General information:
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is the name given to the 2019 novel coronavirus. COVID-19 is the name given to the disease associated with the virus. SARS-CoV-2 is a new strain of coronavirus that has not been previously identified in humans. The 2019-Novel Coronavirus belongs to the genus β. It has a capsule, and its particles are round or oval, often polymorphous, with a diameter of 60-140nm. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV.
BIOCREDIT COVID-19 Ag is a rapid immunochromatographic test for in vitro qualitative detection of coronavirus SARS-CoV-2 antigen from nasopharyngeal samples.
Reagents and materials included:
- Each test device sealed in a foil pouch with a desiccant
- Assay diluent tubes
- Filter caps
- Sterilized swabs for nasopharyngeal specimen collection
- Instructions for use
Principle of the test:
BIOCREDIT COVID-19 Ag is a lateral flow immunochromatographic assay that adopted dual color system. The test contains colloid gold conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If COVID-19 antigen is present in the specimen, a visible black band appears on the test lines (T) as antibody-antigen-antibody gold conjugate complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly.
Results interpretation:
Performance characteristics:
- CE-IVD certificated