INTENDED USE

The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigensin nasopharyngeal swab and 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 and oropharyngeal swab during the acute phase of infection. Positive results indicate thepresence 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 trained clinical laboratory personnel specifically instructed and trained in vitro

diagnostic procedures.

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

COVID-19 Antigen Rapid Test Cassette is an immunoassay based on the principle of the double antibody-sandwich technique. The COVID-19

Antigen Rapid Test Cassette is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab,

from patients who are suspected of COVID-19 by their healthcare provider.

During testing, a specimen migrates upward by capillary action. The SARS-CoV-2 antigens if present in the specimen will bind to the antibody

conjugates. The immune complex is then captured on the membrane by the pre-coated SARS-Co-2 nuclenocapsid protein monoclonal antibody, and a visible colored line will show up in the test line region indicating a positive result. In the absence of SARS-CoV-2 antigens, a colored line will not form in the test line region indicating a negative result.

To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been

added and membrane wicking has occurred.

WARNINGS AND PRECAUTIONS

 For in vitro diagnostic use only.

 For healthcare professionals and professionals at point of care sites.

 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 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.

COMPOSITION

The test cassette contains a membrane strip coated with anti-SARS-CoV-2 nuclenocapsid protein monoclonal antibody on the T test line, and a dye pad which contains colloidal gold coupled with SARS-CoV-2 nuclenocapsid protein monoclonal antibody.

The quantity of tests was printed on the labeling.

Materials Provided

 Test Cassette  Extraction Tube

 Sterilized Swab  Dropper Tip

 Extraction Reagent  Work Station

 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.

 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 a falsely negative result; therefore, training in specimen

collection is highly recommended due to the importance of specimen quality for generating accurate test results.

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Rebecca Yan