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COVID-19 pandemic is the greatest communicable disease outbreak to have hit Malaysia since the 1918 Spanish Flu. In order to detect the COVID-19 to control the disease, MDR launch the suggestion list. Genesis KaiBiLi COVID-19 antigen test get the permits in Malaysia

The list of Covid-19 Antibody, Antigen and Nucleic Acid Amplification Test (NAAT) that is recommended for use based on the decision on the consensus of the Covid-19 Test Kit Expert committee is as follows.

All test submissions are scored according to: -

• the manufacturer reported clinical and analytical performance evidence.

• the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert panels.

• Supporting Documents for COVID-19 IVD Test Kits Special Access Notification.

Below is the list of all tests that have been selected to date and the status is Recommended for Use (please note: list is updated on a routine basis).

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The KaiBiLi TM COVID-19 Antigen Rapid Test Device is an immunochromatographic assay for the qualitative detection of 2019 Novel Coronavirus antigens. This assay is intended for rapid screening in laboratory. The COVID-19 Antigen Rapid Test Device has two letters on the surface of the test device indicating test line (T) and control line (C). Test line and control line in the result window are not visible before applying any samples. The control line is a reference line which indicates the test is performing properly. The control line must appear every time when the test is performed. If SARS-CoV-2 is present in the sample, the test line would appear. The highly selective antibodies to SARS-CoV-2 are used as capture and detector in the assay. These antibodies can detect SARS-CoV-2 antigens directly, with a high accuracy. Target population and user for the test is suspected patients and general population. Target antigen is 2019 Novel Coronavirus nucleocapsid protein antigens. Specimen types of nasal and nasopharyngeal specimen can be used for the test.


Post time: Aug-25-2021