[INTENDED USE]
The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab, nasal swab or oropharyngeal 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 nasopharyngeal swab, nasal swab and oropharyngeal 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. The COVID-19 Antigen Rapid Test Cassette is intended for use by medical professionals or trained operators who are proficient in performing lateral flow tests, The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.
[SUMMARY]
The novel coronaviruses （SARS-CoV-2） belong to the ß 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 is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated 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-coated 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 in vitro diagnostic use only.
● For healthcare professionals and individuals trained in point of care settings.
● 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.
● Do not use this product after the expiration date.
● Please read all the information in this leaflet before performing the test
● 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
● The used test cassette should be discarded according to federal, state and local
regulations.
[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.
● The LOT and the expiration date were printed on the labeling.
[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 swab specimen or a swab in viral transport media(VTM) without denaturing agents. Use freshly collected direct swab specimens for best test performance.
Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection.
