ITEST Helicobacter

Diagnostic kits 25 tests Cat. No. SO 331

Product categories

Purpose and use

The ITEST HELICOBACTER kit is designed for rapid identification of Helicobacter pylori in gastric mucosal biopsy samples by biochemical method. The kit is able to distinguish ulcer disease etiologically related to Helicobacter pylori infection from Helicobacter pylori negative cases due to other specific causes (e.g. gastrinoma, Crohn’s disease, etc.). The detection of peptic ulcers caused by Helicobacter infection allows early initiation of effective anti-Helicobacter treatment.

Principle

Helicobacter pylori produces urease, the detection of which is based on the change in pH when ammonia is produced.

Procedure

Add 2 drops of diluent to the detection tube with dehydrated substrate. After complete dissolution, add the biopsy material to the solution. Close the tube and incubate for 3–4 hours at room temperature. If necessary, incubate the tubes until the next day.

Evaluation

Positive reaction (presence of Helicobacter pylori in the sample) results in the substrate turning pinkish-purple to purple during incubation. If the reaction is negative, the colour of the substrate does not change during incubation, i.e. it remains yellow to yellowish-orange.

Important

The ITEST HELICOBACTER kit is supplied in packs with 25 tests (Cat. No. SO 331) and is for in vitro use only.
Keep the kit in a dark place at 2–8 °C and use by the expiry date on the label.
If the primary packaging of the IVD is damaged, do not use and contact the manufacturer.
Dispose of unused IVDs and empty packaging in accordance with the Waste Act No. 185/2001 Coll.

References

"ITEST is regularly audited by BIOPHARM without significant or critical findings, and is regularly ranked in the highest category in supplier evaluations. Exemplary long-term cooperation provides us with a guarantee of reliability and trust in the quality of services provided."

BIOPHARM

"We started our cooperation with Itest Plus s.r.o at the very beginning of its operation. For almost 30 years, we have been using laboratory services for our own purposes or for contractual testing of our customers' products. We greatly appreciate the professionalism, flexibility and reliability of the entire laboratory team. We would like to thank you for your cooperation so far and look forward to the future."

SVUS Pharma a.s.

"Ferring-Léčiva, a.s. is a company producing sterile and non-sterile medicinal products. We have been cooperating with the ITEST Plus, s.r.o. laboratory for more than 25 years, this cooperation is very valuable to us and we are very satisfied with the range of services and their implementation. The ITEST Plus company offers a wide portfolio of accredited tests, its employees are kind and helpful and respond quickly to all suggestions."

Ferring-Léčiva, a.s.

"We have been cooperating with ITEST plus s.r.o. for many years and are very satisfied with the service, quality of services and communication."

Cayman Pharma

"Itest Plus s.r.o. is for us a synonym for excellent cooperation in the field of laboratory analysis. Professional approach, excellent communication, reliability, speed and accuracy of tests are the calling card of this company and for us the main reasons why this company has been our trusted partner for more than 26 years."

Teleflex

"ITEST provides BIOPHARM with output control of the final product, intermediate products, input raw materials, packaging materials and microbiological monitoring of production areas. The tests are carried out within the scope of sterility and microbial safety tests in accordance with Ph.Eur. and in accordance with the valid contract."

BIOPHARM