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COVID-19 ⁄ Flu A&B Home Test QUICK REFERENCE INSTRUCTIONS
use under Emergency Use Authorization (EUA) only.
For in vitro diagnostic use.
For over-the-counter (OTC) use.
For use with anterior nasal swab specimens.
Carefully read all instructions before performing the test. Failure to follow the instructions may result in inaccurate test results. Refer to the Instruction for Use (IFU) for more complete information at https://wondfousa.com/.
An anterior nasal swab sample can be self-collected by individuals aged 14 years or older. Children aged 2-13 years should be tested by an adult.
Warnings and Precautions
Do not use the test if you have had symptoms for more than 4 days or no symptoms at all.
• Do not use if any of the test kit contents or packaging is damaged or open.
• When collecting a sample, only use the swab provided in the kit.
• All test components are single-use. Do not reuse the test cassette, processing solution, or swab.
• Testing should be performed in an area with good lighting.
• Do not open the test contents until ready for use. If the test
cassette is open for an hour or longer, invalid test results may occur.
• Do not use this test if you have been vaccinated with the FluMist/FluMist quadrivalent live intranasal influenza virus vaccine within the last two weeks.
• Do not conduct this test if prone to nose bleeds or have a nose injury.
• Do not use this test if you are using nasal corticosteroids.
• Do not use this test if you are using zinc-based throat sprays.
• Remove any piercings from nose before starting the test.
• Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.
| Chemical name | Harms (GHS Code) for each ingredient | Concentration |
|---|---|---|
| ProClin 300 |
Causes skin irritation (H315) Causes eye irritation (H320) |
0.05% |
- For the most up-to-date information on COVID-19, please visit: cdc.gov/COVID19.
MATERIALS PROVIDED
Materials required but not provided: Timer or watch.
PREPARING FOR THE TEST
NOTE: Do not open the test materials until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur.
1
Check the expiration date of the test printed on the bottom of the outer box.
2
Ensure all test components are at room temperature (15-30°C/59-86°F) before use.
3
WASH your hands with soap and water for 20 seconds or use hand sanitizer and dry them thoroughly.
4
LOCATE the tube holder on the box (look for the red circle on the kit's box).
5
a)
INSERT the buffer tube into the tube holder. Ensure that the buffer tube is stable and upright.
b) REMOVE the large cap from the buffer tube and set it aside for later use.
6
REMOVE test cassette from sealed pouch and lay it on a flat surface.
Note: If you are swabbing others, please wear a face mask. With children, the maximum depth of insertion into the nostril may be less than ½ to ¾ of an inch, and you may require another adult to hold the child’s head while swabbing.
Sample Collection
7
Remove the swab from the pouch.
- Be careful not to touch the swab tip (soft end) with your hand.
8
a) Carefully insert the swab no more than 3/4 inch (1.5 cm) into the nostril. Slowly rotate the swab at least 5 times against the nostril wall.
- Do not insert the swab any further if you feel any resistance.
b) Remove the swab and repeat in the other nostril using the same swab.
- Check: Did you swab BOTH nostrils?
Sample Collection
9
Immerse the swab into the buffer tube and swirl the swab in the buffer. Ensure the sample is mixed thoroughly by making at least 10 circles
- Sample must be adequately mixed into the buffer, otherwise, incorrect results may occur.
10
Leave the swab in the buffer tube for 1 minute. A timer is recommended for this step.
11
After 1 minute, PINCH the tip of the swab from the outside of the tube to remove any excess liquid from the swab. REMOVE and DISCARD the swab.
12
a) HOLD the buffer tube
upright and SCREW the
large cap back onto the
tube. Ensure a tight fit to
prevent leaking.
b) TWIST to open the small
cap at the top of the tube.
13
Invert the buffer tube and squeeze 4 drops of test sample into the sample well on the test cassette. Then discard the buffer tube.
- Note: Incorrect results may be observed if <4 drops of sample are added.
- Sample must be applied to the test cassette within one hour of completing step 8.
14
Start timer. Read results at 10 minutes.
- Do not interpret results before 10 minutes or after 20 minutes. Inaccurate test interpretations may occur.
INTERPRETING YOUR RESULTS
Look for lines next to ‘C’(Control), ‘F-A’, ‘F-B’ and ‘CoV’
C = Control Line
F-A = Flu A Test Line
F-B = Flu B Test Line
CoV = COVID-19 Test Line
A red line should always appear at the ‘C’ position; this is a control line and signals that the test is working properly.
INVALID RESULT
Check to see if a pink to red line is visible at the control line ‘C’ in the results window. If a line is not visible at “C”, even if any other line is visible in the results window, the result is considered invalid.
