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.
Why choose Serim’s Helicobacter pylori test kit?
- 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