We evaluated the BD GeneOhm MRSA achromopeptidase (ACP) assay, which incorporates a new specimen preparation approach. A total of 1,216 leftover nasal samples were tested; using culture as the gold standard, the sensitivity and specificity were 92% and 94.6%, respectively. The new lysis method provides good sensitivity and simplifies specimen preparation.Methicillin-resistant Staphylococcus aureus (MRSA) is a leading cause of health care-associated infections and is responsible for increased hospital stays with high financial cost (7,19,24). In fact, by 2005 MRSA had a higher mortality rate than tuberculosis, salmonella infection, influenza, and HIV-AIDS combined within the United States (5). Moreover, Delorme and colleagues recently reported an increase of MRSA infections and disease rate in long-term care facility (LTCF) residents between 2006 and 2007 (6). There has been some success reported in the reduction of invasive infection since 2005, but most of the improvement was related to bloodstream infection and may be related to improved central venous catheter management in acute care hospitals (11). Another recent study has shown that a reduction in the rate of MRSA invasive infection must involve more than a general improvement in basic infection control practice, such as improved hand hygiene, since improved hand hygiene did not lower hospitalacquired MRSA colonization (14).MRSA detection is often followed by either decolonization or isolation to reduce MRSA prevalence within hospitals and in the community (4,8,10). In an elegant crossover study of the impact rapid testing has on MRSA transmission, Hardy and colleagues demonstrated significantly reduced transmission when surveillance testing was done using a real-time PCR assay, as opposed to no significant impact when routine, culture-based testing was utilized by the laboratory (9). Thus, rapid and reliable screening tests for MRSA detection are very important. Real-time PCR assays are fast, reliable, and accurate, which has been useful to reduce the incidence of MRSA disease (19,20).Paule and colleagues developed an achromopeptidase (ACP) lysis procedure for high-volume testing and compared its performance with the original BD GeneOhm MRSA lysis kit method (IDI-MRSA assay). The study results demonstrated that the assay performed equally well using both procedures (18). BD Diagnostics subsequently developed an ACP lysis method for use with the BD GeneOhm MRSA kit. The purpose of this current study was to assess the BD GeneOhm MRSA ACP assay for direct detection of MRSA in nasal specimens as part of an application to the U.S. FDA for clearance as an in vitro diagnostic device.Nasal swabs were collected using double-headed BBL culture swabs with liquid Stuart (Becton Dickinson, Sparks, MD) or liquid Amies (Becton Dickinson) transport medium; singleheaded Amies gel swabs without charcoal (Becton Dickinson) were also included. Excess, deidentified nasal specimens were used for testing after routine laboratory procedures were completed. The subjects enrolled ...