Description

Accutrend Cholesterol Strips, developed by Roche Diagnostics, are designed for the precise measurement of total cholesterol levels in capillary whole blood. These strips are intended for in vitro diagnostic use, making them suitable for both healthcare professionals and individuals managing their cholesterol levels, including those with diabetes. However, they are not recommended for use by hemophiliacs, individuals on anticoagulant therapy, or neonates.

Compatibility

These test strips are compatible with the following devices:

• Accutrend Plus
• Accutrend GC
• Accutrend GCT
• Accu-Chek InstantPlus meters

Measurement Principle

The measurement process is based on reflection photometry, utilizing enzymatic conversion and colorimetric detection. This involves cholesterol esterase splitting cholesterol ester into cholesterol and fatty acid, providing a reliable reading within a range of 150–300 mg/dL (3.88–7.76 mmol/L).

Performance

• Measuring Time: 180 seconds
• Sample Volume Required: 15–40 µL
• Precision: Within-run CV of 1.9% and overall CV of 3.1%

Operating Conditions

• Temperature: 18–35°C (64–95°F)
• Relative Humidity: Less than 85%
• Hematocrit Range: 30–55%

Storage Instructions

• Store between 2–30°C (36–86°F)
• Keep the container tightly capped
• Do not freeze
• Ensure usage before the expiration date

Packaging

Each box contains 25 test strips and one code strip for calibration. Proper calibration with the instrument is essential, requiring re-encoding with each new kit.

Usage Instructions

1. Remove a test strip from the container, ensuring it is not discoloured.
2. Insert the strip into a compatible instrument.
3. Apply a drop of fresh capillary blood to the reaction pad.
4. Wait for the measurement, which takes 180 seconds.
5. Results are displayed as a numeric value, with 'Lo' indicating less than 3.88 mmol/L and 'Hi' indicating more than 21.77 mmol/L.

Safety and Handling

These strips are non-hazardous and require no special personal protective equipment. Users should adhere to proper hygiene and infection control procedures, following the safety data sheet for handling and disposal.

Limitations

Certain substances, such as ascorbic acid and acetaminophen at pathological concentrations, may interfere with results. Additionally, excessive squeezing of the puncture site may lead to erroneous readings.

Regulatory Information

Accutrend Cholesterol Strips are CLIA waived and intended for use within the USA. Users are advised to read the Method Sheet and User’s Manual thoroughly before use. Packaging symbols provide guidance on instructions, temperature limitations, expiration dates, and other essential information.