Descrição
【Uso pretendido】
The test is intended for use in the simultaneous rapid in vitro detection and differentiation of
influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen , but does
not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect
influenza C antigens. Performance characteristics may vary against other emerging influenza
viruses.
Influenza A, influenza B, and COVID-19 viral antigens are generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine 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.
Negative COVID-19 results, from patients with symptom onset beyond five days, should be
treated as presumptive and confirmation with a molecular assay, if necessary, for patient
management, may be performed. Negative results do not rule out COVID-19 and should not be
used as the sole basis for treatment or patient management decisions, including infection
control decisions. Negative results should be considered in the context of a patient’s recent
exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
Negative results do not preclude influenza virus infections and should not be used as the sole
basis for treatment or other patient management decisions.
【Certificado】
CE,ISO9001,ISO13485
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