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Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections:
Juliana Trujillo-Gómez1,2,3, Sofia Tsokani4, Catalina Arango-Ferreira1,2
1Department of Paediatrics, Universidad de Antioquia, Calle 67 No. 53-108, Medellín, Antioquia 050001, Colombia.
Background:
The FilmArray Meningitis/Encephalitis(FA/ME) panel brings benefits in clinical practice, but its diagnostic test accuracy (DTA) remains unclear. We aimed to determine the DTA of FA/ME for the aetiological diagnostic in patients with suspected central nervous system(CNS) infection.
Methods:
We performed a systematic review with DTA meta-analysis (PROSPERO: CRD42020139285). We searched Embase, Medline (Ovid), and Web of Science from inception until September 1st, 2021. We assessed the study-level risk of bias with the QUADAS-2 tool and applied the GRADE approach to assess the certainty of the synthesised evidence. We included studies that simultaneously measured the reference test (CSF/blood culture for bacteria, and specific polymerase chain reaction for viruses) and the FA/ME in patients with suspected CNS infection. We performed random-effects bivariate meta-analysis models of combined sensitivity and specificity using CSF/blood cultures(reference test 1) and a final diagnosis adjudication based on clinical/laboratory criteria (reference test 2).
Findings:
We included 19 studies (11,351 participants). For all bacteria with reference test 1 (16 studies/6183 patients) sensitivity was estimated at 89·5% (95%CI 81·1-94·4), and specificity at 97·4% (95%CI 94-98·9). With reference test 2 (15 studies/5,524 patients), sensitivity was estimated at 92·1%(95%CI 86·8-95·3) and specificity at 99.2(95%CI 98·3-99·6) For herpes simplex virus-2(HSV-2), enteroviruses, and Varicella-Zoster virus (VZV), we obtained sensitivities between 75·5 and 93·8%, and specificities above 99% (reference test 1). Certainty of the evidence was low.
Interpretation:
FA/ME may have acceptable-to-high sensitivities and high specificities for identifying bacteria, especially for S.pneumoniae, and viruses, especially for HSV-2, and enteroviruses. Sensitivities for L.monocytogenes, H.influenzae, E.coli, and HSV-1 were suboptimal.
Funding:
None.
Insights
The FilmArray Meningitis/Encephalitis (FA/ME) panel shows high accuracy for diagnosing bacterial and viral CNS infections. While generally effective, sensitivities for certain pathogens like Listeria monocytogenes were suboptimal.
Area of Science:
- Clinical microbiology
- Infectious diseases
- Diagnostic test accuracy
Background:
- The diagnostic test accuracy (DTA) of the FilmArray Meningitis/Encephalitis (FA/ME) panel for central nervous system (CNS) infections requires clarification.
- The FA/ME panel offers potential benefits in clinical practice.
Purpose of the Study:
- To determine the DTA of the FA/ME panel for etiological diagnosis in patients with suspected CNS infections.
- To conduct a systematic review and meta-analysis of existing studies.
Main Methods:
- Systematic review and DTA meta-analysis (PROSPERO: CRD42020139285).
- Searched Embase, Medline, and Web of Science until September 2021.
- Assessed risk of bias using QUADAS-2 and certainty of evidence with GRADE.
- Included studies comparing FA/ME with reference tests (CSF/blood culture, PCR).
- Performed random-effects bivariate meta-analysis for sensitivity and specificity.
Main Results:
- Included 19 studies with 11,351 participants.
- For bacteria (reference test 1), pooled sensitivity was 89.5% (95% CI 81.1-94.4) and specificity was 97.4% (95% CI 94-98.9).
- For reference test 2, pooled sensitivity was 92.1% (95% CI 86.8-95.3) and specificity was 99.2% (95% CI 98.3-99.6).
- For HSV-2, enteroviruses, and VZV, sensitivities ranged from 75.5% to 93.8%, with specificities above 99%.
- The certainty of the evidence was low.
Conclusions:
- The FA/ME panel demonstrates acceptable-to-high sensitivity and high specificity for detecting common bacterial and viral pathogens in CNS infections.
- The panel is particularly accurate for identifying *S. pneumoniae*, HSV-2, and enteroviruses.
- Suboptimal sensitivities were noted for *L. monocytogenes*, *H. influenzae*, *E. coli*, and HSV-1.