- If you do not see a C line, DO NOT CONTINUE reading the results. It means your test is invalid. Repeat the test with a new sample and new test kit materials.
NEGATIVE RESULT
If a control ‘C’ line is visable and you do not see a line at ‘F-A’ , ‘F-B’ or ‘CoV’ , it means the test is negative. The Flu A, Flu B or COVID-19 virus have not been detected.
To increase the chance that the negative result for COVID-19 in accurate, you should test again in 48 hours after the first day of testing.
If respiratory symptoms persist, you seek follow-up care with healthcare provider.
POSITIVE RESULT
If the control line at “C” is visible and any other line or multiple lines on ‘F-A’, ‘F-B’ and/or ‘CoV’ are visible, the test is positive for that virus.
NOTE: Any pink to red test line, no matter how faint, should be considered a positive result when the control line is also present.
Consult your healthcare provider to discuss your positive test result. Self-isolate at home per CDC recommendations to stop spreading virus to others.
SERIAL TESTING
Repeat Testing is needed for all samples that are negative for SARS-CoV-2 on the first day of testing, even if they are positive for influenza A and/or B. Repeat testing is needed to improve test accuracy for SARS-CoV-2. Please follow the table below when interpreting test results. Serial (repeat) testing does not need to be performed if patients have a positive SARS-CoV-2 result on the first day of testing.
Status on First Day of Testing: With Symptoms
| Day 0 (First Test) | Serial Testing? | Day 2 (Second Test) | Interpretation |
|---|---|---|---|
| SARS-CoV-2 (+), Influenza A and B (-) | NO | Not needed | Positive for COVID-19, Presumptive negative for Influenza |
| SARS-CoV-2 (+), Influenza A and/or B (+) | NO | Not needed | Positive for COVID-19, Positive for Influenza A and/or B |
| SARS-CoV-2 (-), Influenza A and/or B (-) | YES | SARS-CoV-2 (+), Influenza A and/or B (-) | Positive for COVID-19, Presumptive Negative for Influenza |
| SARS-CoV-2 (-), Influenza A and/or B (+) | YES | SARS-CoV-2 (+), Influenza A and/or B (+) | Positive for COVID-19, Positive for Influenza A and/or B |
| SARS-CoV-2 (-), Influenza A and/or B (-) | YES | SARS-CoV-2 (-), Influenza A and/or B (+) | Presumptive Negative for COVID-19, Positive for Influenza A and/or B |
| SARS-CoV-2 (-), Influenza A and/or B (-) | YES | SARS-CoV-2 (-), Influenza A and/or B (-) | Presumptive Negative for COVID-19, Presumptive Negative for Influenza |
| SARS-CoV-2 (-), Influenza A and/or B (+) | YES | SARS-CoV-2 (+), Influenza A and/or B (+) | Positive for COVID-19, Positive for Influenza A and/or B |
UNDERSTANDING YOUR RESULTS
Invalid Result: The test could not tell whether or not you have COVID-19, influenza A (Flu A), or influenza B (Flu B). The test needs to be repeated with a new kit and sample.
Negative Result: The virus from COVID-19, Flu A, and/or Flu B were not detected in the sample. A negative result does not mean it is certain that you do not have COVID-19, Flu A and/or Flu B infection. There is a higher chance of false negative results with antigen tests compared to laboratory-based molecular tests. If you tested negative and continue to experience COVID-19, Flu A and/or Flu B-like symptoms, you should seek follow-up care with your healthcare provider. All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary. Negative results do not rule out SARS-CoV-2, Flu A, and/or Flu B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
Positive Result: The SARS-CoV-2, Flu A and/or Flu B virus(es) were detected in your sample. It is very likely that you have the respective infection(s) and are contagious. Please contact your healthcare provider or your local health authorities and follow local guidelines for self-isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive). 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.
RESULTS REPORTING
Report your test result(s) at MakeMyTestCount.Org–this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions.
INTENDED USE
The WELLlife™ COVID-19 / Flu A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare providers.
Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
Storage and Stability
- Store the test kit between 36-86°F (2-30°C) in a place out of direct
- Reagents and devices must be used at room temperature (59-86°F/15-30°C).
- The unsealed cassette is valid for 1 It is recommended to use the test kit immediately after opening. The expiration date is on the package. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
- Read the instructions fully and carefully before performing the procedure. Failure to follow the instructions may result in inaccurate test results.
- In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- Serial testing should be performed in individuals with SARS-CoV-2 negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
- Consistent with serial testing recommendations for SARS-CoV-2, for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.
- An anterior nasal swab sample can be self-collected by individuals aged 14 years and older. Children aged 2 to 13 years should be tested by an adult.
- Do not use on anyone under 2 years of age.
- Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
- This test may only be used in symptomatic individuals.
