UltraGene Assay Combo 4 Screening (CE-IVD)

Intended use
The UltraGene Assay Combo 4 Screening is a multiplex, in vitro real-time RT-PCR diagnostic test intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, Influenza B virus, and/or Respiratory Syncytial Virus (RSV) RNA from upper respiratory specimen collected in transport medium by a healthcare provider (HCP) from individuals suspected by a HCP of respiratory viral infection consistent with COVID-19. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar.
Results are for the identification and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B and/or RSV in humans. The UltraGene Assay Combo 4 Screening is not intended to detect Influenza C virus. RNA from SARS-CoV-2, Influenza A, Influenza B and/or RSV is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, Influenza A, Influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. 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. Laboratories are required to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2, Influenza A, Influenza B, and/or RSV infection and should not be used as the sole basis for diagnoses, treatment, or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.
The UltraGene Assay Combo 4 Screening is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Methodology

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

More information on the UltraGene Assays – Click here