Description
The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments, or outpatients with suspected respiratory tract infection.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.
Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons, when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
The NxTAG® Respiratory Pathogen Panel is a next-generation, closed-tube molecular assay with comprehensive coverage designed to improve your laboratory workflow and enable the simultaneous detection of 20* respiratory pathogens, accommodating the higher throughput required to respond to changes on demand.
The NxTAG Respiratory Pathogen Panel streamlines respiratory testing, allowing you to:
Gain confidence in your results with excellent clinical performance.
Easily detect 20 important pathogens in a single test.
Decrease your hands-on and turnaround time with a quick, easy protocol.
Run 1-96 samples at a time with scalable throughput.
Select any number of targets within the panel to customize the assay.
Viral Targets:
Influenza A
Influenza A H1
Influenza A H3
Influenza B
Respiratory Syncytial Virus A
Respiratory Syncytial Virus B
Rhinovirus/Enterovirus
Parainfluenza virus 1
Parainfluenza virus 2
Parainfluenza virus 3
Parainfluenza virus 4
Human Metapneumovirus
Adenovirus
Coronavirus HKU1
Coronavirus NL63
Coronavirus 229E
Coronavirus OC43
Human Bocavirus
Bacterial Targets:
Chlamydophila pneumoniae
Mycoplasma pneumoniae
