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8th August 2023  Product update: rapidmicrobiology staff writer

Premier® HpSA® FLEX™ Diagnoses H. pylori in Both Preserved and Unpreserved Stools - Now FDA Cleared


Meridian Bioscience, Inc., has received FDA clearance for Premier® HpSA® FLEX™ for the diagnosis of H. pylori in both preserved and unpreserved stools. Premier HpSA Flex joins the extensive Meridian H. pylori portfolio of products that includes BreathID® (urea breath test for H. pylori), Curian® HpSA (fluorescent immuno analyzer antigen test), and ImmunoCard® Stat! HpSA (rapid colorimetric antigen test).

Meridian strives to continuously improve existing products. The Premier HpSA FLEX workflow improvement recently cleared by FDA allows clinicians to use preserved stools in Cary-Blair and C&S in addition to fresh or frozen unpreserved samples. Meridian’s Premier HpSA FLEX test is a non-invasive enzyme immunoassay used to qualitatively detect Helicobacter pylori (H. pylori) specific antigens in fresh, frozen, or preserved human fecal specimens.

Meridian is committed to developing the industry’s broadest range of highly accurate Gastrointestinal diagnostic solutions enabling clinicians to use the sample types and testing platforms required in today’s ever-evolving healthcare landscape,” stated Tony Serafini-Lamanna, President of Meridian Bioscience Diagnostics.

To learn more about H. pylori and Meridian’s testing solutions, please visit www.meridianbioscience.com/hpylori.


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Date Published: 8th August 2023

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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