General Information

HELİCOBACTER PYLORİ

Principle of the Test

Test Procedure

Positive Result

Negative Result:

Helicobacter pylori survives in the stomach by neutralizing stomach acid by means of hydrolyzing urea with its

urease enzyme. The urease enzyme of the microorganism has a unique structure, it has higher a�nity to its

substrate and has higher activity compared to other ureases.

Helicobacter Pylori is a spiral-shaped gram-negative bacteria, which infects gastric mucosa. The involvment of this bacteria in acute and chronic gastritis, intestinal metaplasia, peptic ulcer and gastric cancer pathogenesis has been identified by the conducted epidemiological, experimental and clinical studies.

1) Patient’s name and other information has been written on the top of the test cassette 2) Test lid is opened with removing the label cover from the cassette3) Biopsy samples are placed on the test and the label is sticked back to the test cassette tighlty4) By pressing the buton placed on the buttom part of the label, squashing of biopsy samples is achieved5) Test is put on the flat surface and the coundown begins6) Color change of the yellow circle is controled intermittently

The result is positive if the outer ring's color changes from yellow to reddish/pinkish. The severity of the infection can be guessed depending of the speed of the reaction and the intensity of red color. The inner circle remains yellow and serves as a reference to color change.

If the outer circle remains yellow and there is no change to red then the result is negative. Wait for 60minutes to report negative result.

This product was developed in order to detect the urease activity of H. pylori in stomach biopsy specimens. Urease in the biopsy specimen catalyzes hydrolysis of urea present in the test device. This reaction produces ammonia which leads to an increase in pH of the medium. Increased pH turns the color of the indicator ring from yellow to reddish/pinkish color. The formula of the reaction is as follows:

Urea + Water - Carbon dioxide + Ammonia(NH₂)2CO + H₂O - CO₂ + 2NH₃

Depending on the amount of bacteria in the biopsy, color change will be observed in about one minute after placing the biopsy samples on the test cassette. Color tends to change from yellow to pink/reddish tone. The result is negative when no color change is observed. Maximum one hour enough is enough to get a negative result. Final results of this test are received between a time period of one minute and an hour.

Interpretation Of The Results

Collection of Specimens

Storage and Shelf Life

Warnings and Precautions

Contact Information

www.endosfer.com

Do not use products with damaged packaging.

Do not use if outer ring is not yellow.

Do not use products with damaged packaging.

Oruç Reis Mah. Giyimkent. 17. Sok.No: 38 A Esenler / İstanbul - TURKEY

Tel. : +90 212 438 53 99 Pbx Fax. : +90 212 438 53 98

E-Mail : info@endosfer.com

After the endoscopic examination of the stomach the biopsy specimen should

be taken as usual. Biopsy specimen should be taken from pyloric antrum or

greater curvature. In some cases H. pylori colonization can be patchy and they

can be present at other parts of the stomach. Two or three biopsy specimens

can be taken from di�erent parts if suspicion arise.

Kit can be stored refrigerated at room temperature (2-25°C) until its expiration

dated printed on the label. Shelf life is 24 months after the production.

Read the instructions before using the product.

This is an in-vitro diagnostic device to be used only by

competent and professional sta�.

Do not use past its expiration date.