Description
Lateral flow immunotest for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, nasal or oropharyngeal swabs from subjects suspected of COVID-19 by the healthcare professional.
The purpose of the test is to detect the SARS-CoV-2 nucleocapsid antigen. Antigen is typically detectable in nasopharyngeal, nasal and oropharyngeal swab in the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation to patient history and other diagnostic information is necessary to determine the status of the infection. Positive results do not rule out the presence of infection or co-infection with other viruses. The agent detected may not be the ultimate cause of the disease.
Negative results do not exclude 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 findings should be considered in the context of recent exposures, a patient's history, and the presence of clinical signs and symptoms typical of COVID-19, and are confirmed with a molecular analysis, if necessary for patient management.
It is an 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 onto the conjugation pad.
During testing, the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody conjugated with colored microparticles making the antigen-antibody a labeled complex. This complex migrates by capillary action on 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.
The lack of a 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.
The test is intended for use by professionals and clinical laboratory personnel trained and specifically instructed in in vitro diagnostic procedures.

How to use
1. Collection of samples
Nasopharyngeal swab: Remove the swab from the packaging. Have the patient tilt the head back to an angle of approximately 70 °. Insert the swab into the nostril parallel to the palate (not upwards) until resistance is met or at a distance that is equivalent to that from the ear to the patient's nostril, indicating contact with the nasopharynx. Gently wipe and swirl the swab. Do not move the tampon from that position for a few seconds so that the secretions can be absorbed. Slowly remove the swab, rotating it at the same time. Samples can be taken from both sides using the same swab. It is not necessary to take samples from both nostrils if the tip of the swab is saturated with fluid from the first collection. If a deviated septum or obstruction of any kind makes it difficult to get the sample from one nostril, use the same swab to take the sample from the other nostril.

Nasal swab: with a slight rotation, insert the swab approximately 2.5 cm into the anarchy until the resistance of the turbinates is met. Rotate the pad several times against