sensitivity and corresponding performance at low cTn concentrations when compared to their predecessors, providing a convincing goal for laboratory medicine in helping clinicians in the diagnosis of acute myocardial infarction. Crucial to the clinical utility of highly sensitive cTn assays is the laboratorians’ role in closely scrutinizing proposed assays and defining their value in relation to available evidence. Analytical, as well as pre-analytical and post-analytical, aspects must be documented. In this review, we describe what laboratory professionals should know about their cTn assay performance characteristics and the pre-analytical prerequisites for robustness to ensure optimal post-analytical reporting.

show abstract

Section: Optimizing Analytical Qualitymentioning

confidence: 99%

Section: Optimizing Analytical Qualitymentioning

confidence: 99%

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

View full text Add to dashboard Cite

show abstract

Lot-to-Lot Variation for Commercial High-Sensitivity Cardiac Troponin: Can We Realistically Report Down to the Assay’s Limit of Detection?

Kavsak

Aakre

et al. 2020

Clinical Chemistry

View full text Add to dashboard Cite

The internal quality control in the traceability era

Braga

Pasqualetti

Aloisio

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators. Medical laboratories should know and verify how manufacturers have implemented the traceability of their calibrators and estimate the corresponding MU on clinical samples. Accordingly, the internal quality control (IQC) program should be redesigned to permit IVD traceability surveillance through the verification by medical laboratories that control materials, provided by the manufacturer as a part of measuring systems, are in the clinically suitable validation range (IQC component I). Separately, laboratories should also monitor the reliability of employed IVD measuring systems through the IQC component II, devoted to estimation of MU due to random effects and to obtaining MU of provided results, in order to apply prompt corrective actions if the performance is worsening when compared to appropriate analytical specifications, thus jeopardizing the clinical validity of test results.

show abstract

Daily monitoring of a control material with a concentration near the limit of detection improves the measurement accuracy of highly sensitive troponin assays

Cited by 7 publications

References 9 publications

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Lot-to-Lot Variation for Commercial High-Sensitivity Cardiac Troponin: Can We Realistically Report Down to the Assay’s Limit of Detection?

The internal quality control in the traceability era

Contact Info

Product

Resources

About