Intended use:

STANDARD Q COVID-19 Ag Nasal Test is a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present in human nasal specimen.

• Fast results within 15 mins
• Easy to use - in 3 rapid steps
• Specimen - Nasal swab
• All necessary reagents provided (individually packed)
• Highest accuracy - Sensitivity and Specificity

Test principle:

STANDARD Q COVID-19 Ag Nasal Test device has two pre-coated lines, “C” Control line, “T” Test line on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any specimens. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and mouse monoclonal anti-Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARSCoV-2 antibody conjugated with color particles are used as detectors for SARS-CoV-2 antigen device. During the test, SARS-CoV-2 antigen in the specimen interact with monoclonal anti-SARS-CoV-2 antibody conjugated with color particles making antigen-antibody color particle complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the mouse monoclonal anti-SARS-CoV-2 antibody. A colored test line would be visible in the result window if SARSCoV-2 antigens are present in the specimen. The intensity of colored test line will vary depending upon the amount of SARS-CoV-2 antigen present in the specimen. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line. The control line is used for procedural control, and should always appear if the test procedure is performed properly and the test reagents of the control line are working.

SAMPLING

Reagents and materials included:

• Test device (individually in a foil pouch with desiccant)
• Extraction buffer tube
• Nozzle cap
• Sterile nasal swab
• Buffer tube rack
• STANDARD COVID-19 Ag Positive Control swab
• STANDARD Respiratory Negative Control swab
• Instructions for use

Performance characteristics:

• Sensitivity 97.12%
• Specificity 100%
  

CE-IVD certificated