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
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
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
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
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
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
) 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.