Meningitis/Encephalitis (M/E) Panel Limitations

• Cryptococcus:  Patients with a suspicion of cryptococcal meningitis and a negative Cryptococcus panel result should be tested for cryptococcal antigen (LAB6011).
• HSV: False negative results have been reported for HSV. Patients with a suspicion of HSV M/E and a negative HSV panel result should be tested by HSV 1/2 PCR (LAB917).
• Neisseria meningitidis: Non-encapsulated strains of Neisseria meningitidis are not detected. 
• E. coli K1: Non-K1 E. coli serotypes may be present in a specimen and will not be detected.
• Herpesviruses: CMV, HHV-6, HSV, and VZV exist in latent forms that may be reactivated during infection by other pathogens, including agents not detected by the BIOFIRE ME Panel that may cause meningitis/encephalitis (e.g., Mycobacterium tuberculosis or HIV). HHV-6 can be chromosomally integrated into somatic cells (ciHHV-6) and into the germline (iciHHV-6), allowing for persistent and sporadic reactivation in carriers.
• Antimicrobial treatment: The performance of the panel has not been specifically evaluated for CSF specimens collected from individuals on antimicrobial treatment. Antimicrobial therapy may reduce organism levels in the specimen, leading to a false-negative result.  
• Immunocompromised patients: The performance of this test has not been specifically evaluated for CSF specimens collected from immunocompromised individuals.
• Test of cure: The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
• Shunts: This test is not intended for use with CSF collected from indwelling medical devices.
• False positive results: False positives can be caused by contamination of specimens or the test with organisms shed by otherwise healthy individuals. S. pneumoniae and H. influenzae can be shed from the respiratory tract of healthy individuals. HSV-1 may also be shed from individuals with active or recurrent cold sores.
• Cross-reactivity: Organisms with a known risk for cross-reactivity are listed below.  

BIOFIRE ME PANEL CROSS-REACTIVITY