CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
FDA clears molecular diagnostics quality controls for bloodstream infections
October 2023—The Food and Drug Administration has granted clearance to Streck’s MDx-Chex for BC-GP and MDx-Chex for BC-GN for use in diagnostic procedures. They are quality controls designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for bloodstream infection and sepsis.
MDx-Chex evaluates the entire analytical process of the Luminex Verigene tests, including cell lysis and DNA extraction, as well as DNA hybridization, detection, and analysis. It can be used for assay verification, to track lot-to-lot performance of tests, and to reduce the occurrence of incorrect results due to instrument or assay failures.
MDx-Chex for BC-GP and MDx-Chex for BC-GN cover all targets tested with Luminex Verigene BC-GP and BC-GN within a single positive control tube, respectively. Because each control contains intact, inactivated microorganisms suspended in a matrix of stabilized red blood cells, white blood cells, and blood culture media components, they can be run in the same manner as patient samples, reducing the risk of preanalytical variables that may cause incorrect results.
XiFin launches new Lab Volume Index
XiFin has added new features and insights to its Lab Volume Index. LVI insights and trends are derived from claims transaction data from within the XiFin RPM platform.
The XiFin Lab Volume Index enables views of testing volumes over time and across four key categories of testing: clinical, immunology and microbiology, molecular and genetic, and anatomic pathology. Segmentation is based on the type of testing, not the type of laboratory performing the tests. For example, if the Lab Volume Index is selected for molecular and genetic, it shows the testing volume of all molecular and genetic testing, irrespective of whether it was performed at a hospital lab, one that primarily does pain management and toxicology, or a lab specializing in molecular testing.
The enhanced XiFin Lab Volume Index features a new user-selectable baseline for 2019–2022, making it possible to compare the time going forward including annually. Previously, the baseline was set to 2019. Throughout the pandemic, XiFin says, using that same baseline was a good measure of fluctuations in volume as compared with pre-pandemic average volume. The expanded Lab Volume Index also includes new data from additional labs added after the original baseline period.
The original XiFin Lab Volume Index was measured weekly to trend the surges and lulls during the pandemic. With SARS-CoV-2 testing continuing to stabilize and be replaced by molecular testing, the Lab Volume Index is now measured monthly, normalizing the data to reduce the impact of variations caused by holidays in a given week.
BioMérieux submits 510(k), CLIA-waiver application for Spotfire R/ST panel
BioMérieux has submitted the BioFire Spotfire respiratory/sore throat (R/ST) panel to the Food and Drug Administration for a dual 510(k) clearance and CLIA waiver. The panel is already CE marked.
It is the third panel submitted for FDA review to be used on the Spotfire. Two other FDA-cleared and CLIA-waived panels are available for use on this system: The respiratory panel, which detects 15 of the most common respiratory pathogens, and the respiratory panel mini, which detects five.
Evident announces alliance to automate digital pathology workflows
Evident announced in September an alliance with Corista, Sakura Finetek USA, and Visiopharm to deliver an automated, end-to-end workflow solution for pathology in the United States.
Evident and Corista previously developed a scanner with an image management system that uses Visiopharm’s image analysis and artificial intelligence toolset. Sakura Finetek USA and Evident collaborated to provide an automated staining and whole slide imaging workflow to reduce manual tasks in pathology labs.
“The alliance of these four companies will help drive the adoption of a fully automated pathology system across laboratories,” Lee Wagstaff, vice president of life science sales and marketing at Evident Americas, said in a news release.
Joint report published on multiplex panels for infectious disease
The Association for Molecular Pathology published Sept. 25 a report on the utility of multiplex infectious disease panel testing for the diagnosis of infection in gastrointestinal, central nervous system, lower respiratory tract, and joint specimens.
It’s a joint report, published online ahead of print, of the AMP, American Society for Microbiology, Infectious Diseases Society of America, and Pan American Society for Clinical Virology. The full report is at https://bit.ly/AMPrep-092523.