BD Announces FDA 510(k) Clearance of Simplified Test for Detection of MRSA

BALTIMORE -- BD (Becton, Dickinson and Company), through its BD Diagnostics segment, today announced that the Food and Drug Administration has cleared the BBL CHROMagar MRSA product.  This new prepared plated medium simplifies the process, decreases the time to result and offers high sensitivity and specificity for methicillin-resistant Staphylococcus aureus (MRSA) identification.

BBL CHROMagar MRSA allows microbiology laboratories to identify patients

colonized with MRSA more quickly and easily than the time-consuming and labor-

intensive processes currently available. BBL CHROMagar MRSA allows for the

direct detection and identification of most MRSA within 24 hours. The cost

benefits associated with reducing nosocomial infections can be significant.

"This technology will be extremely useful to those who wish to identify

patients colonized with MRSA," said Dr. Bill Jarvis of Emory University School

of Medicine, and president of Jason and Jarvis Associates. "Since MRSA

colonization leads to infection in a specific patient and is a risk factor for

transmission of MRSA to other patients, rapid identification of those with

MRSA colonization will reduce the risk of infection in colonized patients, by

enabling their clinicians to intervene, and reduce the risk of patient-to-

patient transmission by permitting isolation of those who are MRSA-colonized. 

Furthermore, this technology will markedly increase the rate at which

community-associated or hospital-acquired MRSA patients are identified. Thus,

more rapid isolation and treatment can occur. The multiple benefits of this

rapid identification method will improve patient treatment, reduce the risk of

transmission in healthcare settings, and reduce the burden of MRSA in U.S.

hospitals."

The prevalence of nosocomial infections caused by MRSA has been increasing

for several years in many countries around the world.(1) The Centers for

Disease Control and Prevention (CDC) estimates that between 60,000 and 80,000

Americans die each year from nosocomial infections and the cause in the

majority of cases is S. aureus. 

BBL CHROMagar MRSA utilizes a new chromogenic technology which permits the

detection of MRSA using chromogenic substrates and a cephalosporin. MRSA

strains will grow in the presence of antibiotics and produce mauve-colored

colonies resulting from hydrolysis of the chromogenic substrates. In clinical

evaluations, BBL CHROMagar MRSA displayed 8 percent greater recovery(2) of MRSA than traditional screening algorithm and has the capability to identify MRSA

earlier than most traditional algorithms. This unique technology requires less

technologist time and improves the workflow in the laboratory. BBL CHROMagar

MRSA allows for the direct detection and identification of most MRSA within 24

hours, or at 48 hours with a confirmatory test.

BD is a medical technology company that serves healthcare institutions,

life science researchers, clinical laboratories, industry and the general

public. BD manufactures and sells a broad range of medical supplies, devices,

laboratory equipment and diagnostic products.

References:

     (1) Reacher, M.H. et al. 2000 Bacteremia and antibiotic resistance of its

         pathogens reported in England and Wales between 1990 and 1998:trend

         analysis. Br. Med. J.  320:213-6.

     (2) BBL CHROMagar package insert.

Source:  BD (Becton, Dickinson and Company)