Respiratory Pathogen Profile, PCR
TEST: CTG-105
Methodology
Polymerase chain reaction (PCR)
Test Description
This test is designed to simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. This panel does not detect the 2019 Novel Coronavirus (2019-nCoV). Any positive or negative coronavirus result should not be used to diagnose patients for the 2019-nCoV. Please refer to the CDC website for testing recommendations.
Test Items
- VIRAL PATHOGENS
Adenovirus 1
Adenovirus 2
Human Respiratory syncytical virus A
Human Respiratory syncytical virus B
Human Rhinoviruses 1
Human Coronavirus 229E
Human Rhinoviruses 2
Human Coronavirus HKUI
Human Coronavirus NL63
Human Coronavirus OC43
Human metapneumovirus
Human Parainfluenza virus 1
Human Parainfluenza virus 2
Human Parainfluenza virus 3
Human Parainfluenza virus 4
Influenza A virus Panel (H1 and H3)
Influenza A virus H1-2009
Influenza A virus H3
Influenza B virus
Middle East respiratory syndrome (MERS)
Severe Acute Respiratory Syndrome Coronavirus (SARS)
- BACTERIAL PATHOGENS
Bordetella Panel (B.pertussis+B.bronchiseptica+B.parapertussis)
Bordetella holmesii
Bordetella pertussis
Haemophilus influenzae
Klebsiella pneumoniae
Mycoplasma pneumoniae
Staphylococcus aureus
Streptococcus pyogenes
Streptococcus pneumoniae
Please note: This test does not detect the 2019 Novel Coronavirus (2019-nCoV).
Specimen Requirements
Specimen type: Nasopharyngeal swab
Volume: One swab in viral transport, 0.3 mL minimum
Container: Viral Transport System
Storage Instructions: Per the package insert: Swabs in viral transport media are stable for 30 days at -15°C or below. Swabs in viral transport media are also stable for 4 hours at room temperature and 3 days refrigerated (2º to 8º C).
Causes for Rejection: Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen exceeding storage requirements; specimen types other than nasopharyngeal swab in viral transport media
Limitations
The performance of this test has not been established for patients without signs and symptoms of respiratory infection. Results from this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false positive or false negative values resulting from improperly collected, transported or handled specimens.
Expected Turnaround Time
1 – 2 days. Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider.
CPT: 87486; 87581; 87633; 87798
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