Description

The TROP-T TEST is a high-sensitivity diagnostic assay designed for the precise measurement of cardiac troponin T (cTnT) levels in human blood. This test plays a crucial role in the early diagnosis of acute myocardial infarction (AMI) and the detection of myocardial injury, providing vital support for healthcare professionals assessing patients with suspected acute coronary syndrome (ACS).

Key Features

• Sample Types: Compatible with serum, plasma, or heparinized venous whole blood.
• Sample Volume: Requires only 50–150 μL, depending on the test format.
• Test Formats: Available as both a laboratory-based CLIA test and a point-of-care (POC) test, offering flexibility in various clinical settings.

Test Procedure

• Point-of-Care (POC): Provides results in approximately 12 minutes, enhancing rapid decision-making.
• Laboratory CLIA: Involves incubation, washing, and chemiluminescent detection, with results typically available within 1–2 hours.

Measuring Range and Sensitivity

• Laboratory CLIA: Linear range from 8.00 pg/mL to 10,000 pg/mL.
• Point-of-Care (POC): Range from 40–2000 ng/L.
• Limit of Detection: 8.00 pg/mL for CLIA and <40 ng/L for POC.
• No Hook Effect: Up to 100,000 pg/mL in CLIA format.

Precision and Accuracy

• Laboratory CLIA: Accuracy within ±10% relative deviation, with intra-assay CV ≤8% and inter-assay CV ≤15%.
• Point-of-Care (POC): Repeatability with CV ranging from 9.3% to 12.9% across different concentration levels.

Interferences and Limitations

The TROP-T TEST demonstrates minimal cross-reactivity with skeletal muscle troponin T and is not significantly affected by common interferences such as icterus, hemolysis, and lipemia. However, high concentrations of certain substances like bilirubin, triglycerides, and hemoglobin may interfere with results. Patients taking biotin should inform healthcare providers, as it can affect some test formats.

Storage and Stability

• Storage Conditions: Maintain at 2–8°C and avoid freezing.
• Stability: POC test remains stable for up to one week at room temperature (15–25°C) and should be used within 15 minutes of opening.

Safety and Handling

Intended for professional in vitro diagnostic use only, all patient samples and reagents should be treated as potentially infectious. Proper handling is essential to ensure accurate and reliable results.

Instrument Compatibility

Compatible with specific analyzers such as ECL100 or ECL25 for laboratory CLIA, and cobas h 232 instruments for POC testing, ensuring seamless integration into existing diagnostic workflows.

Important Considerations

The TROP-T TEST is not intended for self-testing and should be interpreted alongside clinical findings and patient history. It is CE marked, underscoring its compliance with relevant quality standards.