The Orient Gene COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen in direct nasal swabs or nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

The COVID-19 Antigen Rapid Test Kit (Swab) is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests.

【TEST KIT COMPOSITION】

【TEST PROCEDURE】

[Specimen Collection]

• Inadequate specimen collection or improper specimen handling may yield a false result.
• Prior to collecting the nasal swab, the patient should be instructed to blow their nose.

Nasal Swabbing:

• Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected.

• Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities.

• Withdraw the swab from the nasal cavity.

Nasopharyngeal Swabbing:

• Tilt the patient’s head back. Insert the swab through the nostril that presents the most secretion under visual inspection.

• Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times.

• Leave the swab in place for several seconds then remove it from the nasopharynx.

[Specimen Preparation]

• Squeeze the buffer vial and add all the extraction buffer into the extraction tube, and put it on the workstation.

• Insert the swab into the extraction tube which contains buffer. Rotate the swab at least 10times while pressing the swab against the bottom and side of the extraction tube.

• Pinch the extraction tube with fingers and roll the swab head against the inside of the Extraction tube when you remove it to release as much liquid as possible. The extracted solution will be used as test specimen.

• Insert a dropper tip into the specimen extraction tube tightly.