Pneumonia Panel Quick Guide

For use with FilmArray , FilmArray® 2.0, and FilmArray® Torch systems
®

RFIT-ASY-0144
To avoid contamination, always wear clean gloves and work RFIT-ASY-0145

behind a protective shield.

Step 1: Prepare Pouch

1
a. Insert pouch into Pouch Loading Station.
b. Place Sample Injection Vial into red well.
c. Place Hydration Injection Vial into blue well.

Step 2: Hydrate Pouch

3x
a. Unscrew Hydration Injection Vial from cap.
2
b. Remove Hydration Injection Vial, leaving cap in Pouch Loading
Station.
c. Insert Hydration Injection Vial into pouch hydration port.
d. Push down to puncture seal then wait as Hydration Solution is
drawn into pouch.
NOTE: Verify that the pouch has been hydrated.

Step 3: Prepare Sample Mix

3a 3b
a. Hold Sample Buffer Ampoule tip facing up and firmly pinch at
textured plastic tab on side of ampoule until seal snaps.
NOTE: Do not touch ampoule tip.
b. Dispense Sample Buffer into Sample Injection Vial using a slow,
forceful squeeze followed by a second squeeze.
NOTE: Avoid generating excessive foaming. 3c 3d
c. Use the Sample Swab to stir the entire specimen for ~10
seconds. 3x
d. Place the swab end into the Sample Injection Vial then break off
the swab handle. Discard the swab handle into an appropriate
3e
3x
waste container and close Sample Injection Vial lid tightly. 3x
e. Invert the Sample Injection Vial 3 times then return to red well
of Pouch Loading Station.

WARNING: The Sample Buffer is harmful if swallowed and can 3x

cause serious eye damage and/or skin irritation.

Step 4: Load Sample Mix

a. Unscrew Sample Injection Vial from cap. 4
b. Wait 5 seconds, then remove Sample Injection Vial, leaving cap
in Pouch Loading Station.
NOTE: Waiting for 5 seconds decreases the risk of contamination.
c. Insert Sample Injection Vial into pouch sample port.
d. Push down to puncture seal then wait as Sample Mix is drawn 3x
into pouch.

Step 5: Run Pouch

3x
a. Follow instructions on computer for starting a test. 3x

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 Pneumonia Panel Quick Guide
For use with FilmArray®, FilmArray® 2.0, and FilmArray® Torch systems

The two-page FilmArray Pneumonia Panel report is displayed FilmArray

FilmArray
upon the completion of a run and contains three sections – Pneumonia
Pneumonia Panel
Panel -- IVD
IVD
Run Information, Detection Summary, and Result Summary. www.BioFireDx.com
www.BioFireDx.com

Run
Run Information
Run Information — Displays information about the sample, Information
Sample ID
ID Example Report
Report Run Date
Date 12 Jul
Jul 2016
2016 12:00
12:00 AM
AM
Sample Example Run 12
protocol (sample type), pouch, instrument, run status, and Protocol
Protocol Sputum
Sputum v3.3
v3.3 Serial
Serial No.
No. 01234567
01234567
Pouch Type Pneumo v2.0 Lot
Lot No. 012345
operator. Shown on both pages of the report. 1 Pouch Type
Controls
Pneumo v2.0
Passed
No.
Operator
012345
Anonymous
Controls Passed Operator Anonymous
Run Status
Status Completed Instrument FA0000
1. Controls: 2 Run Completed Instrument FA0000
Detection
Detection Summary
• If 'Passed', results are valid Bacteria
Summary
Bacteria
• If ' ! Failed’ or ' ! Invalid', RETEST SAMPLE Bin
Bin
Bin (copies/mL)
(copies/mL)
Bin 10^4 10^5 10^6
10^6 ≥10^7
≥10^7
(copies/mL) 10^4 10^5
2. Run Status (copies/mL)
Detected:
Detected: 3a ≥10^7
≥10^7 Klebsiella pneumoniae group
Klebsiella pneumoniae group 3b
• If ‘Completed’, run is complete 10^6
10^6 Streptococcus
Streptococcus pyogenes
pyogenes
10^4
10^4 Haemophilus influenzae
Haemophilus influenzae
• If 'Incomplete', 'Aborted', or any other error message,
Note: Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent
RETEST SAMPLE Note: DetectionSemi-quantitative
of pneumonia. of bacterial nucleic
Binacid may be indicative
(copies/mL) of colonizing
results generated or FilmArray
by the normal respiratory
PneumoniafloraPanel
and may notequivalent
are not indicate the
to causative
CFU/mL and
of pneumonia. Semi-quantitative Bin (copies/mL) results generated by the FilmArray Pneumonia Panel are not equivalent to CFU/mL and do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
agent
do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
Detection Summary — Displays a short summary of test FilmArray
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.

