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Genesis KaiBiLi COVID-19 antigen test get the permits in Belgium

SARS-CoV-2 Overview
The novel coronaviruses belong to the β genus. SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhoea are found in a few cases. The antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

The KaiBiLi COVID-19 antigen test kit reveals if a person is currently infected with the SARS-COV-2 pathogen. Once the infection has gone, the antigens will no longer be present.

The KaiBiLi COVID-19 Antigen Rapid Test Kit uses a specially designed swab to determine whether or not a person is currently infected with COVID-19. The swab is inserted into the nostril and mouth to take samples from the nasal cavity and tonsils.

Collected samples are then placed into an extraction tube that contains approximately 0.5ml of a specially designed virus preservation solution. Then place the specimen on a testing cassette, and an accurate result is revealed within 15 minutes.

The accuracy ratings for the KaiBiLi Antigen Test Kit can be used by medical professionals to confirm current infection. Data collected from test results can be used to investigate the spread of the virus, further inform safe working practices and help to curb the virus.

The current Covid-19 testing process can be highly invasive and time-consuming.

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Genesis KaiBiLi COVID-19 antigen test get the permits in Belgium, and accompanied by the requests of famhp:

• A declaration of conformity with the IVD Directive (98/79/EC);

• Notified body certificate (if applicable);

• A list of (harmonized) standards that have been applied;

• Relevant standard certificates (e.g. EN ISO 13485:2016) (if applicable); • Instructions for use;

• Labels;

• Information on the instrumentation that needs to be used with the test (e.g. open or closed platform test);

• Any relevant validation data that pertain to the test.


Post time: Aug-11-2021