The Sanity-2 Respiratory Pathogen Panel (RPP4) is a multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 viral RNA in nasopharyngeal swab (NPS), oropharyngeal swab (OPS), saliva, sputum and bronchoalveolar lavage fluid (BALF) specimens obtained from individuals suspected of respiratory tract infections and SARS-CoV-2 infection. The kit is intended as an aid in the diagnosis of influenza, respiratory syncytial virus and SARS-CoV-2 infections in conjunction with clinical and epidemiological risk factors.

The kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The kit is intended for use with the Sanity 2.0s System, which is a fully automated system that simplifies the testing process. It combines nucleic acid extraction, real-time polymerase chain reaction (rt-PCR), and result interpretation into a single, streamlined operation. This integrated approach reduces the complexity of the procedure and minimizes the potential for errors, ensuring that the detection of respiratory tract infection is both accurate and efficient.

Principle

The kit used a multiplex TaqMan probe-based one-step reverse transcription polymerase chain reaction (RT-PCR), which enables simultaneous qualitative detection of influenza A (InfA), influenza B (InfB) respiratory syncytial virus (RSV) and SARS-CoV-2, as well as exogenous internal control (SUC2) in RT-PCR tube A and endogenous internal control (human RNaseP gene) in tube B. For ease of storage and transportation, the amplification reagent is designed in pre-distributed dry form.

CE-IVD Marked