Liver-Screen

Overview

Rapid self-test for assessing the physiological state of the liver in blood.

The liver is an essential organ of the human body and plays a critical role in health. It helps to assimilate food, detoxify the blood, synthesise proteins and store energy. 

In the event of a liver problem, a number of symptoms appear, such as the production of dark urine, discoloured stools, lack of appetite, yellowing of the whites of the eyes or the skin (jaundice). Other symptoms may include swelling of the abdomen, a feeling of weakness or extreme tiredness. There may be a number of reasons for these liver disorders, including hepatitis, the side effects of certain drugs, cirrhosis linked to alcohol abuse, and excess weight, particularly in cases of diabetes or hypertension. 

Several diagnostic tests relating to liver function can be carried out, but the most commonly used tests are the measurement of the activity of the transaminase enzymes (ALAT and ASAT). These enzymes are released into the blood by the liver in the event of dysfunction or the development of disease.

LIVER-Screen® is a rapid immunodiagnostic test used to detect an increase in the activity of transaminases (ALAT and ASAT) from a capillary blood sample obtained from the fingertip. The test comes in the form of a cassette containing a strip with two distinct zones for the detection of transaminases (red if positive) and a control zone (blue). 

Who is the test for?

For individuals wishing to determine their transaminase levels in blood are within the normal range or higher then the established norm.

How to use

Liver-Screen CRP teststeps
  1. Prepare the test device, the pipette and the diluent dropper vial. Take them out from the protective pouch (tear at the notch. Remove the screw cap of the diluent dropper vial and leave it nearby). 
  2.  Clean the tip of the middle finger or ring finger with cotton wool moistened with alcohol. Press the lancet firmly against the side of the previously cleaned finger and press the release button. 
  3. Without pressing the bulb, put in contact the plastic pipette with the blood sample. The whole blood migrates into the pipette through capillarity to the line indicated on the pipette.  
  4. Dispense the blood into the sample well of the cassette, pressing down on the bulb of the pipette. Wait 30-40 seconds for blood absorption. Unscrew the blue cap from the dropper bottle, keeping the white cap secure. Add 4 drops of diluent to the well, spacing each drop 2-3 seconds apart. Read the result after 10 minutes. Do not interpret after 15 minutes. 

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Results and recommendations

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Result

Summery

Liver-Screen OCoLEVER 1 1
Liver-Screen  The test is positive
One or two red-coloured lines, in addition to the blue line (C), appear in the reading
area (T) as shown in the three diagrams on the right. This result means that the level of one or both transaminases is higher than normal (80 IU/L) and that you should consult your GP.
Liver-Screen OCoLEVER 4
Liver-Screen ITjagM4AAAAASUVORK5CYII=  Test is negative
A single blue coloured line appears in the reading window under the C (Control) mark. This means that the transaminase level is normal and that the liver is functioning properly.
Liver-Screen LEVER 5
Liver-Screen ABBgCzDbPkWaAAAAAElFTkSuQmCC Invalid result
If no blue line appears in the control area (C) regardless of the number of lines forming under the reading marker (T), the test is invalid. In this case, the test cannot be interpreted and must be considered invalid. It is recommended that the test be repeated using a new LIVER- Screen cassette and a fresh blood sample.

Questions and answers

How does the LIVER-Screen® test work?

In the event of a liver problem, transaminases (ALAT and/or ASAT) fromliver cells enter the bloodstream. The LIVER-Screen® rapid test detectsthese transaminases using specific immunological reagents when thelevel of activity of the two enzymes is greater than 80 IU/L according to theinternational reference method *I.F.C.C. The LIVER-Screen® rapid test usesa pair of antibodies specific for transaminases (ALAT and/or ASAT) whichproduce one or two coloured lines, below the T mark on the cassette, inthe event of an abnormal concentration of transaminases. A control linecapturing excess reagent appears below the C mark on the cassette.* International Federation of Clinical Chemistry.

In the event of liver dysfunction, a number of symptoms may appear, suchas dark urine, discoloured stools, loss of appetite, yellowish discolourationof the whites of the eyes or the skin, swelling of the abdomen, a feelingof weakness or extreme tiredness. In these cases, a LIVER-Screen® test isrecommended. The test can be carried out at any time of the day.

The results are accurate as long as the instructions for use are carefully followed. 

However, the result may be inaccurate if the LIVER-Screen® test is wet before use or if the wrong amount of blood is placed in the sample well. The plastic pipette supplied in the box can be used to ensure that the correct volume of blood is drawn. 

The LIVER-Screen® test should be considered positive when one or two red lines, corresponding to each transaminase (ALAT and ASAT), appear in addition to the blue line. Liver problems can lead to an increase in the concentration of a single transaminase.
The appearance of the blue line simply means that the test has worked correctly.
No. The result must be read within 10 minutes of adding the diluent. The result is reliable for up to 15 minutes.

If the result is positive, it means that the level of ALAT and/or ASAT transaminases in the blood is higher than normal (80 IU/L) and that you absolutely must consult your GP and show him/her the results of this test. Your doctor will then decide what further tests to carry out. Although determining ALT and ASAT levels is useful in diagnosing liver disease, it can be carried out in parallel with measuring the activity levels of other liver enzymes (alkaline phosphatase, lactate dehydrogenase, gamma-glutamyl transferase, etc.) and the concentration levels of other blood parameters such as urea, creatinine or bilirubin. Increased transaminase activity may be linked to other conditions or abnormalities (e.g. intensive sport, excess weight, etc.). Only a doctor can make a diagnosis after confirming these results with a clinical investigation and the results of additional tests.

If the result is negative, this means that the level of ALAT and/or ASATtransaminases is normal and below 80 IU/L. However, if symptoms persist,you should consult your GP.
Studies carried out on the LIVER-Screen® test show a correlation of 89.2%[84.8 – 92.7%]** with the reference method in clinical chemistry. Despite thereliability of this test, false positive or false negative results are possible. **95% CI: 95% Confidence Interval