PHARMA Southern Africa PYLORI-SCREEN® | PYLORI-SCREEN® — Accurate

Pharma Southern Africa Pylori-Screen® — Accurate Helicobacter Pylori TEST

The PYLORI-SCREEN® immunological assay utilizes lateral flow technology to detect circulating IgG antibodies directed against Helicobacter pylori in a single finger-prick whole blood sample. By identifying these specific immunoglobulins, this rapid diagnostic tool aids clinical screening for mucosal colonization associated with chronic gastritis and peptic ulcer disease. The qualitative test system contains a highly specific membrane-bound antigen configuration that reacts with antibodies present in the specimen, providing clear visual results within ten minutes. This rapid in vitro diagnostic test serves as an essential preliminary evaluation for patients presenting with persistent dyspepsia, acid reflux, or recurrent gastric pain.

Product Description

The presence of highly pathogen strains of Helicobacter pylori (HP) colonizing the epithelium surface of the stomach or intestine can induce chronic gastritis that could lead to ulcer and/or cancer. Currently, 90% of the patients suffering from gastric ulcers are infected with bacteria HP. Therefore, it is important to spot the bacteria in order to easily eliminate it using specific antibiotic drugs. The detection of circulating antibodies directed against the bacteria is the most efficient way to diagnose its presence as antibodies are produced by the immune system during the infection process. A positive result can be obtained for patients previously infected with the bacteria HP. PYLORI-SCREEN® by PHARMA Southern Africa is a highly specific immunological rapid test easy to use for the detection of anti-HP antibodies with a finger prick of a whole blood sample.

When Should the TEST Be Performed?

PYLORI-SCREEN® should be performed in the condition of repeated stomach or intestine pains (stomach ache, acidic reflux). The test can be performed at any time of the day

WHAT DO I HAVE TO DO IF THE RESULT IS POSITIVE?

If the result is positive, it means that anti-HP antibodies are present in blood and that you should consult a doctor to show him the test results. Then, the doctor will decide whether additional investigation should be performed as the anti-HP antibodies could be due to previous infection already cured.

Included in KIT

A sealed aluminum pouch containing:

• 1 test device, 1 plastic pipette, 1 desiccant bag


• 1 dropper bottle containing 1 ml of diluent


• 1 sterile lancet for blood sampling


• 1 instruction leaflet


• 1 alcohol swab

How to USE

Please review the information leaflet for image instructions.

Testing procedure always starts with good preparation. Place the content of the box on a clean, dry and flat surface (e.g. table). Then the testing process follows:

1. 
   Wash your hands thoroughly. Use soap and warm water. Dry your hands with a clean towel.
   
   


2. 
   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). Discard the desiccant bag.
   
   


3. 
   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 the cap, just twist and discard the cap when finished.
   
   


4. 
   Clean the end of the middle finger or ring finger with the alcohol swab. Rub the chosen finger towards the tip for 10 to 15 seconds to enhance the blood flow.
   
   


5. 
   Press the platform firmly against the lateral side of the previously cleaned finger, and press the release trigger button.
   
   


6. 
   The tip will automatically retract into the body of the device.
   
   


7. 
   Rub the finger’s end to obtain enough of a whole blood sample.
   
   


8. 
   Without pressing the bulb, put in contact with plastic pipette with the blood sample. The blood migrates into the pipette through capillarity to the line indicated on the pipette. You may rub your finger again to obtain more blood if the line is not reached. As far as possible, avoid air bubbles.
   
   


9. 
   Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb.
   
   


10. 
    Wait 30-40 sec for the blood being totally absorbed into the sample well. Unscrew the blue cap of the diluent dropper bottle (leave the white cap tightly screwed) and add the diluent as follows:
    

    Hold the diluent dropper bottle vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2- 3 seconds between each drop

    
    


11. Read the result after 10 minutes. Do not interpret after 15 minutes.
    
    

Click here to view the patient information leaflet.

Warranty

Our products are covered by a manufacturer’s warranty ranging from 6 months up to a lifetime, subject to the specific item. For detailed warranty information, kindly enquire with our support team.

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