A Respiratory Viral Panel Multiplex Nucleic Acid Assay is an in vitro diagnostic device designed to detect and identify multiple respiratory viruses from a single patient sample, such as nasal or throat swabs, using nucleic acid amplification techniques. This assay typically targets a range of viral pathogens, including influenza viruses, respiratory syncytial virus (RSV), coronaviruses, and others, by detecting their nucleic acids (DNA or RNA).

Intended Use of Respiratory Viral Panel Multiplex Nucleic Acid Assay

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.

Intended Use

A qualitative in vitro diagnostic assay intended to detect Bordetella Pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Device Description

Device consists of reagents, controls, and supporting instrumentation (if applicable) that perform nucleic acid amplification and detection of Bordetella pertussis target sequences extracted from clinical specimens.

Components

• Specimen Preparation Reagents
• Amplification Reagents
• Detection System
• Controls

Results are reported as “Detected” or “Not Detected” for the Bordetella pertussis target. Devices intended for use with instruments may include software that interprets raw signals and displays results. Results must be interpreted by trained laboratory personnel following the instructions for use.

Respiratory Virus Panel Nucleic Acid Assay System

Intended Use

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: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.

Device Description

It is a semi-automated RT-PCR assay for qualitatively detecting viral RNA from unprocessed nasal swabs. The system integrates nucleic acid extraction, reverse transcription, amplification, and visual detection into a self-contained process. It consists of a reusable Dock and a disposable test cassette with reagents. After sample insertion, the system controls fluid flow and detects amplicons, producing a visible colored line at the capture zone.

System comprises a multiplex respiratory viral panel assay and associated instrumentation that automates or supports nucleic acid extraction, amplification, and detection from clinical respiratory specimens.

Performance Testing (Analytical nonclinical) for Respiratory Viral Panel Multiplex Nucleic Acid Assay

• Precision (Repeatability and Reproducibility)
• Limit of Detection
• Analytical Reactivity (Inclusivity)
• Analytical Specificity (Exclusivity)
• Cross Reactivity
• Carryover/Cross-contamination
• Specimen Stability
• Shelf-life Stability
• Fresh versus frozen study
• Assay cut-off.
• Inclusivity
• Safety Testing
• Microbial Interference (Cross Reactivity)/Co-Infection
• Traceability, Stability, Expected values (controls, calibrators, or methods)
• Software Validation and Verification

Clinical Testing :

Required for 510k submission.