H. pylori

PyloriTek® for H. pylori

Serim® PyloriTek Test Kit detects urease activity in gastric biopsy specimens which is a presumptive identification of a Helicobacter pylori infection.

The PyloriTek dry reagent technology has several distinct advantages over other rapid urease tests (RUT) such as HP Fast, Clotest and Pronto Dry.

Why choose Serim’s Helicobacter pylori test kit?

  • PyloriTek can accommodate up to 3 large biopsies per test and provides ability to map results by location.
  • PyloriTek does not require using a separate test device as a control since PyloriTek is the only rapid urease test with a built-in positive control on every test. The positive control is a true analyte, not a reactive control.
  • PyloriTek yields most positive results in as little as 15 minutes; yields negative results in one hour.
  • PyloriTek has a specificity of at least 97%
  • PyloriTek is FDA registered and CLIA waived
  • PyloriTek has been a standard for H. pylori testing for over 20 years
  • Any blood on the sample will not interfere with test results.

Additional information

PyloriTek test results are available within 1 hour so the results can be shared with the patient before he/she leaves the facility. Most positive results appear in 15 minutes or less due to the patented urease PyloriTek reaction method.

Each PyloriTek test has both a built-in positive analyte control and a negative control which run concurrently with the test specimens. The PyloriTek positive control automatically appears on every test within 1-hour without any extra steps or material. With competitive tests, the positive control is run after waiting 24 hours which delays notifying the patient of the results and requires running an additional test

Investigators determined that taking 2 or 3 biopsies from several areas of the stomach can increase chances of finding infection due to the patchy distribution of H. pylori. Biopsies from multiple locations is recommended for many patients and improves test sensitivity in some patients (patients with recent or active bleeding or taking some medications)

Every PyloriTek test provides the capability to test up to 3 specimens from a patient and delivers a separate and distinct result for each biopsy. Other urease tests (HP Fast, Clotest and Pronto Dry) require the use of an additional test device for each additional biopsy which increases the cost of testing.

Published studies in major journals have shown that PyloriTek possesses excellent sensitivity and specificity in diagnosing H. pylori infections. In carefully controlled studies involving over 500 patients, PyloriTek showed average specificity of over 97% and sensitivity of over 96% when compared to at least two reference methods. These studies were conducted at multiple institutions comparing PyloriTek to HP Fast, Clotest and Pronto Dry and histology methods rather than a single, limited study from one institution designed to optimize results. Four additional papers are available upon request, including a pediatric study.

Click here to watch a video on Pyloritek.

Pyloritek Test Kits are not licensed for sale in Canada

Main Areas of Testing:

Helicobacter pylori
  • PyloriTek
Published Pyloritek Studies:
  • Elitsur Y, Hill I. et al. Prospective Comparison of Rapid Urease Tests (PyloriTek, CLO Test) for the Diagnosis of Helicobactor pylori Infection in Symptomatic Children: A Pediatric Multicenter Study. Am J of Gastroent 1998; 93: 217-219
  • Laine L, Lewin D et al. Prospective comparison of commercially available rapid urease tests for the diagnosis of Helicobactor pylori. Gastroint Endoscopy 1996; 44:523-526
  • Murata, H. Kawano, S. et al. Evaluation of PyloriTek Test for Detection of Helicobactor pylori Infection in Cases With and Without Eradication Therapy. Am J Gastroent 1998; 93: 2102-2105
  • Rogge J, Wagner, D. et al. Evaluation of a New Urease Reagent Strip for Detection of Helicobactor pylori in Gastric Biopsy Specimens. Am J Gastroent 1995; 90:1965-1968
  • Wong W M, Wong B. C., et al. An evaluation of the PyloriTek test for the diagnosis of Helicobactor pylori infection in Chinese patients before and after eradication therapy. J Gastroent and Hepatology 2001; 16: 976-980
  • Young E, Sharma T, Cutler A. Prospective evaluation of a new urea-membrane test for the detection of Helicobactor pylori in gastric antral tissue. Gastroent Endoscopy. 1996; 44:527-531
  • Yousfi M, El-Zamaity H. et al. Evaluation of a new reagent strip rapid urease test for detection of Helicobactor pylori infection. Gastroint Endoscopy 1996; 44:519-522

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