It is an immuno-chromatographic assay that applies the antigen-antibody binding specificity to detect nucleocapsid protein from SARS-CoV-2.
The test strip is composed of a sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains colloidal-gold conjugated with a specific monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid (N) protein of SARS-CoV-2. The whole strip is fixed inside a plastic device.
When the sample is loaded into the sample well, conjugates precoated in the reagent pad are dissolved and migrate along the test strip. If SARS-CoV-2 antigen is present in the sample, the immunocomplex formed by viral N protein and conjugates will be captured by the specific anti-SARS-CoV-2 monoclonal antibody coated on the test line region (T). Absence of the T line suggests a negative result. The control line region (C) indicates that the proper volume of sample has been added and the test has completed correctly.
The test strip is compatible with multiple sample types, including Nasopharyngeal, Sputum, Oropharyngeal, and Nasal. The different samples are accommodated via different sampling accessories.
This is a consumable assay kit, validated, supplied and supported by DiagCor.
|Configuration||1 test/pouch, 25 tests/box|
|Analytical sensitivity||≥ 95.1%|
|Reported results||SARS-CoV-2 positive or negative|