The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the fifirst ten days of symptom onset. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confifirmation with a molecular assay, if necessary, for patient management, may be performed. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
|Time to result||15 minutes|
|Shelf life||24 months|
|Specimen type||Nasopharyngeal swab|
• 20 Test cassettes
• 20 Sterile swabs
• 20 Extraction tubes and tips
• 2 Extraction buffer vials
• 1 Workstation
• 1 Package insert
Test Procedure & Interpretation
1. Specimen collection
Use the nasopharyngeal swab provided in the kit.
1. Carefully insert the swab in the patient’s nostril.
2. Swab over the surface of the posterior nasopharynx and rotate the swab several times.
3. Withdraw the swab from the nasal cavity.
2. Sample preparation
1. Insert the test extraction tube into the workstation provided in the kit. Make sure that the tube is standing upright and reaches the bottom of the workstation.
2. Add 300 µL (about 10 drops) of the extraction buffer into the extraction tube.
3. Insert the swab into the extraction tube which contains 300µL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
4. Leave the swab in the extraction tube for 1 minute.
5. Squeeze the tube several times from the outside to immerse the swab. Remove the swab.
6. Push the tip which contains the fifilter onto the extraction tube. Ensure the tip has a tight fifit.
3. Test procedure & interpretation of results