Multicenter Evaluation Demonstrates Excellent Clinical Performance of Congenital CMVTest

Published on 4 Aug 2023

New research shows that the Simplexa® Congenital CMV Direct kit screens samples more accurately than other methods


The importance of newborn screening for congenital CMV

We have been eagerly watching as more states and labs begin to offer newborn screening for congenital cytomegalovirus (cCMV). Awareness of this infection is so important because of its potential complications: even if they show no symptoms at birth, infants infected in utero can develop permanent hearing loss or suffer neurodevelopmental delays or conditions like cerebral palsy. Thus, early diagnosis and treatment are critical for ensuring that newborns achieve the best possible outcomes.

Introducing the Simplexa® Congenital CMV Direct kit

Our scientists are doing their part to provide effective testing for early detection of congenital CMV, as is demonstrated by our FDA-cleared Simplexa® Congenital CMV Direct kit, which provides rapid, easy testing for babies with cCMV using both saliva and urine samples within the first three weeks of life. The test runs on the LIAISON® MDX system, which features a streamlined workflow for running real-time PCR tests for both in vitro diagnostic and laboratory-developed tests.

A multicenter evaluation demonstrated a higher level of clinical accuracy with the newly FDA cleared Simplexa® Congenital CMV Direct assay

A multicenter evaluation published in the Journal of Clinical Microbiology from researchers at Texas Children’s Hospital, Children’s Mercy Hospital in Missouri, Nationwide Children’s Hospital in Ohio, Labcorp, and TriCore Reference Laboratories has demonstrated the clinical performance of this test, which was run on more than 1,800 saliva samples and more than 1,600 urine specimens across the sites. Then, comparing results to two tests that use both PCR and sequencing, the authors concluded that the overall concordance between the Simplexa® test and the conventional methods was “near perfect”.

Here’s what the team found:
More accurate. The Simplexa® test accurately detected congenital CMV in more newborn samples than the other two assays tested. It also correctly identified false-positive results.
Better sensitivity. The improved sensitivity of the Simplexa® Congenital CMV Direct kit enabled detection of lower concentrations of CMV in samples compared to the other tests.
Two sample types validated. Avoid false positives-test both saliva samples for screening and confirm diagnosis in urine as per testing guidelines.
Rapid results. Test results are usually available about one hour after testing starts.

“Our study showed that the Simplexa® Congenital CMV Direct assay could be applied to both saliva and urine specimens collected from newborns less than 21 days of age to effectively rule in or rule out congenital CMV infection in a rapid, sensitive, and specific manner,” the researchers reported. “In most instances, it is recommended that a CMV-positive saliva test be confirmed by urine testing, so the availability of this FDA-cleared test allows institutions to easily use screening and confirmatory testing on-site for the most common congenitally acquired infection.”

Learn more about our Simplexa® Congenital CMV Direct kit here.

Related Content:

  1. LIAISON® MDX – DiaSorin Molecular
  2. Congenital Cytomegalovirus: Updates on Screening & Diagnostic Algorithm
  3. Congenital Cytomegalovirus: The case for newborn screening – Megan Pesch, MD, MS

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