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BD, Check-Points Receive CE Mark for Resistant Organism Screening Test

This article has been corrected to note that the test is a next-gen PCR-based assay not an NGS test.

NEW YORK (GenomeWeb) – Becton Dickinson and Netherlands-based Check-Points Health have received CE marking for a next-generation PCR-based screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs). 

The test runs on the fully-automated BD MAX system and replaces an earlier version, offering improved workflow and an additional target, the companies said today in a statement. 

Carbapenems are a class of drug considered to be a last resort in treating infections, but CPOs produce an enzyme, cabapenemase, that makes these drugs ineffective. 

The BD MAX Check-Points CPO assay detects the five most common carbapenemase genes in less than 2.5 hours, the firms said, adding that screening to detect colonized patients can promote better infection control in hospitals.

"We have been using the Check-Points assay on the BD MAX system for routine screening of CPO for nearly two years, because it provides us the information we need to isolate or de-isolate our high-risk patients shortly after admission," John Rossen, assistant professor of medical microbiology at the University Medical Center, Groningen (UMCG) in the Netherlands and scientific secretary of the ESCMID Study Group for Genomic and Molecular Diagnostics, said in a statement. "This assay has not only improved our turn-around-time, but it also gives us the confidence that we will reduce the risk of transmission and outbreak."

A Check-Points carbapenem-resistant Enterobacteriaceae test which targeted a number of the same genes was criticized in a 2015 study for having a low positive predictive value, with authors noting that use of the rectal swab-based test for screening could potentially lead to false positive results, costly and unnecessary contact precautions, and inappropriate placement of patients into electronic registries that track colonized people in healthcare systems. At the time, Check-Points said it's test emphasized high sensitivity and high negative predictive value.