This article is more than 5 years old. Information may no longer be current.
FDA clears molecular MRSA test
Click Here to Manage Email Alerts
The FDA has granted clearance for an automated molecular test for screening methicillin-resistant Staphylococcus aureus, according to a press release.
BioMerieux announced that its NucliSENS EasyQ test received clearance after achieving clinical sensitivity of 94.7% and clinical specificity of 96.5% when testing nasal samples of adult patients. The sensitivity was 100% and the specificity was 97.3% for nasal samples from children.
The test detects seven of the most common MRSA strains by simultaneously detecting two targets. The system has the capacity to support batch processing of up to 46 MRSA screening tests in a compact space within a 3-hour period.
|
|
With Staphylococcus aureus now being the most common invasive pathogen in the United States, it is exciting to see rapid diagnostic tests being evaluated and approved by the FDA. Rapid diagnostic tests (RDTs) have now been cleared for both nasal swabs and blood cultures to aid in the detection of MRSA. The performance characteristics of each of these RDTs are somewhat different, though each is purported to provide upwards of 85% to 95% sensitivity and specificity when compared to culture. While issues of laboratory expertise, equipment, cost, and practical use of the technology remain unanswered in some clinical scenarios, these tools could prove extremely valuable in the clinical care of patients and in clinical trials of antistaphylococcal therapeutics. Carefully designed trials are critical for us to understand exactly how these RDTs should be employed in pediatric care.
-C. Buddy Creech, MD, MPH
Infectious
Diseases in Children Editorial Board member
 |
Follow the PediatricSuperSite.com on Twitter. |