Evaluation of analytical performance of the Pathfast cardiac troponin I
Francesca Di Serio1, Marco Caputo, Martina Zaninotto
1Department of Clinical Pathology I, University Hospital, Bari, Italy. diseriofrancesca@tiscali.it
Insights
The Pathfast cardiac troponin I (cTnI) assay shows reliable analytical performance, including low detection limits and good precision. This method is suitable for diagnosing acute coronary syndrome (ACS).
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Cardiovascular Diagnostics
Background:
- Cardiac troponins are crucial for diagnosing and managing acute coronary syndrome (ACS).
- The Clinical Laboratory Standards Institute (CLSI) provides guidelines for analytical performance evaluation.
- Assessing new diagnostic methods is essential for improving patient care in cardiology.
Purpose of the Study:
- To evaluate the analytical performance of the Pathfast cardiac troponin I (cTnI) assay.
- To assess the assay's suitability for clinical use in ACS patient management.
- To determine the assay's accuracy and reliability across different sample types and conditions.
Main Methods:
- Evaluated analytical performance according to CLSI guidelines.
- Determined limit of blank (LoB), limit of detection (LoD), imprecision, and linearity.
- Assessed interference from heterophilic antibodies (HA), rheumatoid factor (RF), and human anti-mouse antibodies (HAMA).
Main Results:
- The Pathfast cTnI assay demonstrated consistent results across various sample types (plasma, serum, whole blood).
- Achieved LoB of 0.0048 µg/L and LoD of 0.0066 µg/L, with good precision (CV% 6.0–6.4) at clinically relevant concentrations.
- Observed positive interference in 6 of 12 samples with HA; the 99th percentile limit was 0.013 µg/L.
Conclusions:
- The Pathfast cTnI assay exhibits acceptable analytical performance for clinical use.
- The method is potentially suitable for aiding clinicians in the diagnosis and management of ACS.
- Further evaluation regarding specific interferences may be warranted for comprehensive clinical application.
Background:
Cardiac troponins are considered the cornerstone for risk stratification and diagnosis of patients with acute coronary syndrome (ACS). Following Clinical Laboratory Standards Institute (CLSI) guidelines, we assessed the analytical performances of the Pathfast (Mitsubishi, Japan) cTnI method.
Methods:
We evaluated different sample types. Control materials and lithium heparin plasma pools were used to determine: limit of blank (LoB), limit of detection (LoD), imprecision and linearity. The effects of potential endogenous interfering substances and the possibility of falsely increased cardiac troponin I (cTnI) concentrations attributable to the presence of heterophilic antibodies (HA), rheumatoid factor (RF) and human anti-mouse antibodies (HAMA) in high concentrations were evaluated. The 99th percentile limit of the cTnI value distribution was determined from 320 Caucasian reference individuals.
Results:
No significant differences were found when cTnI concentrations of 40 lithium-heparin plasma samples were compared with the matched values of K(2)-EDTA plasma, whole blood and serum samples. The LoB and the LoD of the cTnI method were 0.0048 and 0.0066 microg/L, respectively. cTnI mean values from 0.66 to 6.0 microg/L showed a total CV% from 6.0 to 6.4. cTnI at a concentration of 0.02 microg/L was associated with a total CV of 9.6%. The method gave a linear response for cTnI concentrations within the measurement range. In six of 12 samples containing HA, a positive interference was demonstrated. The 99th percentile limit of the cTnI distribution in the reference population was 0.013 microg/L.
Conclusions:
The data indicate that the cTnI Pathfast method may be suitable for helping clinicians in the management of patients with ACS.
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