Description
A lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, nasal or oropharyngeal swabs from individuals suspected of having COVID-19 by the healthcare professional.
The purpose is to detect the nucleocapsid antigen of SARS-CoV-2. The antigen is usually detectable in nasopharyngeal, nasal and oropharyngeal swabs in the acute phase of the infection.
It is a lateral immunoassay based on the principle of the double antibody sandwich technique. The SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and is sprayed on the conjugation pad.
During testing, the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody conjugated to colored microparticles making the antigen-antibody complex a labeled complex. This complex migrates by capillary action across the membrane to the test line, where it will be captured by the pre-coated SARS-CoV-2 nucleocapsid protein monoclonal antibody.
A colored test line (T) will be visible in the result window if SARS-CoV-2 antigens are present in the sample.
A missing T-line indicates a negative result.
The control line (C) is used for procedural control, and should be displayed if the test procedure is performed correctly.
Positive test 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 the presence of infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease.
Negative results do not rule out the presence of SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection management decisions. Negative results should be considered in the context of recent exposures, a patient's medical history, and the presence of typical clinical signs and symptoms of COVID-19, and are confirmed by molecular testing, if needed for patient management.
The kit is intended for use by healthcare professionals or personnel qualified to perform lateral flow tests.

How to use
1. Collection of samples
Samples obtained at the onset of symptoms will contain the highest viral levels; samples obtained 5 days after the onset of symptoms will most likely give negative results with respect to an RT-PCR assay.
Inadequate specimen collection, improper specimen handling and/or transportation may give false results; therefore, training in sample collection is highly recommended due to the importance of sample quality in obtaining accurate test results.
The acceptable specimen type for testing is a direct swab or viral transport medium (VTM) swab specimen without denaturing agents.
Prepare the Extraction Reagent tube according to the test procedure and use the sterile swab provided in the specimen collection kit.

Nasopharyngeal swab specimen: Remove the swab from its packaging. Lower your head back to about a 70° angle. Slowly insert the swab into the nostril parallel to the palate (not straight up) until resistance is met or at the distance