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Comparison of a commercial real-time PCR panel to routine laboratory methods for the diagnosis of
1Department of Clinical Microbiology, ACT Pathology, Canberra Hospital, Garran, ACT, Australia.
Abstract:
Meningitis-encephalitis can range from a mild, self limiting illness to a life threatening disease. Rapid microbial diagnosis allows for early targeted management. This study aimed to compare the BioFire FilmArray Meningitis/Encephalitis multiplex PCR panel (ME panel) to traditional testing algorithms for accuracy and turnaround time in the diagnosis of meningitis-encephalitis. From April to November 2018, cerebrospinal fluid (CSF) samples meeting existing laboratory testing criteria for suspected community acquired meningitis-encephalitis were tested on the ME panel and by routine laboratory methods. The methods were compared for accuracy of diagnosis and turnaround time. Where an organism was not identified, the study investigators came to a consensus on whether an infective aetiology was likely based on CSF parameters, clinical features, management and final discharge diagnosis. A total of 147 CSF samples met criteria for testing. Results were concordant in 143 (97%) of cases, including 27 samples where the same organism was identified by both methods. Of the four discordant samples, three organisms identified by the ME panel alone were considered clinically insignificant. One sample, which was culture and antigen positive for Cryptococcus neoformans, was not detected on the ME panel. The ME panel and routine methods identified an organism in 55% and 58% of clinically compatible cases of infection, respectively. The median turnaround time for the ME panel was 2.9 hours, compared to 21.1 hours for routine testing. The ME panel showed high concordance with traditional testing, simplified laboratory workflow, and significantly reduced turnaround time. The failure of the ME panel to detect Cryptococcus spp. is concerning. When cryptococcal meningitis is suspected, we would recommend using culture and cryptococcal antigen testing as the investigations of choice. Despite the availability of molecular assays targeting the common causes of CNS infection, the diagnostic yield remains suboptimal.
Insights
The BioFire FilmArray Meningitis/Encephalitis (ME) panel offers rapid diagnosis for meningitis-encephalitis, significantly reducing turnaround time compared to traditional methods. However, it failed to detect Cryptococcus neoformans, necessitating continued use of culture and antigen testing for suspected cases.
Area of Science:
- Clinical microbiology
- Infectious diseases
- Molecular diagnostics
Background:
- Meningitis-encephalitis presents a spectrum of severity, from mild to life-threatening.
- Rapid microbial diagnosis is crucial for timely and effective patient management.
- Traditional diagnostic algorithms for meningitis-encephalitis can be time-consuming.
Purpose of the Study:
- To compare the accuracy and turnaround time of the BioFire FilmArray Meningitis/Encephalitis (ME) multiplex PCR panel against traditional testing methods.
- To evaluate the diagnostic yield of the ME panel for community-acquired meningitis-encephalitis.
Main Methods:
- A comparative study using 147 cerebrospinal fluid (CSF) samples from suspected meningitis-encephalitis cases.
- Samples were tested using the BioFire FilmArray ME panel and routine laboratory methods.
- Accuracy and turnaround time were compared, with consensus reached for unidentified organisms.
Main Results:
- High concordance (97%) between the ME panel and traditional methods.
- The ME panel demonstrated a significantly reduced median turnaround time (2.9 hours vs. 21.1 hours).
- The ME panel failed to detect one case of Cryptococcus neoformans, which was positive by culture and antigen testing.
Conclusions:
- The BioFire FilmArray ME panel offers a rapid and accurate diagnostic solution, simplifying workflow.
- Culture and antigen testing remain essential for suspected cryptococcal meningitis.
- Despite molecular advancements, the overall diagnostic yield for CNS infections requires further improvement.
