Evaluation of the Performance of a Biofire FilmArray Meningitis/Encephalitis Multiplex Real-Time PCR Assay for Bacterial Meningitis Diagnosis at a Tertiary Care Hospital

Background: Meningitis and encephalitis are critical, life-threatening conditions associated with high rates of morbidity and mortality. Early diagnosis and immediate treatment are essential for decreasing mortality and improving patient outcomes. The Biofire Film Array Meningitis/Encephalitis (ME) panel is a multiplex polymerase chain reaction (PCR)-nucleic acid-based diagnostic assay designed for the rapid diagnosis of bacterial, viral, and fungal pathogens in cerebrospinal fluid. In this study, we evaluated the performance of Biofire Film Array Meningitis/Encephalitis multiplexing real a biofire film array meningitis/encephalitis multiplex real-time PCR assay for the detection of bacterial pathogens in suspected cases of bacterial meningitis. Methods: Cerebrospinal fluid (CSF) and blood samples were collected from 132 intensive care unit (ICU) patients with suspected bacterial meningitis. The clinical samples were analyzed using traditional culture and sensitivity methods, the Biofire Film Array ME Panel multiplex PCR, procalcitonin (PCT), and C-reactive protein (CRP) assays. The sensitivity, specificity and diagnostic accuracy of the Biofire Film Array ME Panel real-time PCR assay were evaluated. Results: A total of 132 patients, with a mean age of 38.9 ± 23.7 years, were included in the study. The mean levels of C-reactive protein (CRP) and procalcitonin (PCT) were 52.41 ± 82.23 mg/L and 3.7 ± 7.6 ng/mL, respectively. Among these patients, 9 (6.8%) had positive cultures for Listeria monocytogenes (n = 6), Streptococcus pneumonia (n = 2), and Neisseria meningitides (n = 1), while 123 patients were culture negative. All 9 culture-positive cases were detected by the Biofire ME Panel, and 114 out of 123 (92.7%) culture-negative cases were confirmed as true negatives by the panel. The Biofire ME Panel demonstrated excellent diagnostic performance, with a sensitivity of 100% (95% CI: 63.06–100%), a specificity of 91.94% (95% CI: 85.67–96.06%), and an overall diagnostic accuracy of 92.42% (95% CI: 86.51–96.31%). Conclusion: The Biofire ME Panel is strongly correlatedwith CSF culture and has excellent diagnostic accuracy for bacterial meningitis. Moreover, the NRS-2002 may be used as a routine test for suspected cases of bacterial meningitis for early diagnosis and optimal treatment to reduce mortality and morbidity.