COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) [CE-IVD]
(CE Marking: NL-CA002-2021-59065)
REAGENTS AND MATERIALS
- COVID-19 Ag strip (20 tests/kit): One aluminum pouch with a strip
- Sample lysis buffer (10 mL): Phosphate solution buffered to pH 7.4 containing NaN3 (<0.1%), a detergent, and blocking proteins
- Extraction Tubes (20 tubes): The tubes and nozzle cap come in a zip-locked plastic bag
- Swabs (20 nasopharyngeal swabs): Individually pouched flocked swabs
- Transfer Pipet (20 transfer pipet): Individually pouched plastic transfer pipet
COVID-19 Ag Detection Kit is an in vitro rapid test for the detection of SARS-CoV-2 antigen in nasopharyngeal or throat secretions, or other clinal samples.
For professional use only
The spread of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has caused a worldwide COVID-19 pandemic. Due to the lack of a vaccine and specific treatment, rapid identification and isolation of COVID-19 patients and asymptomatic carriers is the main strategy to contain this pandemic.
Nucleocapsid protein (NP) is the most abundant protein of SARS-CoV-2, and the detection of NP can be used for the confirmation of SARS-CoV-2 infection.
This assay is based on the specific antibody-antigen reaction with colloidal gold immunochromatography. A monoclonal antibody against SARS-CoV-2 NP conjugated with colloidal gold particles is pre-coated on the conjugation pad. Another monoclonal antibody against SARS-CoV-2 NP is immobilized on the membrane.
During testing, SARS-CoV2 NP present in the samples bind to the monoclonal antibody conjugated colloidal gold. The complex migrates upward by the capillary effect and is captured by the anti-SARS-CoV-2 NP monoclonal antibodies immobilized on the membrane forming a test line (T). The remaining conjugate continues to migrate until it binds to a control reagent and forms a control line (C). The result is visible within 15 minutes.
- The kit needs to be stored at 4 °C ~30 °C and in a dry environment.
- Avoiding freezing strips and buffer.
- The test strip is stable until the expiry date only if it has not been opened and kept in the sealed aluminum pouch.
- Production date and expiration date are shown in the package label.
- Do not open the sealed pouch untill use. Once opened, the strip should be used within 1 hour.