Roche Kebaslater new coronavirus and A/B flu test reagent - Taiwan Registration 64a312a80525783067e8dab334c5ebe2

This product is suitable for use in the cobas Liat system, which uses multiple reverse transcription polymerase to automatically react in real time to qualitatively detect and distinguish whether there is SARS-CoV-2, influenza A and B viral RNA in nasopharyngeal and nasal swabs from individuals with suspected viral respiratory infection. This product is intended for the detection and differentiation of SARS-CoV-2, influenza A and B nucleic acids in clinical specimens, and is not intended for the detection of influenza C virus. In the acute phase of infection, viral RNA from SARS-CoV-2, influenza A, and influenza B can be detected, usually in respiratory specimens. A positive result indicates an active infection, but cannot rule out a bacterial infection or co-infection with other pathogens that is not detectable by this test. Clinical relevance to the patient's medical history and other diagnostic information is necessary to determine the patient's infection status. The detected pathogen may not be the exact cause of the disease. A negative result does not rule out SARS-CoV-2, influenza A and/or B infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results must be combined with clinical observation, patient history, and/or epidemiological information.

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