What is the clinical evidence from this study?

Study design: Other. Population: cardiac diseases. Intervention: Access hs-TnI assay vs. Access AccuTnI+3 and ARCHITECT hs-cTnI assays. Primary outcome: Analytical performance including limits of blank (LoB), detection (LoD) and quantitation (LoQ).

What question did this study set out to answer?

To evaluate and compare the analytical performance of the Access hs-cTnI chemiluminescent immunoassay with the Access AccuTnI+3 and ARCHITECT hs-cTnI assays.

September 23, 2017Clinical Chemistry and Laboratory Medicine (CCLM)

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

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Key result

The Access hs-cTnI assay showed improved analytical sensitivity (LoB 0.6 ng/L, LoD 1.3 ng/L) compared to Access AccuTnI+3, with performance similar to the ARCHITECT hs-cTnI method.

Why the study?

Does the Access hs-TnI assay provide comparable or improved analytical performance compared to existing troponin I assays?

Population

Heparinized plasma samples from healthy subjects and patients with cardiac diseases, and quality control…

Comparison

Access hs-TnI assay using DxI platform vs Access AccuTnI+3 method and ARCHITECT hs-cTnI…

Design

Other

Authors

SMSilvia MasottiHeart Failure / Cardiomyopathy CPConcetta PronteraFondazione Toscana Gabriele Monasterio VMVeronica MusettiScuola Superiore Sant'Anna

Discussion

Member takes

Implication

New Access hs-TnI assay shows superior analytical performance; leaves open clinical validation before practice adoption.

Key Points

To evaluate and compare the analytical performance of the Access hs-cTnI chemiluminescent immunoassay with the Access AccuTnI+3 and ARCHITECT hs-cTnI assays.
Determined the limits of blank (LoB), detection (LoD), and quantitation (LoQ at 10% and 20% CV) following standardized international protocols.
Analyzed quality control materials alongside heparinized plasma, serum, and EDTA plasma samples from healthy individuals and patients with cardiac diseases.
Access hs-cTnI yielded an LoB of 0.6 ng/L, an LoD of 1.3 ng/L, and an LoQ of 2.1 ng/L at 20% CV and 5.3 ng/L at 10% CV.
Access hs-cTnI demonstrated analytical sensitivity superior to Access AccuTnI+3 and exhibited close linear regressions with both AccuTnI+3 and ARCHITECT hs-cTnI methods despite systematic differences.
Troponin measurements were consistent between heparinized plasma and serum samples, but differed significantly between EDTA and heparinized plasma.

Structured PICO

Does the Access hs-TnI assay provide comparable or improved analytical performance compared to existing troponin I assays?

Population

Plasma and serum samples from healthy subjects and patients with cardiac diseases, along with quality control samples, used for analytical assay evaluation.

Exposure

Access hs-TnI assay using DxI platform

Comparator

Access AccuTnI+3 method and ARCHITECT hs-cTnI method

Outcome

Analytical performance including limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CVsurrogate

The new Access hs-cTnI assay demonstrates improved analytical sensitivity compared to the older AccuTnI+3 method, performing similarly to the established ARCHITECT hs-cTnI assay.

Cite This Study

Masotti et al. (2017) studied cardiac diseases. Access hs-TnI assay vs. Access AccuTnI+3 and ARCHITECT hs-cTnI assays was evaluated on Analytical performance including limits of blank (LoB), detection (LoD) and quantitation (LoQ). The Access hs-cTnI assay showed improved analytical sensitivity (LoB 0.6 ng/L, LoD 1.3 ng/L) compared to Access AccuTnI+3, with performance similar to the ARCHITECT hs-cTnI method.

synapsesocial.com/papers/6a6cde8c35aa2c282cdfb507 https://doi.org/10.1515/cclm-2017-0387

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

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