![]() Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results do not preclude flu A, flu B, RSV, or SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The Alinity m Resp-4-Plex assay is not intended to detect influenza C virus infections. The agent detected may not be the definite cause of disease. Positive results do not rule out bacterial infection or co-infection with other viruses. Positive results are indicative of the presence of flu A, flu B, RSV, or SARS-CoV-2 RNA clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. flu A, flu B, RSV, and SARS-CoV-2 RNA are generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Results are for the identification and differentiation of RNA from flu A, flu B, RSV, and SARS-CoV-2. The Alinity m Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection.
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