Jase: How is the antigen test different from the H. pylori blood test?
Kimmi: This one checks a stool sample for H. pylori antigen rather than checking blood for antibodies.
Jase: Does a positive result settle the diagnosis?
Kimmi: No. It points to possible current infection and needs follow-up with a healthcare professional.
Prima Helicobacter Pylori Antigen Test is a single-use stool self-test with a stated cut-off of 10 ng/mL. It is a screening aid, not a diagnosis, and it does not determine treatment. Seek medical advice for a positive result, ongoing symptoms, unexplained weight loss, bleeding, severe pain or other concerns, regardless of the result.
The supplied technical specifications state specificity of 96.6%, sensitivity of 95.2% and accuracy of 96%. These figures do not guarantee an individual result, and both false-positive and false-negative results are possible.
Contents:
- 1 test cassette
- 1 vial with collection stick and dropper containing the diluent
- 1 paper sheet for the collection of the sample
- Instructions for use
Directions
USE PROCEDURE
- Collect the sample using the special collection sheet;
- Unscrew the cap of the vial, plunge the withdrawal stick in 3 different points of the sample and screw the cap back on;
- Break the end of the cap, freeing the dropper part, and dispense 3 drops of the diluted sample into the well (S) indicated on the cassette;
- Wait 10 minutes before reading the result.
RESULTS INTERPRETATION
Negative: no H. pylori antigens have been detected in the sample or their concentration is below the 10 ng/mL cut-off.
Positive: Helicobacter pylori antigens have been detected in the sample, it is necessary to check with a specialist, as a possible bacterial infection is ongoing.
F.A.Q.
What happens if the results reading time is not met?
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
How to prove that the test worked correctly?
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
How to interpret the test if the control and test lines have different intensities?
The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).
BIBLIOGRAPHY
- Shimoyama T. “Stool antigen tests for the management of Helicobacter pylori infection.” World Journal of Gastroenterology. 2013;19(45):8188-9
- Ana Isabel Lopes, Filipa F Vale, Mónica Oleastro. “Helicobacter pylori infection - recent developments in diagnosis.” World Journal of Gastroenterology. 2014 July 28; 20(28): 9299-9313.
- Andreas Mentis, Philippe Lehours, and Francis Francis Megraud. “Epidemiology and Diagnosis of Helicobacter pylori infection”. Helicobacter. 2015 Sep;20 Suppl 1:1-7.
- Zagari RM, Rabitti S, Eusebi LH, Bazzoli F. “Treatment of Helicobacter pylori infection: A clinical practice update.” Eur J Clin Invest. 2018 Jan;48(1). doi: 10.1111/eci.12857.
