Diagnostic Accuracy of Presurgical Staphylococcus aureus PCR Assay Compared with Culture and Post-PCR Implementation Surgical Site Infection Rates.

Nasal colonization with Staphylococcus aureus is a well-referenced risk factor for postoperative surgical site infections (SSIs). Our health care system that performs >40,000 surgeries per year assessed both the diagnostic accuracy of the BD MAX StaphSR assay (MAX StaphSR), a PCR-based test that detects and differentiates S. aureus and methicillin-resistant S. aureus (MRSA), compared with our standard of care culture and the subsequent clinical impact on SSIs 1 year after implementation. In addition, residual specimens were tested by broth-enriched culture. Performance parameters for all methods were determined using latent class analysis. Direct culture was the least sensitive for S. aureus (85.1%) and MRSA (76.7%), whereas the MAX StaphSR assay and broth-enriched culture had similar sensitivities (96.7%) for MRSA. Prospective assessment using MAX StaphSR during a 1-year, postimplementation period revealed a lower rate of SSIs per 100 targeted surgeries (0.3) compared with MRSA-only screening (1.10) and no screening (2.28) (P < 0.05 for StaphSR versus MRSA-only screening and StaphSR versus no testing). MRSA and methicillin-sensitive S. aureus SSIs occurred equally (n = 14 each). The MAX StaphSR assay provided accurate detection of both S. aureus and MRSA nasal colonization in presurgical patients, allowing infection prevention measures, including presurgical prophylaxis, to be implemented in a timely and consistent manner to avoid SSIs.