October 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens.
The H. Pylori Quik Chek test is a rapid diagnostic test that detects H. pylori in 30 minutes. The H. Pylori Chek test is a 96-well plate format diagnostic for laboratories testing large numbers of specimens and can be performed with or without automation in one hour. The company says both exhibit strong performance and offer flexible transport conditions, including room temperature storage of specimens and the use of C&S and Cary Blair transport media.