How does LIVER-Screen works?
In case of liver injury, transaminases (ALT and/or AST) are released by the liver in the blood stream. LIVER-Screen rapid test detects these transaminases thanks to specific immunological reagents for each of both transaminases when their concentration is over 80 IU/L. Abnormal transaminases concentrations will be seen through one or two red lines appearance.
When should the test be used?
In case of liver problems, a number of symptoms may appear including dark urine, light coloured stool, no desire to eat, yellowish eyes or skin, swelling in your belly, weakness or feeling very tired.
It is recommended to perform LIVER-Screen screening test. LIVER-Screen test could be performed any time of the day.
The Liver is an essential organ of the body having a critical role for health. It helps break down food, clean blood, produce proteins and store energy.
In case of liver problems, a number of symptoms may appear including dark urine or light-coloured stool, no desire to eat, yellowish eyes or skin (jaundice), swelling in your belly, weakness or feeling very tired. There might be many reasons for a problem occurrence in liver such as hepatitis, side effects of certain medications, cirrhosis due to heavy drinking, overweight especially in case of diabetes or high blood pressure.
Many tests could be performed on the liver but the most commonly used tests are transaminases (ALT and AST) enzymes assessment. These enzymes are released in the blood by the liver in response to damage or disease.
LIVER-Screen is a rapid immunodiagnostic test for the immunological detection of increased transaminase (both ALT and AST) levels from a finger prick whole blood sample. The test consists on a plastic housing containing one stick having two distinct zones for transaminases detection (red colour when positive) and one control zone (blue colour).
The box contains the material necessary to perform a test:
– 1 sealed aluminium pouch containing:
1 test device, 1 plastic pipette and 1 dessiccant bag.
Only open the protective pouch when you are ready to use the test. The desiccant bag should not be used.
– 1 sterile lancet for blood sampling.
– 1 dropper bottle containing 1 ml of diluent.
– 1 instruction leaflet.
- This test is exclusively intended to in vitro diagnostic. External use only. DO NOT SWALLOW.
- Carefully read the instructions before performing the test. The test is only interpretable if the instructions are carefully respected. Follow strictly the indicated time, whole blood and diluent quantities.
- Store between +4°C and +30°C. Do not freeze.
- Do not use after the expiry date printed on the label and on the protective pouch or if the pouch is damaged.
- Do not re-use LIVER-Screen test.
- Keep out of the reach of children.
- After use, all components can be discarded in a dustbin.
Testing procedure always starts with a good preparation. Place the content of the box on a clean, dry and flat surface (e.g. table). Then the testing follows:
- Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
- Prepare the test device and the pipette. Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Dispose the small dessicant bag.
- Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the lancet cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished.
- Clean the end of the forefinger or of the middle finger with cotton damped with alcohol. Rub the chosen finger towards the tip to later on enhance the blood stream.
- Press platform firmly against the previously cleaned finger, and press the release trigger button.
- The tip will automatically retract into the body of the device.
- Rub the finger’s end to obtain enough whole blood sample.
- Without pressing the bulb, put in contact the plastic pipette with the whole blood sample. The sample migrates into the pipette through capillarity to the line indicated on the pipette. You may rub again your finger to obtain more whole blood if the line is not reached. As far as possible, avoid air bubbles.
- Put the sample collected with the pipette into the sample well of the device, by pressing on the pipette bulb.
- Wait 30-40 sec for the whole blood being totally absorbed into the sample well. Unscrew the blue cap of the diluent vial (leave the white cap tightly screwed) and add the diluent as follows: Hold the diluent vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop.
- Read the result after 10 minutes. Do not interpret after 15 minutes.
The intensity of the lines colour does not have any importance for the interpretation of the test result.
- Negative result:
Only one blue coloured line appears in the control zone (C). This result means that the transaminases concentrations are normal and the liver is functioning correctly.
- Positive result:
In addition to the blue colour line (C), one or two red colour line(s) appear(s) in the detection zone (T) as indicated below.
This result means that either one or both transaminases levels are higher than the norm (80 IU/L) and that you should consult a doctor.
- Non valid result:
If there is no blue colour line in the control zone (C) whatever the line(s) appearing or not in the detection zone (T), the test is inconclusive. It is recommended to repeat the test with another LIVER-Screen and a fresh whole blood sample.
QUESTIONS AND ANSWERS
Can the result be incorrect?
The results are accurate as far as the instructions are carefully respected.
Nevertheless, the result can be incorrect if LIVER-Screen test gets wet before test performing or if the quantity of blood dispensed in the sample well is not sufficient. The plastic pipette provided in the box allows making sure the collected blood volume is correct.
How to interpret the test?
LIVER-Screen test should be considered as positive when, in addition to a blue line, one or two red lines, corresponding to each transaminase (ALT and AST), appear. Hepatic problems may indeed lead to an increased concentration of one transaminase only.
What is the blue line that appears under the mark C (Control) for?
When this blue line appears, it only means that the test was performing well.
If I read the result after 15 minutes, will the result be reliable?
No. The result should be read within 10 minutes after adding the diluent. The result is reliable up to 15 minutes.
What do I have to do if the result is positive?
If the result is positive, it means that the ALT and/or AST transaminase level in blood is higher than the norm (80 IU/L) and that you should consult a doctor to show the test result. Then, the doctor will decide whether additional analysis should be performed. Although ALT and AST level concentration is valuable in the diagnosis of liver disease, it should be used in combination with other hepatic enzymes (alkaline phosphatase, lactate dehydrogenase, gamma-glutamyl transferase…) activity levels and other blood analytes such as urea, creatinine or bilirubin to evaluate the liver function. The increase in transaminases activities could be due to many others reasons (ex: intensive exercise, overweight…). Only a doctor could make a diagnosis after considering clinical investigation and additional test results.
What do I have to do if the result is negative?
If the result is negative, it means that the ALT and/or AST transaminase level is below 80 IU/L and is within the norm. However, if the symptoms persist, it is recommended to consult a doctor.