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 Class | IVD Medical Device (MDA) |
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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
- Do not eat, smoke, chew or drink (except plain water) for 30 minutes before testing.
- Wash hands thoroughly.
- Collect oral then nasal swab samples per the IFU.
- Insert the swab into the extraction buffer and apply drops to the device.
- Read the result at 15 minutes.
Specifications
| Target | SARS-CoV-2 antigen |
| Method | Colloidal-gold immunochromatography |
| Specimen | Oral & anterior nasal swab |
| Sensitivity | 91.23% |
| Specificity | 100% |
| Result time | 15 minutes |
| Storage | Per IFU |
