PRIMA Helicobacter Pylori Antigen test

What is Helicobacter Pylori (H. pylori)?
Helicobacter pylori (H. pylori) is a bacterium found in the stomach and duodenum. It parasitizes in gastric mucus and mucous cells, where it reduces the acidity of stomach acid and cause mild chronic inflammation of the gastric mucosa, or even lead to gastric and duodenal ulcers or gastric cancer.

Most individuals infected with H pylori have few or no symptoms. They may experience minor belching, bloating, nausea, vomiting and abdominal discomfort when the condition progresses to gastritis.

Accepted carcinogen
•International Agency for Research on Cancer - IARC (specialized cancer agency of the World Health Organization) classified Helicobacter pylori as Group 1 carcinogen^
•U.S. Department of Health and Human Services (affiliated with Federal Government of the United States) added Helicobacter pylori (Chronic Infection) to the latest list of carcinogen#

IARC defines Group 1 carcinogen as Sufficient evidence in humans, Helicobacter pylori being the same group as alcoholic beverages, tobacco smoking, criticality cannot be ignored even the level of rish was different.

Global latest prevalence of Helicobacter pylori
According to the study conducted by the Faculty of Medicine of The Chinese University of Hong Kong, revealed that 4.4 billion people worldwide are infected with Helicobacter pylori (H pylori), which could lead to peptic ulcer disease and even gastric cancer, while in Asia (including Hong Kong), more than half of the population are infected with H. pylori.

Hong Kong as well as the nearby countries and regions such as mainland China, Japan, Korea and Taiwan, also had over half of the population infected with H. pylori.

Symptoms of Helicobacter pylori infection
Helicobacter pylori infection show no symptoms during the initial stage, and can remain difficult to detect even after years of incubation. Carriers may experience bloating, excessive gas, sudden weight loss, stomach pain, loss of appetite, and other symptoms common to ordinary gastrointestinal discomfort.
As Helicobacter pylori can induce chronic gastritis, 10-15% of patients will experience gastrointestinal ulcers and symptoms such as bleeding, vomiting, anemia and melena.

Transmission of Helicobacter pylori infection
Mainly transmitted via saliva, bodily fluids, vomit, excrement, sewage and food

Who have higher chance of Helicobacter pylori infection?
•Over the age of 40
•Frequent smoking
•Family medical history
•Living with family members who have Helicobacter pylori infection

Helicobacter pylori and Stomach Cancer (Gastric Cancer)
Many factors increase the risk of developing stomach cancer, Research shows that - helicobacter pylori (a kind of bacterium which survives in the stomach and duodenum) infection may increase the chance of stomach cancer.

What is Stomach Cancer?
Stomach is one part of the digestive system. It secretes gastric acid to help digest and grinds large pieces of food into small ones. The food then enters the intestine by peristalsis for further digestion process.Mutations in stomach cells lead to development into malignant tumour called stomach cancer. The etiology of stomach cancer is so far uncertain.

Stomach cancer is the sixth leading most common cancers in Hong Kong, after liver cancer.

Who have higher chance of developing Stomach Cancer (Gastric Cancer)?
Many factors increase the risk of developing stomach cancer. Research shows that helicobacter pylori (a kind of bacterium which survives in the stomach and duodenum) infection may increase the chance of stomach cancer. Other risk factors include:
•Male
•The older the age, the higher the chance of stomach cancer. There is a sharp rise in - stomach cancer rate in people over age 50
•Consumption of high-salted, pickled and smoked food will increase the danger of having stomach cancer
•People who have stomach polyps, had gastrectomy (stomach removal surgery) or pernicious anaemia (anaemia resulted from deficiency of vitamin B)
Smoking
•People whose immediate family members have had stomach cancer are twice as likely to develop stomach cancer than others

Common symptoms
Patients with stomach cancer can have the following symptoms. However, these symptoms can be caused by other more common illnesses, such as gastritis, stomach or duodenal ulcer. If in doubt, consult a doctor as soon as possible.
•Persistent indigestion, loss of appetite
•Rapid weight loss
•Swelling of abdomen
•Feeling bloated after eating
•Vomiting, even blood in vomitus
•Blood in stools, or black stools
•Anemia, fatigue, weakness

Helicobacter Pylori Antigen test
Detects the presence of specific Helicobacter pylori antigens in stools. If the test result is positive, further examination is needed and consult a physician.

When can the test be used?
The HELICOBACTER PYLORI ANTIGEN Test can be carried out at any time of the day, when you have a bowel movement, and there is no need to follow a specific diet.

^https://monographs.iarc.who.int/list-of-classifications
#https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/listed_substances_508.pdf

Results
Positive: Two coloured bands appear in the reading window by the T (test) and C (control) signs. The T band may be less intense (lighter) than the C line. This result means there is Helicobacter pylori antigen in the faeces and you must consult a physician.

Negative: A coloured band appears only under the C (control) sign.
This result means that there is no Helicobacter pylori antigen in the faeces or that its concentration is below the test’s detection limit (10 ng/ml).

Non invalid result: If no bands appear or if there is only a line under the T (Test) sign, it means that it was not possible to read the result of the test, which must be considered as not valid. It is recommended to repeat the test with a new device and a new faeces sample.

Precautions
READ THE RESULT AFTER EXACTLY 10 MINUTES. The intensity of the line colours is not relevant for the purposes of interpretation of the Test’s results.
•Dispense 3 (or no more than 4) drops of the diluted faeces sample into the well shown on the strip. Wait 1-2 seconds between dispensing one drop
•The HELICOBACTER PYLORI ANTIGEN Test can be carried out at any time of the day, when you have a bowel movement, and there is no need to follow a specific diet.

*Read these instructions for use carefully before performing the test. The Test is reliable only if all the instructions are followed correctly.

Storage
Store in a dry place at a temperature between 4°C and 30°C. Do not freeze.

Kit includes
•Test cassette x 1
•Desiccant bag x 1
•Test diluent x 1
•Small sheet for the collection of the faeces sample x 1
•Instruction x 1"