NEWS
HOME >> NEWS

AMPER obtained the EC DOC for the COVID-19 Antigen rapid testing kit (Colloidal Gold)

Date:2020-07-01
On July 1, 2020, AMPER released an EC Declaration of Conformity for the COVID-19 Antigen rapid testing kit (Colloidal Gold), promoting the sale of the product in the European Union market and other countries that accept the CE mark.
Intended use of the product:
The AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) is a colloidal gold-based lateral flow immunoassay, intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) specimens from individuals who are suspected of COVID-19 by their healthcare provider. 
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection 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, and confirmed with a molecular assay, if necessary, for patient management.
Copyright 2021, AMPER, INC, All rights reserved. Su ICP bei 20001328 No.