Description
This SARS-CoV-2 Antigen Test Kit (Colloidal Gold) is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigen in oropharyngeal, nasal and nasopharyngeal swabs performed on individuals suspected of having COVID -19, according to the evaluation of health professionals. The results are aimed at the detection of the SARS-CoV-2 antigen. The antigen is generally detectable in oropharyngeal and nasopharyngeal swabs performed during the acute phase of infection. A positive result indicates the presence of antigenivirals, but correlation to the patient's medical history and other diagnostic information should also be evaluated to establish the status of infection. A positive result does not rule out the presence of bacterial infections or co-infections with other viruses. The agent detected may not be the actual cause of the disease. A negative result does not rule out SARS-CoV-2 infection and should not be used as the sole basis for making patient management or treatment decisions, including infection control decisions. The negative result should be evaluated in the context of the patient's recent exposure, his history and the presence of clinical signs and symptoms consistent with those of COVID-19; it should also be confirmed with a molecular test, if necessary, for patient management. The Antigen Test Kit for SARS-CoV-2 (Colloidal Gold) is intended for use by medical professionals or trained operators trained in performing lateral flow testing. For professional use only. For in vitro diagnostic use only.
A lateral flow immunoassay is used. Briefly, the SARS-CoV-2 antigen in the sample binds the colloidal gold-labeled anti-SARS-CoV-2 antibodies in the test strip to form immune complexes. When complexes migrate to the T line (coated with anti-SARS-CoV-2 antibodies), those containing the SARS-CoV-2 antigen are captured. Similarly, colloidal gold-labeled dipoll IgY antibody is captured in the control line (coated with goat anti-chicken IgY). Complexes containing the SARS-CoV-2 antigen will produce a colored line at the T line, which indicates that the sample is positive for the SARS-CoV-2 antigen. Similarly, a colored line will also appear in correspondence with the control line, confirming the correctness of the operating procedure and the reliability of the results. A negative sample will produce a single line at the control line, which indicates that no SARS-CoV-2 antigen was detected.
Sensitivity: 90%
Specificity: 99.2%
Overall percentage agreement: 98.4%
LoD: 8x10 ² TCID ₅₀ / ml

How to use
Sample collection
1. Oropharyngeal, nasal and nasopharyngeal swab samples are acceptable for testing with this kit.
2. Collection of the oropharyngeal specimen: insert the swab in the posterior part of the pharynx and in the tonsillar area. Rub the swab on both pillars of the tonsils and in the posterior oropharyngeal part, avoiding contact with the tongue, teeth and gums.
3. Nasal Sample Collection: Insert the swab into one nostril by twisting it gently. The tip of the swab should be inserted to a depth of 2.5cm starting from the opening of the nostril. Rotate the swab 5 times against the nasal wall. Remove and repeat the process with the same swab in the other nostril.
4. Nasopharyngeal specimen collection: insert the swab into the nostrils perpendicular to