What question did this study set out to answer?

To clarify the cause, analytical extent, and clinical impact of a low-end measurement shift observed across specific manufacturing lots of the high-sensitivity cardiac troponin T assay.

February 28, 2013Clinical ChemistryOpen Access

Implications of adjustment of high-sensitivity cardiac troponin T assay

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Why the study?

Does the readjusted standardization of the high-sensitivity cardiac troponin T assay alter the diagnostic accuracy for acute myocardial infarction compared to affected lots?

Population

1033 patients presenting to the emergency department with symptoms of suspected acute coronary syndrome; and…

Comparison

Roche Diagnostics Elecsys Troponin T… vs Roche Diagnostics Elecsys Troponin T…

Design

Editorial

Follow-up

3 hours after emergency department admission

Authors

KHKlaus HallermayerNokia (Germany)JJJochen JarauschRoche Pharma AG (Germany)SMSylvie Menassanch-VolkerRoche (Switzerland)

Discussion

Member takes

Implication

Readjustment of the high-sensitivity troponin T assay standardization corrected a low-end downward shift without affecting the clinical diagnosis of acute myocardial infarction at the 14 ng/L threshold.

Key Points

To clarify the cause, analytical extent, and clinical impact of a low-end measurement shift observed across specific manufacturing lots of the high-sensitivity cardiac troponin T assay.
Conducted internal lot-to-lot comparisons across 127 human samples (3–500 ng/L) using Passing–Bablok regression and verified reference intervals in a healthy cohort (n=739).
Compared diagnostic classification across 1,033 emergency department patients presenting with suspected acute coronary syndrome using an affected lot versus a readjusted standardization lot.
Six manufacturing lots produced between 2009 and 2011 showed a downward shift of 2.7 ng/L (y = 0.99x + 2.70 ng/L) at low concentrations, causing up to 84% of samples to measure below the limit of the blank (3 ng/L) compared to 39% in the readjusted lot.
Restandardization implemented in 2012 restored the 99th percentile upper reference limit to 14.4 ng/L in healthy individuals.
Diagnostic performance remained identical between affected and readjusted lots at 3 hours post-admission, identifying the exact same 94 patients (9.1% of 1,033) with troponin T >14 ng/L and confirmed acute myocardial infarction.

Structured PICO

Does the readjusted standardization of the high-sensitivity cardiac troponin T assay alter the diagnostic accuracy for acute myocardial infarction compared to affected lots?

Population

1033 patients presenting to the emergency department with symptoms of suspected acute coronary syndrome; and a separate healthy cohort (n=739, median age 49 years)

Intervention

Roche Diagnostics Elecsys Troponin T high-sensitivity assay with readjusted standardization (e.g., lot 167345)

Comparator

Roche Diagnostics Elecsys Troponin T high-sensitivity assay with old standardization (affected lots with downward shift, e.g., lot 163704)

Outcome

Diagnostic accuracy for acute myocardial infarction (identification of patients with TnT >14 ng/L 3 hours after ED admission)surrogate

Limitations

Population and risk-stratification studies of apparently healthy cohorts might be affected by the downward shift and must be assessed individually.

Cite This Study

Hallermayer et al. (2013) studied this question.

synapsesocial.com/papers/6a762fd71c684509e2008aa6 https://doi.org/10.1373/clinchem.2012.197103

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Implications of adjustment of high-sensitivity cardiac troponin T assay

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Implications of adjustment of high-sensitivity cardiac troponin T assay

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider