SALIXIUM COVID-19 Rapid Antigen Test (Oral & Nasal Swab)
MDA Registered Reszon Diagnostics / MeDKAD

Made-in-Malaysia COVID-19 antigen self-test using oral + nasal swab samples. 15-minute result; sensitivity 91.23%, specificity 100%.

MDA Reg. No. IVDC5125422-99355
Regulatory ClassIVD Medical Device (MDA)

Product Overview

SALIXIUM is the first made-in-Malaysia COVID-19 rapid antigen self-test, using combined oral and nasal swab sampling to increase detection rate. Colloidal-gold immunochromatographic assay with a 15-minute result.

Unique Selling Points

  • Combined oral + nasal sampling increases detection rate
  • 15-minute result at home
  • Sensitivity 91.23%, specificity 100%
  • Made in Malaysia; selected for national COVID-19 programmes
  • Sterile disposable swabs and waste bag included

Directions for Use

  1. Do not eat, smoke, chew or drink (except plain water) for 30 minutes before testing.
  2. Wash hands thoroughly.
  3. Collect oral then nasal swab samples per the IFU.
  4. Insert the swab into the extraction buffer and apply drops to the device.
  5. Read the result at 15 minutes.

Specifications

<table> <tr><td>Target</td><td>SARS-CoV-2 antigen</td></tr> <tr><td>Method</td><td>Colloidal-gold immunochromatography</td></tr> <tr><td>Specimen</td><td>Oral & anterior nasal swab</td></tr> <tr><td>Sensitivity</td><td>91.23%</td></tr> <tr><td>Specificity</td><td>100%</td></tr> <tr><td>Result time</td><td>15 minutes</td></tr> <tr><td>Storage</td><td>Per IFU</td></tr> </table>

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