Wondfo 2019-nCoV Rapid Antigen Test (Lateral Flow Method) 20 tests

Wondfo 2019-nCoV Rapid Antigen Test (Lateral Flow Method) 20 tests

Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen extracted from the nasopharyngeal swab or oropharyngeal swab specimen.

The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

The test provides preliminary test results. Negative results cannot exclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.

The novel coronaviruses 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

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) 20 tests

Materials Provided
1. 20 Individual sealed pouches, each pouch contains:
1 x Test cassette
1 x Desiccant pouch
2. 20 Sample extraction tube
3. 20 Dripper
4. Extraction buffer (2*6 mL)
5. Instructions for use
6.Nasopharyngeal swab or oropharyngeal swab

TEST PROCEDURE

Please read the instructions for use carefully before performing the test.
1. Nasopharyngeal or oropharyngeal swab specimen extraction
1) Transfer 400 μL (about 10 drops) extraction buffer to the sample extraction tube vertically.
2) Insert the swab which has collected secretions into the specimen extraction buffer and rotate about 10 times to dissolve the specimen in the solution as much as possible.
3) Squeeze the swab tip to keep the liquid in the tube as much as possible.
4) Cover the dripper.
2. Test procedure
1) Remove a test cassette from the foiled pouch by tearing at the notch and place it on a level surface.
2) Add 80 μL (about 3~4 drops) processed specimen to the sample well.
3) As the test begins to work, you will see purple color move across the result window in the center of the test device.
4) Wait for 15~20 minutes and read the results. Do not read results after 30 minutes

LIMITATIONS OF PROCEDURE
1. This reagent is designed to detect SARS-CoV-2 antigen in human nasopharyngeal or oropharyngeal swab specimen.
2. The accuracy of the test depends on the sample collection process. Improper sample collection, improper sample storage, or repeated freezing and thawing of the sample will affect the test result.
3. This reagent is a qualitative assay. It is not designed to determine the quantitative concentration of SARS-CoV-2 antigen. If you need to test the quantitative concentration, please use the relevant professional instruments.
4. The test results of this reagent are for clinical reference only and should not be used as the sole basis clinical diagnosis and treatment. The clinical management of patients should be comprehensively considered based on their symptoms / signs, medical history, other laboratory examinations and treatment response.
5. Limited by the method of antigen test reagents, for negative test results, it is recommended to use nucleic acid detection or virus culture identification methods for review and confirmation.
6. Positive test results do not rule out co-infections with other pathogens. A negative result of this reagent can be caused by

1) improper sample collection, improper sample transfer or handing, the virus titer in the sample is too low;
2) the level of SARS-CoV-2 antigen is below the detection limit of the test.
3) variations in viral genes may cause changes in antibodies determinants.

For in vitro diagnostic use only. For professional use only.