Rapid test for diagnosing Helicobacter infection CITO TEST Helicobacter test cassette for self-control No. 1

CITO TEST® HELICOBACTER is a rapid test for the qualitative detection of H. pylori antigens in fecal samples for the purpose of diagnosing Helicobacter pylori infection at home.

For self-control.

IMPORTANTLY

Please follow the instructions for use to obtain accurate results. There are many reasons for obtaining false results.

After testing, you should consult a doctor with the results. The final diagnosis should be established by a doctor after conducting clinical and additional laboratory tests.

GENERAL INFORMATION

Helicobacter pylori infection is the most common chronic infection in the world.1 More than 50% of the world's population2 and up to 80% of the adult population in Ukraine are currently infected with H. Pylori.3 In Ukraine, infection occurs at a fairly early age, which is accompanied by a high incidence of stomach cancer.

Helicobacter pylori (H. pylori) is a spiral-shaped bacterium that lives in the mucous membrane of the stomach and duodenum and is able to survive in the acidic environment of the stomach. Helicobacter infection can have various manifestations (from asymptomatic carriage to severe symptoms of dyspepsia, including pain and discomfort in the epigastrium, a feeling of fullness after eating, belching, heartburn, nausea), and provokes the development of severe complications, such as gastritis, peptic ulcer of the stomach and duodenum, and stomach cancer. More than 90% of cases of duodenal ulcer and 80% of cases of gastric ulcer are associated with infection with H. pylori.

The importance of timely detection of H. pylori has increased significantly since the correlation between the presence of the pathogen and confirmed diseases of the stomach and duodenum, such as gastritis, peptic ulcer, and stomach cancer, was confirmed. It has been proven that early detection and treatment of Helicobacter pylori eliminates symptoms and leads to a significant reduction in the incidence of stomach cancer.4

Equipment

• Test 1 pc.
• Test tube with solvent 1 pc.
• Non-sterile medical gloves* 1 pair
• Sample container* 1 pc.
• Instructions 1 pc.

Indications for use

TEST PRINCIPLE

The CITO TEST® HELICOBACTER test is a rapid analysis with visual recording of test results. The principle of the test is based on the binding of antibodies to the antigen in a specific way. During testing, a sample of biological material reacts with reagents that have been previously applied and dried on the test membrane. Then the mixture migrates along the test under the action of capillary force. In the case of a positive result, the reagents present in the test result area will capture the mixture, resulting in the formation of a red test line. The mixture will continue to move along the membrane in the direction of the control area of the test, where a red control line is always formed. The presence of this colored line serves as confirmation of a sufficient amount of sample used, filling the membrane capillaries, and is also an internal quality control for the reagents. In the absence of a disease marker in the clinical material sample, the mixture binds only to the reagents in the control area, forming only one red control line.

Reservation

• For self-control.
• Do not use after the expiration date indicated on the package.
• Do not use the test if the packaging is damaged.
• All samples may be considered potentially hazardous and should be handled as infectious material.
• After testing, the test should be destroyed in a waste container.

Method of application

TESTING PROCEDURE

1. Prepare all the materials necessary for the study: test components and a watch.
2. The test cassette and the tube with the solvent must be kept at room temperature for a sufficient time so that their temperature is equal to room temperature (15-30°C).
3. Open the sealed pouch, remove the test cassette and place it on a flat, horizontal surface. Testing should be performed within 2 h (hours) of opening the sealed pouch.
4. Remove the cap from the specimen tube and, using a swab, take a small amount of stool sample (about the size of a match head) from four different areas and place it in the tube. If the stool sample is liquid, use a pipette to take 2 drops of the sample and place it in the tube.
5. Close the tube with the solvent and sample and shake to obtain a homogeneous suspension.
6. Take the sample tube and unscrew the tip of the cap. Add 2 drops of the obtained sample to the S window on the test cassette. Avoid getting solid particles with the liquid into the window of the test cassette.
7. The test result should be recorded after 10 min. The result after 20 min should not be taken into account.

Attention! If the liquid does not flow along the test membrane, mix the sample added to the cassette window with a stick. If the liquid does not move after this, add a drop of solvent to the test window and make sure that the liquid moves along the membrane.

INTERPRETATION OF RESULTS

Positive: Two distinct colored lines appear. One red line should appear in the control region (C) and the other in the test region (T) of the result window.

The intensity of the red line in the test region of the test will depend on the concentration of H. pylori antigens present in the specimen. Therefore, the appearance of a line of any intensity in the test region is considered a positive result.

Negative: One red line appears in the control region (C) of the test result window. No line appears in the test region (T).

Invalid: No control line (C). Insufficient specimen, incorrect test technique, or reagent deterioration are more likely causes of no control line. Review test technique and repeat the test procedure with a new test.

QUALITY CONTROL

The test has an internal control. The red control line that appears in the result window is the same internal control. It confirms sufficient sample volume and correct test technique.

Storage conditions

Store the test sealed at 2-30 ºC. The test is stable until the expiration date indicated on the package. The test should remain in the sealed pouch until use. Do not freeze. Shelf life 24 months.

Technical specifications

Sensitivity and specificity

Sensitivity and specificity of CITO TEST® HELICOBACTER are determined using company standards and in clinical studies and are: sensitivity >99.9%, specificity 99.0%.

LIMITATION

1. For in vitro diagnostic use only.
2. The test is only suitable for testing human stool specimens. Neither the quantitative content of H. pylori antigens nor the degree of increase in its concentration can be determined with this test.
3. A negative result is not definitive, as it is possible that the concentration of H. pylori antigens in the sample may be below the detection limit. If symptoms persist, more reliable methods for diagnosing Helicobacter pylori infection are recommended.
4. This test can be used to make a preliminary diagnosis of H. pylori infection. The final diagnosis should be made by a doctor after all clinical and laboratory tests.
5. After treatment with some antibiotics, the concentration of H. pylori antigens may decrease to concentrations below the minimum acceptable sensitivity level of the test. Therefore, during antibiotic treatment, diagnosis should be performed with caution.

1. Backert, S. Helicobacter pylori research: from bench to bedside / S. Backert, Y. Yamaoka. - Tokyo: Springer, 2016. - 613 p.

2. Universal Recommendations of the World Gastroenterological Organization of Helicobacter pylori in developing countries

3. Dorofeev A.E., Rudenko N.N. Helicobacter pylori infection in Ukraine. How to increase the effectiveness of eradication? - "Gastroenterology" Volume 52, No. 3, 2018

4. Lee YC et al., 2016; Choi IJ et al., 2018

Producer

Location of the legal entity LLC "NVC "PHARMASCO":

03193, Kyiv, Dmytra Lutsenko St., building 10