Salixium Covid-19 Rapid Antigen Test Kit for Self-Testing (Oral + Nasal Swab Samples) - MDA Approved

Salixium Covid-19 Rapid Antigen Test Kit for Self-Testing
Product Registration No.: IVDC5125422-99355

The Salixium Covid-19 Rapid Antigen Test is a colloidal gold immunochromatographic assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human oral and nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection.

The Salixium Covid-19 Rapid Antigen Test is intended for home self-testing. Get your results at ease within 15 minutes from the comfort of your home or any premise of your choice.

Product Features:

• Sensitivity: 97.24%
• Specificity: 100%
• Test time: 15 minutes
• Storage condition: 4 – 30 °C
• Sample type: Oral and anterior nasal swab specimen
• Tested by Halvec Laboratories, free from alcohol and animal DNA
• No pain - Less invasive sample collection method (oral & nasal swab)
• Disposable swabs for oral and nasal are included in individual sterile packing to minimize cross contamination

Directions for Use:

• Do not eat, smoke, chew or drink any beverages (apart from plain water) for at least 30 minutes before collection.
• Take out the extraction buffer tube, press and insert into the designated tube holder (dotted circle) on the box. Peel off the aluminium seal (Be careful not to pour out the liquid).
• Remove one disposable swab (swab 1) from the sterile packaging. Avoid touching any surface or object. Do not touch the fabric tip of the swab.
• Swab the fabric tip on inside of your left cheek (between the cheek and the gum) by rubbing up and down for at least 5 times. Avoid tongue, teeth and gums.
• Repeat step above on the right cheek using the same swab.
• Using the same swab, swab the palate for 5 times.
• Put swab 1 into extraction tube containing buffer.
• Remove another disposable swab (swab 2) from the sterile packaging. Avoid touching any surface or object. Do not touch the fabric tip of the swab.
• Insert only fabric tip of the swab gently into 1 nostril until you feel a slight resistance (approximately 2cm up your nose). Roll the swab around the inside of the nostril, making 5 complete circles. Do not insert the swab too deep inside the nose.
• Repeat step above with the other nostril. (This step can be a little uncomfortable but it should not be painful).
• Put swab 2 into the same extraction tube.
• Immerse the swab heads in the extraction buffer completely; vigorously mix at least 10 times.
• Squeeze liquid from both swabs to keep the solution in the tube as much as possible and then discard the swabs.
• Dispose the used swabs in the biohazard waste bag provided and seal the zipper completely.
• Cover the tube with dripper head firmly, tap the tube and mix the sample solution thoroughly.
• Testing should be performed immediately after the specimen has been collected. Do not expose the specimen at room temperature for prolonged period. Samples are stable up to 30 mins when kept in the extraction buffer provided with the test kit.
• Gently tear open the pouch and remove the test cassette.
• Lay the cassette on a clean, flat work surface. Label the test cassette with sample name.
• Add 2 drops of the sample solution to the sample well. Make sure there is no air bubble. Sample will start wicking up the membrane.
• Read results within 10-15 minutes. Do not interpret the results after 15 minutes. Not following this procedure can lead to inaccurate results.

Contents:
1. Test Device
2. Extraction buffer and dripper
3. Disposable swabs
4. Biohazard waste bag
5. Instruction for use