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AMPER obtained the CE certificate issued by the Netherlands CIBG for the COVID-19 Antigen rapid testing kit (Colloidal Gold)

Date:2020-09-03
On September 3, 2020, Netherlands CIBG issues a CE certificate for the AMPERTM COVID-19 Antigen rapid testing kit (Colloidal Gold), permitting the product selling on the EU market and other countries accepting the CE mark.
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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity and high complexity. 
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.
The AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel.

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