New! CLIAwaived H. pylori Test Kit
CLIAwaived H. pylori Whole Blood Rapid Test. A rapid qualitative immunoassay intended to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human whole blood. FDA-cleared and CLIA-waived. (FDA 510K#: K024360)
The all new CLIAwaived, Inc. H. pylori Rapid Test is a rapid qualitative immunoassay intended to detect the presence of antibodies specific to Helicobacter pylori (H. pylori) in human whole blood. The test provides the aid in the diagnosis of H. pylori infection and is for use by health care professionals only. Heliobacter pylori has been associated with a variety of gastrointestinal diseases. H. pylori infections occur in human populations throughout the world.
- Simple one-step test
- Room temperature storage
- Built-in procedural control
- Fast results in 4 minutes
- Sensitive over 95.1%
- Specific over 92.8%
- FDA-cleared and CLIA-waived
NOTE: The H. pylori Whole Blood/Serum Cassette Test is NOT CLIA-waived when using serum samples.
CPT*: 86318 ($18.09) Serum/Plasma, 86318QW* ($18.09) Whole Blood
Reimbursement shown indicates National Average
CLIA: Moderately Complex/Non-Waived
FDA Cleared/CLIAwaived (Whole Blood)
*It is always the provider's responsibility to establish appropriate coding & charges.