QuidelOrtho Corporation has received FDA 510(k) clearance for its VITROS syphilis assay, enhancing the company’s position as a leader in infectious disease testing.

This assay, available on the automated VITROS 3600, 5600, and XT 7600 systems, is designed for the qualitative detection of total (IgG and IgM) antibodies to Treponema pallidum (TP)-specific antigens in human serum and plasma.

These antibodies, when used alongside non-treponemal tests and clinical evaluations, aid in diagnosing syphilis infections. The VITROS syphilis assay is now accessible in the U.S. and other global markets where QuidelOrtho products are distributed, though it is not intended for blood and tissue donor screening.

QuidelOrtho’s portfolio of infectious disease tests spans various healthcare settings, from point-of-care facilities to high-volume laboratories, and plays a vital role in combating the syphilis epidemic in the U.S. With over 176,000 new cases reported annually and a 36% rise in primary and secondary syphilis since 2021, the need for effective and widely available testing solutions has become increasingly urgent.

Expanding into the U.S. market, this assay aims to provide accurate and timely syphilis diagnosis, which is essential for effective treatment and disease management.

According to Lily Li, Senior Director of Medical Scientific & Clinical Affairs at QuidelOrtho, rapid and reliable testing across various healthcare environments is crucial given the rising rates of syphilis and other STIs.

The CDC's Morbidity and Mortality Weekly Report from February 2024 highlights the recommendation of both nontreponemal and treponemal serologic tests for syphilis diagnosis.

QuidelOrtho remains committed to expanding its range of infectious disease testing solutions, supporting healthcare providers in delivering top-quality patient care.
 

 

 

Source: quidelortho.com

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