(30 days)
The xTAG™ Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings. It is recommended that specimens found to be negative after examination using RVP be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection.
Due to seasonal prevalence, performance characteristics for Influenza A/H1 were established primarily with retrospective specimens.
The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. The R VP primers for detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g. cell culture).
Performance characteristics for Influenza A Virus were established 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 infections 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 a state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
The xTAG™ RVP is a PCR-based system for detecting the presence / absence of viral DNA / RNA in clinical specimens. The oligonucleotide primer / probe components of the xTAGTM RVP have been designed to specifically target unique regions in the RNA / DNA of each molecular species listed in the following Table:
Respiratory viral targets: Influenza A (Matrix Gene), Influenza A H1 (Hemagglutinin Gene), Influenza A H3 (Hemagglutinin Gene), Influenza B, Respiratory Syncytial Virus Type A, Respiratory Syncytial Virus Type B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Amplified products are sorted and analyzed on the Luminex® xMAP instrument, which generates signals based on the acquisition of spectrofluorometric data. The raw signals are median fluorescence intensities (MFI) which are acquired in a Luminex® Output.csv file that is subsequently analyzed by the software component of the xTAG™ RVP to establish the presence or absence of all viral types / subtypes for which a Luminex® microsphere population has been dedicated. The xTAG™ RVP primary components are:
- PCR Primer Mix.
- Target Specific (TS) Primer Mix.
- Coupled Bead Mix.
- Data Analysis Software.
Other reagents required to perform testing with the device include ancillary reagents for which specific lots have been qualified by Luminex Molecular Diagnostics (LMD) and incorporated in the LMD quality system, for use with the xTAG™ RVP.
The xTAG™ RVP has been designed to generate unique PCR products for each of the targets described above with the exception of RSV targets. RSV subtypes detected by the xTAG™ RVP are discriminated at the TSPE step. The discrimination of Parainfluenza subtypes occurs at both the PCR and TSPE step. The detection of Influenza A subtypes is achieved by amplifying conserved regions of the matrix gene common to all subtypes and target specific regions of the hemagglutinin gene (2 sets of PCR primers for the 2 listed subtypes).
Here's a breakdown of the acceptance criteria and the study details for the xTAG™ RVP (Respiratory Viral Panel) Multiplex Nucleic Acid Detection Assay, extracted and organized from the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are implicitly tied to the performance metrics shown in the clinical and analytical studies, primarily Sensitivity and Specificity against comparator methods. The "Call zones" (MFI ≥ 300 for positive,
§ 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.