Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis

Juliana Trujillo-Gómez; Sofia Tsokani; Catalina Arango-Ferreira; Santiago Atehortúa-Muñoz; Maria José Jimenez-Villegas; Carolina Serrano-Tabares; Areti-Angeliki Veroniki; Ivan D Florez

doi:10.1016/j.eclinm.2022.101275

Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis

EClinicalMedicine. 2022 Feb 14:44:101275. doi: 10.1016/j.eclinm.2022.101275. eCollection 2022 Feb.

Authors

Juliana Trujillo-Gómez^{1

2

3}, Sofia Tsokani⁴, Catalina Arango-Ferreira^{1

2}, Santiago Atehortúa-Muñoz^{5

5}, Maria José Jimenez-Villegas^{1

2}, Carolina Serrano-Tabares^{1

6}, Areti-Angeliki Veroniki⁷, Ivan D Florez^{1

8

9}

Affiliations

¹ Department of Paediatrics, Universidad de Antioquia, Calle 67 No. 53-108, Medellín, Antioquia 050001, Colombia.
² Hospital San Vicente Fundacion, Calle 64 # 51D - 154, Medellín 050010, Colombia.
³ Hospital General de Medellín, Carrera 48 # 32-102, Medellín 0500515, Colombia.
⁴ Department of Primary Education, School of Education, University of Ioannina, PO Box: 1186, Ioannina 45110, Greece.
⁵ Hospital Pablo Tobón Uribe, Cl. 78b #69-240, Medellin 11001, Colombia.
⁶ Clínica Universitaria Bolivariana, Carrera 72A # 78b -50, Medellín 050015, Colombia.
⁷ St. Michael's Hospital, Li Ka Shing Knowledge Institute, 8 Shuter St, Toronto, ON M5B 1A6, Canada.
⁸ School of Rehabilitation Science, McMaster University, 1400 Main St. W. Hamilton, Hamilton, ON L8S 1C7, Canada.
⁹ Paediatric Intensive Care Unit, Clínica Las Americas AUNA, Dg. 75B ##2A-80/140, Medellin, Colombia.

Abstract

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.

Keywords: CNS infection; Diagnostic accuracy; Encephalitis; Film array; Meningitis; Meta-analysis; Multiplex PCR.