Simplexa^® Congenital CMV Direct

The only FDA-cleared PCR assay for detection of congenital CMV in both saliva swabs and urine

One test for better newborn outcomes with accurate congenital CMV detection, enabling ability to meet guidelines for saliva screening, confirmation in urine, and minimizing false positives.

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Disease state

Human cytomegalovirus (CMV), a herpes virus, can pass from mother to unborn baby, causing congenital CMV (cCMV) which may lead to severe morbidity or mortality. Transmitted in blood via the placenta to the fetus when the mother has primary CMV infection, up to 40% of fetuses are at risk, and 1-2% when CMV is reactivated during pregnancy.

CMV is the most common congenital infection worldwide, 1 out of 200 infants are born with cCMV infection in the U.S. annually. Newborns can progress to long-term health problems, non-genetic childhood hearing loss, and neurodevelopmental delays. At birth, newborns can be symptomatic (10%) or asymptomatic (90%), and both subgroups can develop hearing defects.

Diagnosis of cCMV is critical for early intervention. Infants with cCMV shed high levels of CMV in urine and saliva. Screening in saliva and confirming in urine provides a definitive diagnosis for congenital CMV per testing guidelines.

Human cytomegalovirus (CMV) is a highly prevalent virus that can lead to severe morbidity and mortality when passed from the mother to an unborn baby

The value of Simplexa^® Congenital CMV Direct

Provides accurate cCMV diagnosis in neonates by minimizing false positives

The power of saliva and urine cCMV testing

Mothers shed CMV through breast milk which may cause false positives shortly after feeding. Testing in urine is critical for definitive diagnosis in infants.

Operational efficiencies with accurate reporting

Minimize time to confirmed infection by having access to confirmatory testing with results in about an hour.

Clinical performance for timely action

High performance in clinical trials with 100% sensitivity (PPA) and 100%/98.6% specificity (NPA) respectively in Urine/Saliva (retrospective study).

How the Simplexa^®
Congenital CMV Direct works

Simplexa^® Congenital CMV Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted urine or saliva swab sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON^® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.

01

Sample-to-answer

Scan 1-8 primary unextracted samples per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON^® MDX instrument, and press run for results in 60 minutes.

02

Intuitive LIAISON^® MDX Studio Software

Integrated QC checks and LIS reporting. View PCR curves and QC Charts and access software even during runs.

03

Broad coverage

Only FDA-cleared PCR assay validated for both saliva swab and urine specimens.

To be used on the LIAISON^® MDX instrument

The LIAISON^® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.

Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.