ACCUTREND Cholesterol test strips, 5 pcs

Instructions for use of the Accutrend cholesterol test strips

The Accutrend Cholesterol test strips are an in-vitro diagnostic that is suitable for self-use.They are used for the quantitative determination of cholesterol in fresh or heparinized fresh capillary blood.These test strips are intended exclusively for use with the Accutrend GC, Accutrend GCT or Accutrend Plus meters.

Purpose and meaning

Determining cholesterol levels provides the doctor with important information about a patient's lipid metabolism.This information can be important for further diagnostic measures, treatment decisions or follow-up monitoring.However, self-checks cannot replace medical checks.The results obtained should be written down and discussed with the doctor.

How the test works

Each test strip contains a test field with special detection reagents.As soon as blood is applied, a chemical reaction occurs that causes the test field to change color.The measuring device registers this color change and converts the measurement signal into the measurement result using the code transmitted via the code strip.

Preparation and execution of the measurement

Only the measuring devices mentioned should be used to determine cholesterol levels in order to avoid incorrect readings.It is important to carefully follow the instructions in this method sheet and the instructions for use of the measuring device.

Precautions and disposal

All components of the pack can be disposed of with household waste.If used in a laboratory or doctor's office, local guidelines should be followed.Liquids or disinfectants must not enter the tube.The stopper contains a non-toxic silicate-based desiccant.If the desiccant is accidentally swallowed, please drink enough water.

Storage and shelf life

The test strips should be stored at temperatures between 2 and 30°C until the stated expiry date.Freezing is not permitted and storage at extreme temperatures should be avoided.Test strips must not be used beyond the stated expiry date.The tube should be closed tightly again immediately after removing a test strip.Cholesterol determinations are carried out at temperatures between 18 and 30°C.For determinations outside this temperature range, the values determined may only be used as a guide, as they can deviate significantly from the correct value depending on the temperature.

Important information on application

When using multiple Accutrend test strips at the same time, care should be taken not to mix up the stoppers.The plug color of the Accutrend Cholesterol and Accutrend Triglycerides test strip tubes is blue, while that of the Accutrend Glucose test strip tubes is white.Mix-ups can affect the stated shelf lives.

Materials supplied and additional requirements

The pack contains test strips and a code strip.Additionally, the Accutrend Control CH 1 solution, a lancing device and one of the measuring devices mentioned are required.

Test execution and controls

To ensure that the system functions properly, the device-specific instructions must be followed.The system requires a hanging drop of blood.Before each measurement, it must be checked whether the test strip can be used.If the window on the back of the test strip has turned bluish, a new test strip should be used.The test strip test area must be completely covered with blood.Occasionally the round window on the back of the test strip may appear stained, but this does not affect the measurement.

Coding and quality control

When a new pack of test strips is opened, the measuring device must be re-coded using the code strip supplied.The procedure is described in the operating instructions for the measuring device.The code strip should be stored outside the test strip tube to avoid damaging the test strips.Accutrend Control CH 1 solution should be used for quality control.The results must be within the defined ranges.

Limitations and Interferences

Disturbances in cholesterol determination can occur due to intravenous infusion of ascorbic acid (vitamin C), bilirubin values over 10 mg/dL, hematocrit values over 55%, methylaminoantipyrine or gentisic acid.

Limits and reference values

The linear measurement range is 3.88-7.76 mmol/L (150-300 mg/dL), and the detection limit is 3.88 mmol/L (150 mg/dL). Values below 5.2 mmol/L (200 mg/dL) are considered normal.Under certain circumstances, different limit values may apply for certain groups of patients, which should be discussed individually with the treating doctor.

No prescription is required for this product.

Manufacturer

Roche Diagnostics Deutschland GmbH, Sandhofer Straße 116, 68305 Mannheim