GOLDSITE SARS-COV-2 AG SELFTES

SARS-CoV-2 Antigen Kit Goldsite - Medical Device

In vitro rapid single-use visual reading immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid (N) antigen in human nasal swab specimens.
The results are for the antigen identification of the SARS-CoV-2 nucleocapsid protein. The antigen is usually detectable in nasal swabs during the acute phase of the infection.
The kit uses lateral flow immunoassay technology. To initiate the test, a self-collected nasal swab sample is placed in the extraction tube. The pre-filled solution in the tube interacts with the sample and facilitates the exposure of the appropriate viral antigens to the antibodies used in the test. The extracted sample is added to the sample well of the test cartridge.
If the extracted sample contains SARS-CoV-2 antigens, a red-pink line will appear in the test line region (T) and a red line will appear in the procedural control line region (C).
The absence of the test line (T) indicates that SARS-CoV-2 antigens are not detected, suggesting that SARS-CoV-2 is not present or is present at very low levels.
Positive results indicate the presence of viral antigens, but a correlation with patient history and other diagnostic information is required to determine the status of the infection. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease.
Negative results should be considered presumed and, if necessary, confirmation with a molecular test for patient management can be performed. Negative results do not rule out COVID-19 infection and should not be used as the sole basis for patient treatment or management decisions, including infection control decisions. Negative results should be considered in the context of recent patient exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19. People who test negative and continue to experience symptoms such as fever, cough, and / or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their doctor or healthcare provider.
The kit is intended for use by non-expert users (self-test) in a private setting to aid in the rapid diagnosis of COVID-19 infections. Children (at least 2 years old) under the age of 15 must be tested by an adult.
Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals heal patients and control the disease more efficiently and effectively.

How to use

Before starting the test, wash your hands with soap and water or use a hand sanitizer. Make sure they are dry before starting the test.
Allow kit to reach room temperature (15-30 ° C) prior to testing Open kit and identify kit components and instructions.

Sample collection
Open the swab package from the end of the swab. Take the swab and, as you rotate it, gently insert the tip of the swab up to 2 cm from the edge of the nostril. Rotate the swab 5 times against the nasal wall. Remove the swab from the nostril and repeat the same procedure in the other nostril, using the same swab.
Do not touch the tip of the swab when handling it.
Children (at least 2 years old) under the age of 15 and people who are unable to perform the test on their own, including the elderly and infirm, should be tested by another adult.

Format

Pack of 1 test.