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PRIMA - Helicobactor Pylori Antigen Test

PRIMA - Helicobactor Pylori Antigen Test

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Helicobacter pylori Test

Self-test for the detection of anti Helicobacter pylori antibodies in whole blood samples

HELICOBACTER PYLORI
Helicobacter pylori is a bacterium, whose ideal habitat is the human gastric mucosa, causing an often asymptomatic infection of the gastrointestinal tract.

WHO IS THIS TEST FOR?
HELICOBACTER PYLORI TEST is useful for a first screening of an ongoing or a past infection of H. pylori.

TECH SPECS:
HELICOBACTER PYLORI TEST is an immunochromatographic device that detects the presence of anti-Helicobater pylori IgG antibodies in blood samples.

Specificity 84.2%
Sensitivity 95.8%
Accuracy 87%

CONTENT

  • 1 test cassette
  • 1 vial with dropper containing the diluent
  • 2 sterile lancets
  • 1 pipette for blood sampling
  • 1 cleanser gauze
  • instructions for use

USE PROCEDURE

  1. Draw a blood sample by using the sterile lancet provided;
  2. Collect the sample indicated with the black line by using the capillary pipette provided;
  3. Deposit the collected specimen into the sample well (S) indicated on the test cassette;
  4. Add 2 drops of the diluent and wait 5 minutes before reading the result.

RESULTS INTERPRETATION

Negative no IgG antibodies against Helicobacter pylori have been detected in the sample or their concentration is below the cut-off of 15 AU/mL.
Positive IgG antibodies against Helicobacter pylori have been identified in the sample, it is necessary to check a possible exposure to the bacterium with a specialist.
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