(29 days)
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 H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, 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 of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are 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 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 influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorties, specimens should be collected with appropriate infections 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.
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 H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
The information provided does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The document is an FDA clearance letter for the NxTAG Respiratory Pathogen Panel, indicating that the device has been substantially equivalenced to a predicate device for its stated indications for use.
While the "Indications for Use" section (Page 3) describes the intended use of the device and some general performance characteristics for influenza A, it does not present a table of acceptance criteria or detailed study results. It mentions that performance characteristics for influenza A were established using specimens from specific influenza seasons, but it doesn't quantify those characteristics or define specific thresholds for acceptance.
Therefore, I cannot fulfill your request for the detailed table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on the provided text. This document is a regulatory clearance, not a performance study report.
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.