- Do not use if any of the test kit contents or packaging is damaged or open.
- Test components are single-use. Do not re-use the test strip, buffer liquid, or swab.
- If any liquid spills from the buffer tube, discard test components and re-start test using new test components.
- Do not read test results before 10 minutes or after 20 minutes. Results read before 10 minutes or after 20 minutes may lead to a false positive, false negative, or invalid result.
- If uncertain how to proceed, contact Technical Assistance at 1-888-444-3657.
- Do not touch swab tip when handling the swab.
- To ensure accurate test results, avoid contamination with liquid gel hand soap, hand sanitizer cream lotion, and fast-drying 80% ethanol hand sanitizer.
- Do not open the test contents until ready for use. If the test cassette is open for an hour or longer, false test results may occur.
- Testing should be performed in an area with good lighting.
- Do not use the test kit after its expiration date.
- Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water. If irritation persists, seek medical advice:
https://www.poisonhelp.org or 1-800-222-1222.
Chemical Information
| Chemical Name | Harms (GHS Code) | Concentration |
|---|---|---|
| ProClin 300 |
Causes skin irritation (H315) Causes eye irritation (H320) |
0.05% |
- For more information on EUAs, please visit:
FDA Emergency Use Authorization. - For the most up-to-date information on COVID-19, please visit:
CDC COVID-19.
LIMITATIONS
- The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between December 2023 and March 2024. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
- A negative test result may occur if the level of antigen in the sample is below the detection limit of the test or if the sample is collected or handled improperly.
- There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 and influenza as compared to a molecular test, especially in samples with low viral load.
- False positive test results are more likely when the prevalence of SARS-CoV-2, influenza A, and/or influenza B is low in the
- Persons with risk factors for severe disease from respiratory pathogens (e.g., young children, elderly individuals, chronic lung disease, heart disease, compromised immune system, diabetes, and other conditions) should contact a healthcare provider; users should also contact a healthcare provider if symptoms persist or worsen.
- This test is read Because test lines can be very faint, users with conditions affecting their vision- such as far-sightedness, glaucoma, or color blindness-are encouraged to seek assistance to interpret results accurately (e.g., reading glasses, additional light source, or another person). This test has not been validated for use by those with color-impaired vision.
- This device is a qualitative test and cannot provide information on the amount of virus present in the specimen.
- This test detects both viable (live) and non-viable influenza A, influenza B, and SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the sample and may or may not correlate with viral culture results performed on the
- Hand soap and hand sanitizers may cause false negative results with this test.
- FluMist/FluMist quadrivalent live intranasal influenza virus vaccine may cause false positive influenza A and B results with this
- Zinc-based throat sprays may cause false positive influenza A results with this test.
- Nasal corticosteroids may cause false negative results with this test.
- This test does not distinguish between SARS-CoV and SARS-CoV-2.
FREQUENTLY ASKED QUESTIONS
A: Potential risks include:
- Possible discomfort during sample collection.
- Possible incorrect test result (see Warnings and Result Interpretation sections for more information).
Potential benefits include:
- The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.
- The results of this test may help limit the spread of COVID-19 and flu to the family of the tested individual and others in your community.
A: There are different kinds of tests for the viruses that cause COVID-19 and the flu. Molecular tests detect genetic material from the virus. Antigen tests, such as the WELLlife™ COVID-19 / Influenza A&B Home Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.
A: A positive result means that it is very likely you have COVID-19 or influenza because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result.
A: A negative test result indicates that antigens from the virus that causes COVID-19 or influenza were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you have a negative result, it does not rule out SARS-CoV-2 or influenza infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take.
A: Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at: https://wondfousa.com/.
A: An invalid result means something with the test did not work properly. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.
A : If uncertain how to proceed, contact Technical Assistance at +1 (888) 444-3657 (9:00 a.m. to 5:30 p.m. CDT M-F) or
IMPORTANT: Do not use this test as the only guide to manage your illness. Consult your healthcare provider if your symptoms persist or become more severe. Individuals should provide all results obtained with this product to their healthcare provider.
INDEX OF SYMBOLS
Do not re-use
Use-by date (Expiration date)
Keep dry
Batch code
Consult instructions for use
Keep away from sunlight
Store at 36~86°F/2~30°C
Manufacturer
Catalogue number
Do not use if package is damaged
In Vitro diagnostic medical device
SUPPORT
If you have questions regarding the use of this product, or if you want to report a problem with the test, please contact Wondfo Product Support at +1 (888) 444-3657 (9:00 a.m. to 5:30 p.m. CDT M-F) or Wondfo USA Co., Ltd. Product Support website: https://wondfousa.com/.
Wondfo USA Co., Ltd.
6720 Cobra Way,
San Diego,
CA 92121 Made in China
