Respiratory Panel

Test code: 97581

Methodology: EM-PCR(TM)
Target Enriched Multiplex PCR(TM) diagnostic panel testing consists of three major steps: extraction, amplification, and
detection. The key to making TEM-PCR(TM) occur successfully lies in the primer mixes and how they allow the
enrichment of multiple targets. The use of target-specific outer primers for the nested PCR reaction at low
concentrations at the initial enrichment step allows high specificity of multiplexing amplification. After initial target
enrichment is complete, biotinylated primers within the reaction carry out the exponential amplification and produce
tagged PCR products for subsequent detection. The detection phase of the process is accomplished by measuring the
fluorescence of special tags that are bound to the target sequences, which have been attached during amplification.
This test has not been cleared or approved by the U.S. Food and Drug Administration.

Clinical significance: The detection and identification of specific pathogen nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in proper diagnosis.
The Respiratory Pathogen Panel is used for the detection of the following respiratory viruses and bacterial pathogens:
Adenovirus
Enterovirus/Rhinovirus
Human bocavirus
Human coronavirus
Human metapneumovirus
Influenza A - human
Influenza B
Parainfluenza
Respiratory Syncytial
Acinetobacter baumannii
Bordetella pertussis
Chlamydophila pneumoniae
Haemophilus influenzae
Haemophilus influeza B
Klebsiella pneumoniae
Legionella pneumophila
Moraxella catarrhalis
Staphylococcus aureus
MRSA
Panton-Valentine
Mycoplasma pneumoniae
Neisseria meningitidis
Pseudomonas aeruginosa
Streptococcus pneumoniae
Streptococcus pyogenes A

The results of this assay should be used in conjunction with other clinical and laboratory findings.