The Biofire® FilmArray® Pneumonia Panel Plus

August 2022
Ampath | ampath.co.za

Overview

Severe pneumonia—including community-acquired (CAP), hospital-acquired (HAP), and ventilator-associated pneumonia (VAP)—remains a leading cause of morbidity and mortality.

Why this matters:

• Rapid and accurate pathogen identification:
  • Supports antimicrobial stewardship
  • Improves patient outcomes
  • Aids infection control
  • Helps tailor antibiotic therapy

About the Panel

The Biofire® FilmArray® Pneumonia Panel Plus is an FDA-cleared, CE-marked, multiplex nucleic acid amplification test for simultaneous detection of multiple pathogens and resistance markers.

Sample types:

• Sputum-like specimens: Sputum and tracheal aspirates
• Bronchoalveolar lavage (BAL)

Turnaround time:

• ~1 hour from sample loading

Specimen mnemonic:

• PNEUMOPCR

Laboratory TAT:

• 6 hours from receipt

Pathogens and Markers Detected

✅ Bacteria (Semi-quantified by DNA copy number)

Enterobacterales:

• Enterobacter cloacae complex
• Escherichia coli
• Klebsiella pneumoniae
• Klebsiella oxytoca
• Klebsiella aerogenes
• Proteus species
• Serratia marcescens

Non-lactose fermenters:

• Acinetobacter calcoaceticus–baumannii complex
• Pseudomonas aeruginosa

Gram-positive bacteria:

• Staphylococcus aureus
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Streptococcus pyogenes

Other Gram-negative bacteria:

• Haemophilus influenzae
• Moraxella catarrhalis

✅ Atypical Bacteria:

• Chlamydophila pneumoniae
• Legionella pneumophila
• Mycoplasma pneumoniae

✅ Respiratory Viruses:

• Adenovirus
• Coronaviruses (seasonal)
• Human metapneumovirus
• Human rhinovirus/enterovirus
• Parainfluenza virus
• Influenza A
• Influenza B
• Respiratory Syncytial Virus (RSV)
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

❗ Note: SARS-CoV-2 is not included in this panel.

✅ Antimicrobial Resistance Markers:

Gram-negative resistance genes:

• CTX-M (ESBL)
• OXA-48-like
• NDM
• VIM
• KPC
• IMP

Gram-positive resistance gene:

• mecA/C (for MRSA)

Performance

Sensitivity and specificity:

• Sputum-like specimens:
  • Sensitivity: 96.3%
  • Specificity: 97.2%
• Bronchoalveolar lavage specimens:
  • Sensitivity: 96.2%
  • Specificity: 98.3%

Semi-quantification bins for bacteria:
10⁴, 10⁵, 10⁶, and ≥10⁷ copies/mL

Important Notes & Considerations

• Interpret results carefully, especially in patients with:
  • Prior hospital admissions
  • Recent or ongoing antibiotic use
  • Colonisation rather than active infection
• The panel detects DNA/RNA, not viability—positive results may reflect non-viable organisms.
• Only the resistance genes listed are detected.
  • Culture remains essential for full susceptibility testing.
• Pathogens NOT detected by this panel (consider additional testing for):
  • Mycobacterial species
  • Cytomegalovirus (CMV)
  • Pneumocystis jirovecii
  • Aspergillus species
  • Stenotrophomonas maltophilia
  • Burkholderia cepacia complex
  • Less common Enterobacterales linked to HAP/VAP
• Semi-quantitative data may overestimate pathogen load and may not match culture results.

🔍 Discuss complex or multi-pathogen results with your microbiologist.

📌 For pricing or medical aid reimbursement queries, contact your Ampath representative.