SARS-CoV-2 Virus Antigen Testing Kit

FDA Registered

EU CE Marking

The SARS-CoV-2 Viral antigen Testing Kit is based on Lateral Flow Detection (LFD) intended for in-vitro qualitative detection of the SARS-CoV-2 virus antigen nucleocapsid (N) from nasal swab, oropharyngeal swab, or nasopharyngeal swab samples.

 

Benefits of the SARS-CoV-2 Virus Antigen Testing Kit:

  • Accurate

  • Low costs

  • CE mark in conformity with In-Vitro Diagnostic Devices Directive 98/79/EC

  • Quick (15 minutes) and convenient

Storage:

1.Store at 2~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.

2.The test cassette should be used within 1 hour after taking out from the foil pouch. Sample diluent should be re-capped immediately after use.

3.Keep away from sunlight, moisture, and heat.

4. Use before the expiration date.

Procedure:

 

Nasal swab specimen

1. Take out the nasal swab provided. Tilt the head of the patient back to the angle of 70°and gently insert the nasal swab into the nostril.

2. Gently rotate and push the swab until resistance is met at the level of the turbinate. Gently rotate the swab against the nasal wall a few times.

3. Samples should be tested immediately after collection. If immediate testing is not possible, the swab should be placed in a dry, sterile plastic tube (not provided) and stored at 2ºC-8ºC for up to 8 hours.

 

Oropharyngeal swab specimen

Let the patient’s head tilt slightly, and expose the pharyngeal tonsils.

1. Hold the swab and wipe the pharyngeal tonsils on both sides of the patient with a little force back and forth at least 3 times. Then wipe up and down the Posterior pharyngeal wall at least 3 times

2. Samples should be tested immediately after collection.  If immediate testing is not possible, the swab should be placed in a dry, sterile plastic tube (not provided) and stored at 2ºC-8ºC for up to 8 hours.

 

Nasopharyngeal swab specimen

1. Carefully insert the swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.

2. Swab over the surface of the posterior nasopharynx. Rotate the swab several times.

3. Samples should tested immediately after collection. If immediate testing is not possible, the swab should be placed in a dry, sterile plastic tube (not provided) and stored at 2ºC-8ºC for up to 8 hours

 

 

 

 

 

 

 

 

Allow the test device, specimen, and extraction buffer to equilibrate to room temperature (10°C ~30°C) before testing.

1.Use an extraction tube (provided) for each specimen to be tested and label each tube appropriately.

2.Peel off the seal of the extraction tube

3.Place the specimen swab in the tube and swirl the swab for 10 times while pressing the swab head against the inside of the tube to release the specimen in the swab.

4.Remove the swab while squeezing the swab head against the inside of the collection tube as you remove it to expunge as much liquid as possible from the swab. Discard the swab. Cap the tube and mix contents by gently swirling. The extraction specimen must be tested immediately.

5.Remove the test device from its sealed foil pouch by tearing at the notch. Dispense 3-4 drops (about 100μl) of extraction specimen from the extraction tube into the sample well of the test device by inverting and squeezing the tube as shown.

6.Read the test results after 15 minutes. Do not read test results after 30 minutes.

 

 

 

 

 

 

 

 

 

 

Positive Result

Colored bands appear at both test line (T) and control line (C). It indicates a positive result for the novel coronavirus Antigen in the specimen.

Negative Result

The colored band appears at the control line (C) only.  It indicates that the concentration of the novel coronavirus Antigen is zero or below the detection limit of the test.

Invalid results

No colored band appears at the control line (C). Whatever colored bands appear at test line (T), the test results will be invalid