For professional use

Description
The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in the nasopharyngeal swab and oropharyngeal swab of individuals suspected of having COVID-19.
The results concern the identification of the SARS-CoV-2 nucleocapsid antigen.
The antigen is usually detectable in the nasopharyngeal swab and oropharyngeal swab during the acute phase of the infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The detected agent may not be the primary cause of the disease.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including decisions about infection control. Negative results should be considered in the context of the patient's recent exposures, history, and presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a backassay as necessary for patient management.
The COVID-19 Antigen Rapid Test Cassette is intended for use by specifically trained clinical laboratory personnel instructed and trained in in vitro diagnostic procedures.
The COVID-19 Antigen Rapid Test Cassette is designed to detect nuclear capsid antigen from SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab of suspected COVID-19 patients.
During testing, a sample migrates upward by capillary action. SARS-CoV-2 antigens, if present in the sample, will bind to the antibody. The immune complex is then captured on the membrane by the SARS-CoV-2 nucleocapsid protein pre-coated monoclonal antibody and a visible colored line will appear in the test line region indicating a positive result.
In the absence of SARS-CoV-2 antigen, a colored line will not form in the test line region indicating a negative result.
To serve as a procedural control, a colored line will always appear in the control line region, indicating that the appropriate volume of specimen has been added and membrane passage has occurred.

How to use
1. Collection of samples :
Samples obtained early in symptom onset will contain the highest viral titers; samples obtained after five days of symptoms are more likely to produce negative results than an RT-PCR test.
Inadequate specimen collection, improper specimen handling and/or transportation may produce false negative results; therefore, skill in sample collection is highly recommended for generating accurate results.

Nasopharyngeal swab specimen: Insert a mini swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not up) until resistance is met or the distance is equivalent to that from the ear to the patient's nostril, indicating contact with the nasopharynx. The swab must reach a depth equal to the distance from the nostrils to the external opening of the ear. Gently rub and roll the swab. Leave the swab in place for several seconds to absorb secretions. Slowly remove the swab by twisting it. Samples can be collected from both sides using the same