ENR Bovine Blood Glucose and beta Ketone / Ketosis Test Meter

[Intended Use]

Blood β-Ketone Test Strips are used to determine the concentration of β-ketone in fresh capillary whole blood from fingertips and venous whole blood.

• The test strips can be used by professionals suffering from diabetes to monitor the β-ketone level at a medical unit.

• This product is for in vitro diagnostic use only and is used as an aid to monitor the effectiveness of diabetes control protocols. It cannot be used for the diagnosis and screening of diabetes, nor as a basis for therapeutic drug adjustment.

[Test Principle]

The sample is absorbed by capillary action. The sample rapidly dissolves β-hydroxybutyrate dehydrogenase (HBDH), Nicotinamide adenine dinucleotide (NAD+), and electron mediators, as well as some non-reactive substances in the reaction zone. The β-ketone in the sample reacts to produce a microcurrent that is detected by the blood β-Ketone meter. The intensity of the current is proportional to the concentration of β-ketone in the blood sample, and the blood β-Ketone meter detects the microcurrent and converts it into a β-ketone concentration result.

[Main Components]

• The main components of the test strips: 5% β-hydroxybutyrate dehydrogenase (HBDH), 5% nicotinamide adenine dinucleotide (NAD+), 25% buffer, 10% stabilizer, 55% nonreactive substances.

• Each pack contains test strips, code chip, instruction manual, and β-ketone control solutions (optional).

• Note: The components in different batches are not interchangeable.

[Storage Conditions]

• Transportation and storage environment: ambient temperature: 4℃-30℃, relative humidity: 10%-85%.

• Unopened test strips should be stored in a dry place away from light and direct sunlight and should not be frozen in the refrigerator.

• Storage environment of test strips after opening: ambient temperature: 4℃-30℃, relative humidity: 10%-85%.

• The test strip container should be tightly sealed every time after taking out the test strips to avoid moisture.

• If the test strips are not stored properly, they will have an effect on the test results.

[Sample Requirements]

• When using a sample of fresh capillary whole blood from the fingertip, the fingertip should be gently rubbed to form a blood drop. The first drop should be wiped away and then use the second drop for the test. Do not squeeze the puncture site.

• Venous whole blood samples must be collected by a healthcare professional. Blood samples may be collected in anticoagulant tubes with sodium heparin, lithium heparin, or EDTA. Do not use tubes with other anticoagulants. Please complete the test within 20 minutes after blood collection.

• Sample size: 0.8μL

• If too much blood is squeezed out and contaminates the test strip or too little blood is squeezed out to fill the reaction zone, please take a new piece of test strip and perform the test again.