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Aehealth BfArM Approval

Aehealth 2019- nCov antigen test has received special approval from the German Federal Institute for Drugs and Medical Devices (BfArM) according to §11 paragraph 1 of the German Medical Devices Act (MPG) of antigen tests for the detection of coronavirus.

Adhering to the philosophy of “Better healthcare for humankind”, Aehealth has been continuously working to satisfy the global demand for rapid tests in the prevention and control of pandemics worldwide. Aehealth 2019- nCoV Antigen Test (colloidal gold ) which is performed with a swab sample from the nasal cavity delivers results in 15 minutes, significantly shortening the detection time, comparing to the PCR method. The test can gives users high flexibility with very good quality results.

German Health Minister Jens Spahn said the approval of COVID-19 antigen tests allows larger population to get tested. The early identification of asymptomatic individuals can efficiently break the chain of infection, stopping the spread of infection.

The Rapid COVID- 19 Antigen Test is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from COVID- 19 in human nasal swabs, throat swabs or saliva from individuals who are suspected of COVID- 19 by their healthcare provider.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease.

Results are for the identification of COVID- 19 nucleocapsid antigen. The antigen is generally detectable in upper respiratory samples or lower respiratory samples during the acute phase of infection.

The positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

The positive results do not rule out bacterial infection or co- infection with other viruses. The antigen detected may not be the definite cause of disease.

The negative results do not rule out COVID- 19 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

The 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 moecular assay, if necessary for patient management.

As the company that holds the certificates of the 2019- nCoV antigen test, Aehealth is committed to making contributions to the global battle against the pandemics. Aehealth’ s multiple COVID- 19 tests have achieved CE mark approval and been validated by the importer's country according to the local standards and regulations. Aehealth is now providing a “PCR+ Antigen+Neutralization Antibody” integrated solution that meets various application scenarios of on- spot diagnosis of COVID- 19 infection.


Post time: Dec-12-2021