We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
LGC Clinical Diagnostics

QuidelOrtho

Develops, manufactures and markets rapid diagnostic tests that focus on infectious diseases, reproductive health, and... read more Featured Products: More products

Download Mobile App




Syphilis Assay Improves Lab Efficiency and Reduces Costs Through Earlier Disease Detection

By LabMedica International staff writers
Posted on 30 Aug 2024

The prevalence of syphilis and other sexually transmitted infections (STIs) in the U. More...

S. has seen a notable increase, with more than 176,000 new syphilis cases reported annually—a 36% rise in cases of primary and secondary syphilis since 2021. This surge underscores the urgent need for comprehensive and accessible diagnostic tools. In response, the Centers for Disease Control and Prevention recommends using both nontreponemal and treponemal serologic tests together to diagnose syphilis effectively. Now, a newly approved syphilis assay can provide timely and accurate diagnoses, which are vital for the effective treatment and management of the disease.

QuidelOrtho Corporation (San Diego, CA, USA) has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its VITROS syphilis assay as part of its menu. This assay, designed for use with the automated VITROS 3600, 5600, and XT 7600 systems, qualitatively determines the presence of total antibodies (IgG and IgM) to Treponema pallidum (TP)-specific antigens in human serum and plasma. The detection of TP-specific antibodies, when evaluated alongside non-treponemal test results and clinical assessments, assists in diagnosing syphilis. The VITROS syphilis assay is not intended for blood and tissue donor screening. With this FDA clearance, the VITROS syphilis assay is now available worldwide wherever QuidelOrtho products are sold.

“As an in-demand assay for a common STI, we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the U.S.,” said Bryan Hanson, Senior Vice President, President North American Commercial Operations at QuidelOrtho. “Not only does this important assay improve laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs.”

“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various healthcare settings is essential,” said Lily Li, Senior Director, Medical Scientific & Clinical Affairs, QuidelOrtho. “The CDC Morbidity and Mortality Weekly Report, updated in February 2024, recommends that both nontreponemal and treponemal serologic tests be used in conjunction to aid in the diagnosis of syphilis.”


New
Gold Member
Latex Test
SLE-Latex Test
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
HAV Rapid Test
OnSite HAV IgG/IgM Rapid Test
New
Whole Blood Control
Lyphochek Whole Blood Control
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: Ear wax could be a possible screening medium for Parkinson’s disease (Photo courtesy of 123RF)

Earwax Test Accurately Detects Parkinson’s by Identifying Odor Molecules

Current tests for Parkinson’s disease (PD) rely heavily on clinical scales and neuroimaging, which are often subjective, expensive, and ill-suited for routine screening. Since most treatments only slow... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: NGS can detect one tumor cell among a million healthy cells from a simple blood sample (Photo courtesy of Shutterstock)

New Tool Detects Breast Cancer Relapses Five Years in Advance

Relapse detection in patients with solid tumors—particularly hormone receptor-positive (HR+) breast cancer—remains a major clinical challenge, as many patients initially respond well to treatment but later... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.