results under each category. Shown on first page of the Detected:

Pneumonia Panel - IVD
Antimicrobial
Antimicrobial Resistance
Resistance Genes
CTX-M
Genes
Detected: CTX-M
www.BioFireDx.com
report. Note: Antimicrobial resistance can occur via multiple mechanisms. A Not Detected result for a genetic marker of antimicrobial resistance does not
Note: Antimicrobial resistance can occur via multiple mechanisms. A Not Detected result for a genetic marker of antimicrobial resistance does not
indicate susceptibility to associated antimicrobial drugs or drug classes. A Detected result for a genetic marker of antimicrobial resistance cannot be
indicate susceptibility to associated antimicrobial drugs or drug classes. A Detected result for a genetic marker of antimicrobial resistance cannot be
definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing and FilmArray
3. If ‘ ’, organism or antimicrobial resistance gene was Run Information
definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing and FilmArray
Pneumonia Panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.
Pneumonia Panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.
Sample
Atypical ID Example Report
Bacteria Run Date 12 Jul 2016 12:00 AM
detected AtypicalProtocol
Bacteria Sputum v3.3 Serial No. 01234567
Detected:
Detected:
Pouch
Viruses Type
None
None
Pneumo v2.0 4 Lot No. 012345
a. Bin (copies/mL) – Estimate of genomic copies shown VirusesControls Passed
Detected: Influenza A
A Operator Anonymous
Detected: Influenza
Run Status Completed Instrument FA0000
for detected ‘Bacteria’ only:
Result Summary
• 10^4 copies/mL Bacteria
• 10^5 copies/mL Bin (copies/mL)
Bin
10^4 10^5 10^6 ≥10^7
• 10^6 copies/mL (copies/mL)
Not Detected Acinetobacter calcoaceticus-baumannii complex
• ≥10^7copies/mL Not Detected Enterobacter cloacae complex
Not Detected Escherichia coli
b. Bin (copies/mL) graph – Bin result is indicated by Detected 10^4 Haemophilus influenzae
Not Detected Klebsiella aerogenes
shading up to the corresponding value. Not Detected Klebsiella oxytoca
4. If ‘None’, no organisms or antimicrobial resistance genes 6 Detected ≥10^7 Klebsiella pneumoniae group
Not Detected Moraxella catarrhalis
were detected Not Detected Proteus spp.
Not Detected Pseudomonas aeruginosa
5. If ‘ ! Invalid’, RETEST SAMPLE Not Detected Serratia marcescens
7 Not Detected
Not Detected
Staphylococcus aureus
Streptococcus agalactiae
Result Summary — Displays a full list of test results for Not Detected Streptococcus pneumoniae
each organism and antimicrobial resistance gene. Shown on Detected 10^6 Streptococcus pyogenes

second page of report. Note: Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent
of pneumonia. Semi-quantitative Bin (copies/mL) results generated by the FilmArray Pneumonia Panel are not equivalent to CFU/mL and do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
6. If ' Detected', organism or antimicrobial resistance relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.
gene was detected Antimicrobial Resistance Genes
Detected CTX-M
• Bin (copies/mL) – See explanation under Detection Not Detected IMP
Not Detected KPC
Summary above. 8 N/A mecA/C and MREJ
Not Detected NDM
7. If ‘Not Detected’, organism or antimicrobial resistance Not Detected OXA-48-like
gene was not detected Not Detected VIM
Note: Antimicrobial resistance can occur via multiple mechanisms. A Not Detected result for a genetic marker of antimicrobial resistance does not
8. If ‘Ø N/A’, antimicrobial resistance gene was not reported indicate susceptibility to associated antimicrobial drugs or drug classes. A Detected result for a genetic marker of antimicrobial resistance cannot be
definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing and FilmArray
Pneumonia Panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.
because an organism associated with the gene was not Atypical Bacteria
Not Detected Chlamydia pneumoniae
detected Not Detected Legionella pneumophila
9. If ‘ ! Invalid’, RETEST SAMPLE Not Detected Mycoplasma pneumoniae
Viruses
Not Detected Adenovirus
Not Detected Coronavirus
NOTE: If repeated ‘Error’ messages are obtained, Not Detected Human Metapneumovirus
Not Detected Human Rhinovirus/Enterovirus
contact BioFire Diagnostics, the local bioMérieux sales Detected Influenza A
representative, or an authorized distributor. Not Detected
Not Detected
Influenza B
Parainfluenza Virus
Not Detected Respiratory Syncytial Virus
RFIT-PRT-0368-01
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