INTENDED USE

The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocap- sid antigens in nasal swab from individuals who are suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasal swab during the acute phase of infection. Positive 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 bacterial infection or  co-infection  with  other  viruses.  The   agent   detected   may   not   be the definite cause of 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 infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular  assay, if necessary for patient management. This kit are for home use by laymen in a non-laboratory setting(such as person’s home or certain non-traditional sites such as offices,sporting events, schools etc.). The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patients clinical manifestations and other laboratory tests.

SUMMARY

The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

PRINCIPLE

The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugat- ed with color microparticles is used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interacts with SARS-CoV-2 antibody conjugated with color microparticles making antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coat- ed SARS-CoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.

WARNINGS AND PRECAUTIONS

•For Self testing in vitro diagnostic use only.This tset cassette is for one-time use and cannot be reused or used by multiple people.

•Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

•Please read all the information in this leaflet before performing the test.

•Do not use this product after the expiration date.

•The test cassette should remain in the sealed pouch until use.

•All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

•Test for children and young people should be used with an adult.

•The used test cassette should be discarded according to federal, state and local regulations.

•Do not use the test on children under 2 years old.

•Small children should be swabbed with the help of a second adult.

•Wash hands thoroughly before and after handling.

COMPOSITION

Materials Provided

•Test Cassettes: each cassette with desiccant in individual foil pouch

•Prepackaged Extraction Reagents:

•Sterilized Swabs: single use sterile swab for specimen collection

•Package Insert

Materials Required but not Provided

•Timer

STORAGE AND STABILITY

•Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The  kit  is  stable  within  the  expiration date printed on the labeling.

•Once open the pouch, the test should be used within one hour. Prolonged exposure  to  hot  and  humid  environment  will  cause  product deterioration.

•DO NOT FREEZE.

SPECIMEN

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results. Acceptable specimen type for testing is a direct nasal swab specimen obtained by the dual nares collection method. Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection.

Nasal Swab Specimen Collection