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.

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