COVID-19 Antigen Rapid Test Advantage

• This test is suitable for all people, regardless of age. It is a nonintrusive method and perfect for everybody.
• Result in 15 min
• Certificate: FDA, CE, BfArM, CIBG

Multiple sample types

Equivalence between NPS, OPS sample types was evaluated using inactivated COVID-19 virus spiked into negative samples (one to one, not pooled) to prepare artificial low positive (approximately 312 TCID₅₀/mL inactivated virus) and moderate positive (approximately 1248 TCID₅₀/mL inactivated virus) samples for each sample type. A total of 10 low positive samples, 11 moderate positive paired samples, and 21 negative paired samples were tested with the COVID-19 Antigen Rapid Testing Kit (Colloidal Gold). As shown in Table 2 below, all low positive and moderate positive paired samples were positive in both sample matrices. All negative paired samples were negative in both sample types.

Table 2. Sample type equivalence: nasopharyngeal swab vs oropharyngeal swab

Clinical performance

A total of 69 oropharyngeal swab specimens, including 35 negative and 34 positive samples, were evaluated with both the COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) and a comparator EUA RT-PCR assay (Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCRFluorescence Probing), purchased from the Sansure Bio Tech Inc. The COVID-19 antigen assays were positive in 32/34 confirmed PCR positive samples (94.12% positive agreement). The COVID-19 antigen was not detected in any of the confirmed PCR negative specimens (100% negative agreement). Results are summarized in the table below.

Sample type equivalence: nasopharyngeal swab vs oropharyngeal swab

Easy to use

1. Specimen: nasopharyngeal swab (NPS), oropharyngeal swab (OPS) and saliva specimens.
2. NPS and OPS collection:

• a. Add whole extraction buffer (~250 μl) into a tube for use.
• b. The disposable sterile cotton swab is inserted into the nasopharyngeal/oropharyngeal cavity and rotated rapidly and gently 5 times in bilateral pharyngeal tonsils and posterior pharyngeal wall to collect mucosal epidermis to avoid contact with oral and lingual mucosa.
• c. Put a specimen swab into a tube with the extraction buffer, fully stir 10 times, squeeze the swab head along the inner wall of the tube.
• d. Take out and discard the swab.

3. Saliva collection:

• a. Keep mouth clean for 3 minutes and stir the upper wall of the mouth with tongue.
• b. Open the device pouch to collect the saliva.
• c. Insert a spare cotton swab and sink the cotton ball into the saliva until the cotton ball is completely wet.
• d. Put the swab into a tube with the extraction buffer, fully stir 10 times, squeeze the swab head along the inner wall of the tube.
• e. Take out and discard the swab.

Specimen Testing

• Take a test device to room temperature and allow it sitting for a few minutes.
• Tear off the pouch at the notch.
• Take out the test device and microdropper.
• Place the test device horizontally on a clean workbench.
• Transfer 2 drops (about 60 μL) of specimen into the specimen (S) hole of the test device.
• Wait 15 minutes to record a test result. Do not record any result after 30 minutes.
• Discard the test device and disinfect the table.
• Report the result.

Interpretation of test result – Results available within 15 minutes!