Tc99mTetrofosminQualityChecker

Utility description: Tc-99m Tetrofosmin

Tc-99m Tetrofosmin Quality Checker — Technetium-99m Tetrofosmin for Myocardial Scintigraphy

ℹ️  Utility checks critical parameters of Tc-99m Tetrofosmin:
    • Radiochemical purity (≥90%)
    • Free pertechnetate (≤5%)
    • Colloidal technetium (≤5%)
    • Stability (use within 4 hours)
    • pH (7.0–8.0), endotoxins, sterility

⚠️  ADVANTAGE: No boiling required! Reaction occurs at room temperature.
    Rapid liver clearance allows earlier imaging compared to MIBI.

Usage:
  Tc99mTetrofosminQualityChecker.exe                            → demo mode (console output)
  Tc99mTetrofosminQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,TimeSincePreparationMin,ProductType

Example (sterility: 0=sterile, 1=contaminated):
  TC99M-TETRO-2026-050,925.0,97.5,1.5,1.0,7.4,10.0,0,5.0,30.0,MyocardialPerfusion

Supported product types:
• MyocardialPerfusion — myocardial perfusion (ischemia, infarction)

— WHY IS THIS NEEDED?
Tc-99m Tetrofosmin (trade name Myoview®) is a lipophilic cationic phosphine complex:
• Accumulates in viable cardiomyocytes proportional to blood flow
• Used for diagnosis of coronary artery disease, myocardial viability assessment
• Key difference from MIBI: faster clearance from liver and lungs, improving image quality of the inferior and anterior walls of the left ventricle in early stages
• Does not require boiling during preparation, which is more convenient in clinical practice

⚠️  CRITICAL:
• Radiochemical purity ≥90% — Low RCP leads to free pertechnetate (stomach/thyroid background) and colloid (liver background). Although Tetrofosmin clears from the liver faster than MIBI, impurities still create unwanted background.
• Preparation Process (Room Temperature) — Kit does NOT require boiling. Addition of eluate and standing at room temperature (usually 15-30 minutes for complete dissolution/reaction, though often usable earlier). Boiling may destroy the complex.
• Stability (≤4 hours) — Prepared drug is stable for 4 hours at room temperature. After this time, RCP may decrease.
• Free pertechnetate ≤5% — Creates artifacts.
• Reduced/Hydrolyzed Tc ≤5% — Accumulates in liver.
• pH 7.0–8.0 — Optimal range for complex stability.
• Endotoxins ≤175 EU/vial, Sterility — standard requirements.

Key features:
• Control of absence of boiling step (drug specificity)
• Assessment of stability time window (4 hours)
• Assessment of suitability for cardiac diagnosis with focus on rapid lung/liver clearance

Critical parameters:
• Radiochemical purity: ≥90.0%
• Free pertechnetate: ≤5.0%
• Colloidal Tc: ≤5.0%
• Usage time: ≤240 minutes (4 hours) after preparation
• pH: 7.0–8.0
• Endotoxins: ≤175 EU/vial
• Sterility: no microbial growth

💡 Usage tips:
1. To determine RCP, TLC is used:
   - System 1 (Acetone): Separates free pertechnetate (moves) from complex and colloid (origin).
   - System 2 (Specific solvent, e.g., dichloromethane/methanol): Separates hydrophilic impurities.
2. Do NOT boil the vial! This is a common error by staff accustomed to MIBI or MAG3.
3. The drug can be administered 15-30 minutes after preparation, but remains stable for up to 4 hours.
4. Due to rapid lung clearance, Tetrofosmin is preferred for patients with COPD or when early imaging is required.

⚠️ Note: Tetrofosmin provides higher signal-to-noise ratio in early stages (15-30 min) due to rapid clearance from heart-surrounding tissues (lungs, liver). This makes it convenient for "stress-rest" one-day protocols.