Challenges in Lower Respiratory

Pneumonia patients need appropriate therapy quickly. Traditional culture methods are insensitive and time consuming, identifying causative agents in days or frequently failing to identify anything at all. Clinicians have to make treatment decisions without knowing the cause of a patient’s symptoms.

Traditional culture testing often takes days to report results.

Culture is Less Sensitive

In a CDC sponsored multi-center study of the etiology of community acquired pneumonia requiring hospitalization, a bacterial agent was only identified in 13% of patient samples.

“The low pathogen-detection yield among adults who were hospitalized for pneumonia highlights the need for more sensitive diagnostic methods and innovative discovery of pathogens.”

– Jain S, et. al.

Empiric Therapy Often Fails

Initial antibiotic treatment fails in 1 of 5 community acquired pneumonia patients, requiring an additional or different antibiotic course, an ER visit, or hospitalization.

The Right Test, The First Time

The Pneumonia Panel will give sensitive, accurate results in about one hour, from a variety of commonly collected lower respiratory tract specimens. These fast, reliable results may allow clinicians to have confidence in making targeted therapy decisions.

Sample to answer in about one hour with the Lower Respiratory Panel (PN)

Detect More Potential Pathogens

PCR detects organism nucleic acids and is not dependent on organism growth. This results in the Pneumonia Panel detecting more bacteria than culture. In the prospective clinical trial for the Pneumonia Panel, a bacterial agent was identified in 50% of patient specimens.

The Pneumonia panel is a diagnostic aid, and should be used in conjunction with other clinical and laboratory findings.

Semi-quantitative Reporting

The Pneumonia Panel has semi-quantitative results for 15 bacteria that may be pathogens or normal flora. These results will be reported in one-log ranges of copies/mL.

Semi-quantitative bin results

How Syndromic Testing May Improve Patient Care

The Pneumonia Panel potential benefits to patient care may include administering the appropriate antibiotic sooner, reducing treatment costs, and improving lab work flow.

Impact on Antibiotic Prescription

The Pneumonia Panel was run on 259 patient samples. Chart reviews revealed that up to 68% of empiric antibiotic courses could have been altered to more targeted therapy.

Antibiotic adjustment could be made on evaluable patients

Average antibiotic interventions per patient enabled by The Pneumonia Panel

Appropriate Antimicrobial Stewardship

Up to 50% of patients could have been de-escalated based on the Pneumonia Panel result, saving more than 18,000 hours of antibiotic use.

Lower Respiratory Panel (PN)

Identifies 33 clinically relevant targets from sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL) samples. For 15 of the bacteria, it provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen.

Syndromic infectious disease testing for Lower Respiratory.

Pneumonia patients are frequently over-treated with antibiotics because it is difficult to quickly identify the pathogen responsible for their symptoms. The Pneumonia Panel delivers fast, accurate pathogen identification in about one hour, which may allow physicians o put patients on appropriate therapy quicker.

BACTERIA

Acinetobacter calcoaceticus baumannii complex
Enterobacter cloacae complex
Escherichia coli
Haemophilus influenzae
Klebsiella aerogenes
Klebsiella oxytoca
Klebsiella pneumoniae group
Moraxella catarrhalis
Proteus spp.
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes

ATYPICAL BACTERIA

Chlamydia pneumoniae
Legionella pneumophila
Mycoplasma pneumoniae

Sample Requirements:

Sputum (including ETA) and BAL (including mini-BAL)

Overall Performance of the Lower Respiratory Panel (PN)

VIRUSES

Adenovirus
Coronavirus
Human Rhinovirus/Enterovirus
Human Metapneumovirus
Influenza A
Influenza B
Parainfluenza Virus
Respiratory Syncytial Virus

ANTIMICROBIAL RESISTANCE GENES

METHICILLIN RESISTANCE
mecA/C and MREJ

CARBAPENEMASES
KPC
NDM
OXA-48-like
VIM
IMP

ESBL
CTX-M

Semi-quantitative Reporting

Concentration of organism is calculated to the nearest whole log and reported in genome copies/mL.