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) using gel- or liquid-reaction media.
PyloriTek test results are available in 1 hour allowing for discussion of the results with the patient before he/she leaves the facility. Most positives appear in 15 minutes or less due to the patented PyloriTek method that allows the urea/urease and ammonia/pH paper reactions to take place in separate, optimal environments which accelerates the rate of the reaction and minimizes blood or tissue fluid masking the color reaction.
Each PyloriTek strip also has a built-in positive analyte control and a negative control which run concurrently with the test specimen. The PyloriTek positive control automatically appears with every test within the normal 1-hour time with no extra steps or materials needed. With competitive tests the positive control is run after waiting 24 hours then inserting a urease positive control material.
Some investigators have reported that, due to the patchy distribution of H. pylori in the stomach 2 or 3 biopsies from several areas of the stomach can increase chances of finding infection. If you choose to take extra biopsies, up to 3 specimens from the same patient can be placed on a single PyloriTek strip with separate and distinct results for each biopsy.
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. This is not data from a single selected study which shows the best results from one institution, but a summary from all the institutions which have done unbiased studies comparing PyloriTek to other RUT and histology methods. Four additional papers are available, including a pediatric study.
Published Pyloritek Studies:
Why choose Serim’s Helicobacter pylori test kit?
- 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
- 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
- yields results in one hour or less
- has a specificity & sensitivity of at least 96%
- can accommodate up to 3 biopsies per test
- is CLIA-waived
Click here to watch a video on Pyloritek.
Pyloritek Test Kits are not licensed for sale in Canada
To place an order, email email@example.com or call 1-800-542-4670.