Flu A/B + COVID-19 Antigen Combo Test Cassette-Professional use

Description

【Intended use】

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.

【Certificate】

CE,ISO9001,ISO13485