Overview
The document discusses the CK-MB FS, a monoclonal solution used in clinical chemistry for the detection of cardiac muscle damage. It highlights the high specificity, stability, and precision of the solution, which is crucial for reliable results in diagnosing myocardial infarction.

Specifications
- High specificity due to monoclonal antibody
- Superior stability and improved precision
- Reliable results with traceability to reference standard ERM-AD 455/IFCC
- Linearity up to 2000 U/L CK-MB
- On-board/calibration stability of 6 weeks

Clinical Use
The CK-MB FS is used for measuring serum and plasma samples and is compatible with various instruments such as Hitachi, Olympus, Abbott Aeroset, and Siemens ADVIA. It is available in different kit sizes for both manual and automated systems.

Performance
The CK-MB FS demonstrates high specificity and good sensitivity, making it a sensitive marker for early diagnosis of myocardial infarction. It can detect CK-MB in serum 1-3 hours before Troponin, with a sensitivity of 94% when combined with Troponin I.

Precision
Data generated on Hitachi 911 shows:
- Within-run precision: Sample 1 (Mean: 26.7 U/L, SD: 0.70, CV: 2.61%), Sample 2 (Mean: 46.6 U/L, SD: 0.85, CV: 1.82%), Sample 3 (Mean: 106 U/L, SD: 1.03, CV: 0.97%)
- Between-day precision: Sample 1 (Mean: 28.2 U/L, SD: 1.05, CV: 3.72%), Sample 2 (Mean: 52.7 U/L, SD: 1.66, CV: 3.15%), Sample 3 (Mean: 109 U/L, SD: 2.32, CV: 2.13%)

Conclusion
The CK-MB FS is a reliable and precise solution for the detection of cardiac muscle damage, offering high specificity and sensitivity. It is suitable for a variety of clinical applications and compatible with multiple diagnostic instruments.