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

Human Respiratory syncytical virus A/B

Human Rhinoviruses

Human Coronavirus 229E

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 B

Middle East respiratory syndrome (MERS)

COVID-19   

BACTERIAL PATHOGENS

Bordetella Panel (B.pertussis+B.bronchiseptica+B.parapertussis)

Haemophilus influenzae

Klebsiella pneumoniae

Mycoplasma pneumoniae

Staphylococcus aureus/pneumoniae

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