Prospective evaluation of real-world performance and clinical impact of the Biofire FilmArray joint infection panel

Limitations of culture-based diagnostic approaches in pathogen detection in joint infections (JI) can be overcome by amplification-based, molecular assays. Recently, a syndromic panel PCR (spPCR) assay (Biofire JI panel; BJA) was approved for pathogen identification from synovial fluid (SF). Here, the performance and the clinical impact of the BJA were assessed in comparison to standard of care diagnostics in a prospective cohort of patients presenting with symptoms consistent with JI. One hundred sixty-five synovial fluids underwent analysis using the BJA. The results were compared with culture-based diagnostics. Discrepant results were re-analyzed using species-specific PCRs or 16S-rDNA sequencing. Clinical data from patients were collected to evaluate the impact on patient management. Twenty-seven of 165 (16.3%) synovial fluid cultures grew bacterial pathogens. In 24/27 cases, the BJA results were concordant. In one case, the cultured pathogen was missed, but three additional pathogens were identified. In 11 culture-negative cases, BJA identified a pathogen. Mean turnaround time in culture-positive samples was 14:11 h and 35:17 h in BJA and culture, respectively. In 11 cases, antibiotic therapy was optimized, based on BJA results. This study demonstrates high sensitivity and specificity (96.3% and 97.8%, respectively) of BJA, as well as a shorter turnaround time than culture-based techniques (21 h faster). Based on analysis of clinical data, antibiotic therapy was optimized due to BJA results in 11 cases. Care must be taken, as important pathogens in prosthetic JI are not included in the panel, restricting its value here.IMPORTANCEPathogen detection is critical for targeted management of joint infections; however, cultural detection of pathogens can be challenging. The Biofire Joint Infection Assay (BJA) is a syndromic panel PCR test that allows culture-independent detection of 31 pathogens. The diagnostic performance and clinical impact were evaluated in a cohort of 160 patients with native and prosthetic joint infections. BJA detected concordant pathogens in 24 of 27 culture-positive cases and enabled the detection of additional pathogens in 11 patients. The time to result was significantly shorter than with standard culture-based diagnostics (14 vs 35 h), and BJA allowed optimization of therapy in 11 patients. The data show that BJA is a relevant addition to the diagnostic options for joint infections. Limitations result from incomplete detection of relevant pathogens, especially in prosthetic joint infections. The use of BJA in daily practice must therefore be accompanied by diagnostic stewardship measures.