General Information:

- Reagent Name: Creatinine

- Reagent Type: Enzymatic

- Test Method: Enzymatic method using creatininase, creatinase, and sarcosine oxidase

Reagent Composition:

- Buffer: Phosphate buffer, pH 7.2-7.4

- Enzymes: Creatininase, creatinase, and sarcosine oxidase

- Substrate: Creatinine

- Chromogen: NADH or 4-Aminoantipyrine (4-AAP)

- Stabilizers: Glycerol, surfactants

- Preservatives: Sodium azide or methylisothiazolone

Physical Characteristics:

- Appearance: Colorless or pale yellow solution

- pH: 7.2-7.4

- Temperature Stability: 2-30°C

Performance Characteristics:

- Linearity: Up to 20 mg/dL

- Sensitivity: 0.1 mg/dL

- Precision: CV ≤ 5%

- Accuracy: ±5% of target value

- Interference: Minimal interference from bilirubin, hemoglobin, or triglycerides

Storage and Stability:

- Storage: 2-30°C

- Shelf Life: 12-24 months from date of manufacture

- Freeze-Thaw Stability: Stable for up to 3 freeze-thaw cycles

Safety Precautions:

- Handling: Wear gloves and lab coat when handling reagent

- Disposal: Dispose of reagent according to local regulations

Quality Control:

- Calibrators: Use creatinine-based calibrators (e.g., creatinine standard)

- Controls: Use creatinine-based controls (e.g., human serum)

- Linearity checks: Perform linearity checks using creatinine-based